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. (shrink)

For a little more than a decade, professional organizations and healthcare institutions have attempted to develop guidelines and policies to deal with seemingly intractable conflicts that arise between clinicians and patients (or their proxies) over appropriate use of aggressive life-sustaining therapies in the face of low expectations of medical benefit. This article suggests that, although such efforts at conflict resolution are commendable on many levels, inadequate attention has been given to their potential negative effects upon particular groups of patients/proxies. Based (...) on the well-documented tendency among many African Americans to prefer more aggressive end-of-life medical interventions, it is proposed that the use of institutional policy to break decision making impasse in cases for which aggressive treatment is deemed "medically inappropriate" will fall disproportionately on that group. Finally, it is suggested that the development and application of institutional conflict-resolution policies should be evaluated in the context of historical and current experiences of marginalization and disempowerment, lest such policies exacerbate that experience. (shrink)