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 grants 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

• When planning initiatives for cooperative agreements, allow several weeks extra for OER approval.
• To request OER approval, send Contact for NIAID Staff a justification and copy of the proposed initiative from the draft initiative package sent to DEA. For more information, see the Early Notification System Cooperative Agreement Clearance Process.

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 Grant Award. For more information, see Contact Staff for Help.

Contact for NIAID Staff

Contact for NIAID Staff

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

Early Notification System Web page

Grants management Infonet site for all NIH policy on cooperative agreements Web page

Human Subjects 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)

Training in the Protection of Human Subjects 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.