Clarifying the Revised Common Rule

Like many others, I attended the 2017 Advancing Ethical Research Conference eager to hear presentations from the experts, but also looking forward to hearing from other attendees about their interpretations of the revisions to the Common Rule. I went in with a list of questions a mile long.

Editor’s note: See for the latest news and information about the revised Common Rule.

Unsurprisingly, there were many available sessions on different aspects of the new Common Rule, from updating SOPs to navigating the review process and everything in between. I attended two of these sessions, one focused on updates to the definition of human subjects research and the other on the benign behavioral exemption. I entered both these sessions, perhaps naively, hoping for a clear road map to application.

The first session was “You’ll Know It When You See It, or Will You?: Defining “Human Subjects Research” Under the Revised Common Rule”, presented by Warren Capell, Dean R. Gallant, and Julia G. Gorey. The new rule specifically identifies four types of activities not considered human subjects research. The presenters identified these activities as carve-outs of the new rule, meant not to be blanket exclusions, but rather to provide clarifying language for IRBs. 

In the second session, “Understanding the Benign Behavioral Intervention Exemption” presented by Karen Christianson, Ivor A. Pritchard, David H. Strauss discussed the SACHRP Recommendations for interpreting this exemption and highlighted all of the criteria that need to be met in order for this exemption to apply.

I appreciated that both of these sessions featured a representative from Office for Human Research Protections who could provide background on the agency’s thought processes in addition to case studies with audience engagement so we could interact and share different interpretations. The most illuminating parts of these sessions were the discussions of the case studies. I was quite surprised at the range of interpretations put forward at both sessions by members of the audience. Especially at the benign behavioral intervention session, each case study was hotly debated and the perceived applicability of the exemption could hinge on the interpretation of one or two words in the regulation. While I didn’t leave either of these sessions with the neat and clean roadmap I hoped for walking in, I did learn a lot from hearing other’s thought processes while working through these tough cases. Hearing from others helped me isolate what key details will be necessary to make these decisions when applying the new Common Rule. It’s clear that the goal of the changes to the new rule are to decrease administrative burden in low-risk studies, but that in order to maintain consistent reviews, much of the interpretation of these new burden-reducing provisions will be need to be established by institutional policy.

Jennie Wyderko, MS, is the research compliance officer at Western Carolina University located in Cullowhee, North Carolina. She oversees and coordinates the IRB, IACUC and IBC for the campus. She is also responsible for oversight of export controls, responsible conduct of research, and conflict of interest as related to research.

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Save the date for PRIM&R’s 2018 Advancing Ethical Research Conference, taking place November 14-17 in San Diego, CA.