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					                                      Northern Illinois University
                      Office of Vice President for Research and Graduate Studies
                                        Policies and Procedures




Approved By: Lisa Freeman, Vice President     Date Approved:
for Research                                  August 23,
                                              2012

                                              Effective Date:
                                              August 24,
                                              2012



Title: External Relationships and Financial Conflicts of Interest in Research


 Policy            Reporting External Relationships and Potential Financial Conflicts of
                   Interest in Research (FCOI).

 Purpose           Northern Illinois University (NIU) depends on its ability to maintain the
                   public’s trust. To ensure adherence to the highest professional
                   standards, its research activities cannot be compromised by or
                   perceived as biased by financial and/or business relationships. This
                   Policy expands upon NIU’s Academic Conflicts of Interest (COI) policy, to
                   specify disclosure requirements for all individuals engaged in research at
                   NIU.

 Rationale         Establish a consistent reporting process to collect information on
                   External Relationships and Significant Financial Interests (SFI) in
                   Research from all research personnel engaged in the design, conduct,
                   analysis and reporting of research, and to oversee and manage SFIs
                   that constitute Financial Conflicts of Interests (FCOIs), in accord with 42
                   CFR 50, Subpart F, and 45 CFR 94, which concerns Objectivity in
                   Research and addresses perceived, potential, or actual conflicts.
                   NIU’s determination of whether a FCOI exists will facilitate its goals of:
                       Safeguarding NIU’s academic integrity in research and educational
                          programs;
                       Ensuring an objective research process free from bias in the
                          design, conduct or reporting of research;
                       Ensuring that NIU personnel and students are assigned duties
                          consistent with their status and or position;
                       Ensuring that sponsor’s access to NIU’s intellectual property
                          rights, equipment and supplies are consistent with applicable law,
                          NIU policy, and NIU’s financial and reputational interests.


                                                                                                 1
Applies To                                     A. Engaged in Personnel Conduct or
                      A. All Research Personnel All Researchthe Design,Engaged in the Design, Conduct o
                                                   individual at Northern Illinois University (NIU).
                         Reporting of Research including faculty, staff and
                         students, and any other pertinent individual at Northern
                                               B. NIU requires that any subcontractors, subgrantees or su
                         Illinois University (NIU).
                                                   written assurance that they and where applicable, the in
Applicability to                                   applicable regulations, including
                      B. NIU requires that any subcontractors, subgrantees or but not limited to those
Subrecipients                                      interest policy will be required to
                         subawardees (or “subrecipients”), at other institutions, adopt and implement a
                                                    NIU provide written assurance
                         engaged in research at will be grounds for immediate termination of the subcon
                                                   to NIU, as the awardee institution any identified financia
                         that they (and where applicable, the individuals or
                                                    for them) have a conflict of interest
                         investigators that work managed, or eliminated. NIU will then report the FCOI t
                         policy (COI) policy that conforms to the applicable
                         regulations, including but not limited to those set forth at
                         42 CFR Part 50 and 45 CFR Part 94. Any subrecipient that
                         does not have such a COI conflict of interest policy will be
                         required to adopt and implement a COI policy prior to the
                         initiation of any work. A subrecipient’s failure to do so
                         promptly upon request by NIU will be grounds for
                         immediate termination of the subcontract or subaward.
                         Assurances made to NIU will include a provision that
                         requires the subrecipient to report to NIU, as the awardee
                         institution, any identified financial conflict of interest. The
                         subrecipient institution will assure that any FCOI has been
                         reduced, managed, or eliminated. NIU will then report the
                         FCOI to any sponsor as required under applicable
                         regulations or policies.
Definitions
                   “Financial Conflict of Interest” means any SFI related to research,
                   determined by NIU to constitute a real or perceived COI affecting
                   research, or affected by research that requires management, reduction
                   or elimination.

                   “Equity Interest” means stock, stock options, or other ownership
                   interests.

                   “Institutional Official” means the person(s) designated by NIU to
                   oversee the solicitation and review of financial disclosure and reporting
                   statements from any investigators or personnel who will be participating
                   in research. The Institutional Official is the Vice President for Research
                   and Graduate Studies or her/his designee(s).

                   “Institutional Responsibilities” means an investigator’s professional
                   responsibilities on behalf of the Institution, and as defined by the
                   Institution in this policy on financial conflicts of interest, which may
                   include, for example, activities such as research, research consultation,
                   teaching, professional practice, institutional committee memberships,
                   and service on panels such as Institutional Review Boards (IRBs) or
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Data and Safety monitoring Boards.

