Docstoc

Compilation of Policies

Document Sample
Compilation of Policies Powered By Docstoc
					                                                   PRINCIPAL INVESTIGATOR ELIGIBILITY
                                                               August 2007
                                                               Policy 1.2.01

Policy:

Faculty and emeritus faculty of the University of Kansas Medical Center (KUMC) and The University of Kansas – Lawrence may be named by
the Vice Chancellor for Research to serve as Principal Investigator (PI) or Project Director (PD) on all extramurally funded projects.

Purpose:

Research is an integral component of the University of Kansas Medical Center’s mission and a portion of all faculty responsibility. As such, PIs
and co-PIs are required to be faculty of the University with all of the privileges and obligations associated with such an appointment. The
University of Kansas Medical Center Research Institute (KUMCRI) manages all funded research and extramurally funded programs, and
monitors compliance with this requirement.

Directors, Research Associates, and Unclassified Professional Staff may be named as Principal Investigator with the approval by the
appropriate chair, dean, and Vice Chancellor for Research or other designee.

Nonresident alien individuals employed by KUMC who meet the criteria may serve as PI or key personnel on a research project as long as
1). The funding agency does not have a citizenship requirement; and 2). The individual possesses, or is in the process of renewing, a visa that
will allow him or her to remain in the United States long enough to be productive on the project.

Faculty not employed by KUMC may apply for a Courtesy Research Faculty Appointment:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/courtesy_research_faculty_appointment_policy.htm


Procedures:

Institutional approval - signature approvals at the department, school, and administrative levels - must be obtained prior to the submission of
the proposal to the funding agency. See the Signature Approvals Process Procedure 1.2.01.

Definitions:

Principal Investigator (PI) or Project Director (PD): All faculty may serve (exercise the privilege of being named) as a PI or project director on
proposals submitted for external support. Unclassified professional staff may qualify to serve as PI; however, justification to designate a person
other than a faculty member as principal investigator must be approved by the appropriate chair, dean, and Vice Chancellor for Research or
other designee prior to submission of a proposal for external funding. The PI is responsible for compliance with all the specific requirements of
both the sponsoring agency and KUMC. In all cases, institutional approval must be obtained prior to the submission of the application to the
funding agency. In accordance with NIH guidelines, multiple KUMC faculty members may be designated as co-PIs who share the authority
and responsibility for leading and directing the projects, intellectually and logistically. Each faculty co-PI is responsible and accountable to the
applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the
submission of all required reports. The presence of more than one identified faculty PI or co-PIs on an application or award diminishes neither
the responsibility nor the accountability of any individual PI.

Research: Including, but not limited to, investigational studies of drugs or devices, laboratory studies, student research, behavioral, and
outcomes research.

Responsible Parties:

Principal Investigators must comply with federal, state and local laws ands regulations, as well as those policies implemented by the University
and the Research Institute. Principal Investigators are responsible for ensuring that their staff are aware of and comply with all applicable laws
and policies.

Related Policies and Links:

KUMC Faculty Handbook http://www2.kumc.edu/aa/fa/pdf/Handbook.pdf
KUMC Research Institute Courtesy Research Faculty Appointments Policy:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/courtesy_research_faculty_appointment_policy.htm
KUMC Research Institute Procedure 1.2.01: Signature Approval Process:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility%20Signature%20Approval%20Process.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
History:

Original Issue Date: 8/22/2007
Current Issue Date: 10/06/2009
RAC approved: 11/09/2007, 09/23/2009
Effective Date: 11/15/2007
                                           SIGNATURE APPROVAL PROCESS
                                                  Procedure 1.a.01

Signature approval by the center ensures that the director has reviewed and approved commitments or requirements of the
individual center involved.

Signature approval by the department indicates the following:
    i. the project is consistent with the overall objectives of the department,
    ii. represents high-quality research, and has substantial scientific merit;
    iii. adequate (co)investigator time is available to conduct the project and the time committed is consistent with the
         terms under which the (co)investigator is employed;
    iv. adequate research space and facilities are available within the department(s) to support the proposed project;
    v. requests for new equipment have been reviewed to determine whether similar suitable equipment might be
         available in the department(s) or school(s); and
    vi. matching funds and resources are available.

Signature approval by the school indicates the following:
    i. the project is consistent with the mission of the school(s);
    ii. the commitment of school resources is consistent with the mission of the school;
    iii. new positions would be available if the project is awarded; and
    iv. the school will guarantee any matching funds.

Finally, administrative signature approval demonstrates the following:
    i. all department and school approvals have been obtained;
    ii. the budget (direct and indirect costs) is appropriate and equipment items are justified;
    iii. facilities and services required will be available when the project is awarded and the costs requested are
          adequate to cover the services required (mathematical and statistical services, computer-related services,
          hospital services, facilities and personnel, animal care services, and electron microscopy and other core or
          institutional services);
    iv. space requirements have been addressed;
    v. new faculty positions would be available if the project is awarded;
    vi. project applications involving the use of human subjects have been submitted to the Human Subjects Committee
          (HSC) in accordance with KUMC policies and sponsor- specific mandates, and pre-award approvals have been
          obtained when required by the University of the granting sponsor;
                     Kansas City – www2.kumc.edu/researchcompliance/human.htm
                     Wichtia – wichita.kumc.edu/research/humansubjects.html
    vii. project applications involving the use of animals have been submitted to the Institutional Animal Care and Use
          Committee (IACUC) in accordance with KUMC policies and sponsor-specific mandates, and pre-award approvals
          are obtained when required by the University or sponsor;
                     www.kumc.edu/lar/acupform.html
    viii. a biohazard form has been submitted to the Institutional Research Safety Committee (IRSC) for all applications,
          and all projects involving Class II, III, or IV biohazard risks have been approved by the IRSC;
                     www2.kumc.edu/researchcompliance/forms/researchsafety.pdf
                     www2.kumc.edu/researchcompliance/irsc.htm
    ix. project applications involving the use of radioactive material have been submitted to the Radiation Safety
          Committee (RSC) in accordance with University policies, and pre-award approvals are obtained when required by
          the University;
                     http://www2.kumc.edu/safety/docs/radpolicies.pdf
    x. applications are complete, conform to funding agency guidelines, and are accurate in terms of forms and budget;
    xi. conflict of interest forms have been submitted for all grant-related personnel, been reviewed by the Research
          Compliance Division in accordance with KUMC policies and procedures governing conflict of interest; and
                     www2.kumc.edu/researchcompliance/coi_disclosure_inst.htm
                     www2.kumc.edu/researchcompliance/coikumcpolicies.htm
    xii. Health Insurance Portability and Accountability Act of 1996 (HIPAA) forms have been submitted for all
          applications involving protected health information.
                     www.kumc.edu/hipaa/
                         Courtesy Research Faculty Appointments
                                     December 2003

Policy Statement
Individuals, not otherwise employed by the University of Kansas Medical Center
(KUMC) who wish to conduct research or participate in a grant or contract on the
KUMC campus must apply for a Courtesy Research Faculty Appointment.

Background
The University of Kansas is legally responsible to state and Federal oversight agencies
for the safety and integrity of the activities conducted on its premises and/or under its
name. Therefore, all research grants and contracts conducted by or on behalf of the
University of Kansas Medical Center must be duly authorized to protect both the
university, the participants, staff and extramural agency. Issues that must be considered
by the authorized agent include but are not limited to, risks and benefits to the university,
facilities and administration fees ( F&A costs), compliance with human subjects or
animal protections, intellectual property, space and equipment, bio-hazard regulations
and Federal immigration laws.

Definition
Duly Authorized Agent – Department Chairs, Center Directors, Deans and Executive
Vice Chancellor

Procedures
    1. The prospective courtesy faculty member should meet with the duly authorized
        agent and come to an agreement on the terms and conditions of the proposed
        research.
    2. A Letter of Request for Courtesy Research Appointment
        http://www2.kumc.edu/researchinstitute/spa/spaforms_internal.html , and a copy
        of the proposal, including the budget, should be filled out and presented to the
        authorized agent for approval.
    3. A Faculty Appointment Form http://www2.kumc.edu/aa/fa/doc/Appt_form.doc
        must be completed by the authorized agent and forwarded to the Dean.
    4. Acceptance or rejection of the request must be made in writing by the Dean and
        forwarded to the Office of Faculty Affairs and Office Sponsored Program
        Administration.
Groups Covered
Any individual not employed by the University of Kansas Medical Center
Exemptions
None
Related Documents
Faculty and Unclassified Staff Handbook -
http://www2.kumc.edu/aa/fa/pdf/Handbook.pdf
Contacts:
Vice Chancellor for Academic Affairs – 588.1258
Vice Chancellor for Research Administration- 588.5436
                                            SPONSORED PROJECTS OR RESEARCH GIFTS
                                                        AUGUST 2008
                                                         Policy 1.1.02

Policy:

All external funds determined to be a sponsored project must be processed through the University of Kansas Medical Center Research
Institute.

Purpose:

The purpose of this policy is to clarify the difference between the sponsored projects and research gifts. In relation to accounting and
financial procedures, the terms have specific differences. Both sponsored projects and research gift funded activities are externally-
supported, with funds typically provided in response to a request or proposal. The classification of funding as "research gift" or
"sponsored project" will affect the way KUMC Research Institute (KUMCRI) accounts for the funds, calculates and applies Facilities &
Administrative (F&A) indirect costs, and reports on the use of the funds to the sponsor or donor and to the Office of the Associate Vice
Chancellor for Research Administration.

Procedures:

Sponsored Projects
Sponsored Projects are externally-funded activities in which a formal written agreement, i.e., a grant, contract, or cooperative
agreement, is entered into by KUMCRI and by the sponsor. Sponsored projects typically have a specified statement of work with
identified deliverables, allow for detailed financial accounting, and have a budget which includes direct and indirect costs of the
research activity.

Sponsored Projects are to be managed by KUMCRI.

The following conditions characterize a sponsored project agreement, and help to distinguish such agreements from gifts:
1. Statement of Work
         Sponsored projects are typically awarded to KUMCRI in response to a detailed statement of work and commitment to a
         specified project plan. As described below, this statement of work is usually supported by both a project description and a
         line-item budget, both of which are essential to financial accountability. The statement of work and budget are usually
         described in a written proposal submitted by KUMCRI to the sponsor for review and agreement.
2. Detailed Financial Accountability
         The sponsored project agreement includes detailed financial accountability, typically including such conditions as:
     •     a line-item budget related to the project plan. The terms of the agreement may specify allowable or unallowable costs,
           requirements for prior approvals for particular expenditures, etc.
     •     a specified period of performance, typically defined with "start" and "stop" dates
     •     a requirement to return any unexpended funds at the end of that period
     •     regular financial reporting and audit, including, for federal and state awards, accountability under the terms of Office of
           Management and Budget circular A-21 and Office of Management and Budget circular A-110. These conditions generally
           define the level of financial accountability associated with a sponsored project.
3. Required Deliverables
         Sponsored project agreements also usually include contractual consideration such as:
    •    terms and conditions for the disposition of tangible properties (e. g., equipment, records, specified technical reports),
    •    intangible properties (e.g., intellectual property [rights in data, copyrights, inventions], testing, or evaluation of proprietary
         property),
    •    other services or considerations specified by the sponsor.

While not all of the above conditions are necessary to define a sponsored project, they are collectively indicative of the increased level
of financial accountability associated with such projects.

Research Gifts
A research gift is defined as any item of value given to the University by a donor who wishes to support the research of a faculty
member or group of faculty members, and who expects nothing of significant value in return, other than recognition and disposition of
the gift in accordance with the donor's wishes. For example, an individual may donate to The University of Kansas Medical Center the
amount of $500,000 with the only stipulations that the funds be used for a specific area of research - such as amyotrophic lateral
sclerosis, “ALS” - and the donor recognized for the contribution.

Therefore, a gift is designated as a Research Gift when it is provided as unrestricted funds or as an in-kind contribution to
support the research of one or more specified faculty members or research programs.

Research Gifts are to be managed by KU Endowment Association.*

                                                                       1
In general, the following characteristics describe a research gift:
1. Research gifts do not carry restrictions, no contractual requirements are imposed and there are no deliverables to the donor. If
         restrictions are imposed on the use of funds, such funds will be regarded as a sponsored project and treated accordingly. A
         research gift may, however, be accompanied by an agreement that specifies the use of the funds for a particular purpose.
2. A research gift is irrevocable. While the gift may be intended for use within a certain timeframe, there is no specified "period of
         performance" or "start/stop" dates as associated with sponsored projects.
3. There is no formal fiscal accountability to the donor beyond periodic progress reports and summary reports of
         expenditures. These reports may be thought of as requirements of good stewardship, and, as such, may be required by the
         terms of a gift. They are not characterized as contractual obligations or deliverables.

Recovery of Direct and Indirect Costs and Gift Fees
Once extramural funds have been classified as sponsored projects or as gifts, the following mechanisms are in place to recover costs
incurred by the University through KUMCRI. In accordance with University of Kansas Medical Center policy, sponsored projects must
recover the full cost of research, both direct and indirect. For more information on indirect costs/overhead please go to
http://www2.kumc.edu/researchinstitute/spa/spabudgetinformation.html. A sponsored project budget will include the University's full
negotiated F&A (indirect) cost rate, unless a waiver of those costs has been approved.

* The KU Endowment Association is a not-for-profit 501(c)(3) corporation established in 1891 to be the official foundation for raising and
managing private funds on behalf of The University of Kansas.

                          DISTINGUISHING BETWEEN RESEARCH GIFTS AND SPONSORED PROJECTS

Distinctions Based On Source of Funds
All funds provided by U.S. Government agencies, at the federal, state, or local level, in support of University activities are treated as
sponsored project funding. Government funds are not treated as gifts. Funding from Voluntary Health Organizations or Associations,
such as the American Cancer Society or American Heart Association are also treated as a sponsored projects.

Distinctions Based on Intent of Donor/Sponsor
In cases where funding is being provided by corporations, foundations or others not specified above, the distinction between research
gifts and sponsored projects will be made based on the nature of the proposal, statement of work, and/or terms of the agreement,
taking into consideration the intent of the donor/sponsor.

Note that, in some situations, associated communications about the award or gift, including written proposal or award documents, or
conversations, have already made it clear that the donor's/sponsor's intent was to classify an award to the University as either a
research gift or a sponsored project. In these cases, the terms of the accompanying agreement may have to be adjusted in consultation
with the donor/sponsor in order to clearly document the intent, and avoid unintended classification, while insuring that appropriate
University and KUEA policies are followed.

                                    THE DECISION-MAKING PROCESS IN UNCLEAR SITUATIONS
In some cases, the distinction between research gifts and sponsored projects can be difficult to determine. If PIs, departments or units
need assistance in determining whether an interaction should be managed as a gift or a grant, please contact KUMCRI Sponsored
Programs Administration at 913-588-1259 or spa@kumc.edu. In the event that a classification still cannot be made, the Associate Vice
Chancellor for Research Administration and the Vice President for Medical Development at KU Endowment Association will jointly
resolve the issue. If necessary, the final arbiter is the Executive Vice Chancellor.

* KU Endowment Association is a not-for-profit 501(c)(3) corporation established in 1891 to be the official foundation for raising and
managing private funds on behalf of The University of Kansas.

Definitions:

Office of Management and Budget circular A-21: Federal circular establishing principles for determining costs applicable to grants,
contracts, and other agreements with educational institutions.

Office of Management and Budget circular A-110: Uniform administrative requirements for grants and agreements with institutions of
higher education, hospitals, and non-profit organizations.

Research Gift: Any item of value given to the University by a donor who wishes to support the research of a faculty member or group of
faculty members, and who expects nothing of significant value in return, other than recognition and disposition of the gift in accordance
with the donor's wishes.

Sponsored Project: Externally-funded activities in which a formal written agreement, i.e., a grant, contract, or cooperative agreement, is
entered into by KUMCRI and by the sponsor. Sponsored projects typically have a specified statement of work with identified
deliverables, allow for detailed financial accounting, and have a budget which includes direct and indirect costs of the research activity.




                                                                     2
Responsible Parties:

This policy shall apply to all KUMC Research Institute staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other
persons at KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or
coordinating or managing research at KUMC.

Exemptions:

None

Related Policies and Links:

KU Endowment Association http://www.kuendowment.org/
KUMC Faculty Handbook http://www2.kumc.edu/aa/fa/Default.htm
KUMC Research Institute Accounting Procedures for Grants and Contracts http://www2.kumc.edu/researchinstitute/spa/acct.procs.html
KUMC Research Institute Sponsored Programs versus Gifts Indicator List
Office of Management and Budget circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
Office of Management and Budget circular A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 08/08/2008
Current Issue Date: 08/08/2008
RAC Approved: 09/24/2008
Effective Date: 09/29/2008




                                                                     3
             GIFT, RESEARCH GIFT OR SPONSORED PROJECT INDICATORS

If after reviewing the definitions and considering the intent of the source of funding and nature of the
agreement in questions, a question remains about the proper classification of an award, the following
list of indicators may be helpful. Taken together with the analysis of the source of funds and the terms
of the agreement, these criteria should help to classify ambiguous awards.

                              Gift - KUEA           Research Gift- KUEA                Sponsored
                                                                                        Project -
                                                                                       KUMCRI
    Purpose              For a general or          Designated as               For a specific statement
                         specific purpose, e.g.,   unrestricted funds to       of work e.g., specified
                         endowment, capital        support the research of     protocol, experiments,
                         projects, or student      one or more specified       testing of hypothesizes,
                         financial aid.            faculty members or          particular line of inquiry.
                                                   research programs
                         May be for any            Supports the research of    Usually for a specified
                         activity at the           one or more specified       research project(s) but
                         University, e.g.,         faculty members or          may be for projects
                         department, library,      research programs.          associated with
                         arts, scholarships,                                   instruction or other
                         facilitates,                                          sponsored activity.
                         research/instruction
                         activities, etc.
    Required             No deliverables.          Same as for Gift            Deliverables defined by
    Deliverables         (stewardship reports                                  formal, written
                         and ability to observe                                agreement, including,
                         at open research                                      reports, research results,
                         reviews are                                           IP rights, equipment, or
                         allowable, as noted)                                  other specified services
                                                                               or considerations. Funds
                                                                               may be withheld pending
                                                                               delivery.
                         No obligation or          Same as for Gift            Sponsor expects access
                         agreement to share                                    to research results and
                         data/research results                                 the ability to audit
                         with donor; donor                                     research results, but not
                         willing to sign gift                                  to prevent publication.
                         agreement
                         relinquishing IP and
                         data rights to
                         University. Donor
                         may request progress
                         reports, as noted
                         above and ability to
                         observe at open
                         research reviews.
                       Gift – KUEA             Research Gift – KUEA   Sponsored Project -
                                                                      KUMCRI
    Tax Implications Qualifies for tax         Same as for Gift       May qualify for basic
                     treatment as                                     research tax credit for
                     charitable                                       sponsor
                     contribution by donor
    Publication      Publication               Same as for Gift       Publication attribution is
    Attribution      attribution may be                               typical and acknowledges
                     encouraged or                                    the sponsor
                     agreement may be
                     silent on attribution
    Form of          Proposal may be           Same as for Gift       Proposal submission
    Proposal         informal e.g., a letter                          required through the
                     proposal from an                                 office of Sponsored
                     individual, a                                    Programs
                     department, office or
                     school
    Stewardship      Often require only        Same as for Gift       May require detailed
                     general stewardship                              financial and other
                     and communication                                reports, e.g., scientific
                     as a courtesy to                                 reports, invention reports,
                     donor, e.g., progress                            financial reports on
                     reports, reports of                              sponsor-specified format,
                     expended funds and                               may include the right of
                     balance, invitation to                           sponsor to audit
                     open reviews of
                     research
    Financial/Budget No requirement or         Same as for Gift       Budget and project
                     expectation of return                            period may lead to
                     of unexpended funds                              unexpended funds that
                                                                      must be returned if no
                                                                      approval to carry forward
                                                                      or extend project
                       No required pre-        Same as for Gift       Certain expenditures may
                       approvals for                                  require prior written
                       expenditures                                   approval by sponsor
                       Some gifts may be       Same as for Gift       Must be separately
                       combined into one                              budgeted and accounted
                       fund (if for the same                          for
                       purpose)




KUEA: KU Endowment Association, http://www.kuendowment.org
KUMCRI: KUMC Research Institute, http://www2.kumc.edu/researchinstitute/
                                            SPONSORED PROJECTS OR RESEARCH GIFTS
                                                        AUGUST 2008
                                                         Policy 1.1.02

Policy:

All external funds determined to be a sponsored project must be processed through the University of Kansas Medical Center Research
Institute.

Purpose:

The purpose of this policy is to clarify the difference between the sponsored projects and research gifts. In relation to accounting and
financial procedures, the terms have specific differences. Both sponsored projects and research gift funded activities are externally-
supported, with funds typically provided in response to a request or proposal. The classification of funding as "research gift" or
"sponsored project" will affect the way KUMC Research Institute (KUMCRI) accounts for the funds, calculates and applies Facilities &
Administrative (F&A) indirect costs, and reports on the use of the funds to the sponsor or donor and to the Office of the Associate Vice
Chancellor for Research Administration.

Procedures:

Sponsored Projects
Sponsored Projects are externally-funded activities in which a formal written agreement, i.e., a grant, contract, or cooperative
agreement, is entered into by KUMCRI and by the sponsor. Sponsored projects typically have a specified statement of work with
identified deliverables, allow for detailed financial accounting, and have a budget which includes direct and indirect costs of the
research activity.

Sponsored Projects are to be managed by KUMCRI.

The following conditions characterize a sponsored project agreement, and help to distinguish such agreements from gifts:
1. Statement of Work
         Sponsored projects are typically awarded to KUMCRI in response to a detailed statement of work and commitment to a
         specified project plan. As described below, this statement of work is usually supported by both a project description and a
         line-item budget, both of which are essential to financial accountability. The statement of work and budget are usually
         described in a written proposal submitted by KUMCRI to the sponsor for review and agreement.
2. Detailed Financial Accountability
         The sponsored project agreement includes detailed financial accountability, typically including such conditions as:
     •     a line-item budget related to the project plan. The terms of the agreement may specify allowable or unallowable costs,
           requirements for prior approvals for particular expenditures, etc.
     •     a specified period of performance, typically defined with "start" and "stop" dates
     •     a requirement to return any unexpended funds at the end of that period
     •     regular financial reporting and audit, including, for federal and state awards, accountability under the terms of Office of
           Management and Budget circular A-21 and Office of Management and Budget circular A-110. These conditions generally
           define the level of financial accountability associated with a sponsored project.
3. Required Deliverables
         Sponsored project agreements also usually include contractual consideration such as:
    •    terms and conditions for the disposition of tangible properties (e. g., equipment, records, specified technical reports),
    •    intangible properties (e.g., intellectual property [rights in data, copyrights, inventions], testing, or evaluation of proprietary
         property),
    •    other services or considerations specified by the sponsor.

While not all of the above conditions are necessary to define a sponsored project, they are collectively indicative of the increased level
of financial accountability associated with such projects.

Research Gifts
A research gift is defined as any item of value given to the University by a donor who wishes to support the research of a faculty
member or group of faculty members, and who expects nothing of significant value in return, other than recognition and disposition of
the gift in accordance with the donor's wishes. For example, an individual may donate to The University of Kansas Medical Center the
amount of $500,000 with the only stipulations that the funds be used for a specific area of research - such as amyotrophic lateral
sclerosis, “ALS” - and the donor recognized for the contribution.

Therefore, a gift is designated as a Research Gift when it is provided as unrestricted funds or as an in-kind contribution to
support the research of one or more specified faculty members or research programs.

Research Gifts are to be managed by KU Endowment Association.*

                                                                       1
In general, the following characteristics describe a research gift:
1. Research gifts do not carry restrictions, no contractual requirements are imposed and there are no deliverables to the donor. If
         restrictions are imposed on the use of funds, such funds will be regarded as a sponsored project and treated accordingly. A
         research gift may, however, be accompanied by an agreement that specifies the use of the funds for a particular purpose.
2. A research gift is irrevocable. While the gift may be intended for use within a certain timeframe, there is no specified "period of
         performance" or "start/stop" dates as associated with sponsored projects.
3. There is no formal fiscal accountability to the donor beyond periodic progress reports and summary reports of
         expenditures. These reports may be thought of as requirements of good stewardship, and, as such, may be required by the
         terms of a gift. They are not characterized as contractual obligations or deliverables.

Recovery of Direct and Indirect Costs and Gift Fees
Once extramural funds have been classified as sponsored projects or as gifts, the following mechanisms are in place to recover costs
incurred by the University through KUMCRI. In accordance with University of Kansas Medical Center policy, sponsored projects must
recover the full cost of research, both direct and indirect. For more information on indirect costs/overhead please go to
http://www2.kumc.edu/researchinstitute/spa/spabudgetinformation.html. A sponsored project budget will include the University's full
negotiated F&A (indirect) cost rate, unless a waiver of those costs has been approved.

* The KU Endowment Association is a not-for-profit 501(c)(3) corporation established in 1891 to be the official foundation for raising and
managing private funds on behalf of The University of Kansas.

