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
TAG ARCHIVES FOR protocol review
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
By Avery Avrakotos, education and policy manager
Last year, I was fortunate to have an opportunity to attend Ethical Issues in Global Health Research (EIGHR): Blending Cultures, Building Capacities, and Bolstering Collaboration. The four-day program, offered by the Harvard T.H. Chan School of Public Health, examined the unique issues that face institutional review boards (IRBs) and researchers reviewing and conducting international research.
As education and policy manager at PRIM&R, I regularly prepare written updates on federal laws, regulations, and news stories related to human subjects protections for distribution to PRIM&R's members, the majority of whom are [...] Read more
by Anne Meade, MS, PMP, Senior Manager for Website and Social Media
IRBs are well versed in the regulations and ethical principles that govern research with human subjects, but what happens when they are presented with a protocol about a disease or disorder about which they are unfamiliar?