Committee: Conflict of Interest in Medical Research, Education, and Practice

Committee Membership Information


Project Title:	Conflict of Interest in Medical Research, Education, and Practice
PIN:	HSPX-H-07-03-A
Major Unit:	Institute of Medicine
Sub Unit:	Board on Health Sciences Policy
RSO:	Field, Marilyn
Subject/Focus Area:	Health and Medicine

Committee Membership

Date Posted: 12/31/2007

Dr. Bernard Lo - (Chair)
University of California, San Francisco

Bernard Lo, M.D., is Professor of Medicine and Director of the Program in Medical Ethics at the University of California, San Francisco. At UCSF, he directs the Research Ethics Component of the NIH-funded Clinical and Translational Sciences Institute and co-directs the Policy and Ethics Core, Center for AIDS Prevention Studies. He is national program director for the Greenwall Faculty Scholars Program in Bioethics. He is a member of the IOM, serves on the IOM Council, and has served as Chair of the Board of Health Sciences Policy and as chair or member of several IOM committees. He cochairs the Scientific and Medical Accountability Standards Working Group of the California Institute for Regenerative Medicine and serves on the Medicare Evidence Development and Coverage Advisory Committee at the Centers for Medicare and Medicaid Services, the Medical Advisory Panel for the Blue Cross Blue Shield Association Technology Evaluation Center, the Ethics Advisory Committee (uncompensated) for Affymetrix (which develops and supplies genetic research products), and two Data and Safety Monitoring Committees at NIH. In the past he served on the National Bioethics Advisory Committee, the Ethics Working Group of the NIH-sponsored HIV Prevention Trials Network, and the Ethics Committee of the American College of Physicians. Dr. Lo is the author of numerous publications, including Resolving Ethical Dilemmas: A Guide for Clinicians. He is board-certified in Internal Medicine and currently teaches courses on clinical ethics and the responsible conduct of research.

Dr. Wendy H. Baldwin
The Population Council

Wendy Baldwin, Ph.D., is director of the Population Council's new Poverty, Gender, and Youth program. Before coming to the Council, she served as Executive Vice President for Research at the University of Kentucky, Lexington. She also spent three decades at the National Institutes of Health (NIH), completing her service as the Deputy Director for Extramural Research, a program that represents more than 80 percent of the NIH budget and that applies conflict of interest policies for researchers who receive NIH funds. Dr. Baldwin, who is a social demographer, has served on National Research Council committees on Assessing Behavioral and Social Science Research on Aging and Assessing Interactions among Social, Behavioral, and Genetic Factors in Health.

Dr. Lisa Bellini
University of Pennsylvania School of Medicine

Lisa Bellini, M.D., Associate Dean for Graduate Medical Education and is also Vice Chair for Education in the Department of Medicine, University of Pennsylvania. Her primary responsibilities revolve around directing educational programs for residents and fellows. She is the Program Director of the Internal Medicine Residency program that has 150 residents. In her role as Vice Chair, she is also responsible for overseeing all of the subspecialty fellowship programs. She spends a large portion of her time teaching trainees at all levels. Given the concentration of teaching experiences on the inpatient services, Dr. Bellini is responsible for the organization and maintenance of the inpatient medicine services that cover over 220 beds and 15,000 admissions per year. In 2005, she assumed responsibility for all of graduate medical education for the health system. As Associate Dean, she oversees the education and training of over 850 residents across 61 different programs. Her primary research interests involve the design, implementation and evaluation of new educational initiatives. Current interests involve issues related to house staff quality of life including sleep deprivation, depression, burn out and empathy. Her clinical interests include general pulmonary medicine, particularly advanced lung disease.

Dr. Lisa Bero
University of California, San Francisco

Lisa A. Bero, Ph.D., is Professor, Department of Clinical Pharmacy, School of Pharmacy and Institute for Health Policy Studies, School of Medicine, University of California, San Francisco (UCSF). She is Vice Chair in the Department of Clinical Pharmacy and Chair of the UCSF Conflict of Interest Committee. She is also a member of the UCSF Academic Senate Vendor Relations Task Force and has served on numerous institutional and international committees related to conflicts of interest. In addition, Dr. Bero is a member of the World Health Organization Essential Medicines Committee and has participated in advising on guidelines related to conflict of interest disclosure for the WHO guidelines development process. She is Co-Director of the San Francisco Branch of the U.S. Cochrane Center, a member of the Steering Group of the Cochrane Collaboration, and editor for the Cochrane Effective Practice and Organization of Care Group, which is conducting a meta-analysis of the literature on interventions to change health professional behavior. She was involved in drafting and incorporating international commentary on the Cochrane Collaboration's Commercial Sponsorship Policy and is currently the Funding Arbiter for the Cochrane Collaboration. Dr. Bero is a consultant to the British Medical Journal. She is a pharmacologist with primary interests in how clinical and basic sciences are translated into clinical practice and health policy. Her program of research includes examining influences on the design, conduct and publication of research findings. She also conducts research on university-industry relationships and university conflict-of-interest policies.

