Ethical Issues in Community and Patient Stakeholder–Engaged Health Research (Philosophy and Medicine, 146)

Acknowledgments
Contents
Editor and Contributors
About the Editor
Contributors
Part I: Theory
	Chapter 1: Introduction: What We Talk About When We Talk About the Ethics of Engaging Patient and Community Stakeholders in Health Research
		References
	Chapter 2: Theorizing Participatory Research
		2.1 Introduction
		2.2 What’s the Point of Participatory Research?
		2.3 Addressing the Challenges of Participatory Research
		2.4 Types of Participatory Research
		2.5 Participatory Research in Health Contexts
		2.6 Conclusion
		References
	Chapter 3: An Evolving Ethical Framework for Patient and Community-Engaged Research
		3.1 Introduction
		3.2 Protecting Enrolled Individuals and Their Data: Belmont Principles and the “Subject” Role
		3.3 Engaging Participants: Embodied Ethical Action
		3.4 Building and Maintaining Partnerships: Relational Ethics
		3.5 Discussion
		References
	Chapter 4: Beyond Good Intentions: Principles for Anti-racist Community-Engaged Research
		4.1 Start Here: Awareness of Institutional Positionality
		4.2 Principles of Anti-racist Community-Engaged Research
		4.3 Conclusion: More than Intent
		References
	Chapter 5: Demystifying How Academic-Community Partnerships Use Reflexivity and Praxis to Promote Participatory Research Principles of Equity and Justice
		5.1 Introduction
		5.2 Greater Lawndale Healthy Work (GLHW) Project Background
			5.2.1 GLHW Council Mission, Values, and Principles
		5.3 Methods: Academic-Community Research Partnership Praxis
		5.4 Results
			5.4.1 Naming the Contradictions in our Research to Co-Develop Solutions
			5.4.2 Praxis Adaptations across the Research Cycle
			5.4.3 Conflicts with our GLHW Principles and Action Steps
		5.5 Discussion
			5.5.1 Impact on Our Academic-Community Partnership
		5.6 Conclusions
		References
Chapter 6: Reflexivity: A Strategy for Ethics- and Values-Driven Community Partnerships in Mental Health
	6.1 Ethics- and Values-Oriented Community Partnership with Reflexivity
	6.2 Relational Frames and Cognitive Fusion
	6.3 Self-as-Context
	6.4 Self-Compassion and Mindfulness
	6.5 Conclusion
	References
Part II: In the Field
	Chapter 7: How Do You Define Community and Why Is it Important?
		7.1 Introduction
		7.2 What Is a Community?
		7.3 Why Is Understanding Community Important for Research?
		7.4 Strategies for Learning More about a Community
			7.4.1 Data-Based Strategies
			7.4.2 Community Engagement Strategies
		7.5 Conclusions
		References
	Chapter 8: Community Researchers and Ethical Considerations: Burdens in the Field
		8.1 Introduction
		8.2 Ethical Challenges Experienced by Community Researchers
		8.3 Lessons from Our Work
		8.4 Key Ethical Considerations
		8.5 Recommendations
		8.6 Conclusion
		References
	Chapter 9: Community-Engaged Research with People with Developmental Disabilities: A Conversation with Community Researchers about their Ethical Inclusion
		9.1 Introduction
		9.2 Creating a Sense of Belonging
		9.3 Fostering Respect and Meaningful Inclusion and Collaboration through Disability-Accommodations
		9.4 Meeting Expectations
		9.5 Conclusions
		Bibliography
			Academic Publications
			Web-Based Resources
	Chapter 10: Community Conversations about Culturally Responsive Health Research for African American Communities
		10.1 Introduction
		10.2 Methods
		10.3 Findings
			10.3.1 Reasons for Not Wanting to Be Involved in Research
			10.3.2 Community Benefits of Research
			10.3.3 Community Risks of Research
			10.3.4 Culturally Responsive Research
		10.4 Discussion
		10.5 Conclusion
		References
	Chapter 11: The Power of Personal Narrative: My Experience with SACHRP, the FDA, and Bioethics
		11.1 Secretary’s Advisory Committee for Human Research Protection
		11.2 U.S. Food and Drug Administration
		11.3 Bioethics
		11.4 The Power of Narrative
		References
Part III: Unique Ethical Considerations
	Chapter 12: Patient Advocacy Organizations and Conflicts of Interest in Research
		12.1 Introduction
		12.2 What Are Conflicts of Interest?
		12.3 How Common Is Industry Funding of Patient Organizations?
		12.4 Why Is Industry Funding of Patient Organizations a Concern?
		12.5 How Does Industry Funding of Patient Organizations Influence Research?
		12.6 How Could the Risk of Undue Influence from Industry Funders Be Managed?
			12.6.1 What More Could Be Done?
		12.7 Conclusions
		References
	Chapter 13: Representing and Protecting: Gatekeepers in Community-Engaged Research
		13.1 Introduction
		13.2 The Limits of Informed Consent and Independent Review in Protecting Third Parties and Groups
		13.3 Types of Gatekeepers
			13.3.1 Formal Leadership Organizations
			13.3.2 Community-Created Research Gatekeeping Organizations
			13.3.3 Informal Community Leaders
			13.3.4 Researcher-Created Gatekeepers
		13.4 Who Represents the Community?
		13.5 Gatekeeping Threats to Voluntariness
		13.6 Conclusion
		References
	Chapter 14: Paying Research Participants and Community and Patient Research Partners: An Engaging Ethical Issue
		14.1 Introduction
		14.2 Applying Ethical Principles to Payments for Research Participants and Research Partners
		14.3 Federal Regulations and Guidance, State Laws, and Institutional Policies
		14.4 Research Funders’ Payment Guidelines
		14.5 Guidance from Professional Organizations
		14.6 Additional Considerations for Paying Research Partners
		14.7 Proposed Models for Ethical Payment of Research Participants
		14.8 Comprehensive Frameworks for Determining Payments for Research Participants and Research Partners
		14.9 Case Study: When Research Partners Are Also Research Participants
		14.10 Conclusion
		References
	Chapter 15: Rethinking Risks and Benefits in Stakeholder-Engaged Research: Lessons from HIV, Substance Use, and Sexual Health Research with Marginalized Communities
		15.1 Introduction
		15.2 Stakeholder-Engaged Research: Lessons from HIV CBR
		15.3 Setting the Stage: Complicated Research/Researcher/Researched Entanglements
		15.4 Scientific Review and Adaptation
		15.5 Power in Partnerships
		15.6 Compensation and Research Economies
		15.7 The Risk of Unrecognized Risk
		15.8 Managing Sensitive Data and Data Sensitivities
		15.9 Dissemination and Knowledge Translation
		15.10 Conclusion
		References
	Chapter 16: Data Decisions and Ethics: The Case of Stakeholder-Engaged Research
		16.1 Introduction
			16.1.1 Definition of Data
			16.1.2 Ownership, Stewardship, Use, Publication, Sharing, Repository, and Open Access
		16.2 Benefits of Sharing Data
		16.3 Responsible Use of Data in Stakeholder-Engaged Research
			16.3.1 Data Ownership
			16.3.2 Data Decisions
			16.3.3 Data Publication Decisions
			16.3.4 Data Agreements
		16.4 Barriers to Responsible Data Sharing
			16.4.1 Lack of Infrastructure
			16.4.2 Ethical Considerations
		16.5 Community Engagement to Strengthen Ethical Data Practices
			16.5.1 Informed