There has been a wording change to VI.13. The question has added a new bullet to address the enrollment of non veterans under IRB-03 studies. However, all IRB (01,02,03) applications will see this update even though they may not indicate IRB-03 in I.1. The question reads the following:
VI.13 Describe EACH of your subject populations
- Include description of any control group(s)
- Specify the Inclusion/Exclusion criteria for EACH group
- Studies under IRB-03 enrolling non veterans as part of the subject population must present a compelling argument to the IRB for the inclusion of non-Veterans (e.g., insufficient number of Veterans; survey of VA employees; study of active duty military; study involving Veterans’ family members), and the research is relevant to the care of Veterans or active duty military personnel.
This is a requirement under 1200.05. Please note all new IRB-03 projects submitted must contain this justification. This is outlined our Investigator's Guide on page 103, Section 7.B.i Inclusion Criteria.