Dr. Eric Campbell
Massachusetts General Hospital

Eric G. Campbell, Ph.D., is an Associate Professor at the Institute for Health Policy and the Department of Medicine at Massachusetts General Hospital and Harvard Medical School. His main research interests lie in understanding the effects of academic-industry relationships on the process and outcomes of biomedical research, investigating the effects of local health care market competition on the activities and attitudes of medical school faculty and understanding the impact of data-sharing and withholding on academic science. In addition, he is researching the role of organizational culture in promoting patient safety and he is participating in a national evaluation of the use of health information technology for the Office of the National Coordinator of Health Information Technology. Dr. Campbell has published numerous articles in professional journals and has delivered numerous presentations at local, national and international conferences on health care policy, medical education and science policy. He served on the IOM Committee on Alternative Funding Strategies for DOD's Biomedical Research Program.

Dr. James F. Childress
University of Virginia

James F. Childress, Ph.D., is the John Allen Hollingsworth Professor of Ethics and Professor of Medical Education at the University of Virginia, where he teaches in the Department of Religious Studies and directs the Institute for Practical Ethics and Public Life. He has served as Chair of the University's Department of Religious Studies and as co-director of the Virginia Health Policy Center. He is the co-author of the widely used and cited textbook, Principles of Biomedical Ethics. Dr. Childress was vice chair of the national Task Force on Organ Transplantation and was a member of the presidentially-appointed National Bioethics Advisory Commission (1996-2001). He has also served on the Board of Directors of the nonprofit United Network for Organ Sharing (UNOS), the UNOS Ethics Committee, the NIH Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, and several Data and Safety Monitoring Boards for NIH clinical trials. He chaired the IOM Committee on Increasing Rates of Organ Donation, co-chaired the National Research Council Subcommittee on Use of Third Party Toxicity Research with Human Test Subjects, and served as a member of IOM committees on assessing genetic risks and establishing a national cord blood stem cell bank program. Dr. Childress is a member of the Institute of Medicine.

Dr. Peter Corr
Celtic Therapeutics

Peter B. Corr, PhD., is General Partner, Celtic Therapeutics Management Company L.L.L.P., a private equity firm focused on the development of innovative therapeutics, alliances that advance solutions for diseases of the developing world, and global advocacy for biomedical innovation. Dr. Corr retired from Pfizer Inc in 2007, where he served as Senior Vice President, Science & Technology. Before that, he served as Executive Vice President, Pfizer Global Research & Development, and President, Worldwide Development. Prior to joining Pfizer in 2000, Dr. Corr was President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis (until the merger with Pfizer) and he previously served as Senior Vice President, Discovery Research, at Monsanto/Searle. Dr. Corr also spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis, where he was Professor of Medicine (Cardiology) and Professor of Pharmacology and Molecular Biology. His research has been published in more than 160 scientific manuscripts. Dr. Corr serves on the Board of Governors of the New York Academy of Sciences, the Board of Regents of Georgetown University, and several other non-profit and for-profit boards. He also is a member of the IOM’s Forum on Drug Discovery, Development, and Translation.

Dr. Todd Dorman
Johns Hopkins University

Todd Dorman, M.D., is Associate Dean and Director of Continuing Medical Education as well as a Professor of Anesthesiology and Critical Care Medicine at the Johns Hopkins Medical Center (JHMC). Among other posts, he is the Vice Chair for Critical Care Services. Dr. Dorman's research interests include informatics applications in the ICU such as remote monitoring of critically ill patients, leadership strategies in the ICU, creation of a culture of safety, and the application of pharmacokinetic models to drug administration in critically ill patients. He has participated in the development and application of conflict-of-interest policies in a number of areas within and outside JHMC, including continuing medical education, medical center relationships with commercial entities, guidelines development, and scientific journal publication. Dr. Dorman is President-Elect of the American Society for Critical Care Medicine.

