Interim Guidance On Research Warranting Special Safeguards To Protect The Rights And Welfare Of Human Subjects 06/24/09. In approving research, Department of Veterans Affairs (VA) regulations and the Federal Policy (Common Rule) for the Protection of Human Subjects at Title 38 Code of Federal Regulations Part 16 (38 CFR 16) require that Institutional Review Boards (IRBs) determine the following:
• The selection of subjects is equitable, “taking into account the purposes of the research
and the setting in which the research will be conducted,” and with particular attention to the
“special problems of research involving vulnerable populations” [38 CFR 16.111(a)(3)].
• “Additional safeguards” are included “to protect the rights and welfare” of subjects who are
likely to be vulnerable to coercion or undue influence” [38 CFR 16.111(b)]. VA Office of Research & Development
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