Consortium Agreement Information for NIH Grants

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 participants.

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 Consortium Agreements information.

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