Research Ethics Consultation: A Casebook

Front Cover
Oxford University Press, USA, Apr 18, 2012 - Medical - 259 pages
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.
 

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Contents

Introduction
1
1 Starting Research
21
2 Enrolling Research Participants
49
3 Protecting Research Participants
78
4 Conducting Research with Vulnerable Populations
100
5 Balancing Clinical Research and Clinical Care
122
6 Navigating Interpersonal Difficulties
157
7 Ending Research
185
Appendices
219
Index
251
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About the author (2012)

Marion Danis is Head of the Section on Ethics and Health Policy in the Dept. of Bioethics at the National Institutes of Health. Emily Largent is Post-baccalaureate Fellow in the Dept. of Bioethics, Clinical Center at the National Institutes of Health. Christine Grady is Acting Chief in theDepartment of Bioethics and Head of the Section on Human Subjects Research at NIH. David Wendler is Head of the Unit on Vulnerable Populations in the Dept. of Bioethics at NIH. Sara Chandros Hull is Director of Bioethics Core, Office of the Clinical Director National Human Genome Research Instituteat NIH. Seema Shah is in the Departments of AIDS, NIAID and Clinical Bioethics, CC at the National Institutes of Health. Joseph Millum is Bioethicist in the Clinical Center Department of Bioethics and Fogarty International Center at NIH. Benjamin Berman is in the Department of Bioethics (ClinicalCenter) at NIH.

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