2020 OHRP EXPLORATORY WORKSHOP
PRACTICAL & ETHICAL CONSIDERATIONS
FOR SINGLE IRB REVIEW
SESSION II:
Effectively Managing Local Context Concerns in Single IRB Review
There are questions about whether local context issues receive adequate consideration in single IRB review of collaborative multi-site research. This session will examine what might constitute legitimate local context concerns and how single IRBs could best ensure that they receive appropriate attention and accommodation.
Moderator: Liza Dawson, PhD
Chief of Bioethics and IRB Chair, Walter Reed Army Institute of Research
Addressing local context issues by single IRBs in multi-site research
Robert Klitzman, MD
Professor of Psychiatry, Columbia University
Dr. Klitzman will describe local context issues that single IRBs might need to address in multi-site research, and discuss challenges and solutions for adequately managing them.
Challenges to reviewing clinical research when local context includes variation in infrastructure and practices
Jonathan M. Green, MD, MBA
Director, Office of Human Subjects Research Protections, National Institutes of Health Intramural Research Program
Differences in institutional clinical care infrastructure and clinical practices could have significant impact on the outcome of the review for different sites in a cooperative research study. The differences are not always apparent, researchers may not consider the differences something worth mentioning to the IRB, and the IRB may not readily detect the differences and their relevance to review. Dr. Green will provide examples of these types of challenges and share ideas for addressing them from the standpoint of the single IRB.
How might a single irb for multisite research address local culture, race, and social class of potential human subjects?
Stephen B. Thomas, PhD
Professor, Health Policy and Management, and Director, Maryland Center for Health Equity, University of Maryland and IRB member for the All of Us program
Experience with regionalized ethics review committees in the United Kingdom and Europe
Sarah J.L. Edwards, PhD
Professor of Bioethics, Department of Science and Technology Studies, University College London
The United Kingdom and the European Union began to defer research review to fewer regionalized review boards years ago. Dr. Edwards will share her knowledge and experience with these regionalized review boards and discuss the value and challenges inherent to inclusion of differing ethical viewpoints among reviewers and apply lessons learned to the single IRB review model in HHS conducted and supported multi-site cooperative research. She will address select ways to account for local circumstances and the communities that host the research.
