Sample IRB Request to Accept IRB Approval from the Grantee
If you are requesting that TOP accept your IRB's approval of your evaluation, please submit a request in hard copy that resembles the letter below:
Technology Opportunities Program
U.S. Department of Commerce
1401 Constitution Avenue, NW
HCHB, Room 4092
Washington, DC 20230
[NAME OF TOP PROGRAM OFFICER]:
As prescribed in Part 27 of Title 15 of the Code of Federal Regulations, the Common Rule for Protection of Human Subjects, our project grant number [INCLUDE GRANT NUMBER or APPLICATION NUMBER here] involves research that requires approval by an Institutional Review Board.
Below are details regarding our IRB approval.
- Date research materials submitted to IRB:
- Name of Institutional Review Board:
- Date research materials approved by IRB:
- IRB's Federal Wide Assurance (FWA) No.: Please note that the IRB approving the research protocol MUST have Federal Wide Assurance on file with the Department of Health and Human Services. A listing of institutions that have FWAs on file can be found at ohrp.osophs.dhhs.gov/irbasur.htm
To satisfy TOP's Human Subject Research Special Award Condition, we have also attached the following required materials:
- A signed and dated approval letter from the IRB with an appropriate assurance for each approved protocol, along with the pertinent comments from the IRB concerning any interim review requirements or other restrictions, and
- All the materials we submitted to the IRB, including the informed consent forms reviewed and approved by the IRB.
If our research or evaluation deviates from materials submitted in this letter, we will seek approval from the Department of Commerce prior to any work involving human subjects being undertaken or any charges for activities involving human subjects being incurred and/or charged to the project.
[YOUR SIGNATURE]