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.
Analysis of Public Comments on the Common Rule NPRM
Data Tables:
Table 1- Responses by Respondent Category
Table 3- Advocacy Groups by Subcategory
Common Rule NPRM Comment Summaries by Respondent Category:
Patients and Patient Representatives
Universities/Medical Centers/IRBs
Departments of Health, Health Officials, Municipal Governments and Epidemiologists
Biorepositories, Affiliated Organizations and Consultants
Professional Societies and Associations
Press Release
May 9, 2016- COGR/APLU/AAU Issue Joint Press Release
HHS Office for Human Research Protections Review of Public Comments on the Common Rule NPRM
Common Rule Notices of Proposed Rulemaking
➣COGR's 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”.
➣COGR’s December 8, 2015 response 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
