Presentations from the 2006 National Conference on Alternative IRB Models:
Optimizing Human Subject Protection
November 19-21, 2006
Marriott Wardman Park Hotel
Washington, DC
Opening Session: Conference Introduction
Moderator:
Robert J. Levine, MA, PhD
Professor, Internal Medicine, Director, Law, Policy and Ethics Core Investigator, International Research Core
Yale University Center for Interdisciplinary Research on Aids
Speakers:
Lowell E Schnipper, MD
Theodore and Evelyn Berenson Professor of Medicine
Harvard Medical School
Chief, Hematology/Oncology Division, Beth Israel Deaconess Medical Center
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Richard W. Bianco, PhD
Associate Vice President for Research and Regulatory Affairs
University of Minnesota
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Panel 1: Liability
What implications would the use of alternative forms of IRB review have for regulatory or civil liability? Under what circumstances would the various forms of alternative review be most appropriate from this perspective?
Moderator:
Judith E. Leonard, JD
Vice President for Legal Affairs, General Counsel
University of Arizona
Speakers:
Alexander E. Dreier, JD
Partner
Hogan and Hartson
(Presentation Not Available)
Diane Lopez, JD
University Attorney
Harvard University
(Presentation Not Available)
Ara Tahmassian, PhD
Associate Vice Chancellor, Office of Research
University of California, San Francisco
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David Wynes, PhD
Senior Associate Vice President for Research
The University of Iowa
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Panel 2: Shared Authority and Responsibilities
How can shared authority and responsibilities best be managed to ensure appropriate control and accountability? Under what circumstances would the various forms of alternative review be most appropriate from this perspective?
Moderator:
Angela Bowen, MD
President
Western IRB
Speakers:
Marjorie Speers, PhD
Executive Director
Association for the Accreditation for Human Research Protection Programs
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Angela C. Wishon, JD
Assist Vice Chancellor, Regulatory Compliance
University of Colorado at Denver and Health Sciences Center
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Don E. Workman, PhD, CIP
Executive Director, Office for the Protection of Research Subjects
Northwestern University
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Brent C. Miller, Ph.D.
Vice President for Research
Utah State University
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Panel 3: Quality of Review, including Capacity to Consider Local Context
What implications would the use of alternative forms of IRB review have for quality of review, including the capacity to fully address issues related to the local context? What are the critical concerns to be addressed? Under what circumstances would the various forms of alternative review be most appropriate from this perspective?
Moderator:
Daniel K. Nelson, MS, CIP
Director, Office of Human Research Ethics
University of North Carolina, Chapel Hill
Speakers:
Suzanne R. Pattee, JD
Vice President of Public Policy and Patient Affairs
Cystic Fibrosis Foundation
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Stephen E. Sallan, MD
Chief of Staff
Dana-Farber Cancer Institute
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Peter Vasilenko, PhD
Director, Human Research Protection Program
Michigan State University
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Stuart Horowitz, PhD, MBA
Director
Miami Children’s Hospital Research Institute
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Panel 4: Costs, Timing, and Loss of Revenues
What are the significant issues surrounding the costs of alternative forms of IRB review? How would the use of alternative forms of IRB review affect the timely completion of milestones in research oversight? Would the use of alternative forms of IRB review have a negative affect on funding for human subjects protection at the institutional level? Under what circumstances would the various forms of alternative review be most appropriate from this perspective?
Moderator:
Martin Charns, DBA, MBA
Professor of Health Services
Director, Program on Health Policy and Management
Boston University School of Public Health
Speakers:
Felix Khin-Maung-Gyi, PharmD, MBA, CIP
Founder and CEO
Chesapeake Research Review, Inc
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Moira A. Keane, MA, CIP
Director, Research Subjects Protection Program-RSPP
University of Minnesota
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Jean-Louis Saillot, MD
Vice President
Head, Global Pharmacovigilance
Schering Plough
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Todd H. Wagner, PhD
Health Economist
Health Economics Resource Center (HERC)
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Plenary Session: Panel Reports
Stakeholder Discussion Groups
Plenary Session:
Turning Recommendations into Actions
Summary and Next Steps
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