Some links will work for NIAID staff only.
|
Standard Operating Procedure Table of Contents
|
|
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 |