Dr. Deborah G. Grady
University of California, San Francisco School of Medicine

Deborah Grady, M.D., M.P.H., is Professor of Medicine, Associate Dean for Clinical and Translational Research, and Director of the Women's Health Clinical Research Center at the University of California, San Francisco (UCSF). She is a general internist who provides clinical care for adult women and is an expert on the risks and benefits of postmenopausal hormone therapy. Dr. Grady has received funding for independent research from NIH, nonprofit, and commercial sources and has led several large, long-term clinical studies. In addition to six current NIH-funded activities, she currently is investigator for one study of treatment for metastatic breast cancer and two studies of treatment for menopause symptoms that are supported by Bionovo through awards to UCSF under university policies that provide for university ownership of the research data, information, and reports resulting from the research and for independence in the publication of research findings. University policies also state that faculty conducting research that is privately sponsored shall not receive honoraria, consulting fees, or other compensation from the sponsor or serve in any board or other decision-making capacity for the sponsor during the course of the research She is one of the Directors of the UCSF Clinical and Translational Science Institute and co-edited Designing Clinical Research, a textbook on clinical research methods. Dr. Grady is also associate director of the San Francisco Coordinating Center, which provides coordination services for multi-center studies in women's health, aging, and related areas. She has participated in the development of practice guidelines and evidence reviews in a number of areas of women’s health and served on the IOM committee that assessed the need for clinical trials of testosterone replacement therapy.

Mr. Timothy Stoltzfus Jost
Washington and Lee University

Timothy S. Jost, J.D., is the Robert L. Willett Family Professor of Law at the Washington and Lee University School of Law. He is a co-author of a casebook, Health Law and is author of Readings in Comparative Health Law and Bioethics and Health Care at Risk, as well as numerous articles and book chapters on health care regulation and comparative health law. Professor Jost was a member of the IOM committee that assessed and recommended improvements in this country's system for protecting human research participants.

Dr. Robert P. Kelch
University of Michigan

Robert P. Kelch, M.D., is Executive Vice President for Medical Affairs at the University of Michigan, Ann Arbor and Chief Executive Officer, University of Michigan (UM) Health System. He oversees the UM Hospitals and Health Centers and the University of Michigan Medical School, including their policies governing conflicts of interest in research, education, patient care, and other areas. Earlier, Dr. Kelch served as Vice President of the University of Iowa Health System and was previously Chair of the Department of Pediatrics at the University of Michigan and physician-in-chief of C.S. Mott Children's Hospital. He has been President of the Society for Pediatric Research and Chairman of the American Board of Pediatrics. Dr. Kelch has also served on the American Association of Medical Colleges task force on conflicts of interest as well as numerous other association committees. He is a member of the Department of Veterans Affairs National Research Advisory Council. His research has focused on pediatric endocrinology. Dr. Kelch is a member of the Institute of Medicine.

Mr. Robert M. Krughoff
Center for Study of Services

Robert M. Krughoff, J.D., is founder and president of Consumers' CHECKBOOK/Center for the Study of Services, an independent, nonprofit consumer organization founded in 1974. The organization publishes local versions of Consumers' CHECKBOOK magazine in seven major metropolitan areas (Boston, Chicago, Minneapolis/St. Paul, Philadelphia, San Francisco/Oakland/San Jose, Seattle/Tacoma, and Washington, DC). The magazine evaluates local service firms such as hospitals, auto repair shops, and banks. The Center also has developed the Consumers' Guide to Hospitals, Guide to Health Plans for Federal Employees, and other materials and services for consumers. Before founding the Center for the Study of Services, Mr. Krughoff served in the U. S. Department of Health, Education, and Welfare (now the Department of Health and Human Services) as Director of the Office of Research and Evaluation Planning and as Special Assistant to the Assistant Secretary for Planning and Evaluation. He currently serves on the board of directors of the Consumer Federation of America (1984 -present) and has served on the board of directors of Consumers Union, publisher of Consumer Reports magazine. He chairs the Technology Assessment Advisory Committee for the ECRI Institute. Mr. Krughoff is a member of the New York Bar and District of Columbia Bar.

