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The "Common Rule" Federal Policy for the Protection of Human Subjects

The Federal Policy for the Protection of Human Subjects, also known as the "Common Rule," governs the ethical conduct of research involving human subjects. Fifteen federal agencies and departments are party to this rule, which first came into effect in 1981. The Rule has not been substantively updated since 1991.

Recognizing that advances in research technologies and approaches, as well as societal values and perceptions, have changed in the intervening 25 years, the Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) led an interagency process to revise the Rule. OHRP issued an Advanced Notice of Public Rulemaking (ANPRM) in 2011. You can find the joint comments of APLU and the Association of American Universities (AAU) on these proposed changes here. Four years later, in September of 2015, OHRP issued a Notice of Proposed Rulemaking (NPRM). You can find the joint comments of APLU-AAU on the NPRM here.

APLU-AAU's comments were one submission out of 2,186 public comments on the 2015 NPRM. The proposed changes will substantially alter the conduct of research involving human subjects for decades to come. In moving from the NPRM to a final rule, federal agencies must take into account the concerns and recommendations submitted during the public comment period. Some provisions of the proposed rule may change based on public feedback. Thus, APLU joined a unique effort to understand the nature of all comments on the Rule, and explore whether the general and research publics believe the proposed changes to the rule will achieve their intended goal. 

APLU-COGR Analysis of Comments on the 2015 NPRM

In December 2015, APLU joined the Council on Governmental Relations (COGR) in analyzing the 2,186 public comments submitted to Regulations.Gov in response to the NPRM. We grouped respondents by category (patient, the general public, university, researcher, etc.), and coded comments on major provisions of the proposed rule. A summary of the findings for each respondent category can be found below. For detailed findings by commenter category, and additional information on this analysis, visit the COGR webpage on Human Subjects, here.

Analysis Findings

Analysis Summary Document

  • This document presents an overview of the content of publicly submitted comments on the Common Rule NPRM, broken down by comment type and responses to particular provisions. This document includes an overview of how the COGR-APLU analysis was conducted. 

Table: Support for NPRM Provisions, by Respondent Type

  • This linked table, derived from the COGR-APLU analysis of public comments on the Common Rule Notice of Proposed Rulemaking, presents levels of response, support, and opposition to specific proposed changes. See the above linked Analysis Summary Document for additional details on the provisions analyzed and how respondents were categorized.