The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, which contains requirements for protection of human subjects in research conducted or supported by the US Department of Health and Human Services.
The Federal Policy for the Protection of Human Subjects (known as the Common Rule) went into effect in 1991 and was revised in 2017. Previously, FDA released guidance for industry on how to handle differences in the revised Common Rule and rules on FDA-regulated research. FDA also addressed some differences with the revised Common Rule in a proposed rule focused on IRB waiver or alteration of informed consent for minimal risk clinical investigations, issued in November 2018. (RELATED: Differences Between HHS and FDA Clinical Trial Rules Spark New Guidance, Regulatory Focus 12 October 2018)…
