15
Nov2015

A Time For Debriefing

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15 Nov
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When we interact with colleagues at the 2015 Social, Behavioral, and Educational Research Conference (SBER15), an extremely helpful insight can arrive at any time, and from any source. But it’s difficult to know in advance when we will perceive it, and how it will affect the way we address our own research responsibilities.

For instance, I had no idea that an insight from a morning presentation would affect the way that I approach a challenge that I occasionally face as IRB Chair at Providence College. From time to time, we receive applications for projects in which advance processes of informed consent are not appropriate because they would “tip off” participants and [...] Read more

14
Nov2015

Are You Sure It’s Even Human?

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14 Nov
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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

14
Nov2015

Single IRB Surprise: Proper Terminology is Key

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14 Nov
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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

10
Nov2015

Webinar Follow-Up: IRB Oversight and FDA Review of Studies that Include IVDs

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10 Nov
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On May 14, PRIM&R hosted a webinar titled IRB Oversight and FDA Review of Studies that Include In-Vitro Diagnostics (IVDs), presented by Jonathan M. Green, MD, professor of medicine, pathology, and immunology, associate dean for human studies, and executive chair of the institutional review board (IRB) at Washington University School of Medicine in St. Louis, MO, and E. David Litwack, PhD, personalized medicine staff at the Office of In Vitro Diagnostics and Radiological Health at the US Food and Drug Administration (FDA).

At the conclusion of the webinar, Dr. Green and Dr. Litwack shared additional insight in response to questions from webinar attendees, and [...] Read more

6
Nov2015

The Pace of Change in Human Subjects Research: An Interview with Heather Kim

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6 Nov
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Heather-Kim-resizedWelcome to the latest installment in our series of featured member interviews. This series highlights individuals within our membership who are making an impact on the research ethics field through their work. This month, we hear from Heather Kim, a senior regulatory compliance auditor in Quality Management for Copernicus Group IRB.

Elise Davis (ED): When and why did you join the field?
Heather Kim (HK): I had just begun my Masters in Regulatory Affairs when we covered the IRB in a basic Part 50 and 56 overview. Around that time, I was looking for [...] Read more

5
Nov2015

Webinar Follow-Up: Identifying and Preventing Distress in Laboratory Animals

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5 Nov
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Recently, PRIM&R hosted a webinar titled Identifying and Preventing Distress in Laboratory Animals, which was presented by Mollie A. Bloomsmith, PhD, and Eric Hutchinson, DVM, DACLAM.

Stress and distress can negatively impact the welfare of laboratory animals and have adverse consequences for research. Minimizing distress in animals is mandated by federal regulations and remains an ethical obligation for research and compliance staff. To take measures to minimize distress, it is essential to understand its causes and manifestations among the various species of laboratory animals.

This webinar provided strategies for detecting signs of distress, identifying research procedures likely to lead to distress, and understanding [...] Read more