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]
- The research will be conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- The research involves the use of educational tests (i.e., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior. The information obtained will not be recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects. Any disclosure of the human subjects' responses outside the research could not reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation.
- The research will involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. The information collected is publicly available, or the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Our evaluation research will involve:
- [In this section you should summarize your research plan and include the types of evaluation instruments you will use, who will be evaluated, whether the evaluation will be done via contract and by whom, and other information as appropriate. There must be sufficient information to determine how the evaluation will be conducted.]
I believe the exemption is warranted because:
- [Explain the specific protections you will be put into place to ensure the exemptions hold. You should clearly specify that procedures you will employ to ensure that protected classes (i.e., prisoners) will be excluded from your research.]
- [If your research will include vulnerable classes (i.e., children, individuals with disabilities, seniors, etc.), you should discuss the specifics safeguards in place to protect these individuals. For example, you should document your organization's and your researcher's qualifications for working with the vulnerable class(es) you plan to include, your procedures to inform individuals of the nature of the research and the risks, and your mechanisms to garner consent.]
- [If data analysis is part of the evaluation, you should describe the database fields that you will block from evaluators and specify how confidentiality of records will be maintained.]
- [In addition, you should include as attachments any items (including your evaluation plan, evaluation contracts, evaluator strategies, evaluator qualifications, sample questions to be used in surveys or focus groups, etc.) that will support your request for an exemption.]
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.