Cooperative Agreements (U)

Purpose

To enable federal agencies to fund awards requiring substantial involvement from agency staff in the research.

Procedure

A cooperative agreement is a grant in the U series that NIAID awards when it expects substantial involvement from NIAID program officers. See the difference between normal involvement and substantial involvement.

NIAID may decide to award a new or renewal investigator-initiated clinical trial or epidemiology study as a cooperative agreement.

For information on converting grant applications to cooperative agreements, see the Conversion of Grants to Cooperative Agreements SOP.

The NIH Office of Extramural Research (OER) approves initiatives for cooperative agreements before we submit them to the NIH Guide for publication.

Program Officers

• To request approval for a cooperative agreement, send a cooperative agreement justification memo and copy of the proposed initiative from the draft initiative package to the Office of Initiative Development (OID). See sample memorandum for use of the cooperative agreement in an RFA.
• For more information, see the Early Notification System Cooperative Agreement Clearance Process.

Office of Initiative Development

• Forward draft initiative and cooperative agreement justification memo to the DEA associate director for extramural science policy, Contact for NIAID Staff, for review and approval.
• If changes are needed, work with the program officer to finalize the initiative.
• Send the approved initiative and memo to the Office of Program Coordination and Operations (OPCO).

Division of Extramural Activities OD Staff

• DEA associate director for extramural science policy reviews initiative and memo.
• DEA approves the initiative and memo and returns it to OID or returns it with suggested changes.
• OPCO prepares an initiative package and forwards it with the cooperative agreement justification memo to the DEA director for signature.
• OPCO scans the cooperative agreement justification memo signed by the DEA director and sends it with the initiative package to OER to request approval.

Grantees and PIs

• If your clinical grant is to be changed to a cooperative agreement, NIAID staff will contact you with the details.

Contacts

Grantees with questions should contact the appropriate program officer or grants management specialist, listed on their Notice of Award. For more information, see Contact Staff for Help.

Contact for NIAID Staff

Contact for NIAID Staff, Office of Program Coordination and Operations

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Big Grants SOP

Cooperative Agreement (CA) Kiosk

Early Notification SOP

ENS & HHS Forecast in the NIH Guide Publishing System

Grants Management Infonet site for All NIH Policy on Cooperative Agreements

Human Subjects Resources SOPs

NIAID Funding Policy and Process SOP

NIH Manual Chapter 54815

Submission Guidelines and Templates for Publications in the NIH Guide for Grants and Contracts

See the following RFAs for examples of Terms and Conditions of Award for cooperative agreements:

• Partnerships for Hepatitis C Vaccine Development
• National Cooperative Drug Discovery Groups for Cancer
• Genomics of Transplantation Cooperative Research Program
• Clinical Trials in Organ Transplantation (CTOT)

Human Subjects Certifications: Training SOP

Definitions

• Normal staff involvement
• Ensuring compliance with general legislative, regulatory or administrative assistance policy requirements.
• Approving receipt plans before award.
• Conducting site visits, if needed, to ensure project performance is adequate.
• Evaluating scientific progress.
• Providing technical assistance at the PI's request.
• Facilitating interactions among grantees, e.g., organizing and holding meetings.
• Temporary intervention in unusual circumstances to correct deficiencies in a project.
• Closely monitoring high-risk institutions.
• Reviewing performance after completion.
• Substantial involvement
• Participating on committees, such as steering committees and sub-committees, central to the activity.
• Participating in protocol design or development.
• Helping to select contractors or other project staff.
• Coordinating or participating in data collection, analysis, and interpretation.
• Coordinating or providing training of project staff in awardee institutions.
• Participating in selection and approval of data analysis mechanisms.
• Approving a stage of a clinical trial or other collaborative project before the next stage starts.
• Co-authoring papers.
• Providing Institute resources, including contractors.
• Helping with management and technical performance.