If genetic analyses will be performed, I suggest you address the following in the cover letter and clarify these issues in the revised IRB application:
1. Describe the analyses that will be conducted on the saliva samples, and the genetic markers that will be analyzed.
2. Clarify the purpose of the genetic testing in this study and revise the Protocol Summary.
3. Clarify in the application and consent form whether subjects will receive their results from the genetic testing.
a. If so, clarify whether the genetic tests to be conducted have been scientifically validated and whether the lab where the testing will take place is CLIA certified.
i. If not, provide an ethical justification for providing subjects with their results from the genetic testing.
b. If not, revise the consent form to indicate that subjects will not be provided with their results from the genetic testing.
4. Revise the application to include background information regarding the genetic testing to be conducted in this study.
5. Clarify in the application and consent form whether there are potential benefits to society as a result of the genetic testing to be conducted in this study.
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