Document Sample
					                      POLICIES AND PROCEDURES

                      FOR THE MANAGEMENT AND


October, 2001                   -1-

       This is a guide to assist principal investigators, program chairs and
research administrators in the management of research projects and
expresses policies and procedures in research related matters and
activities. It contains specific information for proposal preparation and
submission and for the administration of on going research projects. The
guide supplements, but does not supersede, instructions issued through
other BIDMC policy.

      Principal investigators and others responsible for sponsored projects
should read their grant and contract documents carefully and be familiar
with all requirements, terms, conditions, etc. stated therein.


       Research and study on the part of the faculty are essential elements
of the BIDMC Mission. Members of the faculty are encouraged to
undertake research of special interest to them, for both governmental and
private organizations.     Individual researchers are free to pursue
interesting and important leads which may arise during the conduct of
research, subject to the terms of the research agreement and regulations
of the sponsor.

      Sponsored research should be proposed and carried out within a
regular department of the BIDMC, or through the cooperation of several
departments, and be led by a member of the faculty or authorized
professional research staff. Major research projects should be clearly
related to the academic programs of the department or departments
involved and provide opportunities for research training.

    In accepting sponsored research, the BIDMC, the departments, and
members of the faculty or staff accept obligations to furnish:

          1. An appropriate share of the time and talent necessary to perform
             the research.

          2. Reports and publications describing the research performed and
             the results achieved.

          3. Compliance with all terms and conditions of the grant or
             contract, the timely submission of all technical and
             administrative reports, and compliance with all applicable laws
             and regulations.

October, 2001                         -2-
      The budget requested for any research project should be adequate
for the work proposed including student support, possible salary
increases, fringe benefits and indirect costs at standard rates.

      Results of all research should routinely be offered for examination
and publication, as appropriate. The right to publish research results in
appropriate journals should not be relinquished. However, where justified
in certain cases involving research projects completely supported by
external funds, publication may be postponed for reasonable periods of
time. The support of sponsors should usually be acknowledged in

      The Medical Center recognizes that interdisciplinary research is
important today.      Those faculty members jointly interested in an
interdisciplinary problem will team together under the overall guidance of
a leader who will be directly responsible for the conduct of the project.

      When a research agreement is executed between a supporting
agency and the BIDMC, the principal investigator is responsible for the
technical work and is obliged to comply with all terms of the agreement.
The BIDMC is always the grantee or the contractor.

       Federal research agreements normally require retention of records
for a period of three to six years after final closeout of a research
agreement. The Office of Research Administration is designated as the
official office of record for all matters pertaining to the technical and
administrative management of the research agreement; Research Finance
is similarly designated for all matters pertaining to fiscal records. Any
individual originating or receiving correspondence pertaining to a research
agreement will provide a copy of it to the research administrator. The
research administrator will forward the documents to the appropriate
administrative office within BIDMC.


          The Principal Investigator

      In initiating a sponsored research proposal, the faculty or
authorized staff member assumes responsibilities and obligations which
begin with the preparation of the proposal and continue throughout the
conduct of the research program. A final report and other grant/contract

October, 2001                          -3-
closing documents are essential requirements. The research project is not
concluded until these responsibilities are fulfilled.

      As a principal investigator, the faculty or research staff member is
responsible for the overall project and its conduct. The following is not an
inclusive list of responsibilities. The P.I. shall see:

          1. That the research is soundly based, its primary goal is a
             significant contribution to knowledge, and the personnel involved
             are qualified.

