Analysis of Common Rule Comments

In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to 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 2- Results

Table 3- Advocacy Groups by Subcategory

Common Rule NPRM Comment Summaries by Respondent Category:

Patients and Patient Representatives

General Public

Academic Researchers

Universities/Medical Centers/IRBs

Industry/Pharma/Trade Groups

Tribal Nations

Advisory and Related Groups

Independent IRBs

Departments of Health, Health Officials, Municipal Governments and Epidemiologists

Biorepositories, Affiliated Organizations and Consultants

Disease Registries

Professional Societies and Associations

Advocacy Groups

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

​Comments Overview PDF

Common Rule Notices of Proposed Rulemaking

2011 Common Rule ANPRM 

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”.

2015 Common Rule NPRM 

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

Friday, January 1, 2016
Human Subjects