All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms.
This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.
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