Are You Sure It’s Even Human?

AER15 Blog Squad: Jacqueline Tulsky

Exempting, expediting, and generally reviewing categories in social, behavioral, and educational research

Like three wise owls perched on the speakers platform, Kristina Borror, PhD, Jeffrey M. Cohen, PhD, and Dean R. Gallant, AB rolled out multiple vignettes in an interactive teaching format to review some bread and butter topics on IRB guidance at AER15. “What about this example makes it outside the exempt category?” asked Borror, director of Division of Compliance Oversight of the Office of Human Research Protections, of a skeptical audience member.

This triumvirate of veteran educators was simultaneously kind but persistent and demanding of precision in reinforcing one of the teaching points: determining if one of the vignettes was exempt from IRB review or not. Their determination that we all “get it” made this an extremely satisfying workshop. 

Three of many pearls of the workshop were:

  1. A systematic approach to the questions of “Is it human research?” and “Is it exempt?”  revealed how easy it is to confuse the two factors in determining review status. One example presented was a telephone survey asking for people’s opinions regarding the dissemination of an environmental regulation policy. After working through the study methods and data collection with the help of audience members, it was clear that 45 CFR 46 would categorize the study as NOT human research (not about the person who’s being surveyed, anonymous, no private information collected.
  2. Expedited review is not “review light” but the word “expedited” conveys the unfortunate sense to investigators that everything will go faster if they can just make their study fit the criteria. Expedited studies require the same level of detailed review as the “convened review” or full committee review. Rebranding with the label of designated [member] review might go a long way toward clarifying this point for both IRB members and investigators. 
  3. Review categories can change without the study changing. What starts out as expedited, can be sent to full committee if the reviewer is not comfortable being the sole arbiter of the study. A natural corollary of this fact is that, while a single designated reviewer can approve a study as categorized, it takes a full committee to not approve a study. If the study implementation goes smoothly, the initial full review study can be annually reviewed as expedited. The vignette that illustrated the point was a playground observational study that involved passive data collection through an audio recording device. 

While initially thinking perhaps the study could not be approved, a systematic walk-through by the presenters revealed that the study could in fact meet criteria for an expedited review. Interestingly, the designated reviewer declined to be the sole decision-maker in a study with such a novel technique, and the study proceeded to a full review initially. Over time, the study proved to be minimal risk as suspected and was moved to an expedited annual review.

I did not feel “relaxed” after the workshop, but this excellent session definitely reinforced my confidence and resources going into a review of NPRM.

Jacqueline Tulsky, professor of medicine, emeritus at the University of California, San Francisco, is a member of the PRIM&R Blog Squad for the 2015 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blogged here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.