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 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 agency will be required to follow the Federal Policy
for the Protection of Human Subjects (the “Common Rule”). The Department of
Health and Human Services (HHS) has codified the Common Rule at 45 CFR
Part 46, subpart A. Research involving human subjects that is conducted or
supported by HHS and that is not otherwise exempt must comply with 45 CFR
Part 46, which contains additional protections for specific populations.
FDA regulation and the Common Rule contain some differing requirements.
Although FDA and HHS seek to harmonize requirements related to informed
consent where possible, certain requirements of the FDA regulation and the
Common Rule are different. The same study may be subject to both sets of
requirements, either one, or neither. It is the responsibility of sponsors and
investigators to comply with all applicable requirements.