                          DISTINGUISHING BETWEEN RESEARCH GIFTS AND SPONSORED PROJECTS

Distinctions Based On Source of Funds
All funds provided by U.S. Government agencies, at the federal, state, or local level, in support of University activities are treated as
sponsored project funding. Government funds are not treated as gifts. Funding from Voluntary Health Organizations or Associations,
such as the American Cancer Society or American Heart Association are also treated as a sponsored projects.

Distinctions Based on Intent of Donor/Sponsor
In cases where funding is being provided by corporations, foundations or others not specified above, the distinction between research
gifts and sponsored projects will be made based on the nature of the proposal, statement of work, and/or terms of the agreement,
taking into consideration the intent of the donor/sponsor.

Note that, in some situations, associated communications about the award or gift, including written proposal or award documents, or
conversations, have already made it clear that the donor's/sponsor's intent was to classify an award to the University as either a
research gift or a sponsored project. In these cases, the terms of the accompanying agreement may have to be adjusted in consultation
with the donor/sponsor in order to clearly document the intent, and avoid unintended classification, while insuring that appropriate
University and KUEA policies are followed.

                                    THE DECISION-MAKING PROCESS IN UNCLEAR SITUATIONS
In some cases, the distinction between research gifts and sponsored projects can be difficult to determine. If PIs, departments or units
need assistance in determining whether an interaction should be managed as a gift or a grant, please contact KUMCRI Sponsored
Programs Administration at 913-588-1259 or spa@kumc.edu. In the event that a classification still cannot be made, the Associate Vice
Chancellor for Research Administration and the Vice President for Medical Development at KU Endowment Association will jointly
resolve the issue. If necessary, the final arbiter is the Executive Vice Chancellor.

* KU Endowment Association is a not-for-profit 501(c)(3) corporation established in 1891 to be the official foundation for raising and
managing private funds on behalf of The University of Kansas.

Definitions:

Office of Management and Budget circular A-21: Federal circular establishing principles for determining costs applicable to grants,
contracts, and other agreements with educational institutions.

Office of Management and Budget circular A-110: Uniform administrative requirements for grants and agreements with institutions of
higher education, hospitals, and non-profit organizations.

Research Gift: Any item of value given to the University by a donor who wishes to support the research of a faculty member or group of
faculty members, and who expects nothing of significant value in return, other than recognition and disposition of the gift in accordance
with the donor's wishes.

Sponsored Project: Externally-funded activities in which a formal written agreement, i.e., a grant, contract, or cooperative agreement, is
entered into by KUMCRI and by the sponsor. Sponsored projects typically have a specified statement of work with identified
deliverables, allow for detailed financial accounting, and have a budget which includes direct and indirect costs of the research activity.




                                                                     2
Responsible Parties:

This policy shall apply to all KUMC Research Institute staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other
persons at KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or
coordinating or managing research at KUMC.

Exemptions:

None

Related Policies and Links:

KU Endowment Association http://www.kuendowment.org/
KUMC Faculty Handbook http://www2.kumc.edu/aa/fa/Default.htm
KUMC Research Institute Accounting Procedures for Grants and Contracts http://www2.kumc.edu/researchinstitute/spa/acct.procs.html
KUMC Research Institute Sponsored Programs versus Gifts Indicator List
Office of Management and Budget circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
Office of Management and Budget circular A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 08/08/2008
Current Issue Date: 08/08/2008
RAC Approved: 09/24/2008
Effective Date: 09/29/2008




                                                                     3
             GIFT, RESEARCH GIFT OR SPONSORED PROJECT INDICATORS

If after reviewing the definitions and considering the intent of the source of funding and nature of the
agreement in questions, a question remains about the proper classification of an award, the following
list of indicators may be helpful. Taken together with the analysis of the source of funds and the terms
of the agreement, these criteria should help to classify ambiguous awards.

                              Gift - KUEA           Research Gift- KUEA                Sponsored
                                                                                        Project -
                                                                                       KUMCRI
    Purpose              For a general or          Designated as               For a specific statement
                         specific purpose, e.g.,   unrestricted funds to       of work e.g., specified
                         endowment, capital        support the research of     protocol, experiments,
                         projects, or student      one or more specified       testing of hypothesizes,
                         financial aid.            faculty members or          particular line of inquiry.
                                                   research programs
                         May be for any            Supports the research of    Usually for a specified
                         activity at the           one or more specified       research project(s) but
                         University, e.g.,         faculty members or          may be for projects
                         department, library,      research programs.          associated with
                         arts, scholarships,                                   instruction or other
                         facilitates,                                          sponsored activity.
                         research/instruction
                         activities, etc.
    Required             No deliverables.          Same as for Gift            Deliverables defined by
    Deliverables         (stewardship reports                                  formal, written
                         and ability to observe                                agreement, including,
                         at open research                                      reports, research results,
                         reviews are                                           IP rights, equipment, or
                         allowable, as noted)                                  other specified services
                                                                               or considerations. Funds
                                                                               may be withheld pending
                                                                               delivery.
                         No obligation or          Same as for Gift            Sponsor expects access
                         agreement to share                                    to research results and
                         data/research results                                 the ability to audit
                         with donor; donor                                     research results, but not
                         willing to sign gift                                  to prevent publication.
                         agreement
                         relinquishing IP and
                         data rights to
                         University. Donor
                         may request progress
                         reports, as noted
                         above and ability to
                         observe at open
                         research reviews.
                       Gift – KUEA             Research Gift – KUEA   Sponsored Project -
                                                                      KUMCRI
    Tax Implications Qualifies for tax         Same as for Gift       May qualify for basic
                     treatment as                                     research tax credit for
                     charitable                                       sponsor
                     contribution by donor
    Publication      Publication               Same as for Gift       Publication attribution is
    Attribution      attribution may be                               typical and acknowledges
                     encouraged or                                    the sponsor
                     agreement may be
                     silent on attribution
    Form of          Proposal may be           Same as for Gift       Proposal submission
    Proposal         informal e.g., a letter                          required through the
                     proposal from an                                 office of Sponsored
                     individual, a                                    Programs
                     department, office or
                     school
    Stewardship      Often require only        Same as for Gift       May require detailed
                     general stewardship                              financial and other
                     and communication                                reports, e.g., scientific
                     as a courtesy to                                 reports, invention reports,
                     donor, e.g., progress                            financial reports on
                     reports, reports of                              sponsor-specified format,
                     expended funds and                               may include the right of
                     balance, invitation to                           sponsor to audit
                     open reviews of
                     research
    Financial/Budget No requirement or         Same as for Gift       Budget and project
                     expectation of return                            period may lead to
                     of unexpended funds                              unexpended funds that
                                                                      must be returned if no
                                                                      approval to carry forward
                                                                      or extend project
                       No required pre-        Same as for Gift       Certain expenditures may
                       approvals for                                  require prior written
                       expenditures                                   approval by sponsor
                       Some gifts may be       Same as for Gift       Must be separately
                       combined into one                              budgeted and accounted
                       fund (if for the same                          for
                       purpose)




KUEA: KU Endowment Association, http://www.kuendowment.org
KUMCRI: KUMC Research Institute, http://www2.kumc.edu/researchinstitute/
                                                  PROPOSAL AND BUDGET PREPARATION
                                                            February 2008
                                                             Policy 1.1.03

Policy:

The University of Kansas Medical Center Research Institute (KUMCRI) is the vehicle for applications submitted to federal, state, local and
private for-profit and non-profit funding agencies. The Division of Sponsored Programs Administration (SPA) processes all applications except
for clinical trials. Clinical trials agreements and budgets are processed through KUMC Research Institute Division of Clinical Research
Administration. All applications, including funded Clinical Trials, are recorded in the Sponsored Programs Administration databases.

Purpose:

The Sponsored Programs Administration Pre Award office is authorized to assist faculty in the submission and negotiation of all proposals,
including budgets, for new or continued federal and private support of University projects. The proposal budget is a carefully prepared and
detailed explanation of the funds needed to accomplish the project. Budgets prepared for federally-funded projects are subject to the cost
allowability guidelines as detailed in Office of Management and Budget Circular A-21. The Vice Chancellor for Research is authorized to
review and approve such proposals for KUMC.

The KUMC Research Institute Division of Clinical Research Administration will assist faculty and staff in all aspects of clinical research
administration.

Procedures:

    1.    Identify the funding agency and submission deadline.
    2.    Review the funding agency instructions and contact SPA Pre-Award with questions.
    3.    Budget Preparation
                a. Federally funded projects are subject to the specifications outlined in OMB Circular A-21 section J, or application
                     instructions.
                b. Privately funded projects are subject to the specifications of the respective sponsors. Sponsors typically have a specific
                     format in which the budgets should be presented, and it is important that these specifications are followed explicitly.
                c. In general, a budget will consist of an itemization of Direct Costs (salaries, fringe benefits, equipment, travel, supplies, and
                     other direct costs), Facilities and Administration (F&A) Costs, and Cost Sharing when required.
                            i. Institutional Base Salary rates for NIH proposals http://grants.nih.gov/grants/policy/salcap_summary.htm
                           ii. F&A rates http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/rate_agreement_06_05_08a.pdf
                d. Budget Justification: a brief explanation for the items budgeted that corresponds to the project outline. Major cost categories
                     require particular explanation.
    4.    To complete funding agency forms.
    5.    To complete the KUMC Research Institute checklist ensuring Department, Center, School, and Administrative review.
                                                                                                               th
    6.    Submission: take the internal forms and one draft copy of the application to SPA Pre-Award (6 Floor Wescoe Hall, 913-588-1251):
                a. Hard Copies: ten (10) working days prior to the mailing deadline.
                b. GRANTS.GOV applications: twelve (12) working days prior to the submission deadline.
    7.    SPA Pre Award will review your application and contact you regarding any corrections needed. Once SPA Pre-Award has the
          institutional approval and sign-off, you will be contacted to pick up the original for mailing to the funding agency.

For assistance with Clinical Trails Research Agreements, go to http://www2.kumc.edu/researchinstitute/cra/index.html

Definitions:

Cost Sharing or Matching: The value of third party in-kind contributions and the portion of the costs of a federally assisted project of program
not borne by the Federal Government.

Direct Costs: Costs that can be specifically identified with a particular project(s) or activity. Examples of research project-specific expenses
include expenses for equipment, personnel, travel, and other expenses necessary to carry out a research project.

Facilities and Administrative (Indirect) Cost: A broad category of costs that are common to all research projects. “Facilities” is defined in OMB
A-21 as depreciation and use allowances, interest on debt associated with certain buildings, equipment and capital improvements, operation
and maintenance expenses, and library expenses. “Administration” is defined in OMB A-21 as general administration and general expenses,
departmental administration, sponsored projects administration, and student administration and services.

Institutional Base Salary: The annual compensation that the applicant organization pays for an individual’s appointment, whether that
individual’s time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be
permitted to earn outside of the duties to the applicant organization.

Office of Management and Budget (OMB) A-21: Federal circular establishing principles for determining costs applicable to grants, contracts,
and other agreements with educational institutions.
Responsible Parties:

Principal Investigators

Exemptions:

None

Related Policies and Links:

KUMC Office of Compliance Institutional Research Safety Report Form http://www2.kumc.edu/researchcompliance/forms/researchsafety.pdf
KUMC Research Institute Division of Clinical Research Administration http://www2.kumc.edu/researchinstitute/cra/index.html
KUMC Research Institute Sponsored Programs Accounting Internal Checklist
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/checklist_spa_12_11_07.pdf
KUMC Research Institute Sponsored Programs Accounting, Proposal Process
       http://www2.kumc.edu/researchinstitute/spa/spapropprocess.html
KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
OMB Circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 2/29/2008
Current Issue Date: 2/29/2008
RAC approved: 3/28/2008
Effective Date: 4/4/2008
                                                INSTITUTIONAL BASE SALARY
                                                         June 2007
                                                        Policy 1.1.05


Policy:

The Institutional Base Salary (IBS) of a faculty member is the compensation set and approved by the institution through an
annual salary appointment form and paid at the direction of the University from all approved salary sources through the KUMC
payroll and/or the payroll of the affiliated clinical practice plans. The IBS must be included and accounted for as part of the
KUMC institutional effort reporting.

The IBS does not include any one-time bonus or incentive rewards that might be awarded to a clinical faculty member as a
result of Clinical Practice financial management.

Purpose:

NIH policy states that: “Compensation costs are allowable to the extent that they are reasonable, conform to the established
policy of the organization consistently applied regardless of the source of funds, and reflect no more than the percentage of time
actually devoted to the NIH-funded project.”

Most Department of Health and Human Services (DHHS) grant recipients are subject to a statutorily imposed salary limitation.

Procedures:

Clinical Research Faculty
Recent publication of the Revised NIH Grants Policy Statement Notice NOT-OD-05-061 Guidelines for Inclusion of Clinical
Practice Compensation in Institutional Base Salary Charged to NIH Grants and Contracts clarifies the appropriate factors for
establishing the IBS to include Clinical Practice Compensation in charging salaries and personnel costs to grants and contracts:

     …the inclusion of CPC in IBS must be established consistent with the provisions of OMB Circular A-21 (Cost
     Principles for Colleges and Universities). These requirements are addressed under ‘Compensation for personal
     services' Section J.10, which in part states; “Compensation for personal services covers all amounts paid currently or
     accrued by the institution for services of employees rendered during the period of performance under sponsored
     agreements. ” and that payroll distribution “will (i) be incorporated into the official records of the institution, (ii)
     reasonably reflect the activity for which the employee is compensated by the institution, and (iii) encompass both
     sponsored and all other activities on an integrated basis….”

Investigators receiving compensation from the institution (grantee/contractor) and separately organized clinical practice plans,
may include such compensation in the institutional base salary (IBS) budgeted and charged to NIH sponsored agreements if all
of the following criteria are met:
     • the Clinical practice compensation must be set by the institution.
     • the Clinical practice activity must be shown on the institution's payroll or salary appointment forms and records
           approved by the institution.
     • the Clinical practice compensation must be paid through or at the direction of the institution.
     • the Clinical practice activity must be included and accounted for in the institution's effort reporting and/or payroll
           distribution system.
     • the institution must assure that all financial reports and supporting documents associated with the combined IBS and
           resulting charges to NIH grants are retained and made available to Federal officials or their duly authorized
           representatives consistent with the requirements of 45 CFR Part 74.53 (A-110 Subpart C 53).

Set by the institution means that the grantee/contractor institution must be in a position to document and certify that the specified
amount of clinical practice compensation is being paid in essentially the same manner as other specified amounts of the
committed IBS (compensation) of the investigator. Further, this requires that the IBS not vary based on the specific clinical
services provided by the investigator within the periods for which total IBS is certified by the grantee institution.
The NIH recognizes that reimbursement for investigator effort on grants must be provided consistent with the actual institutional
costs of these services in accordance with applicable Federal Cost Principles and other limitations for such reimbursement, such
as the legislative cap on salary reimbursement. The revised criteria support conformance with applicable cost principles and
consistency in the treatment of compensation across the institution regardless of the source of support for compensated
activities.


1
Related Informational Items
The IBS shall reflect 100% of the individual faculty member’s effort, as appropriate, including the following categories: teaching,
research, clinical, and service. No faculty member, including research track faculty members, may be compensated more than
97% on extramural funds. This reflects other University responsibilities including attending Departmental meetings, serving on
Departmental, School, and University committees, advising graduate students, writing grant proposals, etc. The 3% of salary for
research track faculty members must be funded from departmental or school resources. Total faculty effort reflecting the IBS
will be documented from the KUMC payroll records and affiliated clinical practice plan payroll records, if CPC is included in the
IBS.

KUMC provides for regular and consistently executed evaluations on an annual or semi-annual basis, which could result in
meritorious salary increases following completion of the evaluations.

No increase in salary can be made based solely on the receipt of a grant award (quid pro quo). There must be an appropriate,
regular, and consistently executed evaluation recognizing one or more of the following criteria, merit, cost-of-living, tenure or
promotion, in order to implement a salary increase. Additionally, salary increases for an administrative or special assignment
without any decrease in other responsibilities could result in a change in IBS.

Upon completion of the grant award, the salary of the faculty member may not be reduced because of the termination of NIH
funding. However, a change in research effort, apart from the termination of NIH funding, could be deemed cause for less
responsibility and thus less salary. This must be part of the evaluation policy of the School, documented during a regular
evaluation, and applied equally to all faculty.

The annual salary appointment form will include the IBS set by the institution.

Definitions:

The National Institutes of Health (NIH) defines Institutional Base Salary (IBS) as: “The annual compensation paid by an
organization for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other
activities. Base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee
organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds.”

NIH also defines Clinical Practice Compensation (CPC) as: “the compensation provided for the clinical service activities of an
individual.”

Responsible Parties:

KUMC Principal Investigators.

Exemptions:

None.

Related Policies and Links:

KUMC Research Institute Policy 1.1.07: Cost Sharing
        http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Cost_Sharing.pdf
KUMC Research Institute Policy 2.1.02: Time and Effort Reporting:
        http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Time_Effort_Reporting.pdf
NIH Salary Cap Summary http://grants.nih.gov/grants/policy/salcap_summary.htm

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:

Original Issue Date: 1/4/2006
Current Issue Date: 6/13/07
RAC Approved: 7/25/07
Effective Date: 8/20/07




2
                                         FACILITY AND ADMINISTRATIVE (INDIRECT) COSTS
                                                        September 2007
                                                         Policy 1.1.06


Policy:

Vice Chancellor for Research is responsible for ensuring that appropriate Facilities and Administrative (F&A) Costs, or Indirect Costs,
have been included in every proposal.

Purpose:

Facility and Administrative overhead revenue plays a vital role in the administration and conduct of research and sponsored programs.
It is awarded as a means of offsetting a portion of the expenses inherent in the operation of an organization and the performance of its
programs. These expenses include such items as plant operations, maintenance, accounting, administration, core facilities and
services (safety operations, library, etc.) and general and departmental administration. Therefore, it is important that these costs be
included on all grants and contracts unless specifically prohibited by the funding source as a condition of the award. Most federal and
nonfederal funding agencies allow a stipulated rate for calculating these costs.

Departmental administration is defined in Office of Management and Budget (OMB) Circular A-21 as expenses that have been incurred
for administrative and supporting services that benefit common or joint departmental activities or objectives in academic deans’ offices
academic departments and divisions, and organized research units.

Procedures:

Federal rates are negotiated and information concerning the rates, base, and the date of agreement is available on the KUMC
Research Institute website: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/rate_agreement_06_05_08a.pdf

The Principal Investigator must include F&A (indirect) costs as a line item in a proposed budget. Assistance can be obtained from the
KUMC Research Institute Division of Sponsored Programs Administration.

Definitions:

Direct Costs: Costs that can be specifically identified with a particular project(s) or activity. Examples of research project-specific
expenses include expenses for equipment, personnel, travel, and other expenses necessary to carry out a research project.

Facilities and Administrative (Indirect) Cost: A broad category of costs that are common to all research projects. “Facilities” is defined in
OMB A-21 as depreciation and use allowances, interest on debt associated with certain buildings, equipment and capital
improvements, operation and maintenance expenses, and library expenses. “Administration” is defined in OMB A-21 as general
administration and general expenses, departmental administration, sponsored projects administration, and student administration and
services.

OMB A-21: Federal circular establishing principles for determining costs applicable to grants, contracts, and other agreements with
educational institutions.

Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study
specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the
production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and
new processes to meet specific requirements.

Responsible Parties:

Vice Chancellor for Research and all KUMC Principal Investigators.

Exemptions:

Unless the funding source specifically excludes such expenses for the grant program, the Principal Investigator (P.I.) must include
such expenses as a line item in the proposed budget. In some cases, funding agencies will allow a direct cost for administrative
overhead rather than indirect costs. If this is the case, the P.I. must include this cost.

Related Policies and Links:

KUMC Research Institute Division of Sponsored Programs Administration http://www2.kumc.edu/researchinstitute/spa/
KUMC Research Institute Division of Sponsored Programs Administration, F&A Rate Agreement
      http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/rate_agreement_06_05_08a.pdf
KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility:
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
OMB A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 3/1/95
Current Issue Date: 3/9/07, 7/22/08
RAC approved 10/31/07
Effective Date: 11/16/07
                                                                  COST SHARING
                                                                   January 2008
                                                                   Policy 1.1.07

Policy:

The University of Kansas Medical Center Research Institute must ensure that cost sharing requirements of sponsored grants and contract
agreements are proposed, accounted for, and reported in a manner consistent with the requirements set forth in federal regulations, primarily
the Office of Management and Budget circulars A-110 and A-21. It is the responsibility of the Principal Investigator (P.I.) and Department to
assure that appropriate cost sharing has been identified and recorded into the KUMC financial system.

Purpose:

As part of an agreement to award a project, some sponsors may require that the university participate in the total cost of a project. The
university may agree to voluntarily meet this requirement in order to show commitment to the project, or to make a proposal more competitive.
This cooperation to share costs in some extent is referred to as Cost Sharing, or Matching.

The intention of the Research Institute is to assist researchers and departments in understanding cost share by:
         -    Helping researchers and departments determine when cost sharing is required and/or permitted,
         -    Ensuring that the commitment for cost sharing within the institution has been identified and documented,
         -    Providing information regarding the financial and administrative requirements that will result from cost sharing
         -    commitment, and
         -    Establishing procedure for recording cost sharing in the KU Medical Center financial system.

Types of Cost Sharing:
         -  Mandatory Cost Sharing occurs when a sponsor requires cost sharing to be added to a project.
         -  Voluntary Cost sharing occurs when the university commits funds toward a proposed project in order for the proposal to be more
            competitive.
         -  Voluntary Cost Sharing may occur when a sponsor does not fully fund the proposed project.
         -  In Kind Cost Sharing occurs when supplies, services or other non-cash contributions are made to the project. The monetary
            value of these supplies, services or other non-cash contributions will be based on current fair market value at the time of the
            contribution.

Cost Sharing or Not?
        -    If effort is committed and expended but not directly charged to the project, then this is cost sharing.
        -    If a faculty member proposes to spend 20 % effort on a sponsored project, but charges only 10 % salary to the project, then the
             remaining 10 % effort is regarded as cost sharing because the effort is committed, but the entire 20 % is not charged to the
             sponsor.
        -    If a faculty member proposed to spend 20 % effort on a sponsored project, but charges only 10 % salary to the project and
             reduces effort to 10 %, then this is not cost sharing.
        -    If the sponsor reduces the proposed budget and the effort proportionally, then cost sharing is not required.
        -    If the sponsor does not fund a particular individual but the individual will still be a part of the project, then this is cost sharing.

Procedures:

Cost sharing commitments should only be made when required by the competitive nature of the program. Cost sharing mandated by the
sponsor on Federal, State or private awards should be provided from department or school resources. If the sponsor does not require cost
sharing, or if cost sharing is not necessary to ensure the competitiveness of a proposal, then the Principal Investigator should refrain from
making such commitments voluntarily. When the sponsor accepts cost sharing or matching, it becomes a commitment of the University. The
Research Institute requires that Sponsored Programs Administration review agency guidelines and policy guidelines to determine whether cost
sharing is necessary. Funds supporting research which are not provided by a sponsor are considered cost sharing. All cost sharing
commitments on sponsored grants must be reviewed and approved by the Department Chair, School Dean, Vice Chancellor for Research, and
Vice Chancellor for Administration.

To be acceptable as cost sharing, expenditures must meet the following criteria as set forth in OMB circular A-110:
        -   Be verifiable from official University accounting records;
        -   Not be used as cost sharing for any other sponsored program;
        -   Be necessary and reasonable for proper and efficient accomplishment of project objectives;
        -   Be allowable under the applicable cost principles, OMB Circular A-21, agreement and public laws;
        -   Not paid by federal funds under another award;
        -   Be incurred during the effective dates of the grant or contract.

Examples of expenditures which may be used as cost sharing are:
       -    Faculty and staff salaries, or student stipends, and applicable fringe benefits;
       -    Laboratory supplies;
       -    Unrecovered Overhead (F&A).
Examples of expenditures which may not be used as cost sharing are:
       -    Unallowable costs under OMB A-21, such as salaries exceeding the federal salary cap, alcoholic beverages, lobbying,
            entertainment, social club memberships, alumni/ae activities, contingency provisions, and debt. This is not a comprehensive list;
            please refer to OMB Circular A-21 Section J for the list in its entirety.

Cost Sharing after the grant award:
When the grant is awarded, cost sharing commitments are established in the PeopleSoft Financial system by KUMCRI Post Award
Administration and the appropriate department is notified. On-going periodic reviews of cost sharing commitments are conducted by KUMCRI
Post Award Administration. For cost sharing setup and review, contact the Director of Sponsored Programs Administration. The update and
maintenance of cost sharing in PeopleSoft is the responsibility of respective departments. Training in the PeopleSoft aspect of cost sharing is
provided through KUMC Institutional Finance and Administration. For more information regarding training, go to:
http://www2.kumc.edu/finance/peoplesoft_support/training.html.

Per Federal regulations, the P.I. must contribute a percentage of effort toward the project that was awarded by the sponsor. The Research
Institute requires that a P.I. or key personnel contribute no less than 1% effort toward a project. If the sponsor does not pay any salary
expenses on the project, it is reasonable to assume that there is some Principal Investigator effort or effort of other employees that is cost-
shared.

