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FIC Funding Strategy
Consortium
Agreement Information for NIH Grants
Posted July 2002
The grantee, as the direct and primary
recipient of the National Institutes of Health (NIH) grant funds, is accountable to NIH for the
performance of the project, the appropriate expenditure of
grant funds by all parties, and all other obligations of the
grantee, as specified in this policy statement. In general,
the requirements that apply to the grantee also apply to the
consortium participant's).
Written Agreements: The grantee must enter
into a formal written agreement with each consortium participant
that addresses the negotiated arrangements for meeting the
scientific, administrative, financial, and reporting requirements
of the grant, including those necessary to ensure compliance
with all applicable Federal regulations and policies and facilitate
a smoothly functioning collaborative venture.
At a minimum the agreement should include:
- Identification of the
Principal Investigator (PI) and individuals responsible for
the research activity of each consortium participant along
with their roles and responsibilities;
- Procedures for directing and monitoring the research
effort;
- Procedures to be followed in reimbursing each consortium
participant for its effort, including dollar ceiling, method
and schedule of reimbursement, type of supporting documentation
required, and procedures for review and approval of expenditures
of grant funds at each organization;
- If different from those of the grantee, a determination
of policies to be followed in such areas as travel reimbursement
and salaries and fringe benefits;
- Incorporation of applicable public policy requirements
and provisions indicating the intent of each consortium
participant to comply, including submission of applicable
assurances;
- A provision addressing ownership and disposition of data
produced under the consortium agreement;
- A provision making the inventions and patent policy applicable
to each consortium participant and its employees in order
to ensure that the rights of the parties to the consortium
agreement are protected and that the grantee can fulfill
its responsibilities to NIH;
- As appropriate, provisions regarding property (other than
intellectual property), program income, publications, reporting,
and audit necessary for the grantee to fulfill its obligations
to NIH.
- The grantee is responsible for determining whether a consortium
participant has filed assurances with NIH that would cover
its activities within the consortium and, if not, for ensuring
that any required assurances or certifications are submitted
to NIH.
- It is the grantee organization's responsibility to ensure
that all sites engaged in research involving human subjects
have an appropriate Office of Human Research Protection (OHRP)-approved assurance and IRB approval
of the research consistent with 45 CFR Part 46, and to comply
with NIH prior approval requirements related to the addition
of sites not included in the approved application.
- The grantee is responsible for obtaining NIH approval
for any actions to be undertaken by consortium participants
that require such prior approval.
- It is the responsibility of
the grantees to include applicable requirements of the
policy statement in their written agreements and
highlighted that agreements must also include a reference
to the financial conflict of interest policy, intellectual
property, and data sharing requirements.
For more information concerning
Consortiums please refer to the NIH Policy Statement and look
under the title "Consortium Agreements" at: http://grants1.nih.gov/grants/policy/nihgps_2001/part_iib_6.htm
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