Overheard at AER: Conversations on Proposed Changes to the Common Rule


by Rebecca S. Ohnemus, MAA, CRA, Research Officer at University of the Incarnate Word

PRIM&R is pleased to introduce Rebecca Ohnemus, MAA, CRA, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD.

I love listening in on conversations. It’s one of my favorite guilty pleasures. There is little quite as enjoyable as hearing a juicy conversation, perking up your ears, and taking in the drama.
Overheard conversations are even better at conferences. Why? Because when you’re filing out of a room and everyone’s chatting, there is an unspoken rule that you can (very often) politely ask to join in—”I couldn’t help but overhear you talking about…” And, in no time, you’re discussing the implications of an issue on your own institution and sharing stories.

The most vocal audience reactions I overheard on the first day of the 2014 AER Conference occurred following a panel titled “Changes to the Common Rule: Challenges and Opportunities for IRBs.” Maybe it was the time of day, or everyone’s dinner time hunger riling them up, but most likely, it was the topic itself: a discussion of the National Research Council’s (NRC) response to the proposed changes to the “Common Rule” put forward in the Department of Health and Human Services’ 2011 Advance Notice of Proposed Rulemaking (ANPRM).

The panel, presented by members of the NRC (three of whom served on the ad hoc committee convened by the NRC to review and discuss the ANPRM) covered the proposed changes, how they might be implemented by IRBs for improved efficiency, and some of the potential challenges IRBs may face as a result.

While most people aren’t chomping at the bit for the opportunity to revamp their policies, processes, and standard operating procedures, there were more than a few nervous snippets I couldn’t help but overhear, including:

  • “What’s the practical expectation for determining an emotionally charged topic?”
  • “Who will have accountability if researchers make their own determinations? I can’t see how this won’t impact our ability to meet our federalwide assurance. How will we make assurances?”

Several of the conversations I overheard echoed the implementation challenges noted by the presenters, while others commented on the climate at their own institution, citing challenges in knowledge of and adherence to regulation and policy.

Though adoption of these particular proposed changes is uncertain, there will certainly come a time when changes are made. Which do you think may be adopted? Which do you worry about implementing? If you could propose a change to current regulation, what would you most like to see?