No Investigator may change cost sharing items after a grant has been awarded unless approved by the appropriate P.I., Department Chair(s),
Research Institute Official, and, where appropriate, the sponsor. If the sponsor funds a specific percent of effort, the P.I. must utilize those
grant funds for the salary unless a budget change is approved by the Department Chair(s) and Research Institute Official. An exception to the
requirement to notify a sponsor of changes would depend upon sponsor guidelines regarding pre-approval. For instance, the National Institute
of Health (NIH) does not require pre-approval unless changes in status of key personnel lead to the change of time devoted to the project by
25 percent or more from the level indicated in the approved application.

Definitions:

Award: The provision of funds based on an approved application and budget, to an organizational entity or an individual to carry out an activity
or project. This includes both direct and indirect costs (F&A) unless otherwise indicated.

Cost Sharing or Matching: The value of third party in-kind contributions and the portion of the costs of a federally assisted project or program
not borne by the Federal Government.

In-kind Contributions: the value of all non-cash contributions, including services and property, provided by the University and/or third parties.

Key Personnel: The PI and other individuals who contribute to the scientific development or execution of a project in a substantive,
measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other
professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets
this definition. Consultants also may be considered key personnel if they meet this definition. “Zero percent” effort or “as needed” is not an
acceptable level of involvement for key personnel."

Office of Management and Budget (OMB) A-21: Federal circular establishing principles for determining costs applicable to grants, contracts,
and other agreements with educational institutions.

Office of Management and Budget (OMB) A-110: Uniform administrative requirements for grants and agreements with institutions of higher
education, hospitals, and non-profit organizations.

Responsible Parties:

Principal Investigators, Co-Investigators, and appropriate Departments, Chairs, Deans, and Vice Chancellors.

Exemptions:

None.

Related Policies and Links:

KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility:
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
OMB Circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
OMB Circular A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html#23

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259
History:

Original Issue Date: Jan 2005
Current Issue Date: 3/17/2008
RAC approved: 3/28/2008
Effective Date: For New Grants proposed as of 4/7/2008
                                          DISCLOSURE OF CURRENT AND PENDING SUPPORT
                                                          October 2007
                                                          Policy 1.1.16

Policy:

Disclosure of all current grants on which a Principal Investigator (PI) and key personnel are working, as well as pending support, is
necessary when an application is selected to receive a grant award. The Principal Investigator is required to notify Sponsored Program
Administration personnel whenever effort is changed on a project, regardless the amount of effort changed.

Purpose:

The disclosure of other support a Principal Investigator or key personnel is receiving is a requirement of sponsoring agencies in order to
determine time commitments to projects and to avoid effort and scientific overlaps. The faculty member is responsible to ensure that
his or her “other support” page is complete and accurate considering the faculty member is in the best position to know his or her time
commitments and potential sources of support. Current and pending support must be disclosed whether or not salary is being provided
by the project(s). This includes federal, non-federal, industry or institutional support; any grants in direct support of research are
considered “other support”.

Procedures:

“Other support” information is required for all applications that are selected to receive grant awards. Unless otherwise specified in a
Request for Application (RFA), the Principal Investigator should not include information on other support in the grant application
submission. However, for NIH applications, the PI should be prepared to follow “just-in-time” procedures to submit current and pending
other support information upon the request of NIH staff when the application is under consideration for NIH funding. The PI shall report
any changes in other support to NIH as a part of the annual process.

A current and pending support disclosure shall contain the following information:
    -    Name of Principal Investigator
    -    Sponsor
    -    Award number assigned by the sponsor
    -    Title of the project
    -    Project start and end dates
    -    Award amount
    -    Percentage of effort committed
    -    Names of other sponsors to whom the proposal is being submitted

In the case of industry-sponsored clinical trials for which there will only be a very small or unpredictable amount of effort devoted to
each trial, the faculty member may include the following language as part of the other support information submitted to sponsoring
agencies:

          “In addition to the grants listed above, Dr. ___ is involved in clinical trials. The unpredictable nature of the activities in
          these trials makes is impossible to assign a precise level of effort for each trial. Dr. ___ has reviewed his/her clinical
          study obligations and confirms that the aggregate level of effort on all trials listed below does not exceed ____ of
          institutional effort.”

The amount of time allocated to each of the current and pending projects cannot exceed 100% (i.e. 12 person months) effort combined.
If time commitments exceed 100% effort, a justification is necessary to inform the sponsor of how the time will be reallocated to meet all
commitments.

Key personnel effort changes require NIH prior approval:
    -   Withdrawal from the project
    -   Absence for any continuous period of three months or more
    -   Reduction of time devoted to the project by 25% or more from the original effort indicated in the approved application

Definitions:

Key Personnel: The Principal Investigator and other individuals who contribute to the scientific development or execution of a project in
a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have
doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if
their involvement meets the definition. Consultants may also be considered key personnel if they meet this definition. “Effort of zero
person months” or “as needed” are not levels of involvement for those designated as key personnel.
Other Support: Other support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in
direct support of an individual’s research endeavors, including, but limited to research grants, cooperative agreement, contracts, or
institutional awards. Other support does not include training awards, prizes, or gifts.

Responsible Parties:

Principal Investigators

Exemptions:

None

Related Policies and Links:

KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
KUMC Research Institute Policy 2.1.02: Time and Effort Reporting:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Time_Effort_Reporting.pdf
KUMC Research Institute Sponsored Programs Administration Proposal Process
http://www2.kumc.edu/researchinstitute/spa/spapropprocess.html
NIH Grants Policy Statement http://grants2.nih.gov/grants/policy/nihgps_2003/nihgps_2003.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 10/31/07
Current Issue Date: 10/31/07
RAC Approved: 11/28/07
Effective Date: 12/11/07
                                      SPONSORED PROGRAMS AWARDS AND EXPENDITURES
                                                     February 2008
                                                      Policy 2.1.01


Policy:

Expenditures cannot be processed against a grant until funds are secured from the awarding agency. Sponsored program grant and
contract expenditures cannot be processed against a grant or contract prior to, or after, the official grant award dates.

Purpose:

State and institutional policies require that grant income be used for the purpose for which the income was awarded. As a result, “fund
accounting” procedures are utilized and each project must have its own unique account number.

The Research Institute is not in a position to finance or make arrangements to finance awards for which funding is not secured in
advance, nor may the Principal Investigator (P.I.) make expenditures before or after the dates of the award. This date restriction
applies to all purchases and payroll charges.

Funds will not be dispersed, nor an award set up, for payments received that have no corresponding documentation. Therefore, it is
necessary that Principal Investigators follow proposal guidelines to prevent the loss of time and possibly funds.

Procedures:

    1.    Receipt of Award:
          At the time the award document is received, the Post Award office will assign an account number which is to be used on all
          financial transactions. The financial billing or reporting date is noted and all necessary reports will be prepared as of these
          dates. The RI will not accept checks unless accompanied by documentation that provides direction for the use of those funds.
          The RI will not accept cash for deposit in accounts.
    2.    Normal Approval for establishing award accounts:
          Grant awards and finalized contract notifications are normally issued before the actual start date. Accounts are then
          established and expenditures can be made on the first day of the award.
    3.    Payroll over-expenditures:
          Any payroll over-expenditures will be the responsibility of the P.I. and/or Department. Any retroactive pay adjustments will
          need to be reconciled by the P.I. or Department within a 60 (sixty) working day grace period following the grant end date.
          Employees must be transferred off the grant by the P.I. and/or Department, and the Research Institute notified of the transfer
    4.    Inadequate funding within the grant period:
          The P.I. should be aware of account balances and monitor the availability of funds. However, if the P.I. overspends the budget
          of a grant between the start and end dates, it is the responsibility of the P.I. to reconcile those expenditures; purchases will
          automatically be rejected during that period. Retroactive pay adjustments will also need to be reconciled by the P.I. The RI
          will communicate cost overruns to the P.I. and Department within 30 (thirty) days.
    5.    Post expiration expenditures: The RI will not honor expenditures that are dated after the expiration of the award.
    6.    The RI will notify the P.I. of the approaching end date of the grant 60 (sixty) days before the closing date of the grant. Failure
          to respond or failure to receive the notification will not be grounds to alter this policy.
    7.    Internal and external billing expenses:
          Because most funding agencies require final financial reports to be submitted 90 (ninety) calendar days after the award
          expiration, all internal and external billing will need to be submitted no later then 60 (sixty) calendar days from the
          award end date. Any invoice, whether internal or external, that has been approved prior to the end date and sent to the RI
          within that sixty-day period will be honored and charged to the grant. Departments should communicate to vendors time
          constraints for receiving invoices at the end of a project. Invoices that are not received within that sixty-day period will not be
          honored. It will be the responsibility of the PI and the Department to pay those expenditures by other means.

Complete accounting requirements can be found on the KUMC Research Institute Division of Sponsored Programs Administration
website: http://www2.kumc.edu/researchinstitute/spa.

Definitions:

Award: The provision of funds based on an approved application and budget, to an organizational entity or an individual to carry out an
activity or project. This includes both direct and indirect costs (F & A) unless otherwise indicated.

Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study
specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the
production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and
new processes to meet specific requirements.
Responsible Parties:

This policy shall apply to all KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of
Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing
research at KUMC.

Exemptions:

A grantee expecting an award from NIH may incur expenditures to cover costs up to 90 days before the beginning date of the initial
budget period without NIH prior approval. Such expenditures are made at the grantee’s own risk, must be necessary to conduct the
project, must be allowable under the terms of the grant, and must be accompanied by written assurance from the Dean and the Chair of
the Department that the Department will be responsible for the expenditures in the event that the award is not officially received.

Occasionally an award will not arrive until after the start date of the grant. In this situation, the Research Institute may establish an
account before the receipt of the actual award letter if written assurance is received from the Dean and the Chair of the Department that
the Department will be responsible for the expenditures in the event that the award is not officially received.

For both instances above, approval will be given primarily so that the P.I. can receive an account number to begin making expenditures
necessary to start the project. Please submit an Approval for Pre-Award Spending form:
         http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/request_for_preaward_approval_form.doc

Exceptions to these policies can be made by the Vice Chancellor for Research. Decisions are made on a case-by-case basis relating
to need, assurance of award, funding agency policies regarding pre-award expenditures.

Related Policies and Links:

KUMC Faculty Handbook http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/faculty_handbook_06_02_05.pdf
KUMC Research Institute Division of Sponsored Programs http://www2.kumc.edu/researchinstitute/spa/
KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
KUMC Research Institute Approval for Pre Award Spending Form
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/request_for_preaward_approval_form.doc
OMB A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: Oct-2004
Current Issue Date: 4/8/2008
RAC Approved: 4/30/2008
Effective Date: 5/6/2008
                                                       TIME AND EFFORT REPORTING
                                                              September 2007
                                                               Policy 2.1.02


Policy:

The University of Kansas Medical Center Research Institute requires employees to declare and certify the accuracy of the percentage of time
that they charge to sponsored projects. Each department has the primary responsibility to ensure compliance with this policy. If effort is not
properly certified, salary charges must be removed from or be adjusted in the sponsored project account.

Purpose:

Effort reporting is the mechanism used to confirm that salaries and wages charged to each sponsored agreement are reasonable in relation to
the actual work performed. Certification of an effort report must reasonably reflect the activity for which the employee is compensated by the
institution. Effort reporting is a Federal requirement outlined in OMB Circular A-21. Institutions receiving sponsored program grants must
maintain an accurate system for identifying and reporting the effort paid for by the funding agency. The effort reporting system assures
external sponsors that funds are properly expended for the personnel paid for by the grant. Additionally, sponsors and auditors must also be
able to verify that funds allocated for cost sharing have been provided. The effort reporting system is the mechanism used to document cost-
shared salary expenses.

Office of Management and Budget Circular A-21 describes the cost accounting standards that are followed by all universities receiving federal
funding. They include the requirement for monthly distribution of all salaries to appropriate accounts in proportion to the effort expended
toward activities associated with those costs. Under OMB A-21, effort reporting provides the necessary documentation to certify and
substantiate direct labor charges to all sponsored activities.

In application of this requirement severe penalties and funding disallowances could result from inaccurate, incomplete, or untimely effort
reporting. If deviations from this cost accounting standard are found during an audit, disallowances could result which would be charged to the
appointing Department.

Procedures:

    •     Time/effort expectations are established when personnel receive an annual letter of appointment from the Department,
          Center/Institute, and/or School stating the percentage of effort allocated to research or when research effort is redistributed because
          of a reduction or increase of effort resulting from a sponsored program during the year.
    •     All income and designated responsibilities which are compensated by the KUMC payroll or the KUPI payroll must be included in the
          time/effort formula. This must include the time designated for clinical and administrative functions.
    •     At least semi annually, a notice will be sent by the Research Institute to all grant personnel listed on the KUMC payroll denoting a
          record of the proposed time/effort percentages which have initially been designated by the employee in the grant awards and letters
          of appointment.
    •     No employee may designate more than 100% effort. Most employees should leave a percent of effort for commitment of other
          Departmental assignments. Careful allocation, confirmed by the grant award(s) and semi annual confirmation reporting by the
          employee assures appropriate compliance.
    •     The employee or a Department designate agent who is knowledgeable about the employee effort may provide assurance of accuracy
          and reliability of responses.
    •     For individuals with salary over the NIH salary cap, the amount that exceeds the cap must be paid out of a R&D account or other non-
          federal sources.
    •     Employees who fail to comply with this policy will be provided with a reminder. If they do not respond, they may be subject to freezing
          of sponsored research accounts and disciplinary action may be recommended to the appropriate Dean.

Definitions:

Cost Sharing or Matching: The value of third party in-kind contributions and the portion of the costs of a federally assisted project of program
not borne by the Federal Government.

Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study
specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of
useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to
meet specific requirements.

Responsible Parties:

Employees receiving compensation from a sponsored project account.

Exemptions:

None.
Related Policies and Links:

KUMC Research Institute Policy 1.1.06: Facilities and Administrative Costs:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Facilities_Admin_Costs.pdf
KUMC Research Institute http://www2.kumc.edu/researchinstitute/
OMB Circular A-21 http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:

Original Issue Date: Spring 2005
Current Issue Date: 9/18/07
RAC approved: 10/31/07
Effective Date: 11/16/07
                                      COST ALLOWABILITY ON FEDERALLY FUNDED GRANTS
                                                       February 2008
                                                        Policy 2.1.03


Policy:

As an affiliate of an educational institution, the KUMC Research Institute adheres to federal cost accounting standards and therefore
follows the regulations set forth in the Office of Management and Budget (OMB) Circular A-21 on federally funded projects regarding
cost allowability.

Purpose:

Allowable costs are those that are reasonable to the project; allocable; consistent; and conform to the restrictions set forth in the OMB
Circulars and the guiding principles of the sponsoring agency. KUMC Research Institute has the responsibility to ensure that the costs
assigned to a sponsored project are allowable, applicable, reasonable, and treated in a consistent manner according to these costing
principles. Allowability of costs on federally funded projects is subject to the guiding principles set forth in OMB Circular A-21 Section J.

Procedures:

An allowable cost is a cost that has been accounted for in the terms of agreement for the project.
A reasonable cost is a cost that a prudent person would incur that is within the scope of the project.
An allocable cost is a cost that is directly related to the sponsored agreement that specifically furthers the work of the project.
A consistent cost is a cost that is treated in the same manner and placed in the same category as on other projects.

By applying prudent practices to costing decisions, one may determine whether a cost is allowable to a project. Questions to ask to
determine the allowability of a cost are:

-    Is the cost necessary for the continuation of the project?
-    Is the cost reasonable to the scope of the project?
-    Is there an “arm’s length” in the transaction to avoid conflict-of-interest issues?
-    Would the cost survive public scrutiny, i.e. the “front page” test?
-    Is the cost acceptable under the policies of KUMC Research Institute?

If any of the answers to the above questions in relation to your cost is “no”, the cost is not likely to be allowable. If an unallowable cost
has been applied to a federally funded project, the cost must be transferred off the project to a non-sponsored account. Examples of
unallowable costs on a federal grant include: alcohol, bad debt, bonding costs, cell phones, commencement and convocation costs,
contingency provisions, entertainment costs, goods or services for personal use, lobbying, and social club memberships. This is not a
comprehensive list; please refer to OMB Circular A-21 Section J for the full list.

For further clarification regarding the allowability of a cost against a sponsored project, contact Sponsored Programs Administration in
KUMC Research Institute: http://www2.kumc.edu/researchinstitute/spa/spastaff.html

Definitions:

Office of Management and Budget (OMB) A-21: Federal circular establishing principles for determining costs applicable to grants,
contracts, and other agreements with educational institutions.

Responsible Parties:

This policy shall apply to all KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of
Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing
research at KUMC.

Exemptions:

Exceptions may be made on a case-by-case basis as a specific term or condition of a federally sponsored agreement, or with the
written approval by the sponsoring agency.

Related Policies and Links:

OMB Circular A-21, http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259
Post Award Manager: 913-588-1260

History:

Original Issue Date: 2/14/2008
Current Issue Date: 2/14/2008
RAC Approved: 3/28/2008
Effective Date: 4/4/2008
                                       COST TRANSFERS ON FEDERALLY-FUNDED GRANTS
                                                        April 2008
                                                       Policy 2.1.04


Policy:

Upon being incurred, costs on a sponsored project must be allocated to the appropriate project. In the event a cost is applied to an
incorrect project, federal guidelines must be followed in order to correct the error.

Purpose:

Cost Transfers exist to correct errors on federal projects regarding allowability, or to correct clerical errors. Per OMB Circulars A-21
and A-110, allowability factors include reasonableness of the charge, allocability of the charge, and consistency. These factors need to
be adhered to when submitting a request for a cost transfer. An excessive number of cost transfers is a “red flag” for auditors; be
aware of how costs are being applied to a project.

Procedures:

    •     Prior approval is required from the Director of Sponsored Programs before the transfer of costs can occur. This approval must
          be in written form to provide a complete audit trail.
    •     Cost transfers must be supported by documentation and justification provided regarding the purpose of the transfer. The
          explanation must be specific and fully descriptive of the reason for the transfer.
    •     Cost transfers must be completed within 90 days of the original charge, or within 90 days of the discovery of errors.
    •     Transferring costs from one federally-funded project to another to correct cost overruns is not allowable.
    •     Contact your KUMC Research Institute Post-Award Administrator with questions:
          http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/accountant_list.xls

Definitions:

Cost Transfer: An after-the-fact reallocation of the cost, either salary or non-salary, to a sponsored project within a 90-calendar day
period from the accounting date of a transaction.

Office of Management and Budget (OMB) A-21: Federal circular establishing principles for determining costs applicable to grants,
contracts, and other agreements with educational institutions.

Office of Management and Budget (OMB) A-110: Uniform administrative requirements for grants and agreements with institutions of
higher education, hospitals, and non-profit organizations.

Responsible Parties:

This policy shall apply to all KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of
Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing
research at KUMC.

Exemptions:

For transfers involving non-federally funded grants, refer to specific sponsor guidelines.

Related Policies and Links:

KUMC Research Institute Expense Reallocation Request:
        http://www2.kumc.edu/researchinstitute/fas/asp/expense_reallocation_request.asp
NIH Grant Policy Manual: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm#_Toc54600120
OMB Circular A-21: http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
OMB Circular A-110: http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director for Sponsored Programs Administration: 913-588-1259
History:

Original Issue Date: 4/1/2008
Current Issue Date: 4/1/2008
RAC Approved: 4/30/2008
Effective Date: 5/6/2008
                                                        NO-COST EXTENSIONS
                                                             April 2008
                                                            Policy 2.1.05

Policy:

An extension of the final agreement period on a sponsored award may be granted to Principal Investigators (PI) without additional funds
being provided.

Purpose:

Sponsored agreements are written with the expectation that Principal Investigators will complete a project within a certain time frame.
When that time frame cannot be met, the PIs may request a time extension at “no cost”, meaning additional time will be provided to
complete the project, but additional funds will not be provided by the granting agency.

Procedures:

The PI submits a request to his or her KUMC Research Institute Post Award Administrator for a no-cost extension (click here to find out
who your Post Award Administrator is: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/accountant_list.xls ). The Post Award
Administrator will review the request for extension and if the request is justified seek sponsor approval as appropriate. A request is not
considered to be justified if the sole reason for the extension is to spend out the remainder of the funds in the grant.

The request for an extension should contain the following:
        i.        the amount of time being requested to complete the project;
        ii.       a statement explaining the necessity for a time extension;
        iii.      provide information regarding the expenditure of the balance of funds in the project.

If the request is granted, and a new end-date for the project given, all financial and invention reports must be submitted to the Post
Award Administrator no later than the required interval after the new award end-date to complete project close-out.

Responsible Parties:

This policy shall apply to all KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of
Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing
research at KUMC.

Exemptions:

Submitting a request for an extension does not guarantee an approval.

Related Policies and Links:

KUMCRI Request for No-Cost Extensions http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/no_cost_extenstions.asp

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 4/1/2008
Current Issue Date: 4/1/2008
RAC approved: 4/30/2008
Effective Date: 5/6/2008
                                                        SUBRECIPIENT MONITORING
                                                               April 2008
                                                              Policy 2.1.06

Policy:

The KU Medical Center Research Institute requires that subrecipients be monitored to ensure compliance with Federal laws, regulations and
requirements. The Principal Investigator is responsible for the supervision of the technical progress of the subaward.

Purpose:

Monitoring of subrecipients is a collective effort made by KUMC Research Institute staff, Principal Investigators and departmental staff, and the
subrecipient institution that occurs throughout the life of the subaward. For subawards of $500,000 or greater in a fiscal year, the Office of
Management and Budget Circular A-133 requires that subrecipients receiving Federally-funded subawards be closely monitored to ensure
Federal compliance requirements. As the Prime Funding Recipient, KUMC Research Institute is responsible for ensuring that procedures are
in place to monitor subrecipients on a consistent and timely basis, and to ensure audit requirements are fulfilled and any audit findings are
resolved.

KUMC Research Institute, as the pass-through entity for the subaward, has the responsibility of informing the subrecipient of all regulations
and requirements associated with the award. The responsibility also falls on the Research Institute to determine that a subrecipient meets all
criteria of eligibility.

Procedures:

Pre Award:
Principal Invesitgator:
- Includes subrecipient information in proposal
- Obtains sole source justification if necessary

Subrecipient:
Subrecipients must demonstrate that they are willing and able to comply with the requirements set forth in the award. This includes, but is not
limited to: financial system and internal control systems; conflict-of-interest; human and animal subjects approvals; the regulations of OMB
A133; and the skills, location and ability necessary to perform the requirements of the award.
          - Must meet eligibility determinations.
          - Pass debarment and suspension check (www.thefdp.org)
          - Be fully informed of all applicable laws and regulations.
          - Submit an official proposal to be included in the Prime Institution’s proposal:
                     - Statement of work and deliverables
                     - Budget and budget justification
                     - F&A and Fringe Benefits at approved Federal rate
                     - Cost Sharing commitment
                     - Approval signature of institutional official

Life of Award:
Principal Investigator:
The Principal Investigator (PI) of the Prime Institution is the individual with the education and experience to determine whether a subrecipient is
meeting its obligations of the subaward. Therefore, it is imperative that the PI be in regular communication with the subrecipient PI to track and
monitor technical progress.
          - Regularly tracking technical progress of subrecipient
          - Regular contact with the subrecipient Principal Investigator
          - Review and certify invoices

Subrecipient:
- Meets all compliance regulations
- Submits detailed invoices on time
- Regular reporting of progress
- Provides annual review of audit status and take corrective action if necessary.
        - Document when corrective action will be taken
        - Document that actions will be consistent with A133 requirements

Post Award Administrator:
- Tracking that subrecipient is submitting invoices on time
- Monitoring Invoices
         - Invoices arrive on a pre-determined schedule (i.e.; monthly)

                                                                          1
        - Correct level of detail is provided (itemized)
        - Adequate documentation is provided
        - Review to be sure there are no duplicate costs or invoices
        - Items invoiced are in accordance to OMB A-110
        - Invoices arrive within the time frame of the subaward
        - Expenses coincide with research performance
        - Invoices are certified by an institutional official at the subrecipient site.
        - Obtains PI certification to process payment
- Annual review of audit reports. If there are findings, follow up on corrective actions.

Close Out:
Principal Investigator:
- Review deliverables (technical reports and other items)
- Review final invoice
- Final invention/patent report, if applicable
- Final technical report

Subrecipient:
- 90 days before the award end date, communicate with Prime if the project will be completed on time
- File an audit report (or equivalent)
- Submit invoice marked as “Final”
- Submit all close out reports no later than 60 days after subaward end date

Post Award Administrator:
- 30 to 90 days before the award end date, request an itemized invoice marked “FINAL”.
- Obtain all required reports from the subrecipient
- Settle any disputed or unallowable costs
- Verify fulfillment of cost sharing commitments
- Verify compliance with Research Records Retention Policy
- Verify the subrecipient has filed an audit report (or equivalent)

Foreign Entities:
- Consider fixed price contracts
- Determine how fluctuating currency rates will be addressed
- Review U.S. Dept of Commerce Bureau of Security and Industry’s Denied Persons List: http://www.bis.doc.gov/dpl/default.shtm

Definitions:

Debarrment and Suspension: Actions taken by the federal government (Executive Order 12549 and FAR 521.209-5) against organizations or
individuals who have committed fraud or a criminal offense in violation of federal law. Institutions are not allowed to contract with these
organizations or individuals where federal funds are involved.

