Challenging Cases in Clinical Research Ethics
CRC Press (Verlag)
978-1-032-37096-5 (ISBN)
This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations.
Key Features:
• Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise
• Supplemented by short introductions to each section
• Focus on ethical rather than regulatory issues
• Essential reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF
Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies.
Benjamin S. Wilfond, Investigator, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute; Professor, Division of Bioethics and Palliative Care, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA Devan M. Duenas, Coordinator, Research Bioethics Consultation Service, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA Liza-Marie Johnson, Investigator, Bioethics Consultant, and Associate Member (Professor), Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA Holly A. Taylor, Research Bioethicist, Department of Bioethics, Clinical Center, National Institute of Health Bethesda, MD, USA
Foreword
Introduction
A Framework for Research Ethics. Principles of Research Ethics. Topics in Research Ethics . Values of Research Ethics.
Section 1. Collaborative Partnership
Introduction
Case 1.1 Supporting Community-Academic Research Partnerships: Reflections from the Ground
Commentary 1.1.1: Community Partnered Participatory Research in Southeast Louisiana Communities Threatened by Climate Change: The C-LEARN EXPERIENCE. Commentary 1.1.2: Leveraging Academic Institutional Structures to Support Asian American Community Organizations’ Engagement in Research: The Korean Community Service Center. Commentary 1.1.3: Engaging the Sickle Cell Community in Participatory Research. Commentary 1.1.4: Being in Good Community: Engagement in Support of Indigenous Sovereignty.
Case 1.2 Protecting Research Subject Welfare in Preventative Trials for Autosomal Dominant Alzheimer's Disease
Commentary 1.2.1: When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations. Commentary 1.2.2: Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study. Commentary 1.2.3: Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Case 1.3 Studying the Role of Financial Incentives to Promote Hepatitis B Vaccination in a Community Clinic
Commentary 1.3.1: Treatment Incentives and the Nature of the Doctor-Patient Relationship. Commentary 1.3.2: The Ethics of Studying Financial Incentives in Public Health Implementation: Study Design Challenges. Commentary 1.3.3: You Can Lead a Horse to Water, But Can You Pay to Make Him Drink? An Ethical Analysis of Research on Using Incentives to Promote Patient Health.
Case 1.4 A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Paediatric Intensive Care Unit--How to Manage Site-Specific Evidence of Racial/Ethnic Disparity
Commentary 1.4.1: Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials. Commentary 1.4.2: Clinical Trials Not Causing Harm with Potential for Realizing Benefit Should Continue. Commentary 1.4.3: Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
Case 1.5 When a Clinical Trial Is the Only Option
Commentary 1.5.1: "Respect for Persons," Not "Respect for Citizens". Commentary 1.5.2: The Potentially High Cost of a Free Clinical Trial. Commentary 1.5.3: Contextualizing "Choice" for Undocumented Immigrants in U.S. Clinical Trials Research.
Case 1.6 A Randomized Trial of Rapamycin to Increase Longevity and Healthspan in Companion Animals: Navigating the Boundary Between Protections for Animal Research and Human Subjects Research
Commentary 1.6.1: Rapamycin: Risking Harm for Canine Longevity. Commentary 1.6.2: Companion Animal Studies: Slipping Through a Research Oversight Gap. Commentary 1.6.3: Research to Promote Longevity and Health Span in Companion Dogs: A Paediatric Perspective.
Section 2. Respect for Participants
Introduction.
Case 2.1 Ethical Considerations for Unblinding a Participant’s Assignment to Interpret a Resolved Adverse Event
Commentary 2.1.1: Considerations for Unblinding in Biopharmaceutical Industry
Sponsored Trials. Commentary 2.1.2: Blinds and Research Risks. Commentary 2.1.3: The Scientific and Social Implications of Unblinding a Study Subject.
Case 2.2 Should Research Participants Be Notified About Results of Currently Unknown by Potential Significance?
Commentary 2.2.1: The Need for National Guidance Around Informed Consent About GBCA Safety. Commentary 2.2.2: Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice. Commentary 2.2.3: Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance.
Case 2.3 The Ethics of Contacting Family Members of a Subject in a Genetic Research Study to Return Results for an Autosomal Dominant Syndrome
Commentary 2.3.1: What Does the Duty to Warn Require? Commentary 2.3.2: Should Researchers Disclose Results to Descendants? Commentary 2.3.3: Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects.
Case 2.4 Ethics of Continuing to Provide a Drug on an Open-Label Extension Study for an "Unapproved Indication"
Commentary 2.4.1: When Should Open-Label Extension Studies Be Stopped? Commentary 2.4.2: The Role of Clinical Equipoise and Practical Considerations in Deciding Whether to Continue to Provide a Drug on an Open-Label Extension Study for an "Unapproved Indication". Commentary 2.4.3: Open-Label Extension Studies: Are They Really Research?