          2. That human and animal subjects are respected, and all informed
             consent requirements are enforced.

          3. That the budget is adequate to accomplish the research.

          4. That the necessary time and talent are available for commitment
             to the proposed research.

          5. That there is compliance with the terms and conditions of the
             grant or contract, including those covering reports and

          6. That there is registration of permanent equipment purchased
             with grant funds into the BIDMC property inventory control

          7. That there is compliance with safety standards and regulations.

          8. That there is legitimate expenditure of grant/contract funds. No
             funds will be used for purposes other than allowable by the
             terms of the grant and regulations of the sponsor and BIDMC

          The Department

      In supporting sponsored research activities by its faculty and
research staff, departments assume certain responsibilities.     The
department chairman's approval of a proposal certifies:

          1. Compliance with existing BIDMC and departmental policies.

          2. The professional and scholarly quality of the project.

October, 2001                           -4-
          3. The competence of the principal investigator in the area of

          4. The ability of the principal investigator to successfully manage
             the proposed research project.

          5. That the research project relates to the academic objectives of the
             department and provides opportunities for research training.

          6. The capability of the department to provide              necessary
             administrative support (personnel and supplies).

          7. The availability of departmental facilities and equipment to fulfill
             project needs.

          8. The adequacy of the budget and the determination of the
             department to prevent cost overruns.

          9. The recognition of applicable safety standards and regulations
             and the existence of plans for appropriate action to comply with

          The Director, Research Administration

     The Office of Research Administration reviews sponsored research
proposals for compliance with policies of the BIDMC and the potential
sponsor with particular attention given to the following:

          1. That research is carried out within a regular department of the
             BIDMC, or through the cooperation of several departments, and
             led by a member of the faculty or authorized professional
             research staff.

          2. That research activities relate to the educational mission of the

          3. That the publication of results is open and free of inappropriate

          4. The BIDMC retains administrative control and responsibility for
             the work.

          5. That no sponsor or other external party is allowed a continuing
             role in the scientific direction of the research.

October, 2001                           -5-
          6. That reimbursement of the indirect expenses as well as the direct
             costs of the research are adequate.

          7. That all research proposals comply with policies of the BIDMC
             and instructions of sponsoring agencies.

In addition, the Office of Research Administration:

          1. Assists BIDMC personnel in locating potential sources of funding
             for research, fellowships, and other scholarly activities.

          2. Ensures the collection and dissemination of appropriate data
             regarding sponsored and unsponsored research.

          3. Executes and administers subcontractor agreements.


       This section describes the standard procedures and forms for
submitting proposals for sponsored programs, including those for
research, educational activities, facilities, equipment, and service

          General Procedures

       The process of obtaining research support starts with a proposal
written by a member of the faculty or authorized research staff. The
proposal is reviewed by the appropriate department and BIDMC officials,
and submitted to potential sponsors. After grant or contract terms and
conditions are negotiated and an award is made, an account for the funds
is established.      The research activity is directed by the principal
investigator who is also responsible for the timely submission of reports to
the sponsor. Since the grant or contract is a binding legal agreement
between the sponsor and the BIDMC, the Medical Center must play a
significant role in the administration of the project.

          Preparing Proposals

       In preparing a proposal for any sponsored program, the principal
investigator should avail himself or herself, of the advice and counsel of
fellow members of the faculty, the chairman of the department and the
Office of Research Administration as needed.

October, 2001                         -6-
          Routing of Proposals

       Proposals for research will go from the initiating faculty member to
the following, in turn:

          Division Chief
          Department/Division Research Administrators
          Department Chairperson
          Director, Research Administration

      All proposals that include matters of significance regarding the
procurement, use, modification or construction of facilities and plant
equipment will also be routed to the Director, Research Operations. The
Office of Research Administration is available to answer any

          Proposal Review and Approval

          1. Before initiating a proposal and starting it on its way, the
             Principal Investigator must insure that it is complete in all
             respects. He/she should anticipate potential problem areas and
             questions that may arise out of the on-campus reviews and
             attach such explanatory memoranda as may be deemed
             appropriate. Doing this will always save time in the long run.

          2. The Chairperson of the Department reviews proposals for
             compatibility with the intellectual aims and fiscal responsibility
             of the department.

          3. Proposals for interdisciplinary programs involving faculty from
             more than one division or school should be approved by all of the
             department chairpersons involved.

