Session II: Effectively Managing Local Context Concerns in Single IRB Review

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

Dr. Thomas will discuss the challenge and opportunity confronting single IRBs and their responsibility to address local context issues in multi-site research.  These concerns include, but are not limited to, 1) community-culture, 2) disease burden, and 3) social justice issues related to structural inequality. He will include examples from his experience working as a member of the IRB for the All of Us research project, which deals with community-centered local context issues in its review of research protocols.

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.