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AAPOR responds to Federal proposal to change the Common Rule


On September 8, 2015, a Notice of Proposed Rule Making (NPRM) was published in the Federal Register regarding proposed changes to the Common Rule governing human subjects’ research. As these proposed changes are far-reaching and, if adopted, will affect many AAPOR members, especially those that submit their research to IRB’s for review, at its September meeting AAPOR’s Executive Council approved the creation of an Ad Hoc Committee to respond to the proposed changes and develop answers to the 88 questions in the NPRM. The committee was made up of several current and former Standards Committee members: David Cantor, Jill Darling, Tim Johnson, Ron Langley (Chair), John Loft, Mary Losch, Vicki Pineau, Carl Ramirez, and Tim Triplett.

Given the short 90 day deadline for submitting comments (later extended by 30 days), the committee broke into four groups to address broad areas covered in the NPRM; research with biospecimens, secondary research use of data, IRB review and operations, and new exclusion and exemption categories of review.

The committee then met to discuss the response drafts to come to a consensus that the response represented the views of AAPOR as an organization and that our answers to the questions posed were consistent with AAPOR’s Code of Professional Ethics and Practices. The Executive Council approved the response at its December meeting.

The stated goal of the proposed revisions is to increase protections for human subjects while reducing burden, delay, administrative costs, and ambiguity for researchers. The committee thought many of the proposed changes, such as classifying most minimal risk surveys as being excluded from IRB review, removing the need for continuing review of studies where data collection is complete, and having almost all research projects go through a single IRB, could achieve this goal.  Other changes, however, such as regulatory requirements for advance notice of research goals and privacy safeguards for some proposed exemption categories would be of dubious value for this purpose and would make the conduct of some types of research more burdensome and costly for researchers.

Also, of concern to the committee was that several of the proposals for which comment was requested were completely new and not presented in the Advanced NPRM from 2011. Indeed, the NPRM appears to be another ANPRM for comment on tools, options and HHS guidance that have not yet been developed. Key examples include the proposed online decision tool for determining the exemption status of research, the undeveloped data protection requirements/data security determinations that would serve as alternatives to the HIPAA requirements, the as yet to be determined Secretary’s list of minimal risk research, the undetermined list of explicit exclusions, and the proposed template for broad consent.

While a thorough discussion of the issues raised in the NPRM and AAPOR’s response to them is beyond the scope of this article, the full work of the Ad Hoc Committee on your behalf can be found here: AAPOR NPRM Comments