Denied Persons List: A list of individuals and entities that have been denied export privileges. Any dealings with a party on this list that would
violate the terms of its denial order is prohibited.

Office of Management and Budget (OMB) A-133: Circular establishing standards for obtaining consistency and uniformity among Federal
agencies for the audit of States, local governments, and non-profit organizations expending Federal awards.

Prime Institution: Applicant institution which has been awarded the primary grant, contract, or cooperative agreement.

Sole Source Justification: A written statement that the vendor chosen for procurement is the only vendor that is capable of supplying the
commodity or service; the “sole source”. This may occur when the goods or services are specialized or unique in character.

Subaward: An award of financial assistance in the form of money, or property in lieu of money, made under an award by a recipient to an
eligible subrecipient or by a subrecipient to a lower tier subrecipient. The term includes financial assistance when provided by any legal
agreement, even if the agreement is called a contract, but does not include procurement of goods and services.

Subrecipient: The legal entity to which a subaward is made and which is accountable to the recipient for the use of the funds provided.

Vendor: A dealer, distributor, merchant or other seller providing goods or services that are required for the conduct of the research.

Responsible Parties:

The Principal Investigator is ultimately responsible for the monitoring of subrecipient progress and adherence to established regulations.

Exemptions:

For subawards less than $500,000 in a fiscal year, a financial questionnaire may be completed by the subrecipient in lieu of an audit.


                                                                         2
Related Policies and Links:

Executive Order 12549: http://www.epa.gov/isdc/eo12549.htm
Federal Acquisition Regulation: http://www.arnet.gov/far/
Federal Demonstration Partnership: www.thefdp.org
KUMC Research Institute Policy 7.1.08: Research Records Retention:
          http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Records_Retention.pdf
Office of Management and Budget A-133: http://www.whitehouse.gov/omb/circulars/a133/a133.html
U.S. Department of Commerce Bureau of Security and Industry’s Denied Persons List: http://www.bis.doc.gov/dpl/default.shtm

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:
Original Issue Date: 4/1/2008
Current Issue Date: 4/1/2008
RAC approved: 4/30/2008
Effective date: 5/6/2008




                                                                      3
                                                          AUTHORIZATIONS
                                                            February 2008
                                                             Policy 2.1.09

Policy:

Only the Principal Investigator (PI) and appropriately designated personnel have authority over expenditures and management of funds
(Grants, Contracts, Research and Development [R&D] Accounts, Other) held by the KUMC Research Institute.

Purpose:

The number of persons allowed access to funds is limited in order to safeguard the funds and satisfy audit requirements.

Procedures:

Complete and submit a KUMC Research Institute authorization form designating signature authority:
http://www2.kumc.edu/researchinstitute/fas/asp/authorization_form.asp

Responsible Parties:

The Principal Investigator named on the grant is ultimately responsible for assuring all expenditures against the grant are in compliance
with sponsor and KUMCRI policies and procedures.

Exemptions:

In an emergency, a department chair, dean or other administrator of the Medical Center may have access to the grant funds with the
approval of the Executive Vice Chancellor.

Related Policies and Links:

KUMC Faculty Handbook http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/faculty_handbook_06_02_05.pdf
KUMC Research Institute Authorization Form http://www2.kumc.edu/researchinstitute/fas/asp/authorization_form.asp
KUMC Research Institute Policy 1.1.01: PI Eligibility http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 2/14/2008
Current Issue Date: 2/14/2008
RAC Approved: 3/28/2008
Effective Date: 4/4/2008
                                        PRINCIPAL INVESTIGATOR CHANGES OR ABSENCES
                                                          August 2008
                                                          Policy 2.1.11

Policy:

When the Principal Investigator (PI) who has been granted a sponsored award or is participating in other funded research including
privately funded clinical trials is unavailable to fulfill his or her obligations to the award agreement, the sponsoring agency or the project
sponsor, in collaboration with the University of Kansas Medical Center (KUMC) will decide the course of action for the remaining terms
of the award.

Purpose:

Procedures must be followed to ensure the continuation of a project or to transfer a grant to another institution when a PI leaves KUMC
for another university. The sponsoring agency and/or the project sponsor will make the determination as to whether the award or
contract will remain with the University or be allowed to be transferred. If the sponsoring agency or the project sponsor, in collaboration
with the University, accepts a substitute PI for the completion of the project at KUMC, the project will remain.

If the PI is taking a leave of absence from the project, the sponsoring agency requires advance notification so that a substitute PI may
be approved, or a decision made to terminate the project early. For Federal projects, the Office of Management and Budget circular A-
110 states that the absence of a PI for three (3) months or more, or for 25% of the project, requires prior approval from the federal
sponsor. For non-federal projects, refer to the sponsoring agency as requirements may differ. Overall, the procedure will be the same.

Procedures:

I. Transferring an existing grant or contract to another institution:
The PI should contact the KUMC Research Institute Sponsored Programs Administration Post-Award Administrator regarding an
intention to transfer the grant as the procedures for transferring a grant to another institution vary per sponsor.

Before a grant or contract can be transferred, KUMC/KUMC Research Institute must be able to “relinquish” the grant or contract. The
applicable forms relating to early termination of a project should be completed and submitted to Post-Award at the KUMC Research
Institute so that the award can be closed out: 6003 Wescoe Pavilion, MS 1039.

The PI should communicate with the equivalent Sponsored Programs Administration contact at the new institution regarding the new
institution’s requirements for submitting a grant or contract transfer.

II. Notification of change in primary Principal Investigator:
Notify your KUMC Research Institute Post-Award Administrator of a sabbatical or extended leave of absence that will affect the project.
Post-Award changes of the PI require written approval from the sponsoring agency, including sponsor approval of the substitute PI.

Definitions:

Close Out: A procedure to officially conclude a grant. Institute staff must assure that necessary scientific, administrative, and financial
reports have been received, implemented and documented in compliance with federal records management policy.

Grant: financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or
activity.

Office of Management and Budget (OMB) A-110: Uniform administrative requirements for grants and agreements with institutions of
higher education, hospitals, and non-profit organizations.

Responsible Parties:

This policy shall apply to all KUMC Research Institute staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other
persons at KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or
coordinating or managing research at KUMC.

Exemptions:

None

Related Policies and Links:

KUMC Research Institute NIH/DHHS Grant Transfer Guidelines
      http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/steps_for_transferring_a_grant_to_another_institution.html


                                                                      1
KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility
      http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
KUMC Research Institute Policy 2.1.16: Close Out, http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Close_Out.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 08/06/2008
Current Issue Date: 08/06/2008
RAC Approved: 09/24/2008
Effective Date: 09/29/2008




                                                                2
                                                          PROGRAM INCOME
                                                            October 2007
                                                            Policy 2.1.13

Policy:

Program income generated as a result of sponsored projects activities is required to be disclosed to the KUMC Research Institute by
the Principal Investigator.

Purpose:

Income generated on sponsored projects during the project period is reportable per Office of Management and Budget Circular A-110.
Certain income may not be required to be reported to federal sponsors, but all program income is required to be reported to KUMC
Research Institute’s financial officers. This policy is applicable to both federal and nonfederal projects for consistency in reporting.

Program income includes, but is not limited to:
-   Conference or workshop fees;
-   Fees for services, such as laboratory fees;
-   Sale of supplies or equipment purchased or fabricated with project funds;
-   Funds generated from the use, sale, or rental of equipment purchased with project funds;
-   Sale of software, tapes or publications;
-   Royalties from copyrights and patents;
-   Charges for research resources.

Procedures:
Requirements to report program income to sponsors
Reportable: Program income that is generated while a project is active, to be reported on the Financial Status Report of the primary
grant or contract.

Not reportable: Program income that is generated after the time period of the award does not need to be reported to the sponsor unless
otherwise specified. Program income generated as a result of royalties or other income earned from a copyrighted work, patents, or
from inventions.

Sale of Equipment: If authorized by the sponsor, grantees may use the income from the sale of equipment to pay for allowable costs of
the project. There are no reporting requirements for the sale of equipment.

Sale of Property: The guidelines of KU Medical Center shall be followed regarding the dispensation of funds upon the sale of property.

Use of Program Income
Per OMB A-110, program income earned during the project period shall be retained by the recipient and, in accordance with Federal
awarding agency regulations or the terms and conditions of the award, shall be used in one or more of the ways listed in the following:
    -   Additive: Added to the funds committed to the projected by the Federal awarding agency and recipient and used to further
        eligible project or program objective.
    -   Matching: Used to finance the non-Federal share of the project or program.
    -   Deductive: Deducted from the total project or program allowable cost in determining the net allowable costs on which the
        Federal share of costs is based.

If an alternative use of the above is desired, then approval from the sponsor is required.

Roles and responsibilities
Principal Investigators:
-    Disclose in the proposal whether program income may result from the project;
-    If multiple grants are involved, provide the approximate per cent of the costs associated with the income generation paid for by
     each grant;
-    Identification of any non-federal source of funds used to produce the income;
-    The fee structure or basis for the expected or actual amount of income;
-    Disclosure of program income received during the course of the project if not accounted for in the proposal;
-    Detail how program income will be used;
-    Track and confirm program income on financial reports;
-    Inform Sponsored Programs Administration if income is expected after the end of the project.

Department:
-  Assist PI in monitoring program income on financial reports;
-  Assist PI in administrative duties, such as invoicing, receiving funds, and recording program income.
Post Award Administrator:
-   Confirm that program income has been recorded properly and correctly in financial reports;
-   Set up program income accounts;
-   Determine if program income should be reported to the sponsor and report if required;
-   Monitor departments on invoicing, receiving funds, and recording;
-   Determine if use for program income is allowable;
-   At close out, confirm any outstanding program income issues have been addressed and resolved.
-   If the program income is determined to not be accountable under A-110, then the income may be deposited in a restricted fee
    account established through the University Budget Office.

Based on the federal regulations the Research Institute will provide instructions to the departmental grant administrator (DGA) on the
process to be implemented for the management of any amounts determined to be program income.

Definitions:

OMB A-110: Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, and non-
profit organizations.

Program Income: Per OMB A-110, program income is gross income earned by the recipient that is directly generated by a supported
activity or earned as a result of the award. Program income includes, but is not limited to, income from fees for services performed, the
use or rental of real or personal property acquired under federally-funded projects, the sale of commodities or items fabricated under
an award, license fees and royalties on patents and copyrights, and interest on loans made with award funds. Interest earned on
advances of Federal funds is not program income. Except as otherwise provided in Federal awarding agency regulations or the terms
and conditions of the award, program income does not include the receipt of principal on loans, rebates, credits, discounts, etc., or
interest earned on any of them.

Responsible Parties:

Principal Investigators

Exemptions:

This policy does not apply to funds generated through programs from non-sponsored programs. Unless federal agencies or sponsors
indicate otherwise, this policy does not include non-reportable program income.

Related Policies and Links:

KUMC Research Institute Policy 1.1.01: Principal Investigator:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part8.htm?Display=Text
OMB Circular A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259

History:

Original Issue Date: 10/31/07
Current Issue Date: 10/31/07
RAC approved: 11/28/07
Effective Date: 12/11/07
                                                                   CLOSE OUT
                                                                  September 2007
                                                                   Policy 2.1.16

Policy:

Timely submission of the final financial and final technical/performance reports are required to account for the final activities and expenditures
against an award upon the termination of a project.

Purpose:

Sponsors require timely reporting at the official conclusion of a project. Failure to submit a financial report within the specified time frame
exposes the University of Kansas Medical Center (KUMC) to the risk of remedial actions being imposed. Close out is a shared effort between
KUMC Research Institute staff, KUMC Principal Investigators and departmental staff, and sponsoring agencies. The procedures set forth in
this policy are to offer general guidelines to ensure a successful close out. Specific guidelines may be obtained from your Post Award
Administrator, as requirements vary per sponsor.

The proper close out of an award is also important for audit purposes. Close out of a grant does not automatically cancel any requirements for
property accountability, record retention, or financial accountability. Following close out, the grantee remains obligated to return funds due as a
result of later refunds, corrections, or other transactions, and the Federal Government may recover amounts based on the results of an audit
covering any part of the period of grant support.

Procedures:
                                                              I. Non-Clinical Trials
Post Award Administrator
-Sixty (60) calendar days before award end date, send out notification to department and Principal Investigator(s);
-Request final invoices from subrecipients and review, then submit for payment processing;
-Submit final invoices to sponsors;
-Clean up encumbrances;
-Remind department to remove personnel from sponsored project;
-Check outstanding charges (i.e. Inter-departmental Billing, Service Centers, etc);
-Check cost matching requirements and make sure support documentations are in the file;
-Deficit balances on an account must be cleared before the sponsored project can be closed; contact the PI and the department to clear the
deficit;
-Surplus balances are usually cost refundable; however, depending on the sponsor, some surplus balances may be transferred into an
unrestricted fund;
-Collect and review all applicable reports;
-Submit final Financial Status Report, performance and other required reports to sponsoring agency no later than ninety (90) calendar days
after award end date.

Principal Investigator(s)
-Review final expenditures and subrecipient reports;
-Submit final Inventions/Patent Report, if applicable; and
-Submit final Technical/Performance Report.
-If a deficit balance is left on the account, PI/Dept has sixty (60) calendar days after the grant end date to clear the deficit. If the deficit remains
after this time, the Research Institute will transfer the deficit amount to the department R&D account.

Department Responsibilities
Assist Principal Investigator(s) with review of financial reports. A financial review considers the following:
-   Are the expenses allowable, allocable, and reasonable?
-   Are cost transfers required? If so, submit a cost transfer request.
-   Are expenditures supported with the appropriate documentation?
-   Are the expenditures in the correct budget category?
-   Have expenditures been treated consistently?
-   Are subcontracts complete and paid or the encumbrances closed or moved off the grant?
-   Have cost matching requirements been met and recorded in the PeopleSoft Financial System?
-   Are deficit balances on the project transferred to department account? The PI/Dept has sixty (60) calendar days before the close of the
    project to clear deficit accounts.

                                                           Federal Awarding Agencies
Performance Reports detailing the accomplishments of the project compared to the objectives and the findings, or both. The PI should also
give reasons why the goals of the project were not met, if applicable.

Financial Status Report and, if applicable, Report of Federal Cash Transactions. Federal awarding agencies may request additional
information.

Final reports are due ninety (90) calendar days after the expiration or termination of the award. Failure to submit timely and accurate final
reports may affect future funding to the organization or awards with the same PI.
                                                      Non-Federal Awarding Agencies
Contact your Post Award Administrator for sponsor guidelines indicated in the award.

                                                           II. Clinical Trials
Closing Clinical Studies
To close a study with Human Subjects Committee:
-   Complete Continuing Review form http://www2.kumc.edu/researchcompliance/forms/HSC_Continuing_Review.doc
-   Checkmark termination (at end of Section II),
-   Obtain PI’s signature, and
                                                          th
-   Submit original to Clinical Research Administration, 6 floor Wescoe, MS 1039.

Financial Reconciliation of Clinical Studies
-   Fill out Reconciliation form http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/reconciliation_memo.doc, and
                                                                                        th
-   Submit to Sponsored Programs Administration, Clinical Studies Reconciliation, 6 floor Wescoe, MS 1039.

Definitions:

Award: The provision of funds based on an approved application and budget, to an organizational entity or an individual to carry out an activity
or project. This includes both direct and indirect costs (F&A) unless otherwise indicated.

Close Out: A procedure to officially conclude a grant. Institute staff must assure that necessary scientific, administrative, and financial reports
have been received, implemented and documented in compliance with federal records management policy.

Sponsor: Individual or organization that provides funds to a project.

Responsible Parties:

KUMCRI staff, Principal Investigators and departmental staff.

Exemptions:

None.

Related Policies and Links:

KUMC Research Institute http://www2.kumc.edu/researchinstitute/

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Sponsored Programs Administration: 913-588-1259
Director of Clinical Trails Administration: 913-588-0082

History:

Original Issue Date: 9/26/07
Current Issue Date: 9/26/07
RAC approved: 10/31/07
Effective Date: 11/16/07
                                           CONTRACTING FOR CLINICAL TRIALS
                                                     March 2007
                                                     Policy 3.1.01

Policy

The University of Kansas Medical Center Research Institute, Inc. (KUMCRI), also referred to as KUMC Research Institute, is the
official legal entity authorized by The University of Kansas Medical Center (KUMC), Kansas University Physician Incorporated
(KUPI) and it’s affiliated entities, and the University of Kansas Hospital Authority (KUHA) to manage, sign, and administer grants
and contracts for research and extramurally funded programs. The KUMCRI shall contractually serve as the “Institution”.

Purpose

On June 28, 1991, The University of Kansas Medical Center (KUMC) approved the establishment of the Division of Clinical
Trials Research. The goal was to provide administrative assistance to KUMC faculty in conducting clinical trials, seek research
proposals, and increase funding resources for research at KUMC. In 1993, the KUMCRI, a 501 (c)(3) not for profit corporation,
was established to advance the research mission of KUMC by establishing policies and procedures for funded research,
outreach to the community and industry to increase research, and ensure timely transfer of technology developed from the
research at KUMC.

In November of 1995 by reaffirmation of the Executive Vice Chancellor, Donald Hagen, MD, the KUMCRI was charged with the
responsibility of managing all privately funded research, including the management and allocation of both indirect costs and the
appropriate spending of direct costs associated with research.

As of January 1, 2005, the KUMCRI charge was expanded to managing all funded research and extramurally sponsored
programs. More information about the mission and the Divisions and offices within the KUMCRI can be found on the KUMCRI
website, http://www2.kumc.edu/researchinstitute/ .

                             Non-exclusive Indicators for Administration/Management by KUMCRI:

         Award is from a Federal or government entity (including any flow-thru award provisions).
         Award is from the private sector (including individuals) for the work of a specific faculty member, and the work is
         characterized by programmatic objectives that are to be accomplished within a specific time and budget framework.
         The sponsor places restrictions on publication of data from studies supported by the agreement such as a requirement
         for a manuscript, publication or presentation.
         The sponsor requests proprietary rights in data or inventions resulting from activities conducted under an agreement.
         This includes any proprietary rights and/or references to licensing arrangements for patents or copyrights developed as
         a consequence of the activity.
         Studies that are to be conducted on products/processes owned by the sponsor.
         The award comes with expectations, or the sponsor places restrictions on the use of funds/and or retains the right to
         revoke the award.
         The sponsor requires regular financial reports and/or progress reports on the use of funds.
         The sponsor participates in determining the work to be performed or services to be provided.
         The sponsor requires that any unused funds should be returned.
         Stipends are being paid to the subject from the award/grant/agreement.

Procedures

                                                 General Contracting Principles

Compliance with research regulations/law and local IRB policy & procedure
All contracting parties must agree that the obligations under research agreements including without limitation the conducting of
the study, shall be performed in compliance with all applicable Federal, State, University, Research Institute and local, laws,
rules and regulations. This shall include but not be limited to the regulations of the Food and Drug Administration (FDA) and
Form FDA 1572 (when applicable), Statement of the Investigator to follow the protocol, Department of Health and Human
Services (DHHS), Office of Management and Budgets applicable circulars, and other Federal funding agencies.
Notwithstanding the foregoing, the Institution is not certified for Good Laboratory Practices under 21 C.F.R. 58.

All contracting parties must agree that the obligations under any agreement shall be performed in compliance with DHHS
regulations as adopted by the local institutional review board (KUMC Human Subjects Committee [HSC]) policy & procedures.
Contract negotiation with Industry
Academia encourages teaching, freedom on the expression of ideas and results of data, equitable intellectual property
provisions, and providing benefit to the public. Industry is motivated by the competitive advantage for getting a product to
market and prefers to protect its proprietary information. Therefore, contracting with industry requires a balance to be
maintained between the mission and policies of the University and the interests of industry. KUMCRI negotiates contracts
provided by sponsors, or the KUMCRI will provide model contract templates upon request.

Human Research Standards
The University of Kansas Medical Center, The University of Kansas Medical Center Research Institute, Kansas University
Physician Incorporated and its affiliated entities, and the University of Kansas Hospital abide by all applicable federal, state laws
and regulations including institutional policies and procedures regarding human research.

Governing Law
KUMCRI and its affiliates dictate that agreements shall be governed by and construed in accordance with the laws of the State
of Kansas, without regard to the conflict of laws or principles thereof.

Liability
KUMCRI requires industry sponsored contracts to include indemnification language such as the following:

               Sponsor agrees to defend, indemnify and hold harmless the University of Kansas Medical Center
               Research Institute, Inc., University of Kansas Medical Center, Kansas University Physicians, Inc.
               and its affiliates, University of Kansas Hospital Authority, Principal Investigator and duly authorized
               agents or employees of these entities, or other qualified persons working under their direction from
               any and all claims, demands, actions, causes of action suits, equitable and legal of whatsoever
               kind or nature, including all damages, losses, claims predicated on a defective product theory,
               judgments, costs, fees (including reasonable attorneys' fees), based on personal injury (including
               death) or damage to property arising from or pertaining to the activities to be carried out pursuant to
               this Study; provided, however, that the following is excluded from Sponsor’s obligation to indemnify
               and hold harmless:

     a.        the willful or negligent failure of the Institution or Principal Investigator to comply with any
              applicable governmental requirements or to adhere to the material terms of the Study Protocol or
              as the Study Protocol may be subsequently amended by Sponsor; or
     b.       the failure of the Principal Investigator to comply with the written instructions of the Sponsor
              provided they are consistent with the Study Protocol.

Patents
The KUMCRI’s patent policies cover inventions and discoveries made by the University of Kansas Medical Center faculty,
employees and affiliates in the course of their work at the KUMC. When inventions and/or discoveries are made as part as
sponsored research, they fall under the patent policies. KUMCRI acknowledges a sponsor’s prior proprietary standing in
determining the applicability of its policies and acknowledges that in some cases both the sponsor and the institution may make
intellectual contributions to an invention or discovery and shall be owned jointly by the Institution and Sponsor.

Principal Investigator (PI)
The PI is not a party to the agreement, but shall serve as the agent for the institution and signs and acknowledges the
agreement by signature.

Proposal and Budget Preparation
A proposal and budget for a research project will be developed in a manner suited to the sponsor’s requirements and/or PI costs
(when applicable) following KUMCRI policies and procedures. The budget items usually include the following items: salaries and
fringe, materials and supplies, equipment (when applicable), other direct costs such as services (i.e. tests and procedures) and
facilities and administrative costs. More information regarding clinical trial budgets and fees are located at on the Clinical
Research Administration website under “Information for Industry” called Clinical Trials Fact Sheet and KUMCRI SPA website.

Publications and Confidentiality
The KUMCRI on behalf of the University of Kansas Medical Center and affiliates described in this policy, including KU Hospital
must ensure that its faculty, staff, and students may disseminate results of original research in a timely manner. Additionally
KUMCRI recognizes the International Committee of Medical Journal Editors (ICMJE) policy for posting on a website and asks
that sponsors properly register the study and provide evidence of such registration. At the same time KUMCRI acknowledges
the need to preserve intellectual property and to safeguard the sponsor’s proprietary information.

In the case when the KUMCRI has agreed to accept a sponsor’s proprietary information for use in the research project or if the
patent or copyright belong to the sponsor, publication can be deferred for a limited period of time, normally forty-five days. This
allows the sponsor to review and comment. KUMCRI will give the sponsor the option of receiving an acknowledgement in any
publication for its sponsorship of the research. In certain cases, a publication or presentation is delayed for up to ninety days in
order to permit filing of a patent application on the subject matter contained in the material proposed for public dissemination.
Sponsor Insurance (for industry sponsored studies)
The KUMCRI will require the sponsor to maintain adequate liability insurance. A copy of the sponsor’s insurance certificate may
be requested.

Subject Injury
All subject injuries are to be reported per Federal regulations. Research subjects will be provided with any and all medical
treatment reasonably necessary for any injury sustained as a direct result of research procedures. The compensation of
research related injuries section of the contract will include who takes responsibility to pay for such injury and thus shall match
the IRB (HSC) approved section of the consent form. The institution (KUMCRI) requests that pharmaceutical sponsors agree to
reimburse research subjects for the cost of medical treatment reasonably necessary for any injury sustained as a direct result of
research procedures performed in accordance with the protocol.

Subject Safety
The sponsor will promptly report findings to the Institution that could affect the safety of participants, affect the willingness of
subjects to continue participation, affect the conduct of the study, or alter the HSC’s approval to conduct the study per the
Federal Regulations.

The Institution will promptly report findings to the sponsor that could affect the safety of participants or findings that may affect
their willingness to continue participation per the Federal Regulations.

In summary, industry funded or industry sponsored trials start with the KUMCRI Clinical Research Administration Division. All
studies or extramurally funded programs involving research proposal paperwork (Federal or Private) start with the KUMCRI
Sponsored Programs Administration Division. Both Divisions work collaboratively to ensure proper set up procedures are
followed and flow information through their respective databases. A flowchart called Clinical Trials Processing Flowchart is
located on the KUMCRI Clinical Research Administration website under “Information for Industry”.

