Copernicus Group IRB (CGIRB) Chairperson, Glenn Veit, spoke at the Drug Information Association 46th Annual Meeting. Along with colleagues from Duke University Medical Center and Pfizer, Inc., Mr. Veit presented a session titled "Three Perspectives of the IRB Process in Phase I Studies Conducted in an Academic Setting." The session focused on how obtaining Institutional Review Board (IRB) approval to conduct a Phase I clinical trial presents unique challenges for an academic site conducting the study, as well as the pharmaceutical sponsor, and the IRB.
"Having the opportunity to speak with Barry Mangum of Duke University Medical Center and Anne Cropp of Pfizer was professionally rewarding," said Veit. "Our session discussed three challenges ‐ operational, IRB approval process, and oversight ‐ through the lens of three stakeholders ‐ an academic site, the sponsor, and the IRB."
As the IRB representative for the session, Veit provided perspective by identifying the issues that make Phase I research at academic institutions different. He then explained how the IRB uses regulations and the principles of the Belmont Report to resolve those issues in a way that enhances subject safety and assists the sponsor and investigator in meeting goals for the research.
Veit summed up the session saying, "Hopefully the take‐away message is for people to better understand both the importance of IRB review and the potential benefits for all stakeholders."
About Glenn Veit
Veit has been with CGIRB since their first IRB review meeting in 1996. He is a graduate of Duke University and North Carolina Central University School of Law. Veit’s experience in all phases of the clinical trial process and areas of law make him an asset to Copernicus. Contact him at gveit[.]cgirb.com.
About Copernicus Group IRB
Experience and Innovation in Ethical Review™
Copernicus Group IRB (cgirb.com), established in July 1996, is a leading independent institutional review board ("IRB") dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004 and ISO 9001:2008 certification in 2010.
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