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Challenging Cases in Clinical Research Ethics 1st Edition

ISBN: 9781032370958
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2023/11

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344

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Περιγραφή

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.

Περιεχόμενα

Foreword

Introduction

Benjamin S. Wilfond, Liza-Marie Johnson, Devan M. Duenas, and Holly A Taylor

A Framework for Research Ethics. Principles of Research Ethics. Topics in Research Ethics . Values of Research Ethics.

 

Section 1. Collaborative Partnership

Introduction by Benjamin S. Wilfond

 

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 – Benjamin F. Springgate, Olivia Sugarman, Kenneth B. Wells, Lawrence A. Palinkas, Diana Meyers, Ashley Wennerstrom, Arthur Johnson, Catherine Haywood, Daniel Sarpong, and Richard Culbertson. Commentary 1.1.2: Leveraging Academic Institutional Structures to Support Asian American Community Organizations’ Engagement in Research: The Korean Community Service Center – Joon-Ho Yu. Commentary 1.1.3: Engaging the Sickle Cell Community in Participatory Research – Yvonne Carroll. Commentary 1.1.4: Being in Good Community: Engagement in Support of Indigenous Sovereignty – Jessica Blanchard and Vanessa Hiratsuka.

 

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 – Mark Yarborough. Commentary 1.2.2: Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study – Stanley Korenman, Stuart G. Finder, and John M. Ringman. Commentary 1.2.3: Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors – Anne R. Simpson.

 

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 – Hannah Giunta. Commentary 1.3.2: The Ethics of Studying Financial Incentives in Public Health Implementation: Study Design Challenges – Adelaide Doussau and Christine Grady. 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 – Ponni Perumalswami, Andrea Branch, and Rosamond Rhodes.

 

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 – Emma Tumilty and Jeffrey S. Farroni. Commentary 1.4.2: Clinical Trials Not Causing Harm with Potential for Realizing Benefit Should Continue – Brian Michael Jackson. Commentary 1.4.3: Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial – Jennifer B. McCormick and Kent P. Hymel.

 

Case 1.5 When a Clinical Trial Is the Only Option

Commentary 1.5.1: “Respect for Persons,” Not “Respect for Citizens” – Rachel Fabi. Commentary 1.5.2: The Potentially High Cost of a Free Clinical Trial – Elizabeth Heitman. Commentary 1.5.3: Contextualizing “Choice” for Undocumented Immigrants in U.S. Clinical Trials Research – Nancy J. Burke.

 

Case 1.6 A Randomized Trial of Rapamycin to Increase Longevity and Health span 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 – Cheryl Abbate. Commentary 1.6.2: Companion Animal Studies: Slipping Through a Research Oversight Gap – Rebecca L. Walker and Jill A. Fisher. Commentary 1.6.3: Research to Promote Longevity and Health Span in Companion Dogs: A Pediatric Perspective – Benjamin S. Wilfond, Kathryn M. Porter, Kate E. Creevy, Matt Kaeberlein, and Daniel Promislow.

 

Section 2. Respect for Participants

Introduction by Holly A. Taylor.

 

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 – J. Jina Shah and John Bond. Commentary 2.1.2: Blinds and Research Risks – Robert Steel and Marion Danis. Commentary 2.1.3: The Scientific and Social Implications of Unblinding a Study Subject – Lynne M. Quittell.

 

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 – Stephen D. Brown. Commentary 2.2.2: Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice – Caroline J. Huang, W. Patricia Bandettini, and Marion Danis. Commentary 2.2.3: Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance – Nora Hutchinson, Alexander Capron, and Adélaïde Doussau.

 

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? – Seema K. Shah, Sara Chandros Hull, Michael A. Spinner, Benjamin E. Berkman, Lauren A. Sanchez, Ruquyyah Abdul-Karim, Amy P. Hsu, Reginald Claypool, and Steven M. Holland. Commentary 2.3.2: Should Researchers Disclose Results to Descendants? – Mark A. Rothstein. Commentary 2.3.3: Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects – Lauren C. Milner, Emily Y. Liu, and Nanibaa’ A. Garrison.

 

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? – Joshua S. Crites. 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” – Ryan R. Nash. Commentary 2.4.3: Open-Label Extension Studies: Are They Really Research? – Mildred K. Cho.

