Post-approval monitoring (PAM) has traditionally been, and in many ways still is, seen as a program to monitor protocols after approval. At PRIM&R's 2018 IACUC Conference (IACUC18), I attended a fascinating session titled “Quality Assurance Beyond Post-Approval Monitoring”. The session explored the idea that post-approval monitoring, or PAM, should be looked at as monitoring of the animal care and use program not just monitoring of the animal protocols. I have always been interested in quality assurance and quality management and the ideas in this session were very exciting! The notion that a formal PAM program could improve compliance across the animal care and use program in multiple facets is truly energizing. Read more
TAG ARCHIVES FOR protocol review
I recently attended a lecture titled, “Your Parameter is My Process,” in which a former professor of mine recounted her experience working on interdisciplinary research teams. She had noticed that questions she spent years investigating as a hydrologist were, in contrast, boiled down to simple equations or variables in an ecologist’s study—and vice versa. The takeaway was that based on a person’s background, training, education, and experience, they approach a problem differently. Read more
In January 2017, PRIM&R hosted a webinar titled Reducing Noncompliance While Facilitating Research: Strategies for IACUCs, presented by Barbara Garibaldi, DVM, DACLAM, and Emily Hearne, MS. The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (pdf) and send it to email@example.com. Read more
This year’s Advancing Ethical Research (AER) Conference provided me with the depth of knowledge I was expecting, but also with a new perspective that I had not anticipated. Full disclosure: I went to this conference assuming the pre-conference program would be most applicable and useful to my job. The pre-conference that I attended, IRB201, was, indeed, amazing. I walked away having memorized the 45 CFR 46.111 criteria for IRB review and approval and the ability to apply them to a protocol (or at least a practice protocol). Over the last few weeks, this new skill has carried me far; it has substantially refined my pre-review process, allowing me to more thoroughly and efficiently deliver an IRB protocol to my IRB administrator for her review. As one of just four IRB staff members at my institution, anything that streamlines the process and decreases burden is welcomed, and my newfound efficiency has not gone unnoticed or unappreciated. Read more
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