Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the complexity of the informed consent process by providing more flexibility and additional harmonization between the agency’s regulations on human subject protections and the revised Common Rule, which governs research conducted or supported by the US Department of Health and Human Services.
FDA issued two proposed rules in September 2022 outlining changes to the informed consent form and allowing Institutional Review Boards (IRBs) to eliminate continuing review of research under certain circumstances. Additionally, the agency is proposing to harmonize its cooperative research requirements with those in the Common Rule, which requires a single IRB review process for multisite research in most cases. (RELATED: FDA seeks to harmonize human subject protections with revised Common Rule, Regulatory Focus 27 September 2022)…
