Research involving prisoners cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the CRADO.

Waiver requests must be submitted electronically to the CRADO by the VA medical facility Director with the following documents:

1. A letter from the VA medical facility Director supporting the conduct of the VA study involving prisoners;
2. Rationale for conducting the research involving prisoners to include additional ethical protections taken by the proposed research for prisoners to make voluntary and uncoerced decisions whether or not to participate as subjects in research;
3. Documentation of the VA investigator’s qualifications to conduct the research involving prisoners, such as a biosketch and a list of all research team members;
4. Location of institutions where the research is proposed to be conducted;
5. A copy of the IRB approval letter specifically documenting its review determinations according to 45 CFR 46.305(a);
6. A copy of the IRB minutes approving the research with documentation that at least one member of the IRB included a prisoner or a prisoner representative for the review of the research;
7. A copy of the IRB-approved research study;
8. A copy of the IRB-approved informed consent document; and
9. A copy of the written HIPAA authorization.

If such a waiver is granted, the research must comply with the requirements of 45 CFR 46.301 – 46.306.