Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information -

On September 8, 2015, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies collectively issued in the Federal Register1 a notice of proposed rulemaking (NPRM) that would extensively revise the Federal Policy for the Protection of Human Subjects, which is also known as the Common Rule (the Policy). Among the proposed changes in the NPRM are modifications to: (1) exclusions and exemptions from the Policy; (2) conduct and functions of institutional review boards (IRBs); including expedited review and waivers of informed consent; and (3) requirements for institutions engaged in research conducted or supported by a Federal department or agency. This client alert focuses on only those proposed changes that are likely to have the greatest potential impact on the conduct of human biomedical and behavioral research in the United States, if adopted in the final rule.