                                                           Types of Contracts
      A.   Industry-Sponsored Clinical Trials or PI Initiated research with Industry Funding
                1. Contact the KUMCRI Clinical Research Administration (CRA) Division for assistance with study set-up.
                     Provide copies of all information received from the sponsor except for case report forms by placing in the
                     RI/CRA “in box” on 6 Wescoe. Electronic documents can be sent to cra@kumc.edu
                     The CRA Division assigns a project manager called a Clinical Trials Administrator. This person will ensure
                     that all set up elements are complete, including reviewing the consent, budget, and contract for consistency.
                2. The CRA Division will start a file with the Contracts Office of the KUMCRI once a final protocol is received in
                     the Division.
                3. A KUMCRI “good to go” e-mail will be sent to the Principal Investigator and study staff when all set-up
                     requirements have been met (HSC approval, fully executed contract, and administrative approvals via the
                     research administration checklist).
      B.   Clinical Trials Agreements – Federal or Private using partial KUMCRI/CRA Division Services
                1. a. If the clinical research starts at proposal stage: turn in a signed and completed Research Administrative
                     Approval Checklist at the proposal stage with the required attachments to 6014 Wescoe. The checklist and
                     list of required attachments is located on the KUMCRI Sponsored Programs Administration (SPA) website
                     under forms, http://www2.kumc.edu/researchinstitute/spa/
                     b. If the award starts as a contract for service, contact the KUMCRI/Clinical Research Administration Division
                     and/or deliver the documents to the KUMCRI CRA Division mailbox on 6 Wescoe or e-mail to
                     cra@kumc.edu
                2. Once a high scientific score is received, a just in time notification is received or the Coordinating Center or
                     Agency requests IRB submission, contact the KUMCRI/Clinical Research Administration (CRA) Division for
                     assistance with study set-up. Provide copies of all information received from the sponsor except for case
                     report forms.
                               a. The KUMCRI CRA Division may assist with all services described on our website or partial
                               services.
                               b. If the KUMCRI CRA Division is only providing partial service assistance, provide the contact
                               information and/or contract to the CRA incoming box on 6 Wescoe. Electronic documents can be
                               sent to cra@kumc.edu.
                     The KUMCRI CRA Division assigns a project manager called a Clinical Trials Administrator. This person will
                     ensure that all set up elements are complete, including reviewing the consent, budget, and contract for
                     consistency.
                3. The CRA Division will start a file with the Contracts Office of the KUMCRI once a final protocol is received in
                     the Division.
                4. A KUMCRI “good to go” e-mail will be sent to the Principal Investigator and study staff when all set up
                     requirements have been met (HSC approval, a fully executed contract, if a contract is applicable, and
                     administrative approvals via the research administration checklist).
      C. Clinical or Behavioral Research Proposals start with the KUMCRI SPA Division
              1. Turn in a signed and completed Research Administrative Approval Checklist at the proposal stage with the
                   required attachments to 6014 Wescoe. The checklist and list of required attachments is located on the
                   KUMCRI SPA website under forms, http://www2.kumc.edu/researchinstitute/spa/
              2. KUMCRI SPA will review the information provided. If changes are needed, the PI/staff will be contacted.
              3. When the review is complete and accepted by KUMCRI SPA, the proposal documents will be returned to the
                   PI/staff to be sent to the funding agency.
              4. Final HSC approval will be confirmed before final award/contract or grant acceptance.

Definitions

Award: The provision of funds based on an approved application and budget, to an organizational entity or an individual to carry
out an activity or project. This includes both direct and indirect costs (F&A) unless otherwise indicated.

Clinical Trial: Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or
other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent
to assess the agent's safety and efficacy.

Direct Costs: Costs that can be specifically identified with a particular project(s) or activity. Examples of research project-
specific expenses include expenses for equipment, personnel, travel, and other expenses necessary to carry out a research
project.

Facilities and Administrative (Indirect) Cost: Costs that are incurred by a grantee for common or joint objectives and that,
therefore, cannot be identified specifically with a particular project or program. These costs were previously known as "indirect
costs”.

Gift or donation: a voluntary and irrevocable transfer of money, services or property (i.e. equipment, money, personnel time,
etc.) from a donor without any expectation of or receipt of direct economic benefit or provision of goods or services from the
recipient.

Grant or contract: an agreement formalizing the transfer of money or property from a sponsor or funding agency in exchange for
specified services (i.e. research and development), sometimes including proprietary rights to and products derived from the
services, and including financial and/or technical reporting by the recipient as to the actual use of the money or results. The
agreement is enforceable by law, and performance is usually to be accomplished within a specified time frame.

HSC: Human Subjects Committee.

Patent: property right granted by the Government of the United States of America to an inventor “to exclude others from making,
using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for
a limited time in exchange for public disclosure of the invention when the patent is granted.

Protocol: A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must
be approved by an IRB before investigational drugs may be administered to humans.

Principal Investigator (PI) or Project Director (PD): All faculty may serve (exercise the privilege of being named) as a PI or
project director on proposals submitted for external support. Unclassified professional staff may qualify to serve as PI; however,
justification to designate a person other than a faculty member as principal investigator must be approved by the appropriate
chair, dean, and Vice Chancellor for Research or other designee prior to submission of a proposal for external funding. The PI is
responsible for compliance with all the specific requirements of both the sponsoring agency and KUMC. In all cases, institutional
approval must be obtained prior to the submission of the application to the funding agency. In accordance with NIH guidelines,
multiple KUMC faculty members may be designated as co-PI’s who share the authority and responsibility for leading and
directing the projects, intellectually and logistically. Each faculty co-PI is responsible and accountable to the applicant
organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the
submission of all required reports. The presence of more than one identified faculty PI or co-PI’s on an application or award
diminishes neither the responsibility nor the accountability of any individual PI.

Research: Including, but not limited to, investigational studies of drugs or devices, laboratory studies, student research,
behavioral, and outcomes research.

Sponsor: a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or
pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor
does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
Responsible Parties:

This policy shall apply to the KUMCRI sponsors contracting with KUMCRI, all KUMC faculty (regardless of appointment type),
staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of Kansas Physicians Incorporated
and it’s affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing research at KUMC.

Exemptions:

None.

Related Policies & Links:

International Committee of Medical Journal Editors http://www.icmje.org/
KUMC Faculty Handbook http://www2.kumc.edu/aa/fa/Default.htm
KUMC Policies and Procedures http://www.kumc.edu/guides/policyguide.html
KUMC Research Institute http://www2.kumc.edu/researchinstitute
KUMC Office of Compliance http://www2.kumc.edu/compliance/

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Director of Clinical Research Administration: 913-588-1242

History:

Original Issue Date: 3/28/07
Current Issue Date: 3/28/07
RAC approved 4/10/07
Effective Date: 8/20/07
                                                        SUBJECT INJURY PAYMENT
                                                              August 2007
                                                              Policy 3.1.02


Policy:

It is the policy of the University of Kansas Medical Center Research Institute, Inc. (KUMCRI) that for all clinical studies involving
pharmaceutical compounds, experimental devices, or other research involving more than minimal risk, whether publicly or privately
sponsored, whether investigational or marketed pharmaceuticals, all participating subjects will be provided with any and all medical
treatment reasonably necessary for any injury or harm sustained as a direct result of research procedures conducted in accordance
with the research protocol at the Sponsor’s expense. If there is a disagreement between the Sponsor and the KUMCRI, and the Human
Subjects Committee approved informed consent is properly signed by the participating subject, then the informed consent shall control
the payment for subject related injuries.

Purpose:

The University of Kansas Medical Center Research Institute is dedicated to the protection of persons who participate in research as
human subjects. Protecting subjects requires respecting and enforcing regulations that prohibit the requirement of subjects to waive
their rights to compensation, and proactively use methods reasonably calculated to provide for direct medical care of a subject without
any need for legal recourse by a subject.

The purpose of this policy is to define what treatment and compensation will be provided to research subjects as a result of a research-
related injury. This policy is necessary in order to conform with Federal regulations. These regulations require that prospective subjects
be provided with information “for research involving more than minimal risk, an explanation as to whether any compensation and an
explanation as to whether any medical treatments will be provided if an injury occurs and if so, what they consist of, or where further
information may be obtained.” Those regulations also prohibit any informed consent, oral or written, from including “any exculpatory
language through which the subject or the representative is made to waive or appear to waive any of the subjects’ legal rights, or
releases or appears to release the investigator, the sponsor, the institution, or its agents from liability or negligence.” (The Code of
Federal Regulations [CFR] is the codification of the general and permanent rules published in the Federal Register by the executive
departments and agencies of the Federal Government: 45CFR46.116; 21CFR50.20 http://www.gpoaccess.gov/cfr/index.html)

Procedures:

As a part of the clinical study setup and/or the clinical trial agreement negotiations, the sponsor will be required to pay for treatment of
illness or injury suffered by a research subject that directly results from participation in the research. The following language will be
required in all industry sponsored research contracts:

“In addition to its obligations under (“Indemnification”) of this Agreement, Sponsor agrees to reimburse any research subject, or Institute
as applicable, for the costs of medical care provided to address, diagnose and/or treat adverse events and other injuries directly arising
from a subject’s participation in the Study, including medically appropriate follow-up. The Sponsor shall not delay or withhold
reimbursement from any such subject based on the belief than an adverse event or resultant medical care was due to the negligence of
Institute or Investigator, or their failure to follow the Protocol.

“The parties recognize that research subjects’ participation in clinical studies may require additional testing or clinical care that is not
covered by the subjects insurance, managed care, or governmental payers on the grounds that the testing or care is experimental or
related to research. The parties also agree that it is ethically imperative, as well as practically appropriate in reducing Sponsor’s
potential liabilities for indemnification as provided in this Agreement, that Institute and/or Principal Investigator may provide such
additional testing and care in appropriate cases. Therefore, both Institute and Principal Investigator (in his or her clinical capacity)
reserve the right to invoice Sponsor for the cost of such additional testing or care, provided in connection with or as a consequence of
the subject’s participation in the Study, provided that such care is in their reasonable judgment medically indicated; that it is or would be
excluded by the subject’s health care coverage, if any; provided that the condition requiring care is not caused by the negligence or
willful malfeasance of the Principal Investigator or Institution; and provided that the Principal Investigator document(s) the condition and
the charges. Sponsor agrees that it shall pay such charges in addition to any other payments required in this Agreement.”

In addition, no clinical trial contract shall permit the sponsor to limit its own indemnification, or shift to subjects its indemnification risks
with respect to claims or causes of action that arise from the conduct of the sponsor, whether related to the manufacturing, distribution
or quality of a test article, or with respect to the actions of the sponsor in design, conduct and reporting of the research.

In situations where the cost of research-related treatments could be covered by a subject’s insurance, insurance may be billed
consistent with applicable laws, agreements, and regulations.
Definitions:

Adverse Event (AE): A negative experience encountered by an individual during the course of a clinical trial that is associated with the
drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been
determined to be related to the investigational product, it is considered an Adverse Drug Reaction.

Clinical Trial: Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other
pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the
agent's safety and efficacy.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains 1) Data
through intervention or interaction with the individual, or 2) Identifiable private information.

Sponsor: a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical
company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually
conduct the investigation unless the sponsor is a sponsor-investigator.

Responsible Parties:

This policy shall apply to the KUMCRI sponsors contracting with KUMCRI, all KUMC faculty (regardless of appointment type), staff,
postdoctoral fellows, students, trainees, and any other persons at KUMC, University of Kansas Physicians Incorporated and it’s
affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing research at KUMC.

Exemptions:

None

Related Policies and Links:

21CFR50.20 http://www.cfsan.fda.gov/~lrd/cfr50.html
45CFR46.116 http://a257.g.akamaitech.net/7/257/2422/13nov20061500/edocket.access.gpo.gov/cfr_2006/octqtr/45cfr46.116.htm
Code of Federal Regulations http://www.gpoaccess.gov/cfr/index.html
KU Medical Center Office of Compliance Human Subjects Committee http://www2.kumc.edu/researchcompliance/human.htm
KU Medical Center Research Institute Clinical Trials Administration Serious Adverse Event Information
http://www2.kumc.edu/researchinstitute/cra/crasaeinfo.htm

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Corporate Counsel and Contracts Office Division Director: 913-588-2617

History:

Original Issue Date: 8/22/07
Current Issue Date: 8/22/07
RAC approved: 9/26/07
Effective Date: 11/15/07
                                               SPONSOR REPORTING OF ADVERSE EVENTS
                                                           October 2007
                                                           Policy 3.1.03


Policy:

The Sponsor of any clinical trial shall promptly report all findings to the Principal Investigator that could affect the safety of participants,
affect the willingness of the subjects to continue participation, affect the conduct of the study, or alter the Human Subject Committee’s
approval to conduct the study per the Federal Regulations. If the Sponsor discovers results from the research study that directly affect
safety or medical care of current or former participants, the sponsor shall notify the organization of those results.

Purpose:

The University of Kansas Medical Center Research Institute has an ethical obligation to protect human subjects involved in clinical trials.
The proper reporting by all parties involved to KUMC’s local IRB, the Human Subject Committee, ensures compliance with safety
regulations in place to protect human subjects. KUMCRI also adheres to the Federal Regulations protecting human subjects.

21CFR312.32* states:
       The sponsor shall notify all participating investigators in a written IND safety report of:
       (A) Any adverse experience associated with the use of the drug that is both serious and unexpected; or
       (B) Any finding from tests in laboratory animals that suggests a significant risk for human subjects... Each notification shall be
           made as soon as possible and in no event later than 15 calendar days after the sponsor’s initial receipt of the information.

* The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the
executive departments and agencies of the Federal Government: http://www.gpoaccess.gov/cfr/index.html

Procedures:

    -     For Serious Adverse Events, notify FDA within 7 calendar days via fax or telephone; AND notify FDA and investigators within 15
          calendar days by IND Safety Report.
    -     For Routine Event Reporting, notify FDA and investigators within 15 calendar days by IND Safety Report.
    -     If the Sponsor discovers results that directly affect the safety of medical care of current or former participants, the Sponsor notifies
          the organization through the Principal Investigator and the Contracting Entity (the KUMC Research Institute).

Definitions:

Adverse Event (AE): A negative experience encountered by an individual during the course of a clinical trial that is associated with the
drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been
determined to be related to the investigational product, it is considered an Adverse Drug Reaction.

Clinical Trial: Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other
pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the
agent's safety and efficacy.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains
1) Data through intervention or interaction with the individual, or, 2) Identifiable private information.

Sponsor: a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical
company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct
the investigation unless the sponsor is a sponsor-investigator.

Responsible Parties:

This policy shall apply to the KUMCRI sponsors contracting with KUMCRI, all KUMC faculty (regardless of appointment type), staff,
postdoctoral fellows, students, trainees, and any other persons at KUMC, University of Kansas Physicians Incorporated and it’s affiliates,
and KU Hospital staff involved in conducting and/or coordinating or managing research at KUMC.

Exemptions:

None

Related Policies and Links:

21CFR312.32 http://edocket.access.gpo.gov/cfr_2002/aprqtr/21cfr312.32.htm
Code of Federal Regulations: http://www.gpoaccess.gov/cfr/index.html
KU Medical Center Office of Compliance Human Subjects Committee http://www2.kumc.edu/researchcompliance/human.htm
KU Medical Center Research Institute Clinical Trials Administration Serious Adverse Event Information
        http://www2.kumc.edu/researchinstitute/cra/crasaeinfo.htm

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:

Original Issue Date: 10/24/07
Current Issue Date: 10/24/07
RAC approved: 11/28/07
Effective Date: 12/11/07
                                              REIMBURSEMENT OF TRAVEL EXPENSES
                                                         August 2007
                                                         Policy 6.2.01


Policy:

The University of Kansas Medical Center Research Institute adheres to federal, state and sponsor guidelines when processing travel
reimbursements. All travel requests on KUMC Research Institute funds, including federally-funded and privately-funded projects, shall
contain appropriate approvals and be properly reported.

Purpose:

This policy serves to ensure that those who travel on KUMC Research Institute official business are compliant with federal and state
regulations and sponsor guidelines. Per IRS guidelines, all Travel is subject to withholding. Exemptions exist to waive this
withholding requirement in the IRS Accountable Plan Rules which state that travel expenses must have a clear business
connection and be properly documented with expenses submitted in a reasonable amount of time after travel.

Procedures:

Per State of Kansas regulations, any State of Kansas employee embarking on travel on behalf of KUMC or KUMCRI is required to seek
approval for Out-of-State or International Travel. To do so, complete the Pre-Travel Process modules in PeopleSoft prior to travel. See
“Pre-Approval Procedures” in the KUMC Travel Procedural Reference Guide: http://www2.kumc.edu/finance/pdf/Travel.pdf

Medical evacuation and repatriation insurance is provided for all faculty and staff traveling abroad for business; see KUMC International
Programs for further details and contact information: http://www.kumc.edu/international/

When embarking on travel using funds within the KUMC Research Institute, use common sense and good judgment regarding what is
or is not a legitimate business expense. For further information regarding the allowability of items, please see the Travel Procedures:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Travel_Procedures.pdf

Original and itemized receipts, with the appropriate authorizing signatures, are to be submitted to the KUMC Research Institute
Accounts Payable office after the expenses have been entered into the PeopleSoft Travel Module.

Any expenses outside the scope of the travel and allowances for the travel will be borne by the traveler.

Every Principal Investigator (PI), faculty member, or other authorized person for an account at the Research Institute must understand
that his or her signature serves as certification that the requested expense, to the best of his or her knowledge, is furthering the mission
of the University of Kansas Medical Center.

Any payment to an individual requires the signature of the payee and the authorizing signature of the payee’s supervisor, department
chair, or other university administrator. Individuals may not authorize their own reimbursement, per IRS regulations.

Definitions:

Domestic Travel: United States and its territories (American Samoa, Guam, Northern Marianna Islands, Puerto Rico, Virgin Islands).

International Travel: Any travel not defined as Domestic, including Canada and Mexico.

Per Diem: meals and incidental expenses.

Responsible Parties:

Employees of the KUMC, KUMC Research Institute and its affiliates, consultants and research participants traveling on KUMC
Research Institute official business.

Exemptions:

If a department or sponsor has a more restrictive travel policy, then the department or sponsor policy takes precedence.

Related Policies and Links:

Internal Revenue Service, Publication 463 Travel, Entertainment, Gift, and Car Expenses http://www.irs.gov/pub/irs-pdf/p463.pdf
KUMC PeopleSoft Travel Procedural Manual, http://www2.kumc.edu/finance/pdf/Travel.pdf
KUMC Research Institute Policy 1.1.01: Principal Investigator Eligibility:
      http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
KUMC Research Institute Travel Procedure 6.2.01: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Travel_Procedures.pdf
KUMC Research Institute Travel Rates: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Travel_Rates.pdf
KUMC Research Institute Travel FAQs: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Travel_FAQ.pdf
KUMC Research Institute Policy 6.1.06: Payments to Non-employee Nonresident Aliens
      http://www2.kumc.edu/researchinstitute/spa/documents/Nonresident_Alien_Policy.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Controller: 913-588-5749

History:

Original Issue Date: 8/24/07
Current Issue Date: 10/06/09
RAC approved: 11/28/07
Effective Date: 12/12/07
                                              TRAVEL: PROCEDURES
                                                         Procedure 6.b.01
                                                   Original Issue Date: 8/24/2007
                                                   Current Issue Date: 4/22/2009

The KUMC Research Institute (RI) will reimburse persons traveling with funds held by the RI on a “no loss, no gain” basis; in other
words, a traveler should neither lose nor gain personal funds as a result of travel utilizing funds held within the RI. A part of the
IRS Accountable Plan requires that policies and procedures for reimbursable expenses be applied consistently. Thus, the
following is being presented as a guideline for meeting this particular criterion of the IRS Accountable Plan. Additionally, the RI is
accountable to the taxpaying public as well as sponsors that funds are being used appropriately. All travel is ultimately governed
by the rules and regulations of the funding source.


Pre-Travel:
   -   Pre-approval is required; allow yourself plenty of time to gain approval before you expect to leave
   -   Additional pre-approvals may be required for any travel including personal days (see below for further instructions
       regarding combining personal days with business travel).
   -   Complete the Pre-Travel Process Modules in PeopleSoft.
   -   Check U.S. Dept of State International travel warnings list if International travel is planned:
       http://travel.state.gov/travel/cis_pa_tw/tw/tw_1764.html
   -   If traveling Internationally, allow yourself time to obtain a passport, or visa, if applicable
   -   Travel arrangements are made at the most economical rates unless otherwise justified and should utilize the most direct or
       usually travelled route.
   -   Air travel arranged on U.S.-flag air carriers except when unavailable or requires excessive number of flight changes

During Travel:
  -    Maintain documentation: original, itemized receipts
  -    Collect conference or meeting materials that provide the dates and location of the function
  -    Document business versus personal days, if applicable

Post-Travel (Reporting):
  -    Traveler must report and substantiate travel expenses within 60 days of travel
  -    Traveler and an authorized designee has signed the travel voucher
  -    Documentation collected during travel, including flight itinerary, should be attached
  -    If meals are being reimbursed, claim either per diem or submit actual original, itemized receipts
  -    For conferences, submit a detailed agenda showing meals that were provided at the conference
  -    Submit original, itemized receipts
  -    KUMC travelers: complete PeopleSoft Travel Module and submit documentation to RI Accounts Payable department
  -    KUMC Research Institute travelers: submit expenses to RI Accounts Payable department

Allowable and Unallowable Costs:
Allowable:
         -  Alcoholic beverages charged to residual accounts*
         -  Business entertainment charged to residual accounts*
         -  Checked baggage charge assessed by the airline as a requirement (not additional checked baggage fees)
         -  Conference Fees
         -  Currency Conversion Fees
         -  Gasoline; may not be claimed in addition to mileage
         -  Internet access fees when used for official business only
         -  Lodging
         -  Mileage
         -  Meals. NB: The Research Institute makes individual determinations on how much will be reimbursed for meals
            based on what is usual and customary for the city and location in which the expense has been incurred.
            Reimbursement amounts for meals will be reduced if it is considered to be excessive or extravagant, in order to
            comply with IRS Accountable Plan Rules.
         -  Miscellaneous expenses incurred for business purposes while on travel (photocopying, supplies, etc)
         -  Parking. Parking will be reimbursed at the most economical rate unless otherwise justified.
         -  Per Diem, except for same-day, local travel. NB: Per Diem is reimbursed per trip; one cannot claim per diem one day
            and actual expenses the next day.
         -  Taxi/limo/shuttle service while on official business if reasonable and customary
         -  Tips
         -  Tolls
         -  Transportation costs
         -  Vehicle rental where the expense is justified and the most economical mode of transportation.
Unallowable:
        -    Additional costs due to the accompaniment of a spouse and/or family members
        -    Airline Airport Club fees
        -    Airline Upgrades
        -    Alcoholic beverages except as provided for above
        -    Baggage Handling. *Exception: ADA (Americans with Disabilities Act) travelers may claim reimbursement for
             assistance with baggage handling.
        -    Cancellation fees due to a traveler’s failure to cancel reservations in a timely manner
        -    Chartered flights on NSF grants
        -    Child Care
        -    Credit Card membership fees
        -    Formal wear, evening-wear rental expenses
        -    Honoraria
        -    Insurance on airfare
        -    Laundry, dry cleaning, shoe shining service
        -    Mileage between home and official workstation
        -    Non-business entertainment
        -    Parking or traffic fines
        -    Per Diem for same-day, local travel
        -    Personal liability insurance on vehicle rental
        -    Room service, mini-bar, in-room movies, pay-per-view, fitness facilities, spa packages
        -    Souvenirs/Gifts
        -    Taxi/limo service for personal, non-business use
        -    Valet parking
        -    Vehicle Rental where the cost exceeds other modes of transportation (ex: shuttle, taxi, etc.)
        -    Other Personal expenses


                                               Reimbursement to non-employees
         Consultants, participants and other business guests are required to substantiate their travel according to the same
guidelines as KUMC and Research Institute employees, including original itemized receipts. The traveler is required to sign the
documentation and obtain respective KUMC department approval by means of an authorized signature.

                                             Reimbursement to Foreign Nationals
          IRS Accountable Plan Rules stipulate that travel reimbursements to Nonresident Aliens require the same practices as
travel reimbursements to U.S. citizens and resident aliens, with the exception of obtaining a SSN or ITIN from the Foreign National
if s/he does not already possess one.

                                         Faculty who Terminate Employment with KUMC
         When faculty or staff terminate employment with KUMC, it may happen that the department is later notified of an
outstanding travel credit or pending travel plans for the employee. On such occasions, any outstanding credits must be applied
back to the grant from which the funds originated. If the grant funds are no longer accessible (i.e., has been closed out), the funds
must be returned to the sponsor.
         Any outstanding travel plans should be cancelled by the department as quickly as possible and a refund requested.
These funds would also be applied back to the grant from which payment had originated.

                                                    Non-Federal Sponsored Funds
         Expenses charged to a non-federal sponsored account will be reviewed for reasonableness by the RI Accounts Payable
Office and Division of Sponsored Programs and a determination made on a case-by-case basis. If the charge is determined to be
reasonable, the full amount may be charged to the non-federal sponsored account. If the charge is determined to be
unreasonable, the request for reimbursement on the item(s) will be returned to the department and will need to be charged to a
residual account.

                                                           Business Entertainment
          Business Entertainment is defined as social gatherings or social events designed for networking or discussing research
in a relaxed atmosphere. Business entertainment expenses will be reimbursed from F&A (indirect) funds as long as the costs are
reasonable and customary for the city in which the expense occurs. Required documentation for reimbursement includes: original
itemized receipts; a guest list including the names of the individuals and the institution they represent; a copy of a flier or
announcement of the event, if applicable; and, a description of the purpose for the gathering.

