AERA, ICPSR, and COSSA Provide Comments on Revisions to Common Rule

January 2016

On January 6, AERA, the Interuniversity Consortium for Political and Social Research (ICPSR), and the Consortium of Social Science Associations (COSSA) submitted joint comments on proposed revisions to regulations governing human subjects protections in research, often referred to as the Common Rule.

The Notice of Proposed Rulemaking (NPRM), published in the Federal Register on September 8, 2015, included a variety of changes. The Office for Human Research Protection (OHRP), within the Department of Health and Human Services (HHS), compiled a summary of the major proposed revisions to the Common Rule.

The AERA-ICPSR-COSSA comments addressed several areas of the proposed revisions and responded directly to specific questions most relevant to the social and behavioral sciences, including education research, posed by OHRP throughout the NPRM.

The comments supported the proposed exclusion from review of research that does not meet the definition of human-subjects research or is low risk when independent controls are in place and no identifiable information is recorded. The comments also backed up the rethinking of exempt research—in particular, supporting the continuation of an exemption for research in educational settings that involves normal education practices. Also, the comments supported the shift from privileging HIPAA regarding privacy standards in research and the development of a robust decision tool to help investigators to determine when informed consent is needed.

In addition, the comments addressed the secondary research use of collected data, including broad consent for use and oral consent for data re-use; security measures for certain types of research activities; and proposed limitations on re-disclosure.

“The revisions to the Common Rule are significant to education research and all of the social and behavioral sciences in guiding ethical research when human subjects are involved, particularly regarding informed consent, protecting privacy, and allowing for data use under conditions that ensure data security and confidentiality,” said AERA Executive Director Felice J. Levine. “We look forward to seeing the response from HHS on some of the larger issues that require further thought and resolution. This NPRM is a good first step that enhances the protection of human subjects while reducing burden.”

The NPRM builds on responses to an Advanced Notice of Proposed Rulemaking (ANPRM) that was issued in 2011. Levine also led the effort that produced a white paper on behalf of the social and behavioral science community in response to the ANPRM. In addition, she served on the committee that produced the 2014 National Academies report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. This report importantly informed some of the shaping of the NPRM.

It is expected that HHS officials will respond to the comments by the end of the year. Many groups that responded to the NPRM indicated that they would like the opportunity to comment on any further changes that are made based on this set of responses.