The National Academies of Science, Engineering, and Medicine June 29 issued the second and final part of its report on a new regulatory framework for research universities, recommending that the executive branch withdraw the Notice of Proposed Rulemaking (NPRM) for the “Common Rule,” the regulations that govern federally-supported research involving human subjects.
Citing “omissions, the absence of essential elements, and a lack of clarity,” in the proposed rule, the report states that “it would be impractical to use the current NPRM as a basis for achieving a meaningful, consistent, and harmonious revision of the regulations.” The report instead suggests that Congress authorize the formation of an independent national commission to review and modernize the “ethical, legal, and institutional frameworks governing human subjects research” prior to the creation of any new regulations.
In response to the National Academies report, AAMC President and CEO Darrell Kirch, M.D., issued a statement that highlights the potential benefits of creating a commission to reevaluate the Common Rule, stating that it “could ensure the rule more effectively meets the needs of research participants, researchers, and ultimately the patients who will benefit from research advances.” He also notes that implementation of the proposed rule without further revision could hinder recent Administration research initiatives such as the Cancer Moonshot.
The AAMC previously submitted comments on the Common Rule NPRM, [see Washington Highlights, Jan. 8] emphasizing that the research enterprise has advanced dramatically since the regulations were first promulgated in 1991, and expressing concern that the proposed revisions to the rule do not necessarily reflect significant changes to the practice and conduct of clinical research. In particular, the letter highlighted significant concerns with the provision requiring researchers to obtain written consent for all research with unidentified biospecimens, a key issue explored in Academies’ report.
The National Academies committee that produced the report was established in early 2015, with a goal of reviewing current federal research regulations and identifying specific actions that stakeholders might take to reduce regulatory burden and optimize the nation’s investment in research. In addition to its recommendations on human subject’s research, part two of the report also provides recommendations related to research with select agents and toxins, export controls, and reporting information related to intellectual property and technology transfer.