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2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protection

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

Diane Lopez, JD
University Attorney, Harvard University

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 Download Presentation

Angela C. Wishon, JD Assist Vice Chancellor, Regulatory Compliance University of Colorado at Denver and Health Sciences Center Download Presentation

Don E. Workman, PhD, CIP Executive Director, Office for the Protection of Research Subjects Northwestern University Download Presentation

Brent C. Miller, Ph.D. Vice President for Research Utah State University Download Presentation


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 Download Presentation

Stephen E. Sallan, MD Chief of Staff Dana-Farber Cancer Institute Download Presentation

Peter Vasilenko, PhD Director, Human Research Protection Program Michigan State University Download Presentation

Stuart Horowitz, PhD, MBA Director Miami Children's Hospital Research Institute Download Presentation


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 Download Presentation

Moira A. Keane, MA, CIP Director, Research Subjects Protection Program-RSPP University of Minnesota Download Presentation

Jean-Louis Saillot, MD Vice President Head, Global Pharmacovigilance Schering Plough Download Presentation

Todd H. Wagner, PhD Health Economist Health Economics Resource Center (HERC) Download Presentation