Challenging Cases in Clinical Research Ethics

Herausgeber: Wilfond, Benjamin S; Johnson, Liza-Marie; Taylor, Holly A; Duenas, Devan M

• Broschiertes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Taylor & Francis Ltd
• Seitenzahl: 318
• Erscheinungstermin: 22. November 2023
• Englisch
• Abmessung: 174mm x 245mm x 25mm
• Gewicht: 630g
• ISBN-13: 9781032370958
• ISBN-10: 1032370955
• Artikelnr.: 68475572

Autorenporträt

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

Inhaltsangabe

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.