Overview

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.

Full Product Details

Author:   Marion Danis (Head, Section on Ethics and Health Policy, Head, Section on Ethics and Health Policy, Department of Bioethics, National Institutes of Health, USA) ,  Emily Largent, B.S.N. (, Post-baccalaureate Fellow, Department of Bioethics, Clinical Center, National Institutes of Health, USA) ,  Christine Grady, R.N., Ph.D. (, Acting Chief. Department of Bioethics and Head, Section on Human Subjects Research, National Institutes of Health, USA) ,  David Wendler, Ph.D. (, Head, Unit on Vulnerable Populations, Department of Bioethics, National Institutes of Health, USA)
Publisher:   Oxford University Press Inc
Imprint:   Oxford University Press Inc
Dimensions:   Width: 15.50cm , Height: 2.00cm , Length: 23.10cm
Weight:   0.386kg
ISBN:  

9780199798032

ISBN 10:   0199798036
Pages:   288
Publication Date:   14 June 2012
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   To order  
Stock availability from the supplier is unknown. We will order it for you and ship this item to you once it is received by us.

Table of Contents

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 PROTOCOLS CONSULT 2.6: OBTAINING INFORMED CONSENT FROM INDIVIDUALS WHO ARE BLIND, ILLITERATE, OR DO NOT UNDERSTAND THE LANGUAGE IN WHICH CONSENT DOCUMENTS ARE WRITTEN CONSULT 2.7: ASSESSING WHETHER STUDY PROCEDURES ARE COERCIVE OR UNDULY INFLUENTIAL CHAPTER 3: PROTECTING RESEARCH PARTICIPANTS CONSULT 3.1: JUSTIFICATION OF RESEARCH RISKS CONSULT 3.2: EVALUATION OF EVOLVING RISKS CONSULT 3.3: RESPECTING PARTICIPANT PREFERENCES WHILE MINIMIZING RISK CONSULT 3.4: ADDRESSING MEDICAL ERROR CONSULT 3.5: RECONCILING CONFIDENTIALITY AND THE DUTY TO WARN CONSULT 3.6: RISKS TO THIRD PARTIES CHAPTER 4: CONDUCTING RESEARCH WITH VULNERABLE POPULATIONS CONSULT 4.1 EXPOSING CHILDREN TO RISK WHEN THERE IS NO PROSPECT OF DIRECT BENEFIT CONSULT 4.2: INFORMING A MINOR OF HIS DIAGNOSIS CONSULT 4.3: ASSIGNMENT OF A SURROGATE DECISION MAKER BY A COGNITIVELY IMPAIRED RESEARCH PARTICIPANT CONSULT 4.4 CONSENT FOR RESEARCH IN AN EMERGENCY CONSULT 4.5 RESEARCH WITH THE TERMINALLY ILL CONSULT 4.6 CARING FOR THE ECONOMICALLY DISADVANTAGED 1 CHAPTER 5: BALANCING CLINICAL RESEARCH AND CLINICAL CARE CONSULT 5.1: FULFILLING ANCILLARY CARE OBLIGATIONS CONSULT 5.2: DISCLOSURE OF INCIDENTAL FINDINGS CONSULT 5.3: OBLIGATIONS TO INDIVIDUALS TANGENTIALLY RELATED TO RESEARCH CONSULT 5.4: WITHHOLDING CARE FOR REASONS OF SCIENTIFIC VALIDITY CONSULT 5.5: MEETING CLINICAL NEEDS WITHOUT COMPROMISING SCIENTIFIC VALIDITY CONSULT 5.6: ACCESS TO EXPERIMENTAL DRUGS OUTSIDE A STUDY PROTOCOL CONSULT 5.7: NON-COMPLIANCE CHAPTER 6: NAVIGATING INTERPERSONAL DIFFICULTIES CONSULT 6.1: OBLIGATIONS TO PREVENT HARM AND PROTECT CONFIDENTIALITY CONSULT 6.2: EXCLUDING A NON-COMPLIANT PARTICIPANT FROM A STUDY WITH THE PROSPECT OF DIRECT BENEFIT CONSULT 6.3: EXCLUDING A NON-COMPLIANT PARTICIPANT FROM A STUDY WITH NO PROSPECT OF BENEFIT CONSULT 6.4: DISCHARGING AN AT-RISK PARTICIPANT CONSULT 6.5: FUTILE CARE CONSULT 6.6 CONFLICT BETWEEN THE RESEARCH TEAM AND FAMILY MEMBERS CONSULT 6.7: CONFLICT BETWEEN THE RESEARCH TEAM AND SURROGATE DECISION MAKER CONSULT 6.8: RESPECTING MEDICAL BELIEFS CHAPTER 7: ENDING RESEARCH CONSULT 7.1: STUDY DISCHARGE AFTER VIOLATION OF RULES CONSULT 7.2: DISCHARGE TO LESS OPTIMAL CARE CONSULT 7.3: MANAGING PARTICIPANT'S POST-TRIAL EXPECTATIONS CONSULT 7.4: FULFILLING POST-TRIAL OBLIGATIONS TO UNINSURED PARTICIPANTS CONSULT 7.5: PLANNING FOR POST-TRIAL CONSEQUENCES OF TRIAL INTERVENTION CONSULT 7.6: ADDRESSING A REQUEST FOR WITHDRAWAL OF TISSUE SAMPLES CONSULT 7.7: QUESTIONS ABOUT DISCONTINUATION OF A TRIAL BY THE DSMB CONSULT 7.8: ASSIGNING AUTHORSHIP APPENDICES CONSULTATIONS ORGANIZED BY SUBJECT EVALUATION OF THE ETHICS CONSULTATION SERVICE CLINICAL CENTER POLICY M77-2: INFORMED CONSENT CLINICAL CENTER POLICY M-92-7: ADVANCE DIRECTIVES NIH ADVANCED DIRECTIVE FOR HEALTHCARE AND MEDICAL RESEARCH PARTICIPATION CLINICAL CENTER POLICY M87-4: RESEARCH INVOLVING ADULTS WHO ARE OR MAY BE UNABLE TO CONSENT SELECTED PUBLICATIONS INSPIRED OR INFORMED BY THE WORK OF THE BIOETHICS CONSULTATION SERVICE

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Author Information

MD: Head, Section on Ethics and Health Policy, Dept. of Bioethics, NIH; EL: Post-baccalaureate Fellow, Dept. of Bioethics, Clinical Center, National Institutes of Health; CG: Acting Chief. Department of Bioethics and Head, Section on Human Subjects Research, NIH; DW: Head, Unit on Vulnerable Populations, Dept. of Bioethics, NIH; SCH: Director, Bioethics Core, Office of the Clinical DirectorNational Human Genome Research Institute, NIH; SS: Departments of AIDS, NIAID and Clinical Bioethics, CC, National Institutes of Health; JM: Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH; BB: Department of Bioethics (Clinical Center), NIH

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