NIH Staff Involvement on Extramural Awards - Cooperative Agreements

There are two basic mechanisms of award – acquisition and assistance. Acquisition is done through a contract, and is used to achieve a purpose primarily for the direct benefit or use of the federal government; thus the government project officer is very much involved in directing the conduct of the project. On the other hand, assistance can be either through a grant or a cooperative agreement, and is used primarily to support or stimulate investigator-initiated research. A grant involves normal program stewardship by extramural program staff, with no substantial scientific/programmatic involvement by federal staff. The cooperative agreement lies somewhere in between a grant and a contract: although it is an assistance mechanism like a grant, it is used when there is substantial federal staff involvement (more than in a grant), but not to the point of having the federal government play a dominant role in the conduct of the project (as in a contract). Thus, in awarding a grant, the federal government can be considered a “patron” of the research; in awarding a cooperative agreement, the federal government acts as a “partner” in conduct of the research; and in awarding a contract, the federal government is the “procurer” of a service or a product.

ICs make cooperative agreement awards using the code “U” instead of “R” or “P” – for example, making a U01 award instead of an R01 award. Otherwise, the same funding criteria and procedures are used as for grants. The two mechanisms are sufficiently similar that converting an application submitted for an R01 to a U01 when conditions warrant (i.e., substantial federal staff involvement) is easily accomplished, with the nature of the involvement outlined as a term of award. The intent has been to make the awarding of a cooperative agreement legally appropriate, not disruptive to the IC or grantee, and as transparent as possible to the community. Consequently, the awarding of a cooperative agreement has the same implications regarding a grantee’s fiscal and scientific obligations as exist under a grant.

Obviously, there are degrees of collaboration. Whether federal staff involvement in a particular extramural project is significant enough to warrant use of the cooperative agreement is determined on a case-by-case basis. Within the IC, the Extramural Program Management Committee (EPMC) member (or other designated program official) and Grants Management Officer have ultimate responsibility for this determination, with concurrence of the Director, Office of Extramural Programs, OER. When the federal involvement is on the part of intramural staff, coordination of this process includes the IC Scientific Director. Thus in that case, the intramural investigator’s responsibility is to notify the Scientific Director and EPMC member if that investigator is involved in, or is contemplating, a collaboration in an extramural grant. This ensures that there is complete and common understanding about the nature and amount of federal involvement, that there is no conflict of interest in the administration of the grant because of that involvement, and that appropriate terms and conditions reflecting the federal staff involvement are incorporated in the terms of the extramural award. Examples of substantial scientific involvement are appended.

NIH Intramural Staff Involvement in Extramural Awards

Examples of Intramural Scientific Staff Activities that Constitute Substantial Involvement:

  • Acting as the director of a project within a program project (P01) grant
  • Having primary responsibility for a specific aim within a regular research grant (R01)
  • Development of a major data base for an extramural collaborator
  • Participation in a multi-institutional collaborative arrangement with extramural researchers for clinical, prevention or epidemiological studies

Notes:

  1. Involvement may initially begin as not substantial, but evolve over time to become substantial, thus requiring reconsideration of the appropriate mechanism of award.
  2. Certain kinds of involvement, such as acting as a consultant to provide occasional advice or providing occasional sample analyses, clearly do not constitute substantial involvement.
  3. However, it is acknowledged that gray areas may arise that would require determination on a case-by-case basis.

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This page was last updated on Tuesday, August 10, 2021