Ethical and Regulatory Aspects of Clinical Research

Ezekiel J. Emanuel, M.D., Ph.D., is Chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center at the National Institutes of Health. Robert A. Crouch, M.A., is an Assistant Professor in the Biomedical Ethics Unit and the Department of Social Studies of Medicine at McGill University. John D. Arras, Ph.D., is Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia. Jonathan D. Moreno, Ph.D., is Director of the Center for Biomedical Ethics at the University of Virginia. Christine Grady, R.N., Ph.D., is Head, Section on Human Subjects Research in the Department of Clinical Bioethics at the National Institutes of Health.

Contents:Part I. Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and TuskegeePart II. Ethical and Regulatory Guidance for Research with HumansPart III. The Ethics of Clinical Trial DesignPart IV. The Ethics of Research Participant RecruitmentPart V. Informed Consent in ResearchPart VI. Clinical Research with Special PopulationsPart VII. Special Topics in Research EthicsPart VIII. The Behavior of Clinical Investigators: Conflicts of InterestPart IX. Scientific MisconductPart X. Challenges to the Institutional Review Board System