What regulations apply regarding human subject protection in investigational IVD studies?
FDA regulations on “Protection of Human Subjects” and “Institutional Review Boards” (21 CFR Parts 50 and 56) apply to all clinical investigations (investigations involving human subjects) regulated by FDA under section 520(g) of the Federal Food, Drug and Cosmetic Act, as well as other clinical investigations that support applications for research or marketing permits for products regulated by FDA. (21 CFR 50.1, 56.101). As described above, any study using human specimens involves human subjects. FDA has expressed an intent to exercise enforcement discretion regarding informed consent for certain IVD studies, in the guidance entitled, “Guidance for Industry, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies using Leftover Human Specimens that are not Individually Identifiable.” Some research studies involving human subjects that are conducted or supported by a federal department or
