Participants in the Health Care Systems Research Collaboratory’s Workshop on Cluster Randomized Trials: Ethical, Regulatory, and Practical Issues

Name	Title and Affiliation
Monique L. Anderson, MD*	Medical Instructor, Division of Cardiology, Department of Medicine, Duke University School of Medicine
Patrick Archdeacon, MD	Medical Officer, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration
Mark Barnes, JD, LLM	Co-Director, Multi-Regional Clinical Trials Center, Harvard University
Laura M. Beskow, MPH, PhD*	Associate Professor, Duke Clinical Research Institute and Faculty Associate, Trent Center for Bioethics, Humanities & History of Medicine
Barbara E. Bierer, MD*	Senior Vice President for Research, Brigham Research Institute, and Director, Center for Faculty Development and Diversity, Brigham and Women's Hospital; Harvard Medical School
Robert Califf, MD*	Director, Duke Translational Medicine Institute and Vice Chancellor for Clinical & Translational Research, Duke University School of Medicine
Rowena Dolor, MD, MHS*	Director, Duke Primary Care Research Consortium, Duke Translational Medicine Institute
Allan Donner, PhD±	Professor, Department of Epidemiology and Biostatistics, Western University
Susan Ellenberg, PhD*	Senior Scholar, Center for Clinical Epidemiology & Biostatistics – Department of Biostatistics and Epidemiology, and Professor of Biostatistics, University of Pennsylvania Perelman School of Medicine
M. Khair ElZarrad, PhD, MPH*	Science Policy Analyst, National Institutes of Health
Rachael Fleurence, PhD, MSc	Science Program Director, CER Methods and Infrastructure, Patient-Centered Outcomes Research Institute
David Forster, JD, MA*	Chief Compliance Officer, WIRB-Copernicus Group; University of Washington
Sara Goldkind, MD, MA*	Senior Bioethicist, Office of Compliance, Food and Drug Administration
Steve Goodman, MD, PhD, MHS	Chief of the Division of Epidemiology, Department of Health Research and Policy; Co-Director, Meta-Research Innovation Center at Stanford, Stanford University
R. Peter Iafrate, PharmD*	Chairman, Institutional Review Board, University of Florida Health Science Center
Nancy Kass, ScD	Professor of Bioethics and Public Health, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health; Deputy Director for Public Health, Berman Institute of Bioethics
John M. Kessler, PharmD*	Adjunct Associate Professor, UNC Eshelman School of Pharmacy; Chief Clinical Officer, SecondStory Health, LLC.
Michael Lauer, MD	Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health
Joanne Less, PhD*	Director, Office of Good Clinical Practice, Food and Drug Administration
Leanne Madre, JD, MHA*	Director of Strategy, Clinical Trials Transformation Initiative, Duke Translational Medicine Institute
Diane Maloney, JD	Associate Director for Policy, Center for Biologics Evaluation and Research, Food and Drug Administration
Rachael Moloney, MHS*	Research Manager, Center For Medical Technology Policy
Ross McKinney, MD	Director, Trent Center for Bioethics, Humanities & History of Medicine, Duke University; Professor of Pediatric Infectious Diseases, Duke University School of Medicine
Jerry Menikoff, MD, JD*	Director, Office for Human Research Protections, U.S. Department of Health and Human Services
David M. Murray, PhD*	Director, Office of Disease Prevention, Office of the Director, National Institutes of Health
Jane Perlmutter, PhD, MBA	Founder, Gemini Group
Richard Platt, MD, MS*	Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care Institute
Ivor Pritchard, PhD*	Senior Advisor to the Director, Office for Human Research Protections, U.S. Department of Health and Human Services
Jim Sabin, MD	Director, Ethics Program, Harvard Pilgrim Health Care Institute; Clinical Professor, Population Medicine and Psychiatry, Harvard Medical School
Rachel Sherman, MD. MPH	Former Director, Center for Drug Evaluation and Research, Food and Drug Administration; Principal, Drug and Biological Drug Products, Greenleaf Health, LLC
Jeremy Sugarman, MD, MPH, MA*	Deputy Director for Medicine, Johns Hopkins Berman Institute of Bioethics; Professor of Bioethics and Medicine, Johns Hopkins University
Robert Temple, MD*	Deputy Director for Clinical Science, Center for Drug Evaluation and Research, Food and Drug Administration
Pamela Tenaerts, MD, MBA*	Director, Clinical Trials Transformation Initiative, Duke Translational Medicine Institute
Wendy Weber, ND, PhD, MPH*	Branch Chief, Clinical Research in Complementary and Integrative Health Branch, National Center for Complementary and Alternative Medicine, National Institutes of Health
Kevin Weinfurt, PhD	Professor in Psychiatry and Behavioral Sciences, Duke University
David Wendler, PhD*	Head, Unit on Vulnerable Populations, Department of Bioethics, Clinical Center, National Institutes of Health
Ashley Wivel, MD, MSc*	Senior Director, Clinical Effectiveness and Safety, GlaxoSmithKline
David Zhang, PhD	Global Lead, External Collaborations and Strategic Partnership,
	Roche

^*provided feedback on the manuscript

^±conflict of interest, Ottawa co-author