Challenging Cases in Clinical Research Ethics

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.

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics.

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.

Autorentext

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

Inhalt

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: Ackn…