Dr. George Loewenstein
Carnegie Mellon University

George Loewenstein, Ph.D., is the Herbert A. Simon Professor of Economics and Psychology in the Department of Social and Decision Sciences at Carnegie Mellon University. Previously, he was on the faculty of the University of Chicago's Graduate School of Business. His research focuses on behavioral economics and neuroeconomics. He is a fellow of the American Psychological Association and was a member of the National Research Council Committee on a Research Agenda for the Social Psychology of Aging. Dr. Loewenstein is co-editor of Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy as well as author of numerous articles, book chapters, and other publications on topics in economics, psychology and public policy.

Dr. Joel S. Perlmutter
Washington University

Joel Perlmutter, M.D., is Elliot Stein Family Professor of Neurology, Radiology and Physical Therapy at Washington University in St. Louis where he treats patients with movement disorders. He is Director of the American Parkinson Disease Association Advanced Research Center for Parkinson Disease and Director of the Huntington Disease Center of Excellence at the university. Dr. Perlmutter is a member of the American Academy of Neurology, the Parkinson's Study Group, the Huntington's Study Group, and the Dystonia Study Group and is a Fellow of the American Neurological Association. One of Dr. Perlmutter's main research interests is brain imaging. He has participated in the development of conflict of interest policies for clinical research, patient care, and education.

Dr. Neil R. Powe
Johns Hopkins Medical Institutions

Neil R. Powe, M.D., M.P.H., M.B.A., is Professor of Medicine and Epidemiology at the Johns Hopkins School of Medicine and Bloomberg School of Public Health and Director of the Welch Center for Prevention, Epidemiology and Clinical Research, a multidisciplinary clinical research and training center at the Johns Hopkins. Dr. Powe also directs the Clinical Research Scholars Program and the Predoctoral Clinical Research Training Program. He is a member of the Institute of Medicine. He is also a member of the Agency for Healthcare Research and Quality National Advisory Committee, the Board of Trustees of the Roche Foundation for Anaemia Research (an independent medical research charity), and the Secretary's Advisory Committee on Human Research Protections (U.S. Department of Health and Human Service). Dr. Powe's research bridges medicine and public health and includes prevention and screening, clinical epidemiology, patient outcomes research, quality of care, technology assessment, and cost-effectiveness analysis. He has participated in the development of clinical practice guidelines and studied their implementation.

Dr. Dennis F. Thompson
John F. Kennedy School of Government, Harvard University

Dennis F. Thompson, Ph.D., is Alfred North Whitehead Professor of Political Philosophy in the Government Department and Professor of Public Policy in the Kennedy School, Harvard University. He was founding Director of the university-wide Edmond J. Safra Foundation Center for Ethics from 1986 to 2007 and served as Associate Provost and later as the Senior Adviser to the President of the University until 2004. His books include: Restoring Responsibility: Ethics in Government, Business and Healthcare; Political Ethics and Public Office; and Ethics in Congress: From Individual to Institutional Corruption. He is also the author (jointly with Amy Gutmann) of Why Deliberative Democracy? and Democracy & Disagreement. Dr. Thompson, a political scientist, has served as a consultant to the Joint Ethics Committee of the South African Parliament, the American Medical Association, the U.S. Senate Select Committee on Ethics, the U.S. Office of Personnel Management, and the Department of Health and Human Services.

Dr. David A. Williams
Children's Hospital Boston

David A. Williams, M.D., is Chief of Hematology/Oncology and Director, Clinical and Translational Research at Children's Hospital Boston. He is also Leland Fikes Professor of Pediatrics, Harvard Medical School. He was previously Director of the Division of Experimental Hematology and Associate Chair for Translational Research at Cincinnati Children's Hospital Medical Center. He served as the inaugural Director of the Herman B Wells Center for Pediatric Research at the Indiana University School of Medicine and Investigator of the Howard Hughes Medical Institute. Dr. William’s research focuses on the study of blood stem cell biology, blood formation, leukemia, and the treatment of genetic blood disorders using gene therapy. He has received several patents, including three on methods to increase the efficiency of gene transfer for genetic therapies. Dr. Williams is actively involved in gene therapy trials for Fanconi anemia and pediatric cancer. His policy interests include physician-scientist training and the development of more effective approaches to translational research. He is a member of the Institute of Medicine.

Committee Membership Roster Comments

The committee membership information has changed with updating of information for Drs. Corr, Dorman, Lo, Powe, Grady, and Childress; the resignation of Dr. Allan Detsky (12/12/07); and the addition of Drs. Bero (10/30/07), Campbell (10/30/07), and Williams (12/31/07) to the committee.

