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
The Belmont Report serves as the ethical basis upon which regulations on the use of human subjects in research are based. These principles do not technically govern the research process, and yet are essential to ensure that research is done ethically. At the 2014 Advancing Ethical Research Conference, Gigi McMillan interviewed Ilene Wilets, PhD, CIP, executive director of the institutional review board (IRB) at the New York State Psychiatric Institute, for People and Perspectives. During her interview, Dr. Wilets [...] Read more