          4. The Office of Research Administration reviews proposals from the
             standpoint of the academic, fiscal, administrative and other
             requirements of the BIDMC and arranges for such changes as
             may be considered necessary.

          5. The Office of Research Administration will notify the department
             or the principal investigator after the institutional official has
             affixed his/her signature.      It is the responsibility of the
             investigator, or the department, to pick up the signed original
             and to mail or deliver the original, plus the number of copies
             required, to the potential sponsor before their deadline.

October, 2001                          -7-
          6. Essential Funding to be sought.

                a) Fringe benefits and indirect costs must always be fully
                   included at the established rates in all proposal budgets,
                   except where specifically precluded by written instructions of
                   the sponsor.

                b) In addition to fringe benefits and indirect costs, proposal
                   budgets should include funding requests for the items listed
                   below where it is expected that expenditures will be required
                   for such items during the conduct of the project, except
                   where specifically precluded by written instructions of the

                        Core facilities
                        Personnel
                        Consultants/Subcontracts
                        Consumable supplies/special materials
                        Miscellaneous services (maintenance, analytical, service
                         contracts, etc.)
                        Publication costs
                        Travel
                        Equipment

      Faculty members should consider the date set by sponsors for the
receipt of proposals in relation to the time it takes for BIDMC review and
approval, and for mail delivery. Under normal circumstances, processing
requires three working days.

          Important Reminders

          1. Occasionally because of departures from our standard
             procedures, difficulties and misunderstandings may occur.
             Principal investigators should note, that whenever any of the
             fiscal aspects of a proposal, or of an award already made, are to
             be altered in any way, communication of such changes should
             proceed through the same channels as a proposal. In particular,
             changes in the budget of a contract or grant and requests for no-
             cost extensions should be communicated to the sponsor via the
             Office of Research Administration to assure official sanction.
             This is important because the financial terms of any grant or
             contract or other agreement are legally binding upon the BIDMC.
             Faculty members cannot make legal commitments or negotiate

October, 2001                            -8-
                subcontracts except through and with the approval of the
                Director, Research Administration.

          2. When a member of the faculty communicates informally with any
             sponsoring agency or office regarding a possible sponsored
             program of any kind, a broad approximation of the total cost of
             the program may be given but no detailed budget should be
             submitted. Only the president or persons specifically designated
             by him/her can commit BIDMC in the matter of indirect costs or
             other matters which are properly the responsibility of the BIDMC

          3. The principal investigator may have supporting personnel
             consisting of one or more postdoctoral researchers, professional
             specialists, graduate students, undergraduate students,
             laboratory technicians, secretaries, etc., as properly required for
             the successful completion of sponsored work, provided funds are
             available under a given grant or contract to cover the full cost of
             such supporting personnel, including stipends, fringe benefits,
             computing, publishing, equipment, supplies, travel, indirect
             costs, etc.   It should be understood by everyone that no
             commitments of long range or permanent employment can be
             made for any category of such personnel under any sponsored

          4. The Office of Research Administration is available to all members
             of the faculty and staff of the BIDMC during all phases of
             sponsored programs.

          Helpful Suggestion for the Smooth Processing of Proposals

      It is the goal of the Office of Research Administration to see that
your proposal is submitted in the best possible form and that each
proposal is given a close and careful review. Several mistakes commonly
occur in the preparation of a research proposal; the following suggestions
may help avoid these mistakes.

          1. Check the budge carefully. Make sure that the current rates for
             fringe benefits and indirect costs have been used in the
             preparation of the budget.

          2. Make sure that all necessary forms are included with the
             proposal. If the proposal is in response to an R.F.P. or some
             other solicitation, be sure to include all the information

October, 2001                          -9-
          3. If any questions or problems arise during the preparation of he
             proposal, please contact the Office of Research Administration
             (667-0690) rather than waiting until the proposal is completed
             and sent through for processing. This precaution may save you
             and Research Administration valuable time and unnecessary
             revisions later.