Statement of Committee Composition

Disclosure of Conflict of Interest: James Childress

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally-appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest is not an assessment of an individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include, among others, some individuals who have current practice experience advising industry about ethical research conduct.

To meet the need for this expertise and experience, Dr. James Childress is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is a member of ethics advisory panels for Roche (on tissue banking and clinical research) and Johnson & Johnson (on stem cell research).

As described in his biographical summary, Dr. Childress has extensive experience with complicated issues of ethics and public policy as they arise in medical research and practice. He is the author of Principles of Biomedical Ethics, the most widely read textbook on biomedical ethics, now in its 5th edition. Because he has written about the different levels of ethical principles and ethical guidelines, he will be particularly useful as this committee considers overarching principles that can be applied to a variety of situations. Dr. Childress has served on major national committees dealing with sensitive policy issues. These groups include the presidentially-appointed National Bioethics Advisory Commission, the NIH Recombinant DNA Advisory Committee, and the National Research Council Subcommittee on Use of Third Party Toxicity Research with Human Test Subjects. He is also a member of the IOM Board on Health Sciences Policy. We believe that Dr. Childress can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

We have not identified another individual who is available to serve, who does not have a similar conflict of interest, and who possesses the equivalent combination of expertise and experience. Therefore, we have concluded that this potential conflict is unavoidable.

Disclosure of Conflict of Interest: Peter B. Corr

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally-appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest is not an assessment of an individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include, among others, some individuals who have senior-level industry experience in biomedical discovery development, distribution, and industry management.

To meet the need for this expertise and experience, Dr. Peter Corr is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is partner in a private equity firm focused on pharmaceutical development, owns stock and retains stock options in Pfizer, Inc. from his employment at the company, and sits of the Board of Directors of Cbio, an Australian biotechnology company.

As described in his biographical summary, Dr. Corr is General Partner, Celtic Therapeutics Management Company. Before that, he served as Senior Vice President for Science and Technology at Pfizer Inc. and as Executive Vice President, Pfizer Global Research & Development, and President, Worldwide Development. Prior to joining Pfizer in 2000, Dr. Corr was President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis (until the merger with Pfizer). He also served as Senior Vice President, Discovery Research, at Monsanto/Searle. In addition, Dr. Corr has experience in university-based biomedical research at Washington University in St. Louis, where he left the institution as Professor of Medicine and Professor and Professor of Pharmacy and Molecular Biology. We believe that Dr. Corr can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

We have not identified another individual who is available to serve, who does not have a similar conflict of interest, and who possesses the equivalent combination of expertise and experience. We have, therefore, concluded that this potential conflict is unavoidable.

Disclosure of Conflict of Interest: Todd Dorman

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally-appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest is not an assessment of an individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, an individual with current experience in directing a major university program in continuing medical education and in developing and administering conflict of interest policies applicable to such a program.

To meet the need for this expertise and experience, Dr. Todd Dorman is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is a consultant to Electrocore, a start-up medical device firm in the area of neurostimulation and because he directs the continuing education program at the Johns Hopkins Medical Center, which receives funding from medical product companies.

In his role as director of continuing medical education programs at a major academic medical center, Dr. Dorman has experience in developing and implementing conflict of interest policies, which includes assuring institutional compliance with policies of the Accreditation Council for Continuing Medical Education and educating faculty about Council and University policies and requirements. He has interviewed faculty and departmental chairs and conducted web-based surveys of their attitudes, opinions and experiences related to commercial relationships and the potential for conflict of interest and bias. He has also chaired a University task force for Hopkins on Commercial Entity conflict of interest that recommended changes in policies and practices. (Commercial entity policy applies to drug, device, and other companies that make products used on or by patients). In addition, Dr. Dorman supplements the committee's expertise in other areas, including the development of conflict of interest policies for medical societies and scientific journals. He has served on the boards of American Society of Critical Care Anesthesiology and the Society of Critical Care Medicine and on the editorial boards of Critical Care Medicine, ICU Management, and Contemporary Critical Care. We believe that Dr. Dorman can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

We have not identified another individual who does not have a similar institutional conflict of interest and who possesses the equivalent combination and diversity of expertise and experience. Therefore, we have concluded that this potential conflict is unavoidable.