On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of Human Subjects, which is also known as The Common Rule (the Policy). The new rule is effective on January 19, 2018, which is also the compliance date. The Common Rule was originally promulgated in 1991 and the new rule, which will amend 45 C.F.R. Part 46, is the first substantive revision in over two decades. Although FDA has not yet issued a notice of proposed rulemaking, the agency is expected to harmonize its human subjects protection regulations with the Common Rule to the extent permitted under their differing statutory authorities and HHS is required to carry out this harmonization of the two policies under Section 3023 of the 21st Century Cures Act.

The preamble clarifies that the rule is intended to address, and in certain ways, facilitate the broader types of clinical research that are now sponsored by HHS and other federal agencies, and to ensure the protection of human subjects in the context of explosive growth of the use of sophisticated techniques to analyze biospecimens, including genomic sequencing, and very large datasets. Major changes include: (1) new requirements regarding the information that must be disclosed to prospective human subjects during the informed consent process; (2) allowance of the use of broad consent for storage, maintenance, and unspecified future research uses of identifiable private information and identifiable biospecimens; (3) new categories of research that are exempt from IRB review or that would require limited IRB review to ensure adequate privacy safeguards; (4) a new requirement for U.S. institutions engaged in cooperative research to use a single IRB; and (5) removal of the requirement for IRBs to conduct continuing review of studies that undergo initial expedited review as well as certain other types of studies.