          Research Projects Involving Human Subjects

       The Department of Health and Human Services (DHHS) provides a
systemic means, based on established ethical principles, for protecting the
rights and welfare of individuals who may be exposed to the possibility of
physical, psychological, or social injury while they are participating as
subjects in research. The regulation also covers research involving the
human fetus (either in utero or ex utero), organs, tissues, body fluids, and
graphic written or recorded information derived from human sources. It
covers activities which present no physical risk to the subjects, but which
may create legal risks or expose subjects to public embarrassment or
humiliation through breach of confidentiality or invasion of privacy. The
major focus of a project (for example, on a medical procedure) may not be
the sole determinant of the types of risks involved or the need for
additional protection. The safeguarding and confidentiality of medical
records and other forms of data collected on individuals and groups, the
use of such data by the principal investigator conducting the original
research, concurrent uses of the data by other investigators, and the use
of the data for research purposes at a later time are considered within the
scope of this policy.

       DHHS requires written assurances from BIDMC describing its
procedures for adequately protecting the rights and welfare of human
subjects. Safeguarding the rights and welfare of human subjects is, by
DHHS policy, primarily the responsibility of the applicant organization.
The applicant organization is responsible for ensuring that the research
activity described in the application and additional information relating to
human subjects, are reviewed and approved by an Institutional Review
Board (IRB). All investigators must read the Institutional Assurance
(available from the Committee on Clinical Investigation) at least for a year,
as part of their academic responsibility. (See attached)

     If a proposal involves human subjects, the Public Health Service
(PHS) requires that the principal investigator provide, at the end of

October, 2001                        - 10 -
research plan section of the application, under the heading HUMAN
SUBJECTS, DERIVED MATERIALS OR DATA, the following information:

          1. Identify the sources of the potential subjects, derived materials or

                   Describe the characteristics of the subject population, such as
                    their anticipated number, age, sex, ethic background, and
                    state of health.

                   Identify the criteria for inclusion or exclusion.

                   Explain the Rationale for the use of special classes of
                    subjects, such as fetuses, pregnant women, children,
                    institutionalized mentally disabled, prisoners, or others,
                    especially those whose ability to give voluntary informed
                    consent may be in question.

          2. Describe the recruitment and consent procedures to be followed:

                   The circumstances under which consent will be solicited and

                   Who will seek it,

                   The nature of information to be provided to prospective

                   The methods of documenting consent. (A copy of the consent
                    form is required by PHS staff for review purposes.)

          3. Describe      any potential risks - physical, psychological, social,
             legal, or     other - and assess their likelihood and seriousness.
             Describe      alternative methods, if any, that were considered any
             why they      will not be used.

          4. Describe the procedures for protecting against or minimizing
             potential risks and include an assessment of the likely
             effectiveness of such procedures.       Include a discussion of
             confidentiality safeguards, where relevant, and arrangements for
             providing medical treatment, if needed.

          5. Describe and assess the potential benefits to be gained by the
             subjects, as well as the benefits that may accrue to society in
             general as a result of the planned work.

October, 2001                               - 11 -
          6. Discuss the risks in relation to the anticipated benefits to the
             subjects and to society.

     Institutional Review board for the Protection of                Human
Subjects at Risk

       The purpose of the BIDMC Institutional Review Board, known as the
Committee on Clinical Investigation, is to provide for the adequate
discharge of the BIDMC's legal responsibility to safeguard the rights and
welfare of human research subjects.         The CCI functions to review
proposed research projects and activities involving human subjects as well
as to monitor on-going research projects and activities, review adverse
event reports, and maintain records for review by auditors and regulatory

      No research activity involving human subjects, regardless of
sponsorship or sources of funding may be undertaken at BIDMC unless
the CCI has reviewed and approved such activity and the certification of
such review and approval has been submitted to the sponsor in
accordance with the requirements of the sponsor and those of the Medical

          The Board will determine for each activity planned:

