The document discusses significant revisions made to the Common Rule, the primary federal regulation governing the protection of human research subjects in the United States. Announced in the Federal Register on January 19, 2017, the revisions have two principal objectives: to enhance subject protections where necessary while reducing undue administrative burdens. The effective date for the changes is one year after publication, with compliance for multi-institutional research delayed until three years after the publication date. Importantly, studies approved prior to the effective date can elect to follow either the old or new regulations.
Key features of the revisions include improvements to the informed consent process—enhancing both the content and structure of consent forms—as well as provisions for single IRB oversight in many cooperative studies, with expanded exceptions allowed for specific contexts. The revisions also introduce broader definitions and exemptions regarding what constitutes research and add the option for broad consent for certain secondary research uses. Notably, the need for continuing review has been eliminated for many types of studies. However, several proposed changes were not adopted, such as further regulation of de-identified biospecimens and inclusion of non-federally funded clinical trials. Overall, the revisions aim to modernize the Common Rule, balancing participant protection with streamlined research oversight.