 

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! – Toby Schonfeld and Cynthia M. A. Geppert. Commentary 2.5.2: Relieving Investigator Angst After an Appropriate but Concerning Ethics Consultation – Shannon Blee, Hannah Claire Sibold, Margie Dixon, and Rebecca D. Pentz. Commentary 2.5.3: Acknowledging Angst: Research Ethics Consultation in Disclosing Experimental Research Results of Uncertain Benefit – Ryan Spellecy and Alan Nyitray.

 

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? – Ann J. Melvin, Kathleen M. Mohan, Anna Wald, Kathryn Porter, and Benjamin S. Wilfond. Commentary 2.6.2: A Knotty Problem of Intertwined Rights – Ross E. McKinney. Commentary 2.6.3: Consent Is the Cornerstone of Ethically Valid Research: Ethical Issues in Recontacting Subjects Who Enrolled in Research as a Minor – Erin Talati Paquette and Lainie Friedman Ross.

 

Case 2.7 Genotype-Driven Recruitment in Population-Based Biomedical Research

Commentary 2.7.1: Genotype-Driven Recruitment Without Deception – Pilar Ossorio and Marsha Mailick. Commentary 2.7.2: Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment – Sam Doernberg and Sara Chandros Hull. Commentary 2.7.3: Genotype-Driven Recruitment and the Disclosure of Individual Research Results – Laura M. Beskow.

 

Section 3. Fair Participant Selection

Introduction by Holly A. Taylor.

 

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 – Mark Yarborough. Commentary 3.1.2: Ethical and Regulatory Considerations Regarding Enrollment of Incompetent Adults in More Than Minimal Risk Research as Compared with Children – Arthur R. Derse and Ryan Spellecy. Commentary 3.1.3: Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research – Marion Danis, David Wendler, and Scott Kim.

 

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 – Adelaide Doussau and Clark B. Hanmer. Commentary 3.2.2: Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation – Elaine Collier and Marion Danis. Commentary 3.2.3: Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children – Cynthia Wetmore.

 

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 – Seema K. Shah and Kathryn Porter. Commentary 3.3.2: When to Avoid Giving Advice on the Ethical Conduct of Research – Richard R. Sharp and Megan A. Allyse. Commentary 3.3.3: When Research Regulations and Ethics Conflict – Haley K. Sullivan, Derek W. Braverman, and David Wendler.

 

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 – Jessica M. Turnbull and Daniel J. Benedetti. Commentary 3.4.2: Enrolling Foster Youth in Clinical Trials: Avoiding the Harm of Exclusion – Mary V. Greiner and Armand H. Matheny Antommaria. Commentary 3.4.3: No Justification to Exclude State Ward from Paediatric Transplant Research – Kathy J. Forte and Emily E. Anderson. Commentary 3.4.4: Life-Saving Experimental Treatment for a Teenage Ward of the State – Henry Sacks and Rosamond Rhodes.

 

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 – Stephanie C. Chen. Commentary 3.5.2: Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials? – Mark A. Stein and Bryan H. King. Commentary 3.5.3: Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome – Rosamond Rhodes and Alex Kolevzon.

 

Section 4. Favourable Risk-Benefit Ratio

Introduction by Liza M. Johnson.

 

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? – Danielle Whicher and Emily Evans. Commentary 4.1.2: Patient Reported Outcomes at the Crossroads of Clinical Research and Informatics – Eric S. Swirsky and Andrew D. Boyd. Commentary 4.1.3: PROs in the Balance: Ethical Implications of Collecting Patient Reported Outcome Measures in the Electronic Health Record – Joshua S. Crites, Cynthia Chuang, Anne Dimmock, Wenke Hwang, Bobbie Johannes, Anuradha Paranjape, and Albert W. Wu.

 

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? – Jennifer B. McCormick, Joel T. Wu, and Adelaide Doussau. Commentary 4.2.2: Can We Breathe Easy If PAP Therapy Is Withheld? – Holly A. Taylor and Naresh M. Punjabi. Commentary 4.2.3: Risks of Clinical Research Must Be Reasonable and Necessary – D. Gibbes Miller and Scott Y. H. Kim.