“Investigator(s)” refers to the principal investigator (PI), co-
investigator (Co-I) and any other person(s) (e.g., post-doctoral fellows,
senior scientists, graduate students) responsible for the administration,
design, conduct, or reporting of sponsored research.

This definition is not limited to individuals titled or budgeted as
“investigator”. Any individual/relevant personnel may be considered
investigators (and therefore responsible for completing NIU Financial
Relationship Disclosure Forms) if the PI or relevant supervisor
determines that the individual/personnel should be considered an
investigator.

For disclosure purposes, investigator(s) completing the form also
includes immediate family members: his/her spouse, domestic partner,
and dependent children.

“Research” means any systematic investigation designed to develop or
contribute to generalizable knowledge. The term encompasses basic
and applied research and product testing and development. It includes,
but is not limited to, any activity for which research funding is available
from a Public Health Service component that awards funds under grants,
cooperative agreements or otherwise.

“Research Conflict Review Committee” (RCRC) refers to the
University committee that advises the Vice President for Research and
Graduate Studies (VPRGS) on conflict of interest matters in research.
The Provost/VPRGS appoints the committee members and the following
ex-officio, non-voting members: The Vice President and General Legal
Counsel for Legal Services; the Associate Vice President for Research;
the Manager of Technology Transfer; an NIU IRB Chairperson, as a
liaison to/from the NIU IRB, and a Public Relations representative. The
committee, should include a member external to the NIU community,
and at its discretion may also add Ad hoc members if further faculty
representation or non-NIU faculty is desired.

“Research Personnel” means any member of a research team
engaged in the design, conduct or reporting of research; any individuals
identified in university records as on research protocols or anyone the
principal investigator determines qualifies as involved in the design,
conduct or reporting of research.

“Significant Financial Interest” is broadly defined as anything of
monetary value that could include salary or payment for services from
an outside institution, any equity (stock) interests, any intellectual-
property rights, or holding any management position (e.g., director,
officer, trustee, etc.) in a non-NIU entity. It does not include salary,
royalties, or other remuneration from the investigator's home
institution; income from seminars, lectures, or teaching sponsored by
public or nonprofit entities; or income from service on advisory

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                 committees or review panels for public or nonprofit entities.

Procedure        All investigators are required to report SFIs related to research both on
                 an annual basis and any time a new SFI related to research occurs.
                 By January 15 of each calendar year, or upon employment at NIU, any
                 NIU Investigator engaged in Research, or who wishes to be eligible to
                 engage in Research, must complete an Annual Certification of External
                 Activities and Significant Financial Interests Related to Research Form
                 and file this form with the Office of Research Integrity and his/her chair
                 and dean. Investigators should include on this form any information
                 required by their school or administrative unit, which, at a minimum,
                 must include any Significant Financial Interest Requiring Disclosure, and
                 should report any compensation in excess of the reporting thresholds
                 that the Investigator receives OR expects to receive over the
                 upcoming calendar year. The External Activities and Significant Financial
                 Interests Related to Research Form may be obtained through the web at
                 the following link
                 (www.research.niu.edu/divresearch/integrity/index.shtml) or by
                 contacting the Office of Research Integrity at 815-753-1581.

                 Annual disclosures will be collected at the end of the calendar year.
                 Research/Protocol-specific disclosures will be required each time an
                 investigator initiates a new protocol, submits a study for continuing
                 review, submits a grant/contract for basic research, and/or any time a
                 change in financial status occurs. Implementation of an automated
                 system will facilitate the reporting process and provide the necessary
                 checks and balances to aid in managing financial conflicts of interest.
                 Annual disclosures are reviewed for the 12 months prior to the end of
                 the reporting period and the 12 months subsequent to this period.
                 Protocol-specific disclosures are reviewed and acted upon at the time of
                 submission for prospective management.

Responsibility   The Office of Research Integrity (ORI) will collect, review and assess
                 annual and protocol-specific disclosures of external relationships and
                 financial interests in research.

                 All individuals engaged in research are required to submit an annual
                 disclosure form and report on whether or not they have received
                 remuneration for services provided to third party entities. An
                 accounting of any payments received in excess of $5,000 is required,
                 pursuant to 42 CFR 50.603, Subpart F.

                 Based on guidance and precedent established by the Research Conflict
                 Review Committee (RCRC), ORI will document receipt of disclosures,
                 review disclosures over $5,000 and transmit to the RCRC those that the
                 Associate Vice President for Research deems appropriate regardless of
                 amount, for its review and appropriate management of the perceived,
                 potential or actual conflict. ORI, on behalf of the RCRC, will transmit
                 recommended management plans for research involving human subjects
                 to the Institutional Review Board(s) for consideration, final review and
                 approval.

