Marion Danis, Emily Largent, Christine Grady, David Wendler, Sara Chandros Hull, Seema Shah, Joseph Millum, Benjamin Berkman

Research Ethics Consultation

A Casebook

• Broschiertes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Sydney University Press
• Seitenzahl: 288
• Erscheinungstermin: 18. April 2012
• Englisch
• Abmessung: 231mm x 155mm x 20mm
• Gewicht: 386g
• ISBN-13: 9780199798032
• ISBN-10: 0199798036
• Artikelnr.: 37255946

Autorenporträt

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.

Inhaltsangabe

* 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