          1. Whether subjects will be placed at risk.

          2. If risk is involved, whether the knowledge to be gained warrants
             exposing the subject to these risks.

          3. That the rights and welfare of subjects will be adequately

          4. That legally effective informed consent will be obtained by
             adequate and appropriate methods.

          5. That emergency medical treatment is available.

          6. That continuing reviews are conducted and reported at least

          Research Projects Involving Recombinant DNA Molecules

          Research by BIDMC personnel involving recombinant DNA molecules,

October, 2001                          - 12 -
regardless of sponsorship or sources of funding, is conducted only with the
approval knowledge of the HMS Institutional Biosafety Committee (IBC),
and in accordance with the guidelines for Research Involving Recombinant
DNA Molecules, published by the National Institutes of Health. (Policy
Memorandum 321-July 1994.)

      The purpose of the HMS Institutional Biosafety Committee is to
insure that recombinant DNA activities at BIDMC comply with these
guidelines, and is conducted safely.

       All research proposals and projects known to or appearing to involve
recombinant DNA shall be referred to the committee. Further, the
committee must be notified before any research involving recombinant
DNA is initiated, whether or not it is externally funded. The committee
will visit and inspect each laboratory in which recombinant DNA research
is to be conducted and review with the investigator(s) and other personnel
concerned the procedures for complying with the guidelines of the NIH
and other sponsors of research involved. Follow-up visits and inspections
will also be conducted by the committee.

          The HMS Biosafety Committee will:

          1. Advise the BIDMC administration on policies.

          2. Review applications for the support of research involving
             recombinant DNA molecules to insure that the facilities,
             procedures and practices and expertise of the personnel involved
             is satisfactory and, if approved by the committee to certify such
             on the application.

          3. Review the actions of principal investigators           involved with
             recombinant DNA research to insure that proper         safeguards are
             implemented and that the responsibilities of             the principal
             investigator, and others, as specified in Part         IV (Roles and
             Responsibilities) of the guidelines are carried out.

          4. Review on-going research at least annually and, if approved by
             the committee, to certify such to the Vice President for Science
             and Technology.

          Animal Welfare

     The care and use of laboratory animals are governed by The
Laboratory Animal Welfare Act, Public Law 89-544, as amended, and such

October, 2001                          - 13 -
instructions and guides as may be issued by the National Institutes of
Health (OPRR).

      The Institutional Animal Care and Use Committee is mandated by
law. Membership consists of at least five members who are knowledgeable
regarding the care and use of animals used in research, including at least
one veterinarian. The committee maintains oversight of animal facilities
and procedures, reviewing them at least annually and reporting to the
Vice President for Science and Technology.

          Grant or Contract Negotiations

       Administrative negotiations for all grants and contracts and other
research agreements are the responsibility of the Research Administration
Office. All negotiations will be closely coordinated with the principal

          Project Accounts

      Research Administration officially receives all grants or contracts for
the BIDMC.     Awards transmitted directly to principal investigators,
departments, etc. should be delivered immediately to the research
administration to facilitate activation. The financial analyst in Research
Finance will make the funds available to the principal investigator.

      A grant or contract is a legal binding agreement between the
sponsor and BIDMC. Principal investigators are furnished a copy of each
grant or contract. They should review the document carefully, with
particular attention to the scope of work, budget limitations and report
requirements.     Any questions concerning the agreement, or any
modification in terms of cost, are to be referred to the Office of Research

          Project Performance

      After a contract or grant has been received and an account has been
established, the principal investigator, in connection with department
research administrator, is responsible for initiating requests for personnel
appointments and for the purchase of any materials or supplies needed by
the project.    Resources are available throughout BIDMC to provide
assistance to the principal investigator or department research
administrator. If there is an inquiry or requirement that should be met,
this should be addressed to the Research Administration Office. For

October, 2001                       - 14 -
instance, if there are any administrative problems that arise during the
initiation or conduct of the research, the project leader should consult
with Research Administration.

