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Informationen zum Autor Marion Danis is Head of the Section on Ethics and Health Policy, Department of Bioethics, NIH.Emily Largent is Post-baccalaureate Fellow, Department of Bioethics, Clinical Center, NIH.Christine Grady is Acting Chief, Department of Bioethics and Head, Section on Human Subjects Research, NIH.David Wendler is Head, Unit on Vulnerable Populations, Dept. of Bioethics, NIH.Sara Chandros Hull is Director, Bioethics Core, Office of the Clinical DirectorNational Human Genome Research Institute, NIH.Seema Shah is with the Departments of AIDS, NIAID and Clinical Bioethics, CC, NIH.Joseph Millum is Bioethicist, Clinical Center, Department of Bioethics & Fogarty International Center, NIH.Benjamin Berkman is with the Department of Bioethics (Clinical Center), NIH. Klappentext 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 rese Zusammenfassung 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. Inhaltsverzeichnis FOREWORD INTRODUCTION CHAPTER 1: STARTING RESEARCH CONSULT 1.1: ASSESSING SOCIAL VALUE CONSULT 1.2: ASSESSING SOCIAL VALUE FOR LOCAL POPULATIONS CONSULT 1.3: ASSESSING SCIENTIFIC VALIDITY CONSULT 1.4: PLACEBO CONTROLLED TRIALS CONSULT 1.5: STANDARD OF CARE CONSULT 1.6: RECONCILING DIFFERENT JUDGMENTS REACHED BY MULTIPLE IRBS CHAPTER 2: ENROLLING RESEARCH PARTICIPANTS CONSULT 2.1: USE OF NON-MEDICAL CRITERIA IN DETERMINATIONS OF STUDY INCLUSION OR EXCLUSION CONSULT 2.2: EXCLUSION OF AN INDIVIDUAL BASED ON A NEW CO-MORBIDITY CONSULT 2.3: ENROLLING STAFF MEMBERS IN CLINICAL STUDIES CONSULT 2.4: IDENTIFICATION OF POTENTIAL STUDY PARTICIPANTS THROUGH PUBLICLY AVAILABLE RECORDS CONSULT 2.5: ENROLLMENT OF RESEARCH PARTICIPANTS IN MULTIPLE ...
