The Department of Health and Human Services (HHS) and 15 other federal departments and agencies Jan. 18 released the final rule revising the 1991 regulations that govern federally-supported research involving human subjects, also known as the Common Rule. The Common Rule subjects all federally funded research to a standard set of rules, including requirements for informed consent and formal processes for the ethical review of research.
Among the changes to the regulations, the most significant include the mandate that a single Institutional Review Board (IRB) review and approve all multi-site research and the extension of the Common Rule to all clinical trials conducted at a U.S. institution that receives federal funding, regardless of funding source.
The rule also requires new information be added to informed consent documents and the publication of these documents on a public website. The final rule notably exempts certain types of research from the requirements of the rule. It does not include an earlier proposal to require prospective informed consent for future research with unidentified biospecimens, a proposal that was met with significant criticism from various stakeholders.
The release of the final rule represents the culmination of a lengthy revision process beginning in July 2011 when HHS issued an Advanced Notice of Proposed Rulemaking (ANPRM), which represented the first revisions to the regulations in over 20 years. The AAMC submitted a response to the ANPRM supporting the overhaul of the existing regulations. Based on feedback from the ANPRM, in Sep 2015, HHS issued a Notice of Proposed Rulemaking (NPRM) and received over 2,000 comments from a broad spectrum of the research community, many responses expressing opposition to the proposed changes related to the single IRB mandate and the treatment of biospecimens.
In the AAMC’s letter to HHS, the association expressed strong concerns about the most significant changes to the regulations and recommended “revisiting or withdrawal of these proposals and the overall simplification of the proposed rule” given the increase in administrative burden, cost, complexity of the proposed requirements, and lack of flexibility of the rule’s mandates [see Washington Highlights, Jan. 8].