 *Residual Accounts: A Residual Account is created for each Principal Investigator (PI) to hold remaining funds from closed and
                                     completed industry sponsored project accounts.

                                                          International Travel
         Pre-approval from the Research Institute Executive Director or Chief Financial Officer is required before a traveler
embarks on international business. Pre-approval from the sponsor may also be required for International Travel.
         A detailed itinerary is required for International travel, with each day designated as either business or personal. Any
travel day(s) to and from the destination where KU Medical Center business will be conducted are business days. Any non-travel
day where at least four (4) hours are spent conducting KU Medical Center business is considered a business day.
         When you combine Personal Travel with Business Travel internationally, the traveler should keep in mind that there is
a personal tax liability issue if BOTH of the following conditions are met (Internal Revenue Service Publication 463: Travel,
Entertainment, Gift, and Car Expenses):
     1. The total period of the trip is longer than one week, and
     2. At least 25 percent of the trip is personal
In the event that both conditions are met, a portion of the common business expenses that are reimbursed to the traveler,
including airfare, is taxable to the traveler. This requirement applies to travel outside the 50 United States and the District of
Columbia.
         If a traveler does choose to combine personal travel with business travel internationally, the following guidelines will also
apply:

         Airfare
                   •   Airfare reimbursement will be prorated if personal travel exceeds 25% of the travel.
                   •   If the additional personal days increase the cost of the ticket, the traveler is responsible for paying the
                       difference.
                   •   Travelers will be responsible for any additional costs resulting from use of indirect routes or stops for
                       personal reasons.
                   •   Travelers must provide quotes for lowest available airfare for the direct route to your business location for
                       comparison. The traveler will be limited to the cost of the travel by the lower of the direct route to the
                       business destination or the actual airfare; the traveler will bear any additional costs.
                   •   If any portion of the vacation precedes the business period and the business portion is canceled, the trip
                       will be considered vacation and the traveler will be responsible to pay for all travel costs.

         Rental Car
                 •     The most economical rental vehicle will be reimbursed, if the procurement of a rental vehicle is deemed to
                       be necessary to the purpose of the business event, for the portion of the trip that is official business. If any
                       personal days are included, reimbursement will be prorated based on the number of days used for personal
                       and the number of days used for business.
                   •   The State of Kansas does not carry insurance coverage for travelers on personal travel. The KUMCRI will
                       not reimburse travelers for additional vehicle insurance coverage.

         Subsistence Expenses
                 •   When personal days precede the start of official business, reimbursement for lodging and meals (per diem)
                     will begin with the first official business day. Travelers may only request up to 75% reimbursement on that
                     first day of official business.
                 •   When personal days occur after the conclusion of official business, reimbursement for lodging and meals
                     (per diem) will end on the last day of official business. Travelers may only request up to 75%
                     reimbursement on that last day of official business.
                 •   Individual travelers are limited to reimbursement of the single room rate. If a family member or other non-
                     business related person stays in the room with the traveler, it is the traveler's responsibility to have the
                     hotel indicate the single room rate on the receipt at the time of check-out.
                 •   Airport or hotel parking will be reimbursed only for the days of business travel.


                                        Personal Travel combined with Business Travel (Domestic)
          When vacation/personal leave is combined with a business trip, travel is reimbursed only when it is clearly established
that the business travel is the primary consideration; in other words, the majority of the trip must be for business per IRS
guidelines (Internal Revenue Service Publication 463: Travel, Entertainment, Gift, and Car Expenses). Use of vacation/personal
time while on business travel must be clearly indicated on the travel itinerary.
          KUMC Research Institute Executive Director or Chief Financial Officer approval must be obtained for airfare
reimbursement if personal travel exceeds one week. Expenses in excess of the business travel costs are unallowable costs
and may not be charged to a sponsored project. Following are guidelines travelers must be aware of when combining personal
travel with business travel on funds held by KUMC Research Institute:

         Airfare
                   •   Airfare reimbursement will be prorated as appropriate if personal travel is greater than business travel.
                   •   If the additional personal days increase the cost of the ticket, the traveler is responsible for paying the
                       difference.
                   •   Travelers will be responsible for any additional costs resulting from use of indirect routes or stops for
                       personal reasons.
                   •   Travelers must provide quotes for lowest available airfare for the direct route to your business location for
                       comparison. The traveler will be limited to the cost of the travel by the lower of the direct route to the
                       business destination or the actual airfare; the traveler will bear any additional costs.
                   •   If any portion of the vacation precedes the business period and the business portion is canceled, the trip
                       will be considered vacation and the traveler will be responsible to pay for all travel costs.
Rental Car
        •    The most economical rental vehicle will be reimbursed, if the procurement of a rental vehicle is deemed to
             be necessary to the purpose of the business event, for the portion of the trip that is official business. If any
             personal days are included, reimbursement will be prorated based on the number of days used for personal
             and the number of days used for business.
        •    The State of Kansas does not carry insurance coverage for travelers on personal travel. The KUMCRI will
             not reimburse travelers for additional vehicle insurance coverage.

Subsistence Expenses
        •   When personal days precede the start of official business, reimbursement for lodging and meals (per diem)
            will begin with the first official business day. Travelers may only request up to 75% reimbursement on that
            first day of official business.
        •   When personal days occur after the conclusion of official business, reimbursement for lodging and meals
            (per diem) will end on the last day of official business. Travelers may only request up to 75%
            reimbursement on that last day of official business.
        •   Individual travelers are limited to reimbursement of the single room rate. If a family member or other non-
            business related person stays in the room with the traveler, it is the traveler's responsibility to have the
            hotel indicate the single room rate on the receipt at the time of check-out.
        •   Airport or hotel parking will be reimbursed only for the days of business travel.
                                          TRAVEL RATES
                                    MILEAGE REIMBURSMENT RATE:

   Effective for travel beginning on or after January 1, 2009, the IRS mileage reimbursement rate is
                                  $0.55/mile for personal vehicle miles.

    Travel commencing July 1, 2008 through December 31, 2008 will be reimbursed at $0.585/mile.


                                            MEAL TIMES

            Breakfast                          Lunch                           Dinner
        6.30AM - 9.00AM                   11.00AM - 2.00PM                5.00PM - 8.00PM
Example: If you begin your travel
before 6.30AM but no later than
     9:00AM, you may claim
 reimbursement for this meal. If
    you begin your travel after
   9.00AM, you may not claim
  reimbursement for this meal.

                 Meals included in registration fees cannot be claimed for reimbursement.


                                DOMESTIC PER DIEM RATES:
  Meal and Incidental Expenses (M&IE) rates may be found at U.S. General Services Administration
                                   website: www.gsa.gov/perdiem
                       Use the rates/amounts indicated in Column G (M&IE).

                                      Breakdown per location allowance:
                   M&IE         $46       $51      $56       $61       $66      $71
                 Breakfast      10        11       12        13        14       15
                  Lunch         13        14       15        17        18       20
                  Dinner        23        26       29        31        34       36



                              INTERNATIONAL PER DIEM RATES:
           Meal and Incidental Expenses rates may be found at the U.S. Dept of State website:
                             http://aoprals.state.gov/web920/per_diem.asp

                             Use the rates/amounts indicated in column M&IE.

                                         Breakdown on International:
                                               Breakfast 25%
                                                Lunch 25%
                                                Dinner 50%

                                                                                                10/01/09 dm
                                                 TRAVEL FAQ’s

Q: I need another copy of the travel manual; where do I find it?
A: http://www2.kumc.edu/finance/pdf/Travel.pdf

Q: How is meal Per Diem determined?
A: The Research Institute does not utilize the quarter system in order to reimburse per diem. Please refer to the
KUMC Research Institute Travel Rates page for an example of time frames.

Q: Is Per Diem just an allowance for meals?
A: The Per Diem rate covers meals, tips, and other incidental expenses incurred while on official travel.

Q: Does the Research Institute consider a “Continental Breakfast” as a provided meal?
A: No, a “continental breakfast” is not reportable as a provided meal, and the allowance will not be deducted
from your Per Diem.

Q: Is there a limit to how much the Research Institute will reimburse for a meal?
A: The Research Institute makes individual determinations on how much will be reimbursed for meals based on
what is usual and customary for the city and location in which the expense has been incurred. Reimbursement
amounts for meals will be reduced if it is considered to be excessive or extravagant, in order to comply with IRS
Accountable Plan Rules.

Q: If I am claiming Per Diem, but I didn’t eat a breakfast or lunch but I ate a large dinner that is more
than the dinner allowance cost on the “Meal Per Diem” chart, am I only allowed to claim the $22.00
dinner?
A: A Per Diem is just that: a Per Diem. Regardless of the meals you consume, or when, you may claim the full
days’ Per Diem for a full day of business travel as long as your “missed” meal(s) was not provided by a
conference, workshop, or a third party.

Q: My spouse attended a meal. Will the Research Institute reimburse for his/her meal?
A: If your spouse was part of the business discussion, i.e. is a faculty member, then yes, his/her meal will be
reimbursed. However if (s)he attended just as a guest, then his/her meal will not be reimbursed. As with any meal,
a list of attendees will need to be provided if actual costs are being reimbursed.

Q: Will the Research Institute reimburse me for alcoholic beverages charges?
A: Alcoholic beverages may be reimbursed from residual funds as long as the costs are reasonable. Original and
itemized receipts are required, along with a guest list and a copy of a flier for announcement of the event if
applicable.

Q: I am hosting a networking function. May I be reimbursed for this?
A: Business entertainment is defined as gatherings or social events designed for networking or discussing research
in a relaxed atmosphere. These expenses may be reimbursed from a residual account provided that the costs are
reasonable and customary for the city in which the expense occurs. Required documentation for reimbursement
includes: original and itemized receipts; a guest list including the names of the individuals and the institution they
represent; a copy of a flier or announcement of the event if applicable; and, a description of the purpose for the
gathering.

Q: I am claiming reimbursement for a meal, and the group was large enough that gratuity was added into
the total. However, the service was so exceptional, I included extra gratuity. May I claim reimbursement
for the additional gratuity?
A: No. The RI will not exceed the base gratuity in your reimbursement.
Q: I am claiming actual expenses for meals and I submitted my hotel receipt showing that I ordered room
service for my dinner. Why can’t I get that reimbursed?
A: When requesting reimbursement for actual expenses, it is the policy of the Research Institute that original and
itemized receipts be submitted. Hotel invoices are a summary of expenses and cannot provide itemization of the
meal(s). Therefore, when room service is ordered, the receipt that arrives with the meal must be retained and
submitted for reimbursement.

Q: What if I lost a receipt?
A: Because an itemized receipt is necessary for reimbursement, a lost receipt means the item(s) cannot be claimed
for reimbursement. Airlines, hotels, and some restaurants will provide copies of receipts; these copies can be
submitted in lieu of the original as long as the copies are accompanied by an explanation as to why the original
receipt is not available.

Q: Is there a limit as to how much the Research Institute will reimburse on lodging?
A: The RI will reimburse that which is usual and customary for that respective city. Lodging at the conference
hotel will be reimbursed at the conference rate. If the conference hotel is booked and accommodations are made
elsewhere, the RI will reimburse what is usual and customary. In this event, please provide an explanation in the
comments section of the travel module why accommodations were not booked in at the conference hotel.

Q: When entering my lodging in PeopleSoft, do I place all charges paid to the hotel in the “lodging”
category?
A: No. Only the room fees and any applicable lodging taxes should be placed in the lodging category. Any other
items, such as meals, parking, faxing, etc, should be placed in their appropriate categories.

Q: What does the mileage rate cover?
A: The reimbursable mileage rate covers gasoline, oil, maintenance, and other wear-and-tear on a personal vehicle
used in the course of official business.

Q: May I claim mileage from my home to the airport, or should I claim mileage from my official
workstation even if I leave from home?
A: The shorter distance will be determined, and mileage will be reimbursed at that rate.

Q: If I drive to a conference in lieu of flying, how do I figure my mileage reimbursement?
A: You will need to provide documentation regarding the price of airfare. Mileage and subsistence will be
reimbursed up to the rate that it would have taken an individual to fly if the cost of flying was the more
economical option.

Q: I am required to visit various locations throughout the city as a part of my job. How do I get reimbursed
for that mileage?
A: Please complete a mileage log recording the following:
        1. Dates traveled
        2. Starting point
        3. Destination
        4. Distance in miles
A blank mileage log in Excel format that you may use for this purpose may be found at:
http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/blank_mileage_log.xls

Q: Is the turn-around time for reimbursement of International travel the same as reimbursement for
Domestic travel?
A: No. International travel reimbursements generally take longer to process due to currency conversion. It may
take up to a week longer for International travel to be reimbursed, provided that everything is in order. The
reimbursement will be delayed if there are additional questions for the traveler.
Q: Which website does the Research Institute use to determine currency conversion?
A: The RI uses OANDA. Please utilize the “Typical Credit Card Rate” option.
www.oanda.com/converter/classic

Q: May I get my travel reimbursement direct-deposited?
A: Yes. In order to request direct-deposit of travel reimbursement, please contact a KUMC Research Institute
Accounts Payable Accountant for instructions and a form. All future reimbursements will also be direct-
deposited.

A list of AP Accountants may be found at: http://www2.kumc.edu/researchinstitute/fas/post-
award_and_acctg_staff.html

Q: Are travel cash advances given?
A: Not generally. Because the Research Institute is designed to directly pay travel agencies and conference
registrations, cash advances are not given. The Research Institute is also designed to reimburse an individual for
out-of-pocket expenses quickly so as not to cause undue hardship to a traveler, if the appropriate documentation is
submitted in a timely fashion.

Q: May I use a travel agency to book my travel?
A: The Research Institute would prefer that airline tickets be purchased directly from the airline or another online
service such as Expedia.com and paid via the traveler’s personal credit card. The Research Institute is designed to
reimburse an individual for out-of-pocket expenses quickly provided that the appropriate documentation is
submitted in a timely fashion. However, this does not restrict you from utilizing travel agencies; just be aware
that the Research Institute does not have accounts set up with any travel agencies, and that some funding agencies
may restrict where you may make your purchases (minority-owned businesses, etc).

Q: May I rent a vehicle when I arrive at my travel destination?
A: The Research Institute would prefer that you avoid renting a vehicle, and would prefer that you utilize public
transportation whenever possible. If the cost for public transport exceeds the price for a rental car, then the rental
of the vehicle would be justified. For example, if the cost of the taxi fare to and from SEA-TAC airport would
exceed the rate of a vehicle rental, and there are no hotel shuttles available, the rental would be acceptable. The
RI would require in writing that justification. The objective is to be as cost-effective as possible to save your
research dollars.

Q: The Research Institute had already paid for my airfare and registration but I didn’t go to the
conference. Do I need to reimburse the RI?
A: This will be decided on a discretionary basis. However, if the trip was not made due to negligence on the
traveler’s part, the traveler will be expected to reimburse the RI for the expenses. If the trip was cancelled due to
illness, family emergency, work emergency, flight cancellation, bad weather, or any other cause beyond the
control of the traveler, the RI will not expect the traveler to reimburse the expenses.
                                                           PURCHASING
                                                            February 2008
                                                             Policy 6.1.03


Policy:

KUMC Research Institute (KUMCRI) sponsored grants, contracts, and cooperative agreements must meet allowability standards of the
specific sponsor and auditing guidelines when purchasing within the KUMCRI system regardless of whether the purchase is made with
R&D, internal, or other funds established in the KUMCRI.

Purpose:

Office of Management and Budget Circular A-110 outlines procurement procedures for federally-funded projects. For non-federally
funded projects, specific sponsor guidelines will be followed.

Procedures:

Principal Investigator or approved designee signature indicates:
    -     The purchase is reasonable and necessary to the project.
    -     The purchase is at the lowest cost to the project, or is accompanied by a justification.
    -     The purchase meets SPA allowability policies.
    -     The purchase is within the scope and time frame of the project or existing account.
    -     There are ample funds available in the project/account for the purchase.
    -     Faculty resigning from KUMC will need to provide additional purchase justifications regardless of funding source.

Equipment:
    -  Any purchase between $25,000 and $50,000 requires 3 informal bids (telephone quotes, web-based information/quotes, fax
       quotes, etc).
    -  Any purchase greater than $50,000 requires sealed bids and advertising, per the KUMC formal bid process.
    -  Sole-source equipment purchases require a written justification.
    -  All equipment purchased with grants, clinical trials, or R&D accounts will become property of the Medical Center. The
       Research Institute transfers all such equipment to the Medical Center equipment registration office, and the equipment
       ultimately becomes the permanent property of the State of Kansas. Therefore, equipment may be considered for transfer to a
       faculty member’s future place of employment per KUMC guidelines, provided that certain conditions are met, and a State of
       Kansas Form DA-110 completed. For further instructions, please see Appendix A of the KUMC Property – Equipment
       Recovery Policy: http://www.kumc.edu/Pulse/policy/equipmentrecovery.html
    -  Equipment purchases made within the last six months of the project require special approval from the Vice Chancellor for
       Research.

Vendor Requirements:
   -    Funding sources may require the use of vendors in a specific category. Example: small businesses, minority-owned firms or
        women’s business enterprises.
   -    Purchases made with State funds are subject to State of Kansas purchasing guidelines (i.e. State contracts with vendors must
        utilize KUMC Purchasing for acquisition including split-funded purchases).

Purchasing Alternatives:
    -   Leases
    -   Equipment rental

Debarment:
   -   Any vendor/contractor who is debarred from receiving Federal Procurement may not contract with the Research Institute
       where Federal funding is involved, per Federal Acquisition Regulation subpart 9.4.

Definitions:

Equipment: means tangible nonexpendable personal property including exempt property charged directly to the award having a useful
life of more than one year and an acquisition cost of $5000 or more per unit.

Office of Management and Budget Circular A-110: Uniform administrative requirements for grants and agreements with institutions of
higher education, hospitals, and non-profit organizations.
Responsible Parties:

This policy shall apply to all KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC, University of
Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating or managing
research at KUMC.

Exemptions:

None

Related Policies and Links:

Federal Acquisition Regulation: http://www.arnet.gov/far/
KUMC Property – Equipment Recovery Policy: http://www.kumc.edu/Pulse/policy/equipmentrecovery.html
KUMC Purchasing Procedure Manual http://www2.kumc.edu/finance/purchasing/purch_proc_man.html
KUMC Research Institute Policy #1.1.01: Principal Investigator Eligibility:
         http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/PI%20Eligibility.pdf
State Of Kansas Form DA-110 (Disposition of Property): http://www.da.ks.gov/print/pdf/DA110form.pdf
OMB Circular A-110 http://www.whitehouse.gov/omb/circulars/a110/a110.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Controller: 913-588-5749

History:

Original Issue Date: 2/14/2008
Current Issue Date: 2/14/2008
RAC approved: 2/27/2008
Effective Date: 3/4/2008
                                       PAYMENTS TO INDEPENDENT CONTRACTORS
                                                   September 2008
                                                        6.1.04

Policy:

The University of Kansas Medical Center Research Institute (KUMCRI) is required to file Internal Revenue Service (IRS) Form
1099-MISC for payments to individuals for non-employee services that accumulate to $600.00 or more per tax year. IRS
regulations require the recording of payment data beginning with the first dollar paid. Therefore, it is necessary that the
KUMCRI distinguish between an employee and an independent contractor for tax reporting purposes.

Purpose:

During the course of a project, it is sometimes necessary for independent contractors to perform one-time or limited-time
services. Because the services may be for a short duration, or specialized, contracting for independent contractors is more
advantageous to a grant than hiring an employee to perform the duties. However, an independent contractor should only be
contracted for if an employee is neither qualified nor trained to perform the same duties.

An independent contractor is a person who has control over the means and methods of the work to be performed, but the payer
has the right to control or direct the work to be performed. An independent contractor is reimbursed for services through an
accounts payable financial system and issued an IRS Form 1099-MISC.

Independent contractors include speakers, presenters, collaborators, lecturers and other guests of the university who share their
expertise for a limited period of time. Professional Service providers such as attorneys, accountants, and architects, etc., are
not included in the definition of independent contractors for the purposes of this policy.

An employee is an individual over whom the payer has control over what work will be performed and how the work will be
performed. An employee is reimbursed for services through a payroll system and issued an IRS Form W-2.

Procedures:

    -     Verify with your Sponsored Programs Administration Post-Award Administrator that a budget line exists in the grant to
          reimburse independent contractors.
    -     Before work is allowed to begin, a contract must be completed and signed by the contractor and the
          department/authorized persons at University of Kansas Medical Center (KUMC).
    -     At the conclusion of the contract, the contractor should complete the KUMCRI Contractual Services Form. Only original
          forms with an original signature will be accepted:
          http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Contractual%20Service%20Form.doc
    -     The contractor should complete an IRS Form W-9: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/fillable_w-
          9_form.pdf.
    -     The contractor should submit a detailed invoice including description of service performed, dates of service performed,
          and dollar amount owed for services. NB: A copy of the contract is not considered an invoice.
    -     Department/Authorized Persons at KUMC certifies the Contractual Services Form by signing.
    -     Submit the KUMCRI Contractual Services Form, W-9, and invoice, accompanied by any applicable supporting
          documentation, to KUMCRI Accounts Payable at Mail Stop 1039.
    -     Refer to KUMC’s Conflict of Interest policy if the independent contractor is an entity owned by a KUMC employee or
          student, or a family member of a KUMC employee or student.

Definitions:

Independent Contractor: An individual or entity over whom the payer has the right to control or direct only the result of the work
performed, and not the means and methods of accomplishing the result.

IRS Form 1099: Informational return sent to the IRS to report various kinds of non-wage payments made to individuals. These
payments are not subject to tax withholdings but are considered taxable income and required to be reported to the IRS.

IRS form W-2: An employer automatically withholds and pays all of the necessary employee income taxes as required by the
IRS.

IRS form W-9: The standard form used by payers to collect tax identification information and certification.



                                                                 1
Responsible Parties:

This policy shall apply to all KUMCRI staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons
at KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or
coordinating or managing research at KUMC.

Exemptions:

Payments to nonresident aliens for independent personal services follow a different set of IRS tax rules. Please contact your
Sponsored Programs Administration Post-Award Administrator for guidelines on reimbursing a non-employee nonresident for
independent personal services: http://www2.kumc.edu/researchinstitute/spa/spastaff.html

Related Policies and Links:

IRS Form W-9: http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/fillable_w-9_form.pdf
KUMC Office of Compliance Institutional Conflict of Interest Policy http://www.kumc.edu/Pulse/policy/icoi.html
KUMC Research Institute Contractual Service Payment Form
        http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Contractual%20Service%20Form.doc
KUMC Research Institute Policy 6.1.05: Non-cash Research Subject Incentives
        http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/NonCash_Subject_Incentives.pdf
KUMC Research Institute Policy 6.1.06: Payments to Non-Employee Nonresident Aliens (In Process)

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Director of Sponsored Programs Administration: 913-588-1259
Controller: 913-588-5749

History:

Original Issue Date: 9/8/2008
Current Issue Date: 9/8/2008
RAC Approved: 10/22/2008
Effective Date: 10/28/2008




                                                                2
                                           NON-CASH RESEARCH SUBJECT INCENTIVES
                                                         May 2008
                                                        Policy 6.1.05


Policy:

Due to Internal Revenue Service tax reporting requirements, reimbursement requests for participants in a clinical trial require the
collection of specific information. KUMC Research Institute allows for flexibility in the method of reimbursing subjects as long as records
are complete and submitted in a timely manner.

Purpose:

Subjects participating in clinical trials for funded research are considered to be independent contractors, and may be compensated for
their services. With the appropriate documentation from the subject, compensation may take the form of a check, cash, or non-cash
subject incentive. Reimbursing a participant with a non-cash subject incentive for small amounts is sometimes more expeditious than a
check, and easier in certain circumstances. An example of a non-cash research subject incentive is a gift card (Visa gift card, WalMart
or Target gift cards, etc).

The KUMC Research Institute is required to file a 1099-MISC with the Internal Revenue Service for payments to any individual who
receives a total amount of $600.00 or more in a single tax year in the form of subject incentive payments. These payments may be
accumulated from participation in several projects, on several grants, and may be in the forms of cash, check, or non-cash subject
incentives. Therefore, complete documentation must be collected from the subject at the time of payment. IRS regulations require
collection of data at the time of payment, and this begins with the first dollar.

Research subject incentives are not to be used to influence outcomes of clinical research trials, or to be used merely to
inflate the number of persons in a clinical research trial. Such activity is a conflict of interest and corrupts research integrity.

A KUMC or KUMC Research Institute employee may participate in a clinical trial. The employee then becomes a subject for the
duration of the trial and may receive direct payment from the research project.

Research subject incentives are not employee incentives. Employee incentives are gifts reported through payroll.

