The Common Rule Summary Table outlines significant revisions to federal regulations governing human subjects research. The final rule, effective from January 19, 2018 (with special provisions for cooperative research effective January 20, 2020), distinguishes between non-identified and identifiable biospecimens, treating identifiable biospecimens and private information equivalently and providing for ongoing review and potential re-interpretation of these definitions. Informed consent requirements have been enhanced, mandating a concise summary of key information, inclusion of details regarding future use, commercial profit, and whole genome sequencing, and requiring the public posting of consent forms for certain clinical trials. The rule clarifies activities not considered research, such as certain journalistic, public health, and criminal justice undertakings, and modifies as well as expands exemptions—especially for the secondary use of identifiable information under specified conditions. Continuing review is no longer required for most expedited or data-only studies, and annual Investigator confirmation to the IRB is generally not mandated.
The revised rule does not extend requirements to non-federally funded clinical trials but stipulates the use of a single IRB for multisite studies, with specific exceptions allowed. Privacy and security oversight remains primarily the purview of IRBs, with HHS directed to issue related guidance. Several administrative changes are included, such as the elimination of IRB review for grant proposals and the plan to discontinue voluntary Federalwide Assurance extensions. Overall, the revisions aim to clarify and streamline regulatory requirements, enhance protections for research subjects, reduce administrative burden, and align regulatory practice with evolving research methodologies and technologies.
