The National Institutes of Health Clinical Center's Bioethics Consultation Service draws on a decade of experience to share a collection of their most interesting and informative research ethics consultations. The result is insight into the ethical issues that arise in clinical research and the practice of research ethics consultation.

Interesting and important ethical questions confront researchers, regulators, institutional review boards, support personnel, and research participants committed to the ethical conduct of human subjects research at all stages of research. Questions encompass - but are not limited to - study design, enrolling participants, balancing the clinical needs of participants against the research agenda, ending trials, discharging post-trial obligations, and resolving conflicts. Straightforward solutions to these types of questions are often not found in regulations, ethics codes, or the bioethics literature. These resources may leave room for interpretation, offer conflicting guidance, or simply fail to address particular questions. Ethics consultation, which has been offered in clinical care settings with regularity since the 1980s, has since the turn of the century increasingly been sought in the clinical research context. Because there has only lately been recognition that ethics consultants can play a valuable role helping the research community conduct research in the most ethically informed way, there are many open questions in the field of research ethics consultation including the appropriate role of consultants and the best methods of consultation. The Clinical Center Bioethics Consultation Service has been serving the NIH community of researchers, administrators, healthcare providers, and research participants for more than a decade, conducting nearly 1,000 consultations in that time. In this book, members of the Bioethics Consultation Service reflect on this long track-record and unparalleled range of research ethics consultations to share a collection of their most interesting and informative research ethics consultations and to start a dialogue on remaining open questions. Although the NIH experience is unique, this book focuses on cases - and associated lessons - that are generalizable and valuable for the entire clinical research community. This book will be valuable to ethics consultants, clinical investigators, students and teachers, and others desiring insight into clinical research ethics and ethics consultation.

In the following essays discussing clinical ethics consultation, three sorts of reflective writing are presented. The first is a description of a clinical ethics consultation, more generously detailed than most that have been published, yet obviously limited as a documentation of the experiences at its source. It is followed by three examples of a second kind in the probing commentaries by highly regarded figures in biomedical and clinical ethics - François Baylis, Tom Tomlinson, and Barry Hoffmaster. Finally, these are followed by a third variety of reflection in the form of responses to those three commentaries, by Bilton and Stuart G. Finder, and my Afterword - a further reflection on some of the issues and questions intrinsic to clinical ethics consultation and to these various essays. The consultation itself was conducted by Bliton; but Finder not only assisted at one point (he is the `colleague' mentioned in Bliton's manuscript) but frequently participated in the discussions that are invariably part of our clinical ethics consultative practice in our Center for Clinical and Research Ethics at Vanderbilt University Medical Center. It was thus natural for Finder to participate in the response. Each of these essays is fascinating and important on its own; together, however, they constitute a truly unusual and, we believe, very significant contribution that will hopefully figure prominently in subsequent discussions, and in shaping and deepening an endeavor - clinical ethics - still in much-needed search of its own discipline, method rationale and place in the domain of clinical practice more generally. This group of essays is also quite unique, addressing as it does the coherence of a form of practice - and, it must be emphasized, several forms of writing about as well as theoretical proposals for understanding that practice - whose current and future character remains very much in contention. That a situation such as the one discussed here often provokes strong and passionate responses will be no surprise – whether because of its relative novelty, its risky nature, the high stakes involved, or something else. It is in any event a striking feature of ethics consultations that the people directly or even indirectly involved tend at times to feel rather passionately about what is said (and not said), what is done (and not done), and what is then reported (or, it may be, left out). Even so, such energetic feelings, much less the candor of my colleague's response to such passion, are rarely if ever apparent from published reports. For this reason alone, a considerable debt of gratitude is surely owed to our commentators – reflective and deliberative, yet passionate and forceful as each of them are.

Clinical ethicists encounter the most emotionally eviscerating medical cases possible. They struggle to facilitate resolutions founded on good reasoning embedded in compassionate care. This book fills the considerable gap between current texts and the continuing educational needs of those actually facing complex ethics consultations in hospital settings. 28 richly detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult consultations. The cases are grouped together by theme to aid teaching, discussion and professional growth. The cases inform any reader who has a keen interest in the choices made in real-life medical dilemmas as well as the emotional cost to those who work to improve the situations. On a more advanced level, this book should be read by ethics committee members who participate in ethics consultations, individual ethics consultants, clinicians who seek education about complex clinical ethics cases, and bioethics students.

This volume offers a theoretical and practical overview of the ethics of pediatric medicine. It serves as a fundamental handbook and resource for pediatricians, nurses, residents in training, graduate students, and practitioners of ethics and healthcare policy. Written by a team of leading experts, Pediatric Bioethics addresses those difficult ethical questions concerning the clinical and academic practice of pediatrics, including an approach to recognizing boundaries when confronted with issues such as end of life care, life-sustaining treatment, extreme prematurity, pharmacotherapy, and research. Thorny topics such as what constitutes best interests, personhood, or distributive justice and public health concerns such as immunization and newborn genetic screening are also addressed.

This book provides a robust analysis of the history of clinical ethics, the philosophical theories that support its practice, and the practical institutional criteria needed to become a practicing clinical ethicist. Featuring cases and a step-by-step approach, this book combines knowledge points associated with moral philosophy and medicine with general skill objectives for ethics consultants. The book aids in developing analytic moral reasoning skills for clinical ethicists, fostering the comprehensive education and professional development of clinical ethics consultants. In addition, it offers key components of how an ethics consultation curriculum manifest in an educational venue for clinical ethicists are illustrated. Adaptable and relevant for educating multiple disciplines in health care, this resource enables ethicists to understand the philosophical foundations and practical application of clinical ethics.

28 detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of difficult consultations.