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                 Pursuant to the revised final rule “Responsibility of Applicants for
                 Promoting Objectivity in Research for which Public Health Service
                 Funding is Sought and Responsible Prospective Contractors” (42 CFR 50;
Regulatory       45 CFR 94) the US Public Health Service regulation (includes the NIH)
Responsibility   states:
                 The primary goals of the federal regulations are to manage, reduce, or
                 eliminate financial conflicts of interest. The regulation requires the
                 institution to:
                       Develop internal policies and procedures; designate an official or
                        establish a process to review disclosure of significant financial
                        interests and to manage any determined to be financial conflicts
Institutional           of interest (FCOI).
Responsibility
                       Ensure its investigators disclose any "significant financial
                        interest" to the institution.
                       Report to the federal government funders if it believes an
                        investigator’s significant financial interest could affect the
                        research (42 C.F.R. part 50, subpart F (grants and cooperative
                        agreements) and 45 C.F.R. part 94 (contracts)).

                 Significant financial interest means anything of monetary value
                 including, but not limited to:

                    1. Salary or other payments for services (e.g., consulting fees or
                       honoraria) that, when aggregated for the investigator and the
                       investigator's spouse and dependent children over the next twelve
                       months, are expected to exceed $5,000
                    2. Equity interests (e.g., stocks, stock options or other ownership
                       interests) that, when aggregated for the investigator and the
                       investigator's spouse (domestic partner, and/or dependent
                       children), will either (a) exceed $5,000 in value (as determined
                       through reference to public prices or other reasonable measures
                       of fair market value) or (b) represent more than a 5 percent
                       ownership interest in any single entity
                    3. Intellectual property rights (e.g., patents, copyrights and royalties
                       from such rights) that, when aggregated for the investigator and
                       the investigator's spouse and dependent children over the next
                       twelve months, are expected to exceed $5,000.

                 The term does not include the following:

                        1. Salary, royalties, or other remuneration from the University;
                        2. Income from seminars, lectures, or teaching engagements
                           sponsored by public or nonprofit entities;
                        3. Income from service on advisory committees or review panels
                           for public or nonprofit entities.

                 The principal investigator/project director is responsible for:
                     each proposed activity,
                     determining who meets the definition of investigator,
                     ensuring and certifying that each investigator/relevant research
                                                                                               5
                        personnel has submitted a completed “Disclosure of Financial
                        Interests Associated with Research Protocols” form to the ORI.
                        Such disclosure forms must be completed, submitted, reviewed
                        and approved/managed by ORI before a proposal is endorsed by
                        NIU and forwarded to National Institutes of Health (NIH), National
                        Science Foundation (NSF) or American Heart Association (AHA).

                  Travel disclosure is subsumed under Significant Financial Interest and is
                  factored into the determination of whether an SFI constitutes an FCOI.
Travel            It includes disclosure of any reimbursed or sponsored travel (i.e., that
                  which is paid on behalf of the investigator and not reimbursed to the
                  Investigator so that the exact monetary value may not be readily
                  available), related to their institutional responsibilities. The disclosure
                  requirement does not apply to travel reimbursed or sponsored by a
                  Federal, state, or local government agency, an Institution of higher
                  education as defined at 20 U.S.C. 100(a), an academic teaching
                  hospital, a medical center, or a research institution that is affiliated with
                  an Institution of higher education. In accord with federal regulation,
                  NIU requires, at a minimum, the following disclosures:
                       The purpose of the trip,
                       The identity of the sponsor/organization,
                       The destination, and the
                       Duration

                  In accordance with the Institutional FCOI policy, NIU’s Institutional
                  Official will determine if further information is needed, including a
                  determination or disclosure of monetary value, to determine whether
                  the travel constitutes an FCOI with the PHS-funded research.

Thresholds        NIU has adopted the greater than $5,000 threshold for mandatory
                  reporting of a significant financial interest as anything of monetary value
                  including equity interests (e.g., stocks, stock options, or other
                  ownership interests). The relationship between the investigator and
                  sponsor that exceeds $5,000 in value and represents more than a 5%
                  ownership interest in any single company, regardless of value, if that
                  equity or ownership interest is held in a company whose financial
                  interests would reasonably appear to be affected by the researcher's
                  activities, will be scrutinized by the Office for Research Integrity and the
                  RCRC (and includes the equity interests of the investigator's spouse
                  (domestic partner), or dependent children.
                 The institution is responsible for providing guidelines, consistent with the
Relatedness
                 regulation, to determine whether an Investigator’s SFI is related to PHS
Assessment and
                 funded research and if so, whether the SFI qualifies as an FCOI.
Determination of
                 Investigator SFI’s are related to PHS funded research when the
an SFI
                 Institution, through its designated official(s), reasonably determines that
                 the SFI could be affected by the PHS-funded research; or is an entity
                 whose financial interest could be affected by the research. If the
                 Institution through application of its policy determines that the SFI could
                 directly and significantly affect the design, conduct or reporting of the
                 PHS-funded research then a FCOI exists.