 

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 – Holly Fernandez Lynch, Luke Gelinas, and Emily A. Largent. Commentary 4.3.2: Best to Exclude but Pay – Marion Danis, Sam Doernberg, Matthew Memoli, and Joseph Millum. Commentary 4.3.3: To Pay or Not to Pay? Withholding Payment from Research Participants – Rosamond Rhodes and Michael Danziger.

 

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 – Robert M. Nelson. Commentary 4.4.2: Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Paediatric Conditions – Kathryn M. Porter, Anne Stevens, and Benjamin S. Wilfond. Commentary 4.4.3: When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Paediatric Study Population – Jeff Matsler and Jamila M. Young.

 

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 – Yoram Unguru. Commentary 4.5.2: Bringing Known Drugs to Paediatric Research: Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk – Akshay Sharma and Liza-Marie Johnson. Commentary 4.5.3: Balancing Scientific Progress with Paediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future – Susannah W. Lee and Jessica C. Ginsberg.

 

Section 5. Informed Consent

Introduction by Liza M. Johnson.

 

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 – Tomas J. Silber. Commentary 5.1.2: The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability – Amrutha Baskaran and Robert M. Sade. Commentary 5.1.3: Which Alternatives Should Investigators Disclose to Research Subjects? – John Phillips and David Wendler.

 

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 – Christopher R. DeCou, Seema K. Shah, and Kathryn M. Porter. Commentary 5.2.2: A Stepwise Approach to Ethically Assess Pragmatic Cluster Randomized Trials: Implications for Informed Consent for Suicide Prevention Implementation Research – Cory E. Goldstein and Charles Weijer. Commentary 5.2.3: Informed Consent in a Pragmatic Emergency Suicide Trial: Rejecting the Research-Practice Distinction – Kristin Canavera and Kendra Parris. 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 – Neal W. Dickert.

 

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 – Erin Talati Paquette and Lainie Friedman Ross. Commentary 5.3.2: Informed Consent and the Implications for Statutory Rape Reporting in Research with Adolescents – Stacy Hodgkinson, Amy Lewin, Bora Chang, Lee Beers, and Tomas Silber. Commentary 5.3.3: Community, Context, and the Contrasting Roles of Clinicians and Researchers: Challenges Raised by Statutory Rape – Stuart G. Finder and Stanley Korenman.

 

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 – Brooklyn Aaron, Jessica Ginsberg, and Jason Lesandrini. Commentary 5.4.2: Risks to Relationships in Kidney Transplant Research with Living Donors and Recipients – Philip Ghobrial, Sanjeev Akkina, and Emily E. Anderson, Stephanie A. Kraft.

 

Case 5.5 Navigating Parental Permission for Neonatal Research

Commentary 5.5.1: Informed Consent and Parental Permission for Research: Rules, Roles, and Relationships – Robin N. Fiore and Reid Cushman. Commentary 5.5.2: Research Involving Premature Infants: Timing Is Everything – Leah R. Eisenberg. Commentary 5.5.3: Precluding Consent by Clinicians Who Are Both the Attending and the Investigator: An Outdated Shibboleth? – Anita Shah, Kathryn Porter, Sandra Juul, and Benjamin S. Wilfond.

 

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 – Holly A. Taylor and Douglas B. Mogul. Commentary 5.6.2: Constrained Adolescent Autonomy for Healthcare Should Include Participation in Survey Research – Amy E. Caruso Brown. Commentary 5.6.3: Respecting Parental Permission and Maintaining Flexibility in Online Research Involving Adolescent Participants – Esther Elise Knapp

 

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 – Emily E. Anderson. Commentary 5.7.2: How Should Investigators Advertise on social media for Research Opportunities? – Ryan Spellecy and Lindsay D. Nelson.

 

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 – Jeffrey R. Botkin. Commentary 5.8.2: Single IRBs Are Responsible to Ensure Consent Language Effectively Conveys the Local Context – Sara Chandros Hull and Adam I. Schiffenbauer. Commentary 5.8.3: Solving the Single IRB/Boilerplate Bind: Establishing Institutional Guidelines – Melissa E. Abraham, Elizabeth Hohmann, and Megan Morash.

 

Appendix A. Cases Organized by Principles. Appendix B. Cases Organized by Topics. Appendix C. Cases Organized by Values.