When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research.
The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
Trudo Lemmens is Professor and Scholl Chair in Health Law and Policy in the Faculty of Law, the Dalla Lana School of Public Health, and the Joint Centre for Bioethics at the University of Toronto. Duff R. Waring is an assistant professor in the Department of Philosophy at York University.
Acknowledgments Introduction TRUDO LEMMENS and DUFF R. WARING * Uninformed Consent: The Case of Jesse Gelsinger PAUL L. GELSINGER PART ONE: REGULATION * Questions and Challenges in the Governance of Research Involving Humans: A Canadian Perspective KATHLEEN CRANLEY GLASS * Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research ANNA MASTROIANNI and JEFFREY KAHN PART TWO: CONFLICT OF INTEREST * The Ethical and Legal Foundations of Scientific 'Conflict of Interest' SHELDON KRIMSKY * Self-Censorship JAMES ROBERT BROWN * Promoting Integrity in Industry-Sponsored Clinical Drug Trials: Conflict of Interest for Canadian Academic Health Sciences Centres LORRAINE E. FERRIS and C. DAVID NAYLOR * The Human Subjects Trade: Ethical, Legal, and Regulatory Remedies to Deal with Recruitment Incentives and to Protect Scientific Integrity TRUDO LEMMENS and PAUL B. MILLER PART THREE: LIABILITY * Bringing Research into Therapy: Liability Anyone? MARY M. THOMSON * Legal Liability for Harm to Research Participants: The Case of Placebo-Controlled Trials DUFF R. WARING and KATHLEEN CRANLEY GLASS * Her Majesty's Research Subjects: Liability of the Crown in Research Involving Humans SANA HALWANI Contributors Index