                                                                                                  6
Management             Disclosures of investigator financial relationships with
Plan - General          external entities that constitute a SFI (pursuant to 42
                        CFR 50, Subpart F; 45 CFR Part 94) and are identified as
                        a FCOI require development of an appropriate
                        management strategy, endorsed by the institution and approved
                        by the IRB. The plans focus on the management, reduction,
                        modification, elimination or divestiture of the FCOI. Management
                        plans are developed on a case by case basis, but adhere to RCRC
                        Committee precedent where applicable, and may include, but are
                        not limited to, some or all of the following actions:
                       disclosure of the relationship in the protocol informed
                        consent and in any subsequent written or oral
                        presentations or publications;
                       disclosure to all participating investigators in multi-site trials and
                        same site research personnel;
                       removal of the investigator as principal investigator, or restricting
                        the investigator from a part of or the entire research project, such
                        as precluding his/her participation in recruitment, the informed
                        consent process, data analysis, or a specific procedure; reducing
                        the amount of remuneration allowable for services provided to the
                        entity;
                       eliminating the interest completely or permitting the investigator
                        to withdraw from participation in the research;
                       and monitoring of research by independent reviewers.

Management       When a Significant Financial Interest determined to constitute a
of Existing      FCOI is identified/exists, and there are compelling circumstances, which
Conflict of      warrant continued participation of the investigator in the study, the
Interest Plans   RCRC may recommend an explicit Conflict of Interest Management
                 Plan (MP).

                 The plan is developed after discussion by the Committee and
                 transmitted to the IRB, when human subjects are involved. The Office of
                 Research Integrity is responsible for implementing the final
                 management plan approved either by the IRB (human subjects
                 research) or the RCRC for non-human subjects research. The following
                 steps are required:

                 1. Signed Agreement
                 The investigator signs an agreement accepting the plan, which is copied
                 to the RCRC, IRB, OSP, the Dean, and the department chair. Final IRB
                 approval of the study is contingent upon this signed agreement.

                 2. Assurance of Continued Compliance
                 The investigator signs a written assurance, at least once a year, of
                 continued compliance with the existing plan for the duration of the
                 study, unless the relationship changes, which requires a plan
                 modification or termination if the FCOI no longer exists and more than
                 12 months has passed.

                 3. Notification of Changes
                 The investigator is responsible for notifying the ORI and IRB of
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                  any changes, in a timely manner, of his/her financial interests or
                  relationships, so it can be determined whether further management is
                  necessary.

Appeal            Individual right of appeal. Any investigator, pursuant to the policy
                  definition, may appeal the RCRC’s recommendation to the IRB for
                  research pertaining to human subjects, or to the Committee itself for
                  non-human subjects research. An investigator dissatisfied with his/her
                  appeal may submit his/her disagreement in writing to the Provost for
                  final resolution.

Retrospective    Retrospective review of newly identified SFI’s. Identification of
Review of Newly untimely or any delayed disclosure of an SFI by an Investigator, not
Identified SFI’s previously reviewed by the Institution during ongoing PHS Funding,
                 requires the IO’s review within 60 days of determination: if its related to
                 PHS funded research, and if an FCOI exists. Such a determination
                 requires:
                     1) Implementation – at least in the interim – of a management plan
                        that specifies the actions that have been and will be taken to
                        manage the FCOI moving forward; and
                     2) Completion of a retrospective review of the Investigator’s
                        activities and the PHS-funded research to determine whether any
                        PHS funded research or a portion of it, conducted during the
                        noncompliance period was biased in the design, conduct or
                        reporting of such research within 120 days of the Investigator’s
                        noncompliance. Such noncompliance may have occurred due to
                        the Investigator’s failure to disclose an SFI which is deemed an
                        FCOI, the Institution’s failure to review or manage said FCOI, or
                        the Investigator’s failure to comply with a management plan.
Mitigation
Reports          Mitigation Reports. As appropriate, the Institution shall update the
                 previously submitted FCOI report specifying the actions taken to
                 manage the FCOI moving forward. If the institution determines there
                 was bias it must notify the PHS awarding component promptly and
                 submit a mitigation report to that component. The mitigation report
                 must include:
                     1) The key elements documented in the retrospective review and a
                        description of the impact of the bias on the research project and
                        the institution’s actions/action plan to eliminate or mitigate the
                        effect of the bias
                     2) Subsequently the institution will submit annual reports, as per the
                        regulation. Depending on the nature of the FCOI the institution
                        may decide that additional interim measures are necessary
                        regarding the investigator’s participation in the PHS-funded
                        research project between the date of the FCOI or the
                        investigator’s noncompliance is determined and the completion of
                        the institution’s retrospective review.
Public
accessibility    Public accessibility. Prior to any expenditure of funds from a PHS
                 supported study, NIU will ensure the FCOI information will be accessible
                 to the public providing for written responses to requests within 5
                 business days based, on the following criteria, within reason:
                                                                                               8
               1) The SFI was disclosed and is still held by the senior/key personnel
                  defined in the regulation; and
               2) NIU determines that the SFI is related to PHS-funded research;
                  and
               3) NIU determines that the SFI is a FCOI.

