Conversion of Grants to Cooperative Agreements

Purpose

To convert grants to cooperative agreements when NIAID staff need to have substantial involvement in the research.

Procedure

A cooperative agreement is a grant in the U series for which NIAID program officers are substantially involved in the research; see definitions of normal involvement and substantial involvement.

See the April 15, 1994, Guide notice on the need for converting applications to cooperative agreements, and the July 19, 2002, Guide notice stating that NIAID may decide to award a new or renewal investigator-initiated clinical trial or epidemiology study as a cooperative agreement.

Conversion can take place within NIAID only if one or more of the following conditions exist:

• Application is a new or renewal of an investigator-initiated clinical trial or a prevention, education, control intervention, or epidemiologic study for more than $500,000 in direct costs in any year.
• NIAID holds the investigational new drug application and gives regulatory support to a grantee.
• Subjects in clinical research have more than a minimal risk.
• Grantees will acquire, store, modify, or use dangerous biological agents.

Both NIAID and PI must agree to the terms and conditions of award for a cooperative agreement. A PI may request more money because the new terms and conditions may increase research costs.

Use the following process to convert a grant to a cooperative agreement.

Program Officers

• Do not convert a grant to a cooperative agreement unless you are certain your division has the resources. Be sure your division can commit staff time and other resources, including funds, needed for a more involved role. Your division must have qualified staff to do the additional work so that a grantee's research is not unreasonably delayed (i.e., more than a couple of weeks).
• Make sure funds are available. Contact your supervisor for help.
• Identify applications that should be converted. For example, those that:
• Meet one or more of the conditions in the bulleted list above and, possibly, have an initial peer review recommendation to use a cooperative agreement or a Council recommendation for conversion to a cooperative agreement.
• Have your division director document his or her approval in a memo or an email. See instructions for the Email Conversion Request.
• Discuss the reasons for a conversion and proposed terms and conditions of award with the grants management specialist to iron out any issues before contacting a PI.
• Develop the terms and conditions of award with the grants management specialist. Make sure the terms and conditions are scientifically correct, and the institute can provide the assistance required. For clinical studies or trials, cooperative agreements are also subject to NIAID's Clinical Terms of Award.
• Negotiate new terms and conditions of award with the PI and institution. The institution needs to agree to the conversion.
• Prepare an Email Conversion Request.
• Send terms and conditions to the PI and institution for signature.
• Indicate on the Program Officer Checklist whether the PI needs to address the Clinical Terms of Award.

Grants Management Staff

Grants Management Specialists

• Develop the terms and conditions of award with the program officer.
• Ensure that the terms and conditions meet grants policy requirements.
• Negotiate the final terms and conditions of award and possibly budget revisions.

Grants Management Officers

• Review justification and terms of conditions of award and make necessary corrections.
• Send to DEA director for approval.

Division of Extramural Activities OD Staff

• If DEA director approves conversion, OD staff change activity code in IMPAC, inform grants and program staff of approval, and send approval package to Grants Management Program.
• When determined necessary by the DEA director, get approval from NIH Office of Extramural Programs (OEP) Contact for NIAID Staff.

Principal Investigators and Institutional Officials

• Sign and send your acceptance of the terms and conditions of award to the grants management specialist.
• You can request more money if a conversion increases your costs.

Grants Staff

• Negotiate and make awards.

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.

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

NIH OEPContact 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

Cooperative Agreement (CA) Kiosk

Cooperative Agreements SOP

Email Requesting Conversion of Application to Cooperative Agreement

Grants Management Infonet Web site, Policy Topic: Cooperative Agreement Awards

Investigator-Initiated Clinical Trial Planning and Implementation Grants SOP

Investigator-Initiated Clinical Trials Resources main page

July 8, 2002, Guide notice, Monitoring of Clinical Trials and Studies

Grant Types for activity codes