Research Ethics Roundup: The FDA as an Independent Agency, Criticism of Proposed Revisions to the Common Rule, and More

This week’s Research Ethics Roundup explores debates on regulations and regulators: NPR covers a critique of revisions to the Common Rule, a Nature editorial responds to legislation that would loosen FDA regulations, former FDA commissioners ask Congress to make the agency more independent, and a new software aims to reduce the quantity of animals used in research.

Heat on White House to Scrap Redo of Human Research Rules: Rob Stein of NPR writes that a recently released report from the National Academies of Sciences, Engineering, and Medicine was highly critical of revisions to the Common Rule proposed by the Department of Health and Human Services (DHHS). The Academies wrote that the proposal is “marred by omissions, the absence of essential elements, and a lack of clarity,” arguing that the development of revisions to the Common Rule should begin anew and should be guided by an independent commission. DHHS is currently reviewing the Academies’ report, as well as over 2,100 public comments on their proposal. 

Test tubesFDA Should Stand Firm on Stem-Cell Treatments: An editorial published by Nature rejects a call to reduce regulation of stem-cell treatments in the United States because, the authors write, the argument “wrongly implies that the FDA is holding back therapies that work.” According to the editorial, only “proper clinical trials” can identify safe and effective treatments. By eliminating the mandate for thorough clinical testing, the proposed changes in the REGROW Act would allow patients to access treatments despite “minimal safety data and little attention to efficacy.”

Former Commissioners: Make FDA an Independent Agency: Helena Bottemiller Evich, writing for Politico, reports that six former FDA commissioners requested that Congress “make the FDA an independent agency.” The FDA is responsible for regulating “more than a quarter of the economy and deals with critical food and drug safety” issues, but the former commissioners argued that such important work is fettered by bureaucracy and congressional politics. The commissioners said they intend to write a white paper outlining their argument for the incoming presidential administration.

Experimental Design AssistanLab_animal_caret: Improving the Scientific Method: Speaking of Research reports on the success of the software package, Experimental Design Assistant (EDA). EDA was released by the National Center for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs), the same organization that produced the influential ARRIVE guidelines, and already boasts over 400 registered users. The software’s prominence advances NC3Rs’ aim to reduce the quantity of animals used in research, but one “R” of NC3Rs platform, refining animal research studies, has been less affected.