Case 2.5 Supporting Investigators in Challenging Cases: Unease in the Face of an Ethically Appropriate Action
Commentary 2.5.1: Researchers Experience Moral Distress Too! Commentary 2.5.2: Relieving Investigator Angst After an Appropriate but Concerning Ethics Consultation. Commentary 2.5.3: Acknowledging Angst: Research Ethics Consultation in Disclosing Experimental Research Results of Uncertain Benefit.
Case 2.6 Recontact and Recruitment of Young Adults Previously Enrolled in Neonatal Herpes Simplex Virus Research
Commentary 2.6.1: Research Recruitment of Adult Survivors of Neonatal Infections: Is There a Role for Parental Consent? Commentary 2.6.2: A Knotty Problem of Intertwined Rights. Commentary 2.6.3: Consent Is the Cornerstone of Ethically Valid Research: Ethical Issues in Recontacting Subjects Who Enrolled in Research as a Minor.
Case 2.7 Genotype-Driven Recruitment in Population-Based Biomedical Research
Commentary 2.7.1: Genotype-Driven Recruitment Without Deception. Commentary 2.7.2: Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment. Commentary 2.7.3: Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Section 3. Fair Participant Selection
Introduction.
Case 3.1 Is It Ethical to Enrol Cognitively Impaired Adults in Research that is More than Minimal Risk with No Prospect of Benefit?
Commentary 3.1.1: Inconsistent Approaches to Research Involving Cognitively Impaired Adults: Why the Broad View of Substituted Judgment Is Our Best Guide. Commentary 3.1.2: Ethical and Regulatory Considerations Regarding Enrolment of Incompetent Adults in More Than Minimal Risk Research as Compared with Children. Commentary 3.1.3: Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research.
Case 3.2 Should Patients Be Required to Undergo Standard Chemotherapy Before Being Eligible for Novel Phase I Immunotherapy Clinical Trials?
Commentary 3.2.1: A Rationale for Relaxing the Requirement to Undergo a Noncurative Chemotherapy for Advanced Cancer in a Phase I Immunotherapy Trial. Commentary 3.2.2: Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation. Commentary 3.2.3: Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children.
Case 3.3 Involving Pregnant Women in Research: What Should We Recommend When the Regulations Seem Ethically Problematic?
Commentary 3.3.1: Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favour of the Ethically Preferable Outcome. Commentary 3.3.2: When to Avoid Giving Advice on the Ethical Conduct of Research. Commentary 3.3.3: When Research Regulations and Ethics Conflict.
Case 3.4 Regulatory, Legal, Ethical, and Practical Challenges of Enrolling Wards of the State in Research
Commentary 3.4.1: Fuzzy Logic: How the Practicalities of State Involvement Shape the Most Ethically Supportable Way Forward. Commentary 3.4.2: Enrolling Foster Youth in Clinical Trials: Avoiding the Harm of Exclusion. Commentary 3.4.3: No Justification to Exclude State Ward from Paediatric Transplant Research. Commentary 3.4.4: Life-Saving Experimental Treatment for a Teenage Ward of the State.
Case 3.5 Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography
Commentary 3.5.1: Fair Participant Selection: A Negative Obligation Not to Exclude. Commentary 3.5.2: Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials? Commentary 3.5.3: Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome.
Section 4. Favourable Risk-Benefit Ratio
Introduction.
Case 4.1 Obligations to Act on Patient Reported Outcomes in Electronic Health Records
Commentary 4.1.1: Informed Consent for PROs in EHR Research: Are Additional Requirements Necessary? Commentary 4.1.2: Patient Reported Outcomes at the Crossroads of Clinical Research and Informatics. Commentary 4.1.3: PROs in the Balance: Ethical Implications of Collecting Patient Reported Outcome Measures in the Electronic Health Record.
Case 4.2 A Trial to Test a Novel Approach to Diabetes Prevention
Commentary 4.2.1: Is It Ethically Acceptable to Screen Patients for Obstructive Sleep Apnea and Not Offer Them Positive Air Pressure Therapy in a Clinical Trial? Commentary 4.2.2: Can We Breathe Easy If PAP Therapy Is Withheld? Commentary 4.2.3: Risks of Clinical Research Must Be Reasonable and Necessary.
Case 4.3 Is It Ethically Appropriate to Refuse to Compensate Participants Who Are Believed to Have Intentionally Concealed Medical Conditions?
Commentary 4.3.1: Mutual Obligations in Research and Withholding Payment from Deceptive Participants. Commentary 4.3.2: Best to Exclude but Pay. Commentary 4.3.3: To Pay or Not to Pay? Withholding Payment from Research Participants.
Case 4.4 Ethical Drug Development for Rare Childhood Diseases: When There are Limited but Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?
Commentary 4.4.1: The Use of Paediatric Extrapolation to Avoid Unnecessary Paediatric Clinical Trials. Commentary 4.4.2: Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Paediatric Conditions. Commentary 4.4.3: When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Paediatric Study Population.