      One of the most important responsibilities of the principal
investigator and department research administrator is to keep track of
project expenditures and commitments and to prevent them from
exceeding the budget or being used for inappropriate purposes. Even if
the project leader designates other persons as "authorized signers"
for his project, he/she remains the person solely responsible for
operating within the budget. Monthly fiscal status reports issued by
Research Finance assist in monitoring expenditures of project funds.
Specific questions concerning these reports should be addressed to the
financial analyst assigned to the department.

       The product or deliverables of most sponsored projects is a report or
series of reports. The principal investigator should make sure that he/she
knows the sponsor's requirements for reporting and plans the work of the
project so that all required reports are carefully prepared and submitted
by their due dates.

          Expenditure of Grant/Contract Funds

       The grant/contract period begins on the effective date of the
agreement and runs for the length of time indicated on the award
document. Expenditures incurred prior to the effective date of the
grant/contract may not be charged against the project account unless
specifically authorized in the award document or by the Director of
Research Administration.     No expenditures may be made after the
scheduled expiration date of the agreement unless approved by the


      Sponsors generally allow principal investigators the freedom to
pursue interesting and important leads which may arise during the
conduct of a sponsored project. They may also discontinue or modify
unpromising lines of inquiry. However, when such modifications result in
a major deviation from original research objectives, prior approval must be
obtained from the sponsor.

       Similarly, reasonable flexibility is provided the principal investigator
in the expenditure of funds.           However, there are certain specific
restrictions on rebudgeting. The expenditure of any funds in excess of the

October, 2001                       - 15 -
amount budgeted for any item in the budget should be cleared with the
research administrator.        In some cases, Director, Research
Administration, has been delegated authority to approve minor deviations;
in others, such as changes in senior personnel (including sabbatical
leave), changes in patient care costs, or the acquisition or expensive
equipment, prior written approval of the sponsor is required. Requests to
sponsors for approval of changes in program objectives or in the
authorized budget are initiated by the principal investigators and
transmitted via the department research administrator to the Director,
Research Administration, who will provide the necessary BIDMC
endorsement on the request.


      Although general questions concerning purchasing procedures
should be referred to the Purchasing Department, questions relating to
the appropriateness of purchases under grants and contracts should be
addressed to Research Administration.       Government contracts often
contain specific purchasing requirements - or limitations. Many require
prior approval by the sponsor before certain types of expenditures can be

       Requests for sponsor's approval should normally be in the form of a
letter from the principal investigator addressed to the sponsoring agency
program manager and endorsed by an institutional representative. Such
a letter should be forwarded through the department administrator to
Research Administration for endorsement.


       Foreign travel requires prior approval under most government
contract and should be processed through the research administrator
approximately two months in advance of departure to allow adequate time
for arrangements. (Some sponsors require filling out a form.)

      Domestic travel expenses for food and lodging will be reimbursed on
the basis of actual and reasonable costs. Receipts are required for all
expenses in excess of $25; receipts should be obtained for all expenses.

      Government grant or contract funds may be used for domestic travel
to scientific or technical meetings, provided funds for such travel were
included in the proposal budget, and provided the travel is approved by
the principal investigator. Government regulations and contracts do
not permit charges for entertainment.

October, 2001                     - 16 -

      Property purchased under government sponsorship usually falls
into one of these two categories:

       Grants and other Agreements: The property listed in the proposal
and authorized by the grant may be purchased without further approval.
Title to property costing less than $1,000 will vest in the BIDMC upon
receipt. However, for equipment costing $1,000 or more, the sponsor may
reserve the right to retain the title (an option that is rarely exercised).
Once title to the property is acquired under grants or contracts, the
department is responsible for care and custody of the property (just as if
the property has been purchased with BIDMC funds).

      Contracts:   Title to property purchased or fabricated under a
contract is, in many cases, vested in the government. Inventories are
required. Title to equipment costing $1,000 or more may be requested
upon the expiration of the contract.

       Title to government-furnished equipment for use on a contract or
grant is vested in the government, and usually the BIDMC can obtain title
only if declared surplus by the government.

