Webinar: (2021-07) Thorny Questions in Everyday IRB Deliberations: An Interactive, Case-Based Approach

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Description

IRB review of human subjects research consistently presents a range of ethical and regulatory challenges in even the simplest of research protocols. In this session, we will start with a wide variety of biomedical and social and behavioral science studies, and choose several to explore the often thorny ethical and regulatory issues that are part and parcel of an IRB’s everyday reviews.

Attendees will have the opportunity to choose topics of interest to focus the conversation. Potential topics include ethical justification for randomized clinical trials; use of placebo; financial conflicts of interest; inclusion (and exclusion) of vulnerable subjects; phase 1 trials and risk-benefit analysis; compensation (and coercion) of subjects; optimizing informed consent; secondary research findings; data and safety monitoring; and assessment and minimization of risk.

This case study-based Zoom meeting offers attendees the opportunity to interact with the speakers and other participants on screen. Through a combination of active audience participation and very brief didactic episodes, the speakers will highlight the challenges, how those challenges fit within the regulatory criteria for approval, and best practices for review. Attendees will leave with a framework for IRB members and administrators to use in effectively reviewing protocols involving these thorny components.

Agenda

Explore several studies, and parse out ethical and regulatory issues that are part and parcel of everyday reviews
Highlight the challenges in reviewing protocols with thorny components, how those challenges fit within the regulatory criteria for approval, and best practices for review

What will I learn?
How to use the ethical and regulatory framework in the Common Rule to address challenging components of everyday IRB deliberations.

Who should attend?
This program is geared toward HRPP/IRB personnel and those working in research programs more broadly including HRPP/IRB directors, members, chairs; researchers and research staff; and more.

Continuing Education
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More

Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.

If you prefer, you can find a paper registration form here. Please send the completed form to registration@primr.org.

Contributors

Mina P. Busch, MS, CCRP, CIP

Mina P. Busch is the program manager for Education and Outreach in the Office of Research Compliance and Regulatory Affairs at Cincinnati Children's Hospital. She oversees training development and delivery for over 800 Clinical Research Professionals and 3000 researchers overall.

Mina has been involved with clinical research for over 15 years and has developed numerous in-house training programs benefitting clinical researchers and the IRB. She has also contributed to a number of Collaborative Institutional Training Initiative (CITI) modules and resources. Mina is very interested in Research Ethics and continuous educational improvement.

Mina holds an MS in education from the University of Dayton and a BS in business administration from the University of Cincinnati. Go Bearcats!
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.”

Thank you

Description

Contributors

Mina P. Busch, MS, CCRP, CIP

Bruce Gordon, MD