Case 4.5 Greater than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Paediatric Populations
Commentary 4.5.1: Balancing Risk and Reward: Greater Research Oversight Is Appropriate for Novel Therapies for Children with Life-Limiting Illness. Commentary 4.5.2: Bringing Known Drugs to Paediatric Research: Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk. Commentary 4.5.3: Balancing Scientific Progress with Paediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future.
Section 5. Informed Consent
Introduction.
Case 5.1 The Ethics of Disclosing to Research Subjects the Availability of Off-Label Marketed Drugs
Commentary 5.1.1: Researchers Have an Ethical Obligation to Disclose the Availability of Off-Label Marketed Drugs. Commentary 5.1.2: The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability. Commentary 5.1.3: Which Alternatives Should Investigators Disclose to Research Subjects?
Case 5.2 A Pragmatic Trial of Suicide Risk Assessment and Ambulance Transport Decision Making Among Emergency Medical Services Providers: Implications for Patient Consent
Commentary 5.2.1: Improving Care for Suicidal Patients While Protecting Human Subjects: Addressing Ethical Challenges in Mental Health Research Involving Emergency Medical Services Providers. Commentary 5.2.2: A Stepwise Approach to Ethically Assess Pragmatic Cluster Randomized Trials: Implications for Informed Consent for Suicide Prevention Implementation Research. Commentary 5.2.3: Informed Consent in a Pragmatic Emergency Suicide Trial: Rejecting the Research-Practice Distinction. Commentary 5.2.4: A Pragmatic Trial for Emergency Medical Service Providers’ Prehospital Response to Suicidality: Consent Is Not Essential, but Limited Patient Engagement May Be Meaningful.
Case 5.3 The Obligations to Report Statutory Sexual Abuse Disclosed in a Research Study
Commentary 5.3.1: The Moral and Legal Need to Disclose Despite a Certificate of Confidentiality. Commentary 5.3.2: Informed Consent and the Implications for Statutory Rape Reporting in Research with Adolescents. Commentary 5.3.3: Community, Context, and the Contrasting Roles of Clinicians and Researchers: Challenges Raised by Statutory Rape.
Case 5.4 Conjoined Consent: Informed Consent When Donor and Recipient Are Both Research Participants
Commentary 5.4.1: Moving Beyond Standard Informed Consent for Interventional Organ Transplant Research. Commentary 5.4.2: Risks to Relationships in Kidney Transplant Research with Living Donors and Recipients.
Case 5.5 Navigating Parental Permission for Neonatal Research
Commentary 5.5.1: Informed Consent and Parental Permission for Research: Rules, Roles, and Relationships. Commentary 5.5.2: Research Involving Premature Infants: Timing Is Everything. Commentary 5.5.3: Precluding Consent by Clinicians Who Are Both the Attending and the Investigator: An Outdated Shibboleth?
Case 5.6 Click Here to Complete This Survey: Online Research, Adolescents, and Parental Consent
Commentary 5.6.1: Digital Negotiations: Navigating Parental Permission and Adolescent Assent for On-Line Survey Participation. Commentary 5.6.2: Constrained Adolescent Autonomy for Healthcare Should Include Participation in Survey Research. Commentary 5.6.3: Respecting Parental Permission and Maintaining Flexibility in Online Research Involving Adolescent Participants.
Case 5.7 When Professional Meets Personal: How Should Research Staff Advertise on social media for Research Opportunities?
Commentary 5.7.1: Sharing Research Opportunities on Personal Social Media Accounts and Fair Subject Selection. Commentary 5.7.2: How Should Investigators Advertise on social media for Research Opportunities?
Case 5.8 The Limitation of "Boilerplate" Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel
Commentary 5.8.1: The Bane of "Boilerplate" Language in Research Consent Forms: Ensuring Consent Forms Promote Autonomous Authorization. Commentary 5.8.2: Single IRBs Are Responsible to Ensure Consent Language Effectively Conveys the Local Context. Commentary 5.8.3: Solving the Single IRB/Boilerplate Bind: Establishing Institutional Guidelines.
Appendix A. Cases Organized by Principles. Appendix B. Cases Organized by Topics. Appendix C. Cases Organized by Values.
| Erscheinungsdatum | 24.11.2023 |
|---|---|
| Zusatzinfo | 1 Line drawings, black and white; 1 Illustrations, black and white |
| Verlagsort | London |
| Sprache | englisch |
| Maße | 174 x 246 mm |
| Gewicht | 1100 g |
| Themenwelt | Medizin / Pharmazie ► Gesundheitswesen |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Medizinethik | |
| Studium ► Querschnittsbereiche ► Geschichte / Ethik der Medizin | |
| Naturwissenschaften ► Biologie | |
| Recht / Steuern ► Allgemeines / Lexika | |
| Recht / Steuern ► EU / Internationales Recht | |
| ISBN-10 | 1-032-37096-3 / 1032370963 |
| ISBN-13 | 978-1-032-37096-5 / 9781032370965 |
| Zustand | Neuware |
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