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: [...] Read more


I attended Thursday’s Single IRB AER15 Pre-Conference program and found it educational, thought-provoking, and beneficial. While my institution (Cincinnati Children’s Hospital) has been steadily expanding into the realm of single IRBs, in my role as an educator, I’ve only recently become involved.  That’s why I chose this topic.

Let’s jump in with some terminology….

So what is a single IRB as compared to a central IRB? I’ve been calling all studies involving reliance on multiple IRBs central IRBs, so learning that I had it wrong was my first surprise. Proper terminology is key. The difference is that networks and/or consortia [...] Read more


AER15 Blog Squad: Jacqueline TulskyJacqueline Tulsky: What challenge do I hope to address at the conference?

Prisoners, drug users, persons living with mental illness. Care to name three groups who are more equally in need of human research and human research protection?  And now with the rapid rise in innovative technologies uniquely suited for use in these complex groups, the approach to ethical protection for them and their investigators is faced with many unanswered challenges. For example, the ethical and legal dilemma involved in data gathering with mobile tracking devices at the time of potentially illegal behavior [...] Read more


Courtney Zwieg: Next Generation IRB MeetingsCourtney Zwieg: Our institution is currently undergoing a myriad of changes. For one, we are streamlining our standard operating procedures, which seem to evolve with every change in technology. While we formerly received and sent everything out in paper format, we now accept most things via electronic file; however, we still receive paper copies of submission forms. Furthermore, we recently started to utilize electronic signatures by the chairs of our IRBs. While at the AER Conference, I hope to gather information so that [...] Read more


I’m thrilled to have the opportunity to be a member of the Blog Squad for PRIM&R’s 2015 Advancing Ethical Research Conference (AER15). Last year was my first year attending the AER conference in Baltimore and it was, beyond a doubt, the most educational experience in my limited time in research. I’m very new to the world of IRBs and research administration and the conference helped me jump in with both feet.

During my time in Baltimore last year, the question I heard almost as much as "Where are you from?" was "How did you get into research?" [...] Read more