Procedures:

Non-Cash Research Subject Incentives:
    -  A subject may only receive $100.00 compensation by means of non-cash research subject incentives for the duration of the
       study. A subject may receive compensation above $100 per study, but only $100 of the compensation may be made by means
       of a non-cash research subject incentive. The remainder of compensation, if any, should be paid via check.
    -  There are two options for purchasing by department personnel (PI, study coordinator, etc):
            •    A requisition may be entered in PeopleSoft payable directly to the Vendor.
            •    The use of a personal credit card after which a requisition is then entered into PeopleSoft reimbursing the purchaser.
    -  The KUMC BPC card is not an option when purchasing non-cash research subject incentives.
    -  At the time of purchase, the KUMCRI Subject Incentive Form must be completed and e-mailed to RINSTAP@kumc.edu, faxed
       to 913-588-5758, or accompany the request for payment. A voucher will not be processed for payment without this completed
       form. The form may be found at: http://www2.kumc.edu/researchinstitute/fas/forms/kumcri_subject_incentive_form.doc
    -  The following information must be collected from the subject and submitted to the Research Institute Accounts Payable office
       within five (5) working days of presenting a subject with a non-cash subject incentive:
                 Speed Type (Grant Number)
                 First and Last name of the subject
                 Complete home address of the subject, including street address, city, state and zip code
                 Social Security Number of the subject
                 Amount paid
                 Type of non-cash research subject incentive (WalMart gift card, Target gift card, savings bond, etc)
                 Forms may be found at the following websites: http://www2.kumc.edu/researchinstitute/fas/asp/rinst.asp, or in
                 spreadsheet format: http://www2.kumc.edu/researchinstitute/fas/forms/subject_incentive_form.xls
    -  If you have any questions regarding what is or is not considered a research subject incentive, contact your Post-Award
       Administrator before compensation is requested: 913-588-1251, or
       http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/accountant_list.xls

Definitions:

IRS Form 1099: Informational return sent to the IRS to report various kinds of non-wage payments made to individuals. These
payments are not subject to tax withholdings but are considered taxable income and required to be reported to the IRS.

                                                                    1
Non-cash research subject incentive: Cash-equivalent payment, such as a gift card or savings bond, for participation in a research
study.

Research Subject Incentive: Check, cash, or non-cash compensation for participation in a research study.

Responsible Parties:

This policy shall apply to all KUMC Research Institute staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other
persons at KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or
coordinating or managing research at KUMC.

Exemptions:

A waiver from collecting SSNs may be obtained when the nature of the research is such that the subjects either do not have SSNs, a
home address, or are not willing to divulge the information due to fear of reprisal or stigma. A detailed justification, in writing, may be
submitted to the Senior Deputy Director and Chief Financial Officer by the Project Investigator. The approval of the Controller or Senior
Deputy Director and Chief Financial Officer is required.

Related Policies and Links:

KUMC Office of Compliance http://www2.kumc.edu/compliance/
KUMCRI Subject Incentive Form http://www2.kumc.edu/researchinstitute/fas/forms/kumcri_subject_incentive_form.doc
KUMCRI Subject Payment Request: http://www2.kumc.edu/researchinstitute/fas/asp/subject_payment_request.asp

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Controller: 913-588-5749

History:

Original Issue Date: 6/4/2008
Current Issue Date: 6/4/2008
RAC Approved: 6/25/2008
Effective Date: 7/2/2008




                                                                     2
                                  PAYMENTS TO NON-EMPLOYEE NONRESIDENT ALIENS
                                                 December 2008
                                                   Policy 6.1.06

Policy:

Payments issued to nonresident alien individuals with funds held by University of Kansas Medical Center Research Institute may
be subject to federal and state income tax withholding per State of Kansas and Internal Revenue Service regulations.

Purpose:

The University of Kansas Medical Center Research Institute (KUMCRI) adheres to the regulations pursuant to Section 1441 of
the Internal Revenue Code which states that a withholding agent is required to withhold federal income tax from all payments
made to or on the behalf of a nonresident alien, and all such payments are to be reported to the Internal Revenue Service.

As of the 2008 calendar tax year, the State of Kansas required withholding on all payments to nonresident alien individuals
which are subject to federal withholding.

KUMCRI also adheres to the guidelines and regulations set forth by US Citizenship and Immigration Services when issuing
payment to a nonresident alien individual.

This policy encompasses payments that are processed through the KUMCRI accounts payable system. This includes
independent personal services such as speakers, presenters, collaborators, lecturers and other guests of the university who
share their expertise for a limited period of time, and non-service payments such as scholarships and fellowships, royalties,
prizes or awards.

Procedures:

Compensating nonresident aliens can be a confusing process due to the guidelines in place depending upon an individual’s
immigration status and tax situation. Therefore, a “Procedures” page has been created to assist departments in the preparation
of processing payments to nonresident alien individuals. The Procedures are intended to address issues and give guidance on
how to proceed with obtaining the necessary documentation in order to comply with reporting requirements.

           NB: Assume that every payment to a nonresident alien is subject to tax withholding until proven otherwise.

                           This policy is not and should not be used as formal tax or legal advice.

Definitions:

Nonresident Alien (Foreign National): A nonresident alien is an individual who is neither a U.S. citizen nor a resident alien; a
resident of a foreign country under the residence article of an income tax treaty is a nonresident alien individual for purposes of
withholding.

Resident Alien: Any person not a citizen of the United States who is residing the in the U.S. under legally recognized and
lawfully recorded permanent residence as an immigrant. Also known as "Permanent Resident Alien," "Resident Alien Permit
Holder," and "Green Card Holder."

Withholding Agent: A withholding agent is a U.S. or foreign person that has control, receipt, custody, disposal, or payment of
any item of income of a foreign person that is subject to withholding. A withholding agent may be an individual, corporation,
partnership, trust, association, nominee (under section 1446 of the Code), or any other entity, including any foreign intermediary,
foreign partnership, or U.S. branch of certain foreign banks and insurance companies. You may be a withholding agent even if
there is no requirement to withhold from a payment or even if another person has withheld the required amount from the
payment.

Responsible Parties:

Departments and individuals involved in the process of compensating nonresident alien individuals with KUMCRI funds.

KUMCRI and University of Kansas Medical Center faculty and staff shall adhere to federal guidelines regarding Foreign
Nationals.
Exemptions:

Tax treaties exist between the United States and some foreign governments that, with the completion of appropriate forms and
documentation, waive the withholding requirement or a portion thereof.

Tax is not withheld on foreign-sourced income.

Related Policies and Links:

Internal Revenue Code 1441
          http://ecfr.gpoaccess.gov/cgi/t/text/text-
idx?c=ecfr&sid=6fff7bde0158047bcddd0c04099dc6ba&rgn=div8&view=text&node=26:12.0.1.1.1.0.2.46&idno=26
IRS Form 8233, Exception from Withholding on Compensation for Independent (and Certain Dependent) Personal Services of a
          Nonresident Alien Individual http://www.irs.gov/pub/irs-pdf/f8233.pdf
IRS Form W-7, Application for IRS Individual Taxpayer Identification Number http://www.irs.gov/pub/irs-pdf/fw7.pdf
IRS Form W-8BEN, Certificate of Foreign Status of Beneficial Owner for United States Tax Withholding
           http://www.irs.gov/pub/irs-pdf/fw8ben.pdf
IRS Publication 515, Withholding of Tax on Nonresident Aliens and Foreign Entities
          http://www.irs.gov/publications/p515/index.html
KU Legal Services for Students, http://www.legalservices.ku.edu/
KUMC Office of International Programs http://www.kumc.edu/international/
KUMC Research Institute Contractual Services Form
          http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Contractual%20Service%20Form.doc
KUMC Research Institute Nonresident Alien Summary Form
KUMC Research Institute Procedure 6.a.06: Procedures
KUMC Research Institute Procedure 6.b.06: Visa Types

Contacts:

Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Director of Sponsored Program Administration: 913-588-1259
Controller: 913-588-5749

History:

Original Issue Date: 12/17/2008
Current Issue Date: 12/17/2008
RAC Approved: 02/25/2009
Effective Date: 02/27/2009
                                PAYMENTS TO NON-EMPLOYEE NONRESIDENT ALIENS
                                               Procedure 6.b.06
                                                  Original Issue Date: 12/17/2008
                                                        Updated: 8/1/2009


I.    Procedures
      A. If at all possible, before your guest arrives, please determine if your guest will be entering the country with a
         payable visa status/type. Certain visa statuses/types have restrictions that would prevent KUMC Research
         Institute (KUMCRI) from issuing payment to your guest:
           http://www2.kumc.edu/researchinstitute/spa/documents/Nonresident_Alien_Visa_Types.pdf

      B. After arrival, or at the time of participation in a Clinical Trial, have your guest complete the KUMCRI
         Nonresident Alien Summary Form:
          http://www2.kumc.edu/researchinstitute/spa/documents/Nonresident_Alien_Summary.pdf

      C. Be sure to obtain a copy of the I-94. The I-94 is required for payment for services performed in the U.S.
         Without the I-94, the visitor will not be eligible for payment because they will not be able to document
         their immigration status. The I-94 is collected upon departure from the U.S., so collecting this
         information after your guest leaves is impossible.

      D. Withholding
          1. Federal: 30%
          2. State of Kansas: 5%
          3. There is no de minimus

      E. Tax Treaties
          If the recipient’s tax country has an exemption from withholding due to a tax treaty, and the appropriate tax
          treaty exemption forms are completed and submitted to the KUMCRI’s Accounts Payable office in a timely
          manner, then the tax withholding or a portion thereof may be waived. Please be aware that changes can be
          made to tax treaties after the dates that the treaties are posted on the IRS website; search for
          announcements regarding changes in the tax treaty. Updates can be found under IRS Publication 901, U.S.
          Tax Treaties: http://www.irs.gov/publications/p901/index.html.
          A list of treaties may be found at:
                    http://www.irs.gov/businesses/international/article/0,,id=96739,00.html.
          If a tax treaty is in place between the United States and the nonresident alien’s tax country, the nonresident
          alien has an option of claiming the treaty, or not. If the treaty is claimed, the nonresident alien will need to
          obtain a SSN or ITIN and complete Form 8233, Exemption from Withholding on Compensation for
          Independent (and Certain Dependent) Personal Services of a Nonresident Alien Individual. If the treaty is
          not claimed, compensation will be subject to withholding.

      F. “Grossing Up”
         “Grossing Up” is not an allowable expense on a federally-funded project. The RI does not allow “grossing up”
         on any project.


II.   Types of Payments
      A. Travel
          1. Per IRS guidelines, all Travel is subject to withholding. Exemptions exist to waive this withholding
              requirement. Travel not covered under the IRS Accountable Plan Rule will be subject to
              withholding (see KUMCRI Travel Policy 6.1.01:
              http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Travel.pdf
          2. Travel is not covered by any tax treaty.
          3. Withhold at 30% Federal; 5% State.
B. Independent Personal Services (speakers, presenters, collaborators, lecturers and other professional
   services)
     1. KUMCRI Contractual Services Form
         http://www2.kumc.edu/researchinstitute/spa/SPA_Forms/Contractual%20Service%20Form.doc
     2. Form 8233 if claiming a tax treaty.
     3. KUMCRI Nonresident Alien Summary
     4. Process through PeopleSoft and submit all original paperwork to KUMCRI Accounts Payable. Keep one
         set of copies for your records.

         Example for payment reflecting withholding:
           Payee         Vendor Code        Account Code      Account Code Type         Amount
           John Smith    NRA                2501              Guest Speaker              1000.00
           John Smith    NRA                022170            NRA W/H – Federal          (300.00)
           John Smith    NRA                022175            NRA W/H – State             (50.00)
                                                              Check total:                650.00

          Example for payment reflecting a tax treaty:
          Payee          Vendor Code        Account Code       Account Code Type          Amount
          John Smith     NRA                2501               Guest Speaker              1000.00

C. Human Research Subjects in Clinical Trials
    1. Due to a reclassification on the IRS Form 1042-S, Foreign Person’s U.S. Source Income Subject to
       Withholding, participants in a clinical trial are no longer considered “independent contractors”.
    2. There are no tax treaty benefits under the new classification. Withhold at 35% (30% Federal, 5% State).
    3. F/J Students may be reimbursed for participation in a clinical trial.
    4. The Study Coordinator should determine the residency status of the participant.
                   1. If U.S. Citizen or Resident Alien for Tax purpose, process as usual.
                   2. In Nonresident Alien, collect KUMCRI Nonresident Alien Summary Form. DO NOT
                       collect information from a participant on a Contractual Services Form.
    5. Process through PeopleSoft as follows:

           Payee          Vendor Code       Account Code      Account Code Type         Amount
           John Smith     NRA               5700Q             Human                      150.00
                                                              Subject/Participant
           John Smith     NRA               022170            NRA W/H – Federal           (45.00)
           John Smith     NRA               022175            NRA W/H – State              (7.50)
                                                              Check total:                 97.50

D. Scholarships/Fellowships
    1. “Qualified” expenses (tuition and fees, books) are not subject to withholding. Process as usual.
    2. For “unqualified” expenses (travel, room and board, service-related research), withhold at 19% (14%
       Federal; 5% State) for F, J, M or Q students; withhold at 35% for all others, if not treaty-eligible.
    3. Form W-8BEN, Certificate of Foreign Status of Beneficial Owner for United States Tax Withholding, if
       claiming a tax treaty. Withhold at appropriate amount if reduced rate.
    4. Process through PeopleSoft and submit all original paperwork to KUMCRI Accounts Payable. Keep one
       set of copies for your records.

         Example of Travel Reimbursement for F,J,M,Q student:
           Payee          Vendor Code     Account Code      Account Code Type           Amount
           Jane Smith     NRA             2501              Travel (unqualified)          728.00
           Jane Smith     NRA             022170            NRA W/H – Federal            (101.92)
           Jane Smith     NRA             022175            NRA W/H – State               (36.40)
                                                            Check total:                  589.68

E. Royalties
    1. Withhold at 35%
    2. If treaty-eligible, collect completed Form W-8BEN if nonresident alien is eligible to claim tax treaty
       benefits.
    3. Process through PeopleSoft and submit all original paperwork to KUMCRI Accounts Payable. Keep one
       set of copies for your records.
        F. Prizes and Awards
            1. Prizes and awards are not tax treaty-eligible payments and will be subject to 35% withholding.
            2. Cash-equivalent payments are subject to withholding. The department will need to determine the
                fair market value of the cash-equivalent payment and either provide those funds to remit to the
                IRS and State from a residual account*, or collect the withholding amount from the recipient.

       *Residual Accounts: A Residual Account is created for each Principal Investigator (PI) to hold remaining funds from closed and
                                           completed industry sponsored project accounts.

III.     More Definitions and Links

              Immigration and Naturalization Services Form I-94: Arrival/Departure Records issued by U.S. Customs
              and Border Protection at the Port of Entry, http://www.uscis.gov/propub/DocView/afmid/dat/I_94.PDF

              Internal Revenue Service Form 8233: Exemption From Withholding on Compensation for Independent
              (and Certain Dependent) Personal Services of a Nonresident Alien Individual. Form 8233 must be filed to
              claim a tax treaty, http://www.irs.gov/pub/irs-pdf/f8233.pdf

              Internal Revenue Service Form W-8BEN: Certificate of Foreign Status of Beneficial Owner for United
              States Tax Withholding, http://www.irs.gov/pub/irs-pdf/fw8ben.pdf


              ITIN, form W-7: http://www.irs.gov/pub/irs-pdf/fw7.pdf

              Social Security Numbers: http://www.ssa.gov/pubs/10096.html

              Passport: An official document issued by the government of a country to one of its citizens and, varying from
              country to country, authorizing travel to foreign countries and authenticating the bearer's identity, citizenship,
              right to protection while abroad, and right to reenter his or her native country.

              Visa: A U.S. visa allows the bearer to apply for entry to the U.S. in a certain classification. A visa does not
              grant the bearer the right to enter the United States. The Department of State (DOS) is responsible for visa
              adjudication at U.S. Embassies and Consulates outside of the U.S. The Department of Homeland Security
              (DHS), Bureau of Customs and Border Protection (BCBP) immigration inspectors determine admission into,
              length of stay and conditions of stay in, the U.S. at a port of entry. The information on a nonimmigrant visa
              only relates to when an individual may apply for entry into the U.S. DHS immigration inspectors will record
              the terms of your admission on your Arrival/Departure Record (I-94 white or I-94W green) and in your
              passport.

              IRS Form 1040NR-EZ http://www.irs.gov/pub/irs-pdf/f1040nre.pdf
              IRS Publication 515, Withholding of Tax on Nonresident Aliens and Foreign Entities:
                     http://www.irs.gov/pub/irs-pdf/p515.pdf
              IRS Publication 901, U.S. Tax Treaties: http://www.irs.gov/publications/p901/index.html
              IRS Tax Treaties: http://www.irs.gov/businesses/international/article/0,,id=96739,00.html
              United States Immigration Support: http://www.usimmigrationsupport.org/
              Visa Waiver Countries: http://travel.state.gov/visa/temp/without/without_1990.html#countries

                  NB: Be sure all forms are complete and in ink. The IRS will not accept incomplete forms.
              Payments to Nonresident Aliens for Independent Personal Services VISA TYPES
                                                   Procedure 6.b.06

VISA   Description                       Explanation                                            Documents Required
                                         A nonimmigrant may enter the U.S. in B-1 status in     ·Copy of the I-94 (both
                                         order to engage in a "usual academic activity" for a   sides)*
                                         period not lasting longer than nine (9) days at any    ·Copy of Passport ID Page
                                         single institution, and may be paid a for              ·Copy of Visa
       Business Visitor. Eligible to
                                         independent personal services as well as               ·Form 8233 if claiming tax
       receive honoraria and
B-1                                      associated incidental expenses. In order to enter      treaty
       reimbursement for travel
                                         the U.S. under this provision, the visa holder may     ∙KUMCRI Nonresident
       expenses.
                                         not accept honoraia from more than five (5)            Alien Summary
                                         institutions or organizations within a six (6) month   ·KUMCRI Contractual
                                         period. This is referred to as the "9-5-6 Rule".       Services Form

       Visitors for pleasure. Eligible   The individual on a B-2 visa must have already
       to receive honoria and            been present in the U.S. when services were
       reimbursement for travel          requested; payment cannot be made to a speaker
B-2*   expenses if the visitor was       entering on a B-2 in order to perform services.
       already present in the U.S. at    Payments to an individual entering to provide
       the time the service was          services on a B-2 visa puts the individual's
       requested .                       immigration status in jeopardy.

                                                                                            ∙Copy of I-94
                                                                                            ∙Copy of Passport ID page
                                                                                            ·Copy of Visa
                                         KUMCRI may only compensate KUMC F1                 ∙Form W-8BEN
                                         Students for participation as a Human Subject in a · Copy of KUMC-issued
F-1    Students
                                         Clinical Research Trial. See "Procedures 6.a.06" Form I-20
                                         for details.                                       ·KUMCRI Nonresident
                                                                                            Alien Summary Report
                                                                                            ∙KUMCRI Contractual
                                                                                            Services Form

F-2    Dependents of F-1                                   CANNOT PAY


                                      Compensation for independent personal services            Compensation for
                                      cannot be made to H visa holders. H visa holders          independent personal
       Nurses. Authorized to work for are only allowed to receive compensation as
H-1A                                                                                            services cannot be made
       sponsoring agency only.        employees through their sponsoring organization.          to H visa holders.
                                      If your guest is an H visa holder, your guest's           For Travel
                                      sponsoring agency will be required to submit an           Reimbursements: ·Copy of
                                      invoice for the individual's services. KUMCRI             I-94 ·Copy of Passport
                                      Accounts Payable will then issue payment directly         ·Copy of Form I-797A
       Professionals. Authorized to
                                      to the sponsoring organization. Payment to the            ·Travel Expense Report
H-1B   work for sponsoring agency
                                      sponsoring organization may not be subject to             ·Original, itemized receipts
       only.
                                      withholding depending on its tax status.



H-4    Dependents of H-1                                   CANNOT PAY
                                                                                               ∙Copy of I-94(both sides)
                                                                                               ·Copy of DS-2019
                                                                                               ∙Copy of Passport ID page
                                            KUMCRI may only compensate KUMC J1                 ∙Form W-8BEN
                                            Students for participation as a Human Subject in a ·KUMCRI Nonresident
J-1       Students
                                            Clinical Research Trial. See "Procedures 6.a.06" Alien Summary
                                            for details.                                       ∙KUMCRI Contractual
                                                                                               Services Form

                                                                                            ·Copy of I-94(both sides)
                                                                                            ·Copy of Passport ID page
                                                                                            ·Copy of DS-2019
                                                                                            ·Written authorization from
                                                                                            the organization that
                                            Non-Student J-visa holders may receive payment prepared the DS-2019, if
J-1*      Non-Students                      for independent personal services or honorarium applicable*
                                            with permission.                                ·KUMCRI Contractual
                                                                                            Services Form
                                                                                            ·KUMCRI Nonresident
                                                                                            Alien Summary
                                                                                            ·Form 8233 if claiming a
                                                                                            tax treaty
                                                                                              ·Copy of I-94(both sides)
                                                                                              ·Copy of Passport ID page
                                            J-2 may receive compensation without restrictions
                                                                                              ·Copy of DS-2019
                                            if the J-2 is in possession of an E.A.D.
                                                                                              ·KUMCRI Contractual
                                            (Employment Authorization Document) card.
              Dependents of J-1 visa                                                          Services Form
J-2                                         Although the RI does not reimburse for an
                    holders                                                                   ·KUMC Nonresident Alien
                                            employer-employee relationship, a J-2 must be
                                                                                              Summary
                                            authorized to work in order to receive non-
                                                                                              ·Form 8233 if claiming a
                                            employee compensation.
                                                                                              tax treaty

*Although non-student J-1 visa holders sponsored by other institutions may receive compenation for brief services
performed at KUMC, the individual must have written approval from the sponsoring organization to do so. This protects
the J-1 visa holder's immigration status . Failure to obtain the appropriate authorization from the sponsoring organization
before payment is made may be considered by the federal government to be a violation of the individual's visa status. If
this occurs, the individual will lose that visa status, the rights associated with it, and asked to leave the United States.

VISA      Description                       Explanation                                          Documents Required
                                                                                                 Compensation for
          Individual of extraordinary
                                                                                                 independent personal
          ability in the sciences,
                                         O-1 Visa holders are employer-specific. If the O-1      services cannot be made
O-1       education, business, athletics
                                         is sponsored by another institution, treat as H-1B.     to O visa holders
          or the arts. Work authorized
                                                                                                 sponsored by another
          for sponsoring agency only.
                                                                                                 institution.
                                            *Contact Sponsored Programs Administration, spa@kumc.edu, if you have a
                                            guest arriving to the U.S. to provide independent personal services on an O-1
                                            Visa.
WAIVER
                                                                                                 ∙Copy of Passport
          Visitors for business on a Visa                                                        ·Copy of I-94W
WB
          Waiver                                                                                 ∙Form 8233 if claiming a tax
                                          A visa waiver entrant may undertake any activity
                                          that is appropriate on a B visa and be treated for     treaty
                                                                                                 ·KUMCRI Nonresident
          Visitors for pleasure on a Visa tax purposes the same as a B visa holder.
WT                                                                                               Alien Summary
          Waiver
                                                                                                 ∙KUMCRI Contractual
                                                                                                 Services Form


                                                                                                                   12/22/08dm
CANADIAN CITIZENS
Although Canadians are allowed to enter the United States without a visa, compensating Canadians for
Independent Personal Services while in the United States falls under the same guidelines as reimbursing any
nonresident alien. If a Canadian citizen cannot produce an I-94, the individual is presumed to be present in the
United States under "B" status. A copy of a photo ID is required. Tax Treaty: Article VII


* The I-94 is required for payment for services performed in the U.S. Without the I-94, the visitor will not be
eligible for payment because they can't document their immigration status. The I-94 is collected upon departure
from the U.S., so collecting this information after your guest leaves is impossible.


U.S. Department of State Visa Types, http://travel.state.gov/visa/temp/types/types_1286.html

You may also contact the KUMC Office of International Programs for assistance with immigration and visa
questions: http://www.kumc.edu/international/ or 913-588-1480
              KUMC RESEARCH INSTITUTE NONRESIDENT ALIEN SUMMARY
                        To document immigration status for U.S. tax reporting purposes


Name: ___________________________________                    U.S.-issued SSN/ITIN: ___________________

   If no SSN/ITIN, has one been applied for?: ___NO (Please apply for one)
                                              ___ YES (Attach a copy of the application)

Country of Tax Residence: ___________________________________________________________

Payment Address:__________________________________________________________________

                   __________________________________________________________________

Current Immigration Status: ______Citizenship_________________ Date of Entry: ___________

Primary Purpose for This Visit: ____________________________________________________

_____________________________________________________________________________

                                       Previous Visits to the United States
                                     Year         #/days Present      Immigration
                                                                         Status
                                     20__
                                     20__
                                     20__
                                     20__


   Signature: ___________________________________ Date: _________________________

                      ************************DEPARTMENT USE BELOW*************************

                         Please attach: ___ Copy of I-94 ____ Copy of Passport ____ Copy of Visa
                                      If J-1 student: above and: ___ Copy of DS-2019
                      If J-1 non-student: above and: ____ Copy of DS-2019 and written authorization

                               Department Certification regarding taxpayer identification numbers
       I certify that I have complied with Treasury Regulation Section 301.6109 1(c) regarding taxpayer identification
    numbers. Although requests have been made, the above nonresident alien has not provided the University of Kansas
     Medical Center Research Institute with a valid taxpayer identification number (Social Security Number or Individual
                                               Taxpayer Identification Number).

