Extending/Renewing

AMENDING

If a PI makes changes to research after a CoC has been issued, they may be required to formally amend the CoC by the issuing NIH agency.

PIs should consult with their NIH representative first to learn if what they are changingin the currently approved protocol requires an amendment to the existing CoC for the research. Changes to the research protocol may not be substantive enough to warrant a change but this is determined by the NIH agency under which the CoC was issued. For more information, see:

Amending the CoC should be done only after you have submitted an amendment to change your IRB application and obtained IRB approval for the changes.

EXTENDING/RENEWING

The NIH requires that CoCs be extended/renewed by their agencies within 2-3 months of the expiration date found on the official CoC documentation.

It is recommended that PIs consult with their NIH representative first to learn if a formal application to extend/renew the CoC is required. A formal application may not be required if enrollment of subjects is complete and/or no identifiable data is retained by the researchers. For more information, see:

PROCEDURES

1. If an amendment or extensionapplication is required by the NIH issuing agency, the PI may be asked to work within the new NIH online application system. However, PIs are more typically required to complete the Certificate of Confidentiality Extramural Research Projects Application found at:

Go to Step 3

1. If an amendmentor extension applicationis not required by the NIH issuing agency, you must still complete an abbreviated application process for the U-M HRPP.

Go to Step 4

1. Submit the CoC application packet to . The documents should be submitted as one continuous file, and must include:
2. The dated cover memo (to the attention of the NIH representative) on PI’s departmental letterhead
3. The completed CoCExtramural applicationor a copy of the online CoC application, as required by the NIH agency
4. The IRB approval letter for the amended IRB application
5. The IRB approved consent/assent document(s),if revised as part of the changes
6. The PI-signed Letter of Assurances (using the U-M template; found at HRPP CoC webpage)

Go to Step 5

1. Submit the U-M HRPP CoC Amendment/Extension packet to . The documents should be submitted as one continuous file, and must include:
2. The U-M HRPP Amended/Extended CoC Checklist found at: (see second paragraph from end)
3. A copy of the NIH letter or email stating that a formal amendment/extension application is not required
4. The PI will be notified of the outcome of the DIO review, after which they may submit their materials to the NIH (if an application is required).

For questions:

IRBMED Applications: Joe Austin, Assistant Director,

IRB-HSBS Applications:Mary Ramirez, Assistant Director,

7.27.2016