PRIM&R recently completed a draft of our comments to the Department of Health and Human Services (DHHS) in response to their Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, If adopted, the proposals in the NPRM will result in the first revision to the Common Rule since 1991, and the most substantive revisions to the core regulations governing federally funded human subjects research in the United States since 1981. PRIM&R believes that, without question, an improved and modernized system of human subjects protection will better serve both research subjects and science. But we conclude that neither the scientific community nor the public can have confidence that better, consistent, and ethically sound practices will emerge from the regulatory changes proposed by this NPRM.
Below is a brief summary of our recommendations:
- The proposals to redefine research with biospecimens as human subjects research and require broad consent for biospecimen use do not represent an improvement over the current system; they are unlikely to further the interests of subject autonomy and may create new obstacles to research participation. Alternative models need to be studied if the rules on the use of biospecimens and personally identifiable data are to respect subjects’ wishes and protect their interests while also allowing researchers to access a wide range of biospecimens and data. The proposed regulatory change lacks adequate warrant in the absence of a more careful evaluation of their implications and feasibility.
- Mandating reliance on a single IRB in all cases of multi-site research is overly rigid. The Common Rule should continue to permit research institutions and research funders to develop and evaluate cooperative reliance models and case-by-case decisions regarding the use of a single IRB when that will best balance efficiency and quality of review in light of the particularities of each multi-site study or trial.
- Many of the revisions related to the new category of exclusions and the expansion of exemptions unduly reduce the protection of human subjects, reflect an oversimplification of what is entailed in meaningful ethics review, and lack essential requirements for investigator education about the ethics of research and the grounds for excluding or exempting studies from the requirements of the Common Rule.
- As the locus of responsibility for human research protections shifts away from institutions, the role of the individual investigators grows and along with that must come regulations to define and enforce investigators’ responsibilities to protect human subjects.
- We endorse the idea that information must be presented to potential subjects in a manner that facilitates understanding, but question the value of the requirement that informed consent forms must be posted on a federal website.
PRIM&R thus does not believe efforts to finalize the NPRM as it is should move ahead. Rather, the many shortcomings in this attempt at comprehensive reformulation—a few of which are catalogued in our comments—suggest a better way forward: thoughtful, incremental revisions of individual Common Rule provisions that reflect careful study and input along the way from the research protections community, researchers, and the public. We invite your reflections on our draft comments and welcome you to quote it in your own comments.
PRIM&R’s most recent blog post analyzing the NPRM’s proposed changes can be found here.
Comments on the NPRM are being accepted on the proposed rule through January 6, 2016 at 5:00 PM ET.