                 ________________________________________________________________________
                          Signature of Department Approval Authority, Department, and Date

                  Contact KUMCRI Accounts Payable if you have any questions: rinstap@kumc.edu
                          NONRESIDENT ALIEN TAX COMPLIANCE (non-employees)
                                          SUMMARY GUIDE

* The KUMC Research Institute (KUMCRI) will withhold taxes on all payments to nonresident aliens unless
appropriate documentation has been provided to waive the withholding (Tax Treaty, Accountable Plan
Documentation, etc.)

* Complete the KUMCRI Nonresident Alien Summary Form (KUMCRI Policies and Procedures Web Site)

* Account Codes for Withholding>
                                     FEDERAL W/H                  022170
                                     State/Kansas W/H             022175

* The KUMCRI will not refund withholding after payment has been processed

* The KUMCRI Accounts Payable office requires 7 working days to process payments to nonresident alien
individuals

* Study Coordinators are responsible for collecting information regarding immigration status before allowing an
individual into a study.

* Grossing-up is not an allowable expense on federally-funded projects. The RI does not allow grossing-up on any
project.


SERVICE(Independent Personal                              NON-SERVICE                  (Royalty,
Services, Research Participant)                           Scholarship/Fellowship*, Prizes/Awards)
TREATY                       NO TREATY                    TREATY                        NO TREATY
Form 8233                    Withhold @ 30% Fed           Form W-8Ben                   *F/J/M/Q Withhold @
                             Withhold @ 5% State                                        14% Federal
                                                                                        Withhold @ 30% Fed
                                                                                        Withhold @ 5% State
Treaty-eligible:             Not Treaty-Eligible:         Treaty-eligible:              Not Treaty-eligible:
Independent Personal         Research Participant         Royalty Payments              Prizes /Awards
Services                     Payments                     Scholarship/Fellowship

* Travel not covered under the IRS Accountable Plan Rule will be subject to withholding.

Independent Personal Services: Withhold at 30% Federal and 5% State. Form 8233 when claiming tax treaty.
KUMCRI Contractual Services Form and KUMCRI Nonresident Alien Summary Form. Process through PeopleSoft and
forward original paperwork to KUMCRI Accounts Payable.

Research Participant: Withhold at 30% Federal and 5% State. KUMCRI Nonresident Alien Summary Form. Process
through PeopleSoft and forward original paperwork to KUMCRI Accounts Payable.

Scholarships/Fellowships (non-service): F/J/M/Q withhold at 14% Federal and 5% State. All others, withhold at
30% Federal and 5% State. Form W-8Ben when claiming tax treaty. Process through PeopleSoft and forward original
paperwork to KUMCRI Accounts Payable.

Royalties: Withhold at 30% Federal and 5% State. Form W-8Ben if claiming tax treaty. Process through PeopleSoft and
forward original paperwork to KUMCRI Accounts Payable.

Prizes and Awards: Withhold at 30% Federal and 5% State. Process through PeopleSoft and forward original
paperwork to KUMCRI Accounts Payable. * Cash-equivalent payments are subject to withholding. Please refer to Procedure
6.b.06, E. Prizes and Awards
                                                                                                               8/1/2009
                                                   SCHOLARSHIPS AND FELLOWSHIPS
                                                             July 2008
                                                           Policy 6.1.07


Policy:

KUMC Research Institute adheres to IRS reporting guidelines regarding stipends, scholarships and fellowships for graduate students,
postdoctoral fellows, and clinical fellows enrolled at KU Medical Center paid with funds managed by the KUMC Research Institute.

Purpose:

The purpose of this policy is to clarify the difference between a scholarship or fellowship and a stipend for tax reporting purposes per Office
of Management and Budget A-21, Internal Revenue Code Title 26 Section 117(b), and Internal Revenue Service (IRS) Publication 970.

“Scholarship” or “fellowship” is not an interchangeable term with “stipend”. A stipend is taxable income. Technically, all income
received is taxable. However, IRS Title 26 Section 117 offers potential exclusions from income for certain items (tuition, required fees,
books and course-required supplies) when classified as scholarships or fellowships. However, this potential exclusion from income is not
available for stipends. Recipients of a scholarship or fellowship may be required, as a condition of receiving the award, to perform certain
activities or attend specific classes; these are not considered “services” because the benefits to the recipient are educational in nature, and
the University does not gain from the activities. Scholarships or fellowships cannot be payments for services rendered as that constitutes a
wage and is therefore reportable as such through payroll.

A scholarship or fellowship is a non-taxable payment to a candidate recipient if the terms of the scholarship or fellowship meet IRS
guidelines (see below). If any part of the scholarship or fellowship falls outside the listed potential exclusions, then that portion is taxable.
As an example, if the recipient receives scholarship funds that cover both tuition and room and board, the amount received for tuition is tax-
free, while the amount received for room and board is taxable. Regardless, the entire amount of a scholarship or fellowship is taxable
if the recipient is not a candidate for a degree. As such, postdoctoral fellowships are usually taxable as no degree is being sought.
Predoctoral scholarships and predoctoral fellowships are generally without tax consequences as long as the Federal Codes below are met.
The recipient should be aware that scholarships and fellowships may have potential for tax consequences.

Per IRS Publication 970, a candidate for a degree is a person who:
        1. Attends a primary or secondary school or is pursuing a degree at a college or university, or
        2. Attends an accredited educational institution that is authorized to provide:
                  a. A program that is acceptable for full credit toward a bachelor’s or higher degree, or
                  b. A program of training to prepare students for gainful employment in a recognized occupation.

Stipends are regular allotments or allowances to students to defray living expenses. The stipend does not meet the same requirements as
those set forth for scholarships and fellowships; therefore the stipend payment has tax consequences. Stipends are not to be confused
with wages. Wages for services are reported through payroll.

Federal Codes:
Per Internal Revenue Code Title 26 Section 117 (b):
         (b) Qualified scholarship
                    For purposes of this section--
                            (1) In general
                        The term ``qualified scholarship'' means any amount received by an individual as a scholarship or fellowship
                        grant to the extent the individual establishes that, in accordance with the conditions of the grant, such amount
                        was used for qualified tuition and related expenses.
                            (2) Qualified tuition and related expenses

                    For purposes of paragraph
                           (1), the term ``qualified tuition and related expenses'' means--
                                      (A) tuition and fees required for the enrollment or attendance of a student at an educational
                                      organization described in section 170(b)(1)(A)(ii), and
                                      (B) fees, books, supplies, and equipment required for courses of instruction at such an educational
                                      organization.

 Per IRS Publication 970, scholarships and fellowships are tax free only if:
    -   The recipient is a candidate for a degree from an accredited educational institution, whether it is a primary or secondary school, or
        college or university;
    -   The recipient uses the scholarship or fellowship to pay for qualified educational expenses such as:
             o Tuition and fees required to enroll at or attend an eligible educational institution.
             o Course-related expenses such as fees, books, supplies, and equipment that are required for the courses at the eligible
                 educational institution. These items must be required of all students in the course of instruction.

                                                                        1
    -      The terms of the scholarship or fellowship do not require that it be used for other purposes, such as room or board, or specify that
           it cannot be used for tuition or course-related expenses.

    Expenses that do not qualify; i.e. are taxable:
    -  Room and board
    -  Travel
    -  Research not associated with the completion of a degree (Service-related Research)
    -  Clerical help
    -  Equipment and other expenses that are not required for enrollment in or attendance at an eligible educational institution
    -  Fees paid to the institution as a condition of enrollment or attendance

Procedures:

The department requesting payment must appropriately identify the payment as a scholarship, fellowship, or stipend, and indicate the tax
status.

The KUMC Research Institute does not give tax advice or assist individuals with their tax issues.

Definitions:

Compensation: wages, tips, and other compensation for work performed subject to income tax withholding.

Fellowship: An amount paid for the benefit of an individual to aid in the pursuit of study or research.

IRS Form 1099: Informational return sent to the IRS to report various kinds of non-wage payments made to individuals. These payments
are not subject to tax withholdings but are considered taxable income and required to be reported to the IRS.

IRS form W-2: An employer automatically withholds and pays all of the necessary employee income taxes as required by the IRS.

Office of Management and Budget A-21: Federal circular establishing principles for determining costs applicable to grants, contracts, and
other agreements with educational institutions.

Scholarship: An amount paid or allowed to, or for the benefit of, a student at an educational institution to aid in the pursuit of studies.

Stipend: A taxable payment made to an individual in accordance with pre-established levels to provide for the individual's living expenses
during the period of training.

Wage: The compensation to an employee, agreed upon by the employee and employer, for work completed by the employee.

Responsible Parties:

The responsibility is ultimately with the recipient of a scholarship, fellowship or stipend to determine if your payment is taxable and to file
the appropriate forms on the recipient’s individual income tax return.

Exemptions:

None

Related Policies and Links:

Internal Revenue Code Title 26, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+26USC117
Internal Revenue Service Publication 970, http://www.irs.gov/publications/p970/index.html
Office of Management and Budget Circular A-21, http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636
Senior Deputy Director and Chief Financial Officer: 913-588-5469
Controller: 913-588-5749

History:

Original Issue Date: 7/15/2008
Current Issue Date: 7/15/2008
RAC approved: 8/26/2008
Effective Date: 9/3/2008


                                                                         2
                                                           RESEARCH CONFIDENTIALITY
                                                                 August 2007
                                                                 Policy 7.1.01

Policy:

If you are involved in any privately funded research you may have an obligation to keep certain information confidential. If the research is a
clinical trial, do not share confidential information about the trial in writing unless the exact wording has been approved in writing by: 1. the
sponsoring agency, and 2. the KUMC Human Subjects Committee (HSC), and 3. the KUMC Research Institute (KUMCRI). For specific
stipulations regarding publication, refer to the original, signed contract.

Purpose:

When KU Medical Center Research Institute enters into a research contract with a faculty member and a funding source, there is almost always
a confidentiality agreement section that binds all parties to non disclosure of certain information without written approval of the other parties. In
clinical trial research, this is always the case. The investigator, and anyone involved in the trial who received information regarding the protocol,
must keep all information strictly confidential.

Information which is usually confidential includes the name of the company, the drug information, the protocol number, the dosage, etc. Most
companies will not allow the title of the trial to be posted or advertised on lists. Listing of trials for the purpose of recruitment of patients, even
when only done in the corridors or offices of the clinics, does not maintain confidentiality. Some staff have chosen to list the title of the trials on
their CV as evidence of their research experience. The aforementioned examples must have written approvals. An example of the type of
general information that can be shared is, “A multi center, double-blind study for a long-acting beta agonist for subjects with asthma”.

Care must be taken when sharing information verbally with others on the staff or in situations where staff can be overheard by patients, visitors,
or other unauthorized persons. Companies are very serious about confidential information. Protection of human subjects’ information is very
seriously monitored by the HSC. Breech of contract by disclosure of confidential information is a very serious offense for the KUMCRI and
KUMC.

As of April 13, 2003, the U.S. Department of Health and Human Services required compliance with regulations mandated in HIPAA. These
requirements stipulate that researchers be aware of, and follow, the HIPAA Privacy and Security Rules.

Procedures:

Approval must be received in writing by the sponsoring agency, the KUMC Human Subjects Committee (HSC), and the KUMC Research
Institute, Inc. before confidential information can be shared.

All KUMC Research Institute staff must sign a confidentiality agreement.

Definitions:

HSC: Human Subjects Committee.

Responsible Parties:

This policy shall apply to all KUMC faculty (regardless of appointment type), staff, postdoctoral fellows, students, trainees, and any other persons
at KUMC, University of Kansas Physicians Incorporated and it’s affiliates, and KU Hospital staff involved in conducting and/or coordinating or
managing research at KUMC, and all KUMC Research Institute personnel.

Exemptions:

None.

Related Policies and Links:

KU Medical Center Office of Compliance http://www2.kumc.edu/researchcompliance/human.htm
National Institute of Health, HIPAA Privacy Rule http://privacyruleandresearch.nih.gov/clin_research.asp
The National Human Research Protection Advisory Committee http://www.hhs.gov/ohrp/nhrpac/documents/nhrpac14.pdf

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:
 Original Issue Date: June 1997
 Current Issue Date: 8/22/07
 RAC approved: 9/26/07
 Effective Date: 11/15/07
                                                PUBLICATIONS AND CONFIDENTIALITY
                                                            July 2008
                                                           Policy 7.1.07


Policy:

The University of Kansas Medical Center Research Institute (KUMCRI) ensures, concurrent with University of Kansas Medical Center
(KUMC) guidelines, that faculty, staff, and students may freely publish research results. At the same time, KUMCRI acknowledges the
need to preserve intellectual property and to safeguard the proprietary information of both the sponsor and University.

Purpose:

Dissemination of research results is the right, obligation, and in some cases, a specific requirement of faculty, staff, and students. The
University safeguards and reserves the right to publish and disseminate research results. Authors and researchers are entitled and
encouraged to share their research articles to in order to foster greater communication of knowledge. Most government grants and
cooperative agreements specify or imply that research publication is expected and an obligation of the funding. The National Institutes
of Health (NIH) requires that the author’s final version of any peer-reviewed journal article that resulted from NIH-funded research be
submitted to PubMed Central.

However, based upon the terms of agreement with the sponsor, a limited time may be given to the sponsor to review the information
before publication or presentation. If confidential or sensitive information relating to intellectual property resides in the material
proposed for publication or presentation, the sponsor will have an additional amount of time in order to proceed through the patent
application process, or applicable protections.

Ultimately, the University must adhere to a standard of openness and a policy that prohibits secrecy in research.

Procedures:

    -     A deferment of upward to forty-five (45) days can be placed on publications and presentations if a patent or copyright belongs
          to the sponsor and/or the University. This deferment allows the responsible entity time to review and comment upon the
          publication.
    -     If a patent is to be filed on the subject matter contained in the material proposed for publication or presentation, a deferment of
          upwards to ninety (90) days can be imposed in order to permit time to file a patent application.
    -     As of April 7, 2008, all articles arising from NIH funds must be submitted to PubMed Central upon acceptance for publication.
    -     As of May 25, 2008, NIH applications, proposals, and progress reports must include the PubMed Central reference number
          when citing an article that falls under the policy and that is authored or co-authored by the investigator, or arose from the
          investigator’s NIH award.

Definitions:

Copyright: a Copyright is a form of protection provided to the authors of “original works of authorship” including medical, scientific,
literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished.

Intellectual Property: Property from original thought protected by law: original creative work manifested in tangible form that can be
legally protected, e.g. by a patent, trademark, or copyright. These creative works can be shared or can enable others to recreate,
emulate, or manufacture them.

Patent: a property right granted by the Government of the United States of America to an inventor “to exclude others from making,
using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a
limited time in exchange for public disclosure of the invention when the patent is granted.

Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study
specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the
production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and
new processes to meet specific requirements.

Sponsor: Individual or organization that provides funds to a project.

Responsible Parties:

This policy shall apply to all KUMCRI staff, KUMC faculty, staff, postdoctoral fellows, students, trainees, and any other persons at
KUMC, University of Kansas Physicians Incorporated and its affiliates, and KU Hospital staff involved in conducting and/or coordinating
or managing research at KUMC.



                                                                        1
Exemptions:

The U.S. Government may have contracts that require confidentiality where security considerations in the national interest are involved.

Related Policies and Links:

NIH Public Access Policy http://publicaccess.nih.gov/index.htm
PubMed Central http://www.pubmedcentral.nih.gov/
U.S. Patent and Trademark Office http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2128_01.htm

Contacts:

Vice Chancellor for Research 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:

Original Issue Date: 08/05/2008
Current Issue Date: 08/05/2008
RAC Approved: 09/24/2008
Effective Date: 09/29/2008




                                                                   2
                                                   RESEARCH RECORDS RETENTION
                                                           January 2008
                                                           Policy 7.1.08


Policy:

Research Records are to be retained by the University of Kansas Medical Center (KUMC) for a period of not less than six (6) years
after the submission of the final report and close-out procedures on the research project for which the Research Records were
prepared, unless a longer retention period is specified by the sponsor, funding source, or other regulation.

Data collected as a part of research is the property of the University of Kansas Medical Center (KUMC). KUMC compensates
researchers and allows students to produce work; as a result, the work/data becomes the property of the university. Thus, researchers
may not copy, remove, or destroy data without the explicit written permission from the Vice Chancellor for Research. For example, if a
researcher leaves the university, a copy of the data may not be taken without the written permission from the Vice Chancellor for
Research.

The retention of the original Research Records shall be the responsibility of the Principal Investigator on behalf of KUMC, but at all
times shall remain the property of KUMC, unless otherwise specified by law, regulation or agreement.

Purpose:

This KUMC policy assures that Research Records are appropriately archived and retained, and available for review under the
appropriate circumstances. The Principal Investigator is responsible for the maintenance and retention of Research Records in
accordance with this policy and this policy exists so the KUMC and Principal Investigator can:
         1) verify compliance with Federal, State, and local laws, and supporting regulations;
         2) ensure the protection of intellectual property;
         3) fulfill contractual obligations and sponsored project agreement requirements;
         4) support issues of scientific integrity;
         5) support issues of human subject and animal use;
         6) assure appropriate use of recombinant DNA, etiologic agents, radioactive materials, etc., and;
         7) avoid disputes among researchers and protect the rights of all those participating in the research, including postdoctoral
              fellows, students, and staff.

Procedures:

Retention of Research Records:
         -   The Principal Investigator is responsible for the collection, management, storage and retention of Research Records.
         -   Principal Investigators should adopt an organized system of data collection and record retention and ensure compliance
             by all his/her direct reports regarding such data, including the use and retention of Laboratory Notebooks as appropriate.
         -   Research Records will be maintained in the department or division in which they were produced or in a network-based
             electronic file with access limited to authorized personnel.
         -   Research records must be retained on the University campus or campus affiliate (including University approved long term
             storage facilities), unless specific permission to do so has otherwise been given by the Vice Chancellor for Research.
         -   Principal Investigators must retain or otherwise archive Research Records for a minimum period of 6 years on research
             not involving human subjects and a minimum of 15 years on research involving human subjects or human subjects
             materials. If, however, the research is funded by contract, the terms of the Contract/Agreement shall supersede this
             policy, if more conservative. Adequate funding must be available to pay for storage prior to agreeing to a contract that
             specifies how long records are to be maintained.
         -   If the research involves Protected Health Information (PHI), the Principal Investigator must retain the permission to use
             the PHI for 6 years beyond the expiration date of the authorization (i.e. the consent form or authorization).
         -   Principal Investigator will maintain all documents involved in the study at the investigative site or at an appropriate KUMC-
             approved storage facility.
         -   If the research involves pediatric subjects then the records shall be retained for a minimum of 25 years after completion or
             termination of the study.
         -   An investigator involved in the research of drugs, devices, or biologics being in tested in humans for FDA approval shall
             retain records “for a period of 2 years following the date a marketing application is approved for the drug for the indication
             for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication,
             until 2 years after the investigation is discontinued and FDA is notified [sic]” 21CFR312.62.c. Please note: this length of
             time can be much greater than 2 years. Written confirmation should be received from the sponsor and/or FDA granting
             permission to destroy the records.
         -   When research results in an invention assigned to the KU Medical Center, and made available for commercialization, the
             original research lab log book that verifies the original discovery must be forwarded to the Research Institute. It will be
             archived in a fireproof locked safe for security purposes. This archive becomes the responsibility of the Vice Chancellor
             for Research.
Transfer of Research Records
         -   The Principal Investigator directing a research project may take copies of Research Records not involving human
             subjects, upon written approval of the Vice Chancellor for Research.
         -   The Institution must retain all original Research Records and data. Any patient/subject records will require appropriate
             patient/subject authorization for use and disclosure to another entity.
         -   If a Grant is being transferred to another Institution with the Principal Investigator, then the Principal Investigator is
             responsible for leaving the original of all Research Records and data with the KUMC.
         -   Before transferring the a grant and a copy of the Research Records, the Principal Investigator must ensure that any
             special conditions stated in the grant, contract, or cooperative agreement are met.
         -   The department is responsible for archiving the Research Records for a period not less than six (6) years following the
             transfer of the Principal Investigator or the term of the grant or agreement, whichever is longer.
         -   Prior to the removal of any tangible research product from KUMC, the recipient/institution must execute a Material
             Transfer Agreement (MTA) with KUMC.

Access to Research Records
        -   Where necessary, the KUMC has the right to access all Research Records and to take custody thereof, in a manner
            specified by the Executive Vice Chancellor or his/her designee.
        -   The Research Records shall be available to representatives of external sponsors of the research or designated
            governmental officials, when such access is appropriate.
        -   Any disputes regarding requests for original Research Records, copies, or transfer of Research Records will be resolved
            by the Executive Vice Chancellor or his/her designee.

Destruction of Data
         -   When the Research Records have met the applicable retention guidelines, the documents will be shredded and the
             following recorded: Principal Investigator name; protocol identifiers such as funding source or sponsor (when applicable),
             protocol number (when applicable), HSC, IACUC or committee identifier; date shredded; person shredding the
             documents; and a summary of documents shredded.
         -   If the study is an industry-sponsored study, prior to shredding documents or disposal of materials, the sponsor will be
             contacted and written permission obtained to destroy the documents.
         -   Records/data cannot be destroyed until the institutional requirements for data destruction are met.

This policy shall not be construed to authorize or condone destruction of any document in contemplation of or in anticipation of, or
during, any litigation or investigation. This prohibition of destruction is applicable regardless of whether the document is otherwise
eligible for or past the point at which it may be destroyed. Questions regarding this requirement should be directed to the Office of the
General Counsel.

Definitions:

HSC: Human Subjects Committee.

Human Subject: As defined by the Code of Federal Regulations Title 45 Part 46.102, means a living individual about whom an
investigator (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual,
or 2) Identifiable private information.

IACUC: Institutional Animal Care and Use Committee

Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study
specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the
production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and
new processes to meet specific requirements.

Research Records: Information needed for the purpose of a research study, regardless of form or the media on which is may be
recorded. Research Records may include technical data, computer software, laboratory worksheets, memoranda, notes or exact
copies thereof that are the result of original observation and activities of a study, and any records that are necessary for the
reconstruction and evaluation of reported results of the research and the events and processes leading to those results. Items which
constitute research data under this policy include, but are not limited to: laboratory notebooks, samples of chemicals and materials
synthesized during research, specimens, vouchers, computer files or other electronic data, video tapes and audio tapes.

Sponsor: Individual, company, institution or organization taking responsibility for initiation, management and financing of study.

Tangible Research Product: A wide range of tangible property resulting from the conduct of research, as distinct from copyrightable
expressions and patentable inventions. Tangible Research Products include but are not limited to items and products that may confer a
public benefit through commercial licensing and may include biological materials, such as cell line and plasmids; chemical compounds;
electrical schematic diagrams; mechanical design drawings; and more abstract products such as detailed descriptions or compilations
of laboratory procedures, analytical methods, or other such “know-how”.
Responsible Parties:

This policy shall apply to all University of Kansas University Medical Center faculty, staff, postdoctoral fellows, students, trainees, and
any other persons at KUMC or KUMC Research Institute involved in the design, conduct, or reporting of research at the KUMC,
including all research projects on which those individuals work, regardless of funding source for the project.

Exemptions:

None

Related Policies and Links:

KUMC Faculty Handbook, http://www2.kumc.edu/aa/fa/
KUMC Human Subject Committee, http://www2.kumc.edu/researchcompliance/human.htm
KUMC Information Resources Policies and Operational Protocols http://www2.kumc.edu/ir/policy/
KUMC Record and Retention Schedule http://www.kumc.edu/Pulse/policy/recordretention.html
21 CFR § 312.62 – Investigator Record Keeping and Record Retention for Clinical Drug or Biological Trails
21 CFR § 812.140 – Investigator Record Keeping and Record Retention for Device Trails
ICH Guideline for Good Clinical Practice, Part 4.9,
http://www1.va.gov/oro/apps/compendium/Files/good%20clinical%20practice.htm#contents
OMB Circular A-110, §.50 Retention and access requirements for records.
http://www.whitehouse.gov/omb/circulars/a110/a110.html
Federal Acquisition Regulation (FAR), http://www.arnet.gov/far/
48 CFR Part 27 (for contracts awarded by the Federal government) § 27.403 Data rights – General
52.227-14 Rights in Data – General (Clauses & Forms)
Kansas Statues Annotated § 75-3504, on public records disposition Agreement Term + 5 years http://www.kslegislature.org/legsrv-
statutes/getStatuteInfo.do
National Institutes of Health (NIH) Office of Extramural Research, http://grants1.nih.gov/grants/oer.htm
Final NIH Statement on Sharing Research Data, Notice NOT-OD-03-032, Released February 26, 2003
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
NIH Grants Policy Statement (3/01) Part II, Subpart A
http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm
NIH Guide, Volume 25, Number 23, July 12, 1996: Public Health Service Policy Relating to Distribution of Unique Research Resources
Produced with PHS., http://grants.nih.gov/grants/guide/notice-files/not96-184.html
National Science Foundation (NSF) Grant Policy Manual (NSF 02151) § 734. Dissemination and Sharing of Research Results.
http://www.nih.gov/science/models/sharing.html

Contacts:

Vice Chancellor for Research: 913-588-7068
Associate Vice Chancellor for Research Administration: 913-945-6636

History:

Original Issue Date: 8/30/2004
Current Issue Date: 1/31/2008
RAC approved: 2/27/2008
Effective Date: 3/4/2008

				
DOCUMENT INFO