            NIU must make the following information available in writing (or on its
            website):
               1) The investigator’s name, title and role regarding the research
                  project;
               2) Name of the entity in which the SFI interest is held;
               3) Nature of the SFI; and
               4) Approximate dollar value of the SFI (dollar ranges are
                  permissible) or a statement that the interest is one whose value
                  cannot be readily determined through reference to public prices or
                  other reasonable measure of fair market value.

            If NIU uses a website to provide the information it will be updated
            annually. It will also be updated within 60 days of receipt or
            identification of any more information concerning additional SFIs of the
            senior/key personnel for the PHS funded research project not previously
            disclosed or upon disclosure of an SFI that qualifies as an FCOI by new
            senior/key personnel on the PHS funded project.
            When NIU responds to written requests for information it will note that
            the information is current as of the date of the letter and is subject to
            updates at least annually and within 60 days of identification of a new
            FCOI.

            FCOI information made available to the public shall remain available for
            at least 3 years from the date of the most updated information.
Appeal
            Employees are subject to the ordinary disciplinary process of
            NIU if they fail to fully and truthfully disclose activities or
            relationships that could reasonably be viewed as significant
            financial interests or financial conflict of interests or fail to
            comply with any stipulated plan for managing the disclosed
            conflict. (See policies and procedures adumbrated under the
Sanctions   Academic Policies and Procedures Manual
            http://www.niu.edu/provost/policies/appm/II23.shtml).

            Other potential actions include, but are not limited to:
                Inclusion in NIU’s faculty file a letter from the appropriate
                  school or university official(s) indicating that the
                  individual’s good standing has been called into question
                Determination that the individual is precluded from
                  conducting research, teaching or organizing Continuing
                  Education programs, IRB or IACUC approval, or
                  supervising graduate students
                Non-renewal of appointment
                Dismissal from the college where the individual holds an
                  academic appointment.
                Failure to disclose known financial conflicts of interests or
                                                                                        9
                            to follow an appropriate prescribed management plan
                            may be a serious breach of this reporting process and
                            may itself be considered ethical misconduct or
                            professional dishonesty
                           Allegations against an employee for breach of this
                            process should be reported confidentially, in writing to
                            the employee's supervisor and/or the NIU research
                            integrity officer (RIO).


Confidentiality      All information disclosed by an employee for the purpose of financial
                     disclosure and management, and all official records of disclosure and
                     management shall be deemed confidential. Any information disclosed by
                     an employee as required by this process shall be used solely for the
                     purpose of administering and/or executing this policy and may not be
                     disclosed or used for any other purpose unless required by law.
                     Unauthorized disclosure of any such information shall be deemed to be
                     unethical behavior and a violation of this policy and subject to
                     appropriate disciplinary action to the extent practicable;

                     NIU is required to make certain information available, upon request, to
                     Federal agencies sponsoring work at the University regarding all
                     conflicting interests associated with the PHS funded project identified by
                     NIU and how those interests have been managed, reduced, or
                     eliminated to protect the research from bias. NIU maintains records of
                     all financial disclosures and all actions it takes with respect to each
                     conflicting interest for a three-year period. For sponsored research
                     activities, records will be retained in accord with state records act
                     (http://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=86&ChapterID=2)
                     for 3 years from the date of submission of the final expenditures report
                     or where applicable, from other dates specified by requirements of the
                     sponsoring agency. The above notwithstanding, all such records shall be
                     retained for the period of time as may be required by law.

Approval Status Approved


                     __________________________________________________
Office of the        Lisa Freeman, DVM, Vice President for Research and Graduate Studies
Vice President for
Research and
Graduate Studies




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