PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more
TAG ARCHIVES FOR IRB
Meet Julie Simpson, PhD, director of research integrity services, affiliate assistant professor of college training, and affiliate assistant professor of education at the University of New Hampshire and, along with Ted Myatt, one of two new members of PRIM&R's Education Committee! She is highlighted this month as a research ethics professional making an impact on both her institution as well as the PRIM&R community at large. Read more
The annual Workload and Salary Survey reports offer insight into workload trends, salaries, and staffing patterns for IRB and IACUC offices. By publishing these reports, PRIM&R provides its members, and the wider research oversight committee, a valuable tool to aid in resource management. In this blog, we’ll focus on the 2015 IRB Workload and Salary Survey results. Read more
It seems that in many cases, IRB offices are struggling with processing and turnaround time of new and revised protocols. This can lead to overloaded agendas, which may not allow all IRB members enough time to review every item on the agenda prior to the IRB meetings. Jon Newlin, assistant director in the Office of the HRPP at North Shore-LIJ, explained during his presentation at the 2015 Advancing Ethical Research Conference (AER15), "Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience," that to rectify this problem his institution consolidated their IRBs into one roster. In this process, they reduced their IRB from more than 20 voting members to nine with 60 [...] Read more
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