Sample Exemption Request Letter from the Grantee


If you are requesting an IRB Exemption, please submit a request in hard copy that resembles the letter below.

Please note that some Institutional Review Boards review evaluations and determine that full review is not warranted. Providing TOP a copy of an IRB's preliminary review determination is NOT sufficient. Only the Department of Commerce can confer an exemption to an evaluation. You may, however, provide a copy of the IRB's determination along with the materials you submitted to them.
 

Technology Opportunities Program
U.S. Department of Commerce
1401 Constitution Avenue, NW
HCHB, Room 4092
Washington, DC 20230

[NAME OF TOP PROGRAM OFFICER]:

Based on review of the policy described in Part 27 of Title 15 of the Code of Federal Regulations, the Common Rule for Protection of Human Subjects, we request an exemption for the proposed evaluation for our TOP project grant number [INCLUDE GRANT NUMBER or APPLICATION NUMBER here].

As described in 15 C.F.R. 27.101(b) we believe that the following exemption(s) listed below apply to our proposed evaluation: [From the exemptions listed below, INCLUDE ONLY THE EXEMPTION(S) THAT APPLY TO YOUR RESEARCH]

Our evaluation research will involve:

I believe the exemption is warranted because:

I request an exemption based on the research and evaluation information submitted at this time. I recognize that we cannot proceed with any research or evaluation activities that involve human subjects until this exemption is approved.

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]