Buch, Englisch, 288 Seiten, Format (B × H): 156 mm x 234 mm, Gewicht: 471 g
A Casebook
Buch, Englisch, 288 Seiten, Format (B × H): 156 mm x 234 mm, Gewicht: 471 g
ISBN: 978-0-19-979803-2
Verlag: Oxford University Press
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.
Zielgruppe
- Practicing research ethicists can use it as a reference. - Ethicists who are devising ethics support services for clinical investigators can use the casebook to understand how an ethics consultation service might be organized, how consultations are handled, and how to document consultation. - Researchers and research staff can reference the book to address ethical concerns they are facing or to identify proactively ethical concerns that may arise. - Some medical schools have introduced courses on research ethics for their students, and undergraduate and graduate courses focusing on the ethical aspects of human subjects research are now common. Teachers and professors can use the book for teaching purposes, drawing on the case studies to generate critical thinking and debate. - Regulatory bodies can utilize the book when drafting guidelines. The selected cases will highlight common concerns and practical problems faced by researchers and research participants that may be appropriately addressed through regulation. - Additional readers include IRB members, ethics bodies, and sponsors of research.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
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