          Handling Property

      Responsibility: the principal investigator(s) named in the contract is
responsible for the care, control, and custody of property accountable
under that contract.

      Administration: the BIDMC property administrator is responsible for
establishing uniform property control procedures and for maintaining
central property records for all sponsored projects. This will assist
principal investigators in meeting contractual obligations with respect to

       Receipt: Principal investigators must insure that all permanent
equipment is entered into the BIDMC property inventory control system as
it is delivered or brought on to BIDMC campus.

      Sponsor Requirements: Since requirements for property control vary
between government agencies, it is necessary to read the terms of the
contract or grant to insure that basic requirements are satisfied. For

October, 2001                      - 17 -
further details and for information about acquisition, transfer of title,
equipment disposal and inventory, contact the Office of Research

          Shared Use of Equipment

      The Office of Management and Budget (OMB) circular A-110
requires that during the time equipment is held by us for a government
sponsored project or program. The equipment should be available for use
on other projects or programs, provided such other use will not interfere
with the work on the project or program for which the equipment was
originally acquired. Priority for other use is: 1) other projects or programs
of the same Federal agency; 2) projects or programs of other Federal
agencies; 3) activities not sponsored by the Federal Government (if the
property is owned by the Federal Government, authorization of the Federal
agency concerned may be required.)

      BIDMC policy requires that all special purpose equipment shall be
shared by investigators to the maximum extent possible, within limits of
regulations of the sponsors, and the terms under which the equipment
was acquired, as long as other use does not interfere with the work for
which the equipment was originally acquired.


The Directors of Research Administration and Research Finance will
execute the BIDMC's reporting responsibilities by either transmitting the
reports to the sponsor, or when agency instructions permit, insuring that
the principal investigator or other responsible administrative official
submits the reports directly to the sponsor, within the time allowed. In
this case, a copy must be furnished to the research administrator.

      Principal investigators and administrative officials will execute their
reporting responsibilities in accordance with the following guidelines:

      Performance Reports - The principal investigator will submit both
periodic and terminal reports to Research Administration for transmittal,
unless the sponsor's instructions permit direct reporting. If a direct report
is done, Research Administration should be furnished with a copy.

      Invention Reports - "Patent and Copyright Policy" required immediate
reporting to the Vice President, Science and Technology, any new
inventions and discoveries. The V.P. of Science and Technology will make
required reports to sponsors based on information received.

October, 2001                       - 18 -
      Property Reports - The property administrator will process the
property reports required by funding agencies. Reports will be prepared
from data in the inventory control system file, managed by the property
administrator. The property administrator should ascertain that the
property reports agree with accounting records, where applicable.

       Fiscal Reports - Prepared and submitted by Research Finance,
periodically and/or on termination, in accordance with the sponsor's
instructions. Expenditures are subject to the sponsor's approval, or
disallowance if not in accordance with the approved budget. In both
cases, the research accountant and the principal investigator should
coordinate with each other, prior to submission. Fiscal reports prepared
for submission with renewal or continuation proposals must be verified by
the research accountant. Final fiscal reports cannot contain outstanding
commitments. It is the responsibility of the principal investigator to
ascertain that all outstanding commitments are liquidated by the
termination date of a grant or contract. This will allow the submission of
the fiscal report in a timely fashion.

       The acceptance of a research grant or contract carries with it the
obligation to submit technical and administrative reports by the times
prescribed by the sponsor. The principal investigator and administrative
officials concerned are responsible to see that the terms of the agreement
are met in every way.

       Adherence to these aspects of research grants and contracts can be
beneficial to both investigators and the BIDMC. The timely submission of
all required reports will aid in creating and maintaining good relationships
between BIDMC and the sponsoring agencies. In the long run, if goodwill
exists, then the sponsors of our research will be more receptive to our
proposals for support in the future.


      If we are to continue to receive the external support that we need to
do research, we must do the best that we can to meet our contractual
obligations. The full cooperation of al principal investigators and BIDMC
administrative officials is important.

October, 2001                      - 19 -

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