Virtual Roundtable: IRB Case Studies

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Description

Join your fellow PRIM&R members on Monday, October 30, 1-2 PM ET, to discuss four case studies that illustrate the wide variety of ethical and regulatory challenges in biomedical and social, behavioral, and educational research protocols. Building on the September 21 webinar, Questions in Everyday IRB Deliberations: An Interactive, Case-Based Approach, members will have the opportunity to work though cases in an informal, collegial format, facilitated by the webinar speakers, Bruce Gordon, MD and Sue Logsdon, as well as several members of PRIM&R’s Membership Committee.

Virtual Roundtables are an exclusive benefit for PRIM&R members.

Contributors

Bruce Gordon, MD

Bruce Gordon is Assistant Vice-Chancellor for Regulatory Affairs, and Professor of Pediatrics in the Division of Pediatric Hematology/Oncology at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board since 1992, served as chair since 1996, and as executive chair since 2011.

He has served on a variety of national committees and task forces, including the Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee, the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the NIH Regulatory Burden Advisory Group Human Research Subcommittee, the AAMC Informed Consent Working Group, and the National Institute of Environmental Health Sciences (NIEHS) Best Practices Working Group for IRB Review of Disaster and Emergency Related Public Health Research. He was the first chair of the National Cancer Institute Pediatric Central IRB.

Dr. Gordon served on the Board of Director’s for PRIMR from 2015 to 2021. He has been a faculty member at every ARENA/PRIMR national meeting since 2002, and was the co-chair for the 2009 AER Conference. He is an active participant in PRIMR’s "At Your Doorstep" educational programs, including IRB 101, 200 and 250 programs.

He was co-developer of the Investigator Responsibility pre-conference workshop at the 2008 through 2011 annual meetings. He co-developed “Collaborating for Compliance” workshop, which has been presented as a stand-alone program since 2013. He co-developed an “IRB Chairs Boot Camp” program, which was presented at the 2014 and 2016 PRIMR AER meetings. He co-developed a “Vulnerable Subjects” program which was presented at the 2016 PRIMR AER meeting, and is currently part of the “At Your Doorstep” curriculum.

Dr. Gordon serves on the AAHRPP Council on Accreditation, and has been a faculty member at numerous AAHRPP conferences and a frequent AAHRPP site visitor. He is a founding member of the Collaborative Institutional Training Initiative (CITI) and served on the Executive Advisory Committee for the program. He is the author of two modules for the Human Subjects Research course. He co-developed a course related to research involving vulnerable subjects, and is the author of three modules for that course

Dr. Gordon is the author of numerous original papers, chapters, review articles, and abstracts regarding human subjects protections and research ethics, and is the co-editor of the third edition of “IRB: Management and Function.”
Sue Logsdon

Ms. Logsdon is a Senior IRB Analyst in the Office of Regulatory Affairs at the University of Nebraska Medical Center (UNMC) with more than 18 years' experience in the field. She has particular expertise in research involving human biologic materials (including FDA regulations concerning IVDDs and LDTs), and in exercise science and biomechanics. She is the author of numerous papers and has presented locally [and nationally] on a variety of topics related to the ethics involving human subjects research. Ms. Logsdon is co-author of "Research Involving Human Biospecimens” in the 3rd edition of “IRB: Management and Function” . She received her Master’s degree in exercise science from Virginia Tech. Before beginning her career at UNMC, she worked at Creighton University conducting research focused on the prevention of osteoporosis and falls in the elderly.