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
TAG ARCHIVES FOR IRB
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
Welcome 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
From its inception, one of PRIM&R's goals has been the education of research ethics and oversight professionals. To do this, we host conferences, short courses, webinars, and other offerings, such as PRIM&R’s online and member-only Knowledge Center, to assist our community in their daily work. The newest tool was brought about by our Knowledge Center Advisory Group. It's my pleasure to share PRIM&[...] Read more
Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about Julia Spesivtseva, MBA, CIP, senior IRB coordinator at University of Texas Southwestern Medical Center.
PRIM&R: When and why did you join the field?
Julia Spesivtseva (JS): I joined the field of clinical research, and subsequently the institutional review board (IRB), almost seven years ago. I have found it to be both fascinating and complex, and one of the fields where science and ethics are truly integrated.
PRIM&R: What is [...] Read more