The document presents a detailed analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) of public feedback submitted in response to the 2015 Notice of Proposed Rulemaking (NPRM) for revisions to the "Common Rule," the cornerstone policy governing protection of human research subjects in the United States. The analysis encompasses over 2,100 public comments and focuses on significant NPRM proposals, such as expanding the definition of “human subject” to cover non-identified biospecimens, mandating broad consent for secondary research use of biospecimens, restricting Institutional Review Board (IRB) waiver of consent, requiring single IRB review for multisite studies, extending Common Rule coverage to all clinical trials at federally funded institutions, and introducing standard data security safeguards, as well as posting consent forms to a federal website.
Findings indicate substantial opposition from patients, researchers, universities, biorepositories, and medical centers to key proposed changes, particularly those concerning biospecimens and consent processes. The majority view holds that expanding the definition of human subject and mandating broad consent would significantly impede research, limit biospecimen availability, raise costs, and negatively impact scientific progress and patient outcomes—concerns heightened by burdensome administrative requirements and perceived lack of supporting data. In contrast, the general public and advocacy groups were more divided, with support often rooted in ethical and privacy considerations rather than logistics or research implications. Support was stronger for adding security safeguards to protect biospecimen and data privacy, while opinions on single IRB use and expanding Common Rule coverage were mixed. Overarching criticisms include the NPRM’s complexity, poor drafting, lack of clarity, and inadequately addressed practical and ethical consequences. Both advisory bodies and a significant proportion of institutional commenters called for substantial revision or withdrawal of the NPRM, emphasizing the need for simplification, better evidence, and more effective means of balancing participant protection with the advancement of medical research.
In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to regulations.gov in response to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (Common Rule). Respondents were grouped by category (e.g., patient, public, university, researcher, etc.) and comments on major provisions coded. A summary and table of the findings, as well as summaries for each respondent category, can be found below. For more information on this analysis, please contact Lisa Nichols, Director for Research & Regulatory Reform.
Data Tables:
Common Rule NPRM Comment Summaries by Respondent Category:
Press Release
HHS Office for Human Research Protections Review of Public Comments on the Common Rule NPRM
Common Rule Notices of Proposed Rulemaking
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2011 response to the Department of Health and Human Services (HHS) and White House Office of Science and Technology Policy (OSTP) advanced notice of proposed rulemaking (ANPRM) on Human Subjects Protections also known as the “Common Rule”.
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to the HHS Common Rule notice of proposed rulemaking (NPRM) and response summary
➣Summary of Proposed Changes provided by HHS, Office of Human Research Protections
