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NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 2

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NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 2 # # # # # # # # # Ethical and # Policy Issues # in International # Research: # Clinical Trials # in Developing # Countries # # # # VOLUME II # COMMISSIONED # PAPERS AND STAFF ANALYSIS # # Bethesda, Maryland May 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 Cover photo, top right, courtesy of James V. Lavery # # # # # # # # # Ethical and # Policy Issues # in International # Research: # Clinical Trials # in Developing # Countries # # # # VOLUME II # COMMISSIONED # PAPERS AND STAFF ANALYSIS # # Bethesda, Maryland May 2001 # # # # # # # # # # ISBN 1-931022-14-3 National Bioethics Advisory Commission Harold T. Shapiro, Ph.D., Chair President 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. The 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 Alexander Morgan Capron, LL.B. Millennium Pharmaceuticals Inc. Henry W. Bruce Professor of Law Cambridge, Massachusetts University Professor of Law and Medicine Co-Director, Pacific Center for Health Policy and Ethics Bette O. Kramer University of Southern California Founding President Los Angeles, California Richmond Bioethics Consortium Richmond, Virginia Eric J. Cassell, M.D., M.A.C.P. Clinical Professor of Public Health Bernard Lo, M.D. Weill Medical College of Cornell University Director New York, New York Program in Medical Ethics Professor of Medicine R. Alta Charo, J.D. The University of California, San Francisco Professor of Law and Medical Ethics San Francisco, California Schools of Law and Medicine The University of Wisconsin Lawrence H. Miike, M.D., J.D. Madison, Wisconsin Kaneohe, Hawaii James F. Childress, Ph.D. Thomas H. Murray, Ph.D. Kyle Professor of Religious Studies President Professor of Medical Education The Hastings Center Director, Institute for Practical Ethics Garrison, New York Department of Religious Studies The University of Virginia William C. Oldaker, LL.B. Charlottesville, Virginia Senior Partner Oldaker and Harris, L.L.P. David R. Cox, M.D., Ph.D. Washington, D.C. Scientific Director Co-Founder and General Counsel Perlegen Sciences NeuralStem Biopharmaceuticals Ltd. Santa Clara, California College Park, Maryland Rhetaugh Graves Dumas, Ph.D., R.N. Diane Scott-Jones, Ph.D. Vice Provost Emerita, Dean Emerita, and Professor Lucille Cole Professor of Nursing Psychology Department The University of Michigan Boston College Ann Arbor, Michigan Chestnut Hill, Massachusetts CONTENTS The Challenge of Equivalent Protection............................................................. A-1 Bernard M. Dickens University of Toronto Attitudes and Experiences of U.S. and Developing Country Investigators Regarding U.S. Human Subjects Regulations ..................................................... B-1 Nancy Kass and Adnan A. Hyder Johns Hopkins University The Relevance of Culture for Informed Consent in U.S.-Funded International Health Research........................................................C-1 Patricia A. Marshall Loyola University Chicago Comparative Analysis of International Documents Addressing the Protection of Research Participants...............................................................D-1 Staff Analysis National Bioethics Advisory Commission International Perspectives on Protecting Human Research Subjects ................. E-1 Jeremy Sugarman, Benjamin Popkin, Judith Fortney, and Roberto Rivera Duke University v THE CHALLENGE OF EQUIVALENT PROTECTION Commissioned Paper Bernard M. Dickens University of Toronto A-1 1. Introduction itle 45 of the Code of Federal Regulations Part 46 (45 CFR § 46) addresses the protection of human Tsubjects of biomedical and behavioral research, including “research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States” § (46.101(a)). Part 46 regulates the process of review of research proposals through Institutional Review Boards (IRBs) and substantive rules required to be observed on such general matters as informed consent and such special matters as research involving prisoners, children, and pregnant women. Part 46.101 provides in paragraph (g) that the policy on protection of human subjects “does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research.” § 46.101(h) provides that: [w]hen research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly (sic) Declaration (Declaration of Helsinki amended 19891) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a Department or Agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the Department or Agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy…. This intention to accommodate studies the policy covers that are conducted in a foreign country therefore depends on a determination that “the procedures prescribed by the institution” afford human subjects at least equivalent protections to those provided in the policy. The reference to “procedures” repeats the policy’s recognition that “procedures normally followed” in foreign countries “may differ from those set forth in this policy.” This raises the issue of whether equivalent protection is focused only on matters of institutional review procedures, where the equivalent structure and functioning of an IRB are required, or whether equivalence must extend beyond the process of review to include the substance of the proposal to be reviewed, including, for instance, subjects’ informed and voluntary consent and appropriate acquisition and research use of fetal tissues. The example provided suggests the latter. The Declaration of Helsinki is established and periodically revised by the World Medical Association (WMA), described in the policy as the World Medical Assembly, perhaps confused with the World Health Organization’s governing body, the World Health Assembly. Most recently revised in 1996, the Declaration of Helsinki is modestly entitled only as “Recommendations guiding physicians…” and, in contrast to the WMA Declaration of Geneva, which “binds physicians,” provides in its Introduction that “[i]t must be stressed that the standards as drafted are only a guide to physicians all over the world,” and that physicians “are not relieved from criminal, civil and ethical responsibilities under the law of their own countries.” The procedural content of the Declaration of Helsinki is rudimentary. In its Basic Principles, Article 1.2 requires that a research protocol: should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed. A-3 Departmental and Agency heads responsible for determining equivalent protection must therefore look beyond the claim of a foreign institution that its review procedure conforms to the Declaration of Helsinki. Compliance with the Declaration’s guiding recommendations and an accordingly
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