Ethical and Policy Issues in Research Involving Human Participants Volume II Commissioned Papers and Staff Analysis Bethesda, Maryland August 2001 The National Bioethics Advisory Commission (NBAC) was established by Executive Order 12975, signed by President Clinton on October 3, 1995. NBAC’s functions are defined as follows: a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters: 1) the appropriateness of departmental, agency, or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and 2) applications, including the clinical applications, of that research. b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles. c) NBAC shall not be responsible for the review and approval of specific projects. d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council. National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979 Telephone: 301-402-4242 • Fax: 301-480-6900 • Website: www.bioethics.gov ISBN 1-931022-17-8 Ethical and Policy Issues in Research Involving Human Participants Volume II Commissioned Papers and Staff Analysis Bethesda, Maryland August 2001 National Bioethics Advisory Commission Harold T. Shapiro, Ph.D., Chair President Emeritus and Professor of Economics and Public Affairs The Woodrow Wilson School of Public and International Affairs Princeton University Princeton, New Jersey Patricia Backlar Laurie M. Flynn* Research Associate Professor of Bioethics Senior Research and Policy Associate Department of Philosophy Department of Child and Adolescent Psychiatry Portland State University Columbia University Assistant Director New York, New York Center for Ethics in Health Care Oregon Health Sciences University Carol W. Greider, Ph.D. Portland, Oregon Professor of Molecular Biology and Genetics Department of Molecular Biology and Genetics Arturo Brito, M.D. Johns Hopkins University School of Medicine Assistant Professor of Clinical Pediatrics Baltimore, Maryland University of Miami School of Medicine Miami, Florida Steven H. Holtzman Chief Business Officer Millennium Pharmaceuticals, Inc. Alexander Morgan Capron, LL.B. Cambridge, Massachusetts Henry W. Bruce Professor of Law University Professor of Law and Medicine Bette O. Kramer Co-Director, Pacific Center for Health Policy and Ethics Founding President University of Southern California Richmond Bioethics Consortium Los Angeles, California Richmond, Virginia Eric J. Cassell, M.D., M.A.C.P. Bernard Lo, M.D. Clinical Professor of Public Health Director Weill Medical College of Cornell University Program in Medical Ethics New York, New York Professor of Medicine University of California, San Francisco R. Alta Charo, J.D. San Francisco, California Professor of Law and Bioethics Law School and Medical School Lawrence H. Miike, M.D., J.D. University of Wisconsin Kaneohe, Hawaii Madison, Wisconsin Thomas H. Murray, Ph.D. James F. Childress, Ph.D. President Kyle Professor of Religious Studies The Hastings Center Professor of Medical Education Garrison, New York Director, Institute for Practical Ethics Department of Religious Studies William C. Oldaker, LL.B. University of Virginia Senior Partner Charlottesville, Virginia Oldaker & Harris, L.L.P. Washington, D.C. Co-Founder and General Counsel David R. Cox, M.D., Ph.D. NeuralStem Biopharmaceuticals Ltd. Scientific Director College Park, Maryland Perlegen Sciences Santa Clara, California Diane Scott-Jones, Ph.D. Professor Rhetaugh Graves Dumas, Ph.D., R.N. Psychology Department Vice Provost Emerita, Dean Emerita, and Boston College Lucille Cole Professor of Nursing Chestnut Hill, Massachusetts University of Michigan Ann Arbor, Michigan *Resigned on May 10, 2001. CONTENTS Research Ethics in Australia............................................................................... A-1 Donald Chalmers University of Tasmania Location of the Office for Protection from Research Risks Within the National Institutes of Health: Problems of Status and Independent Authority........................................................................................ B-1 John C. Fletcher University of Virginia Privacy and Confidentiality in Health Research ................................................ C-1 Janlori Goldman and Angela Choy Georgetown University An Examination of Issues Presented by Proposals to Unify and Expand Federal Oversight of Human Subject Research .................................... D-1 C.K. Gunsalus University of Illinois at Urbana-Champaign The History, Function, and Future of Independent Institutional Review Boards..................................................................................................... E-1 Erica Heath Independent Review Consulting, Inc. The Danish Research Ethics Committee System—Overview and Critical Assessment .......................................................................................................... F-1 Søren Holm University of Manchester Vulnerability in Research Subjects: A Bioethical Taxonomy ............................. G-1 Kenneth Kipnis University of Hawaii at Manoa Reflections on the Organizational Locus of the Office for Protection from Research Risks .................................................................................................... H-1 Charles R. McCarthy Protectionism in Research Involving Human Subjects........................................ I-1 Jonathan D. Moreno University of Virginia Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research.......................................................... J-1 National Bioethics Advisory Commission Local Institutional Review Boards...................................................................... K-1 Steven Peckman University of California-Los Angeles Institutional Review Board Assessment of Risks and Benefits Associated with Research ...................................................................................................... L-1 Ernest D. Prentice and Bruce G. Gordon University of Nebraska Medical Center Oversight of Human Subject Research: The Role of the States......................... M-1 Jack Schwartz Office of the Maryland Attorney General v Privacy and Confidentiality: As Related to Human Research in Social and Behavioral Science .............................................................................................. N-1 Joan E. Sieber California State University, Hayward Unfulfilled Promise: How the Belmont Report Can Amend the Code of Federal Regulations Title 45 Part 46—Protection of Human Subjects.................................................................................................. O-1 Harold Y. Vanderpool University of Texas Medical Branch, Galveston The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation .............................................................................................. P-1 Charles Weijer Dalhousie University Charles Weijer of Dalhousie University, Halifax, Nova Scotia, Canada, prepared a paper for NBAC on the topic of protecting communities in research. That paper was published in 1999 in the journal Cambridge Quarterly of Healthcare Ethics. The reader can find the article at the following citation: Weijer C. 1999. Protecting Communities in Research: Philosophical and Pragmatic Challenges. Cambridge Quarterly of Healthcare Ethics 8:501–513. The papers included in this volume were edited to conform to minimal stylistic consistency. The content and accuracy of the papers are the responsibility of the authors, not the National Bioethics Advisory Commission. vi RESEARCH ETHICS IN AUSTRALIA Commissioned Paper Donald Chalmers University of Tasmania A-1 Preface ustralia has had a comparatively creditable record of ethical research involving humans. The litany of Acriticism about shoddy medical research documented in the epochal article by Professor Beecher (Beecher 1966, 1968; Levine 1986) has not occurred in this country. Comparatively fine as the Australian record may be, that record is not unblemished. A report commissioned by the Commonwealth Government in 1994 by Professor Margaret Allars into unsatisfactory aspects of the collection, manufacture, and injection of human growth hormone (Allars 1994) recommended that aspects of the research structure had to be reassessed. In particular, the Allars Report recommended a review of the National Health and Medical Research Council (NHMRC) Statement on Human Experimentation and the Supplementary Note on Reproductive Technology Procedures. Similarly, the Commonwealth Minister for Health (now called the Commonwealth Minister for Health and Aged Care) referred ethical concerns about two postwar procedures and one multi- center clinical trial in the 1990s to the Australian Health Ethics Committee (AHEC). The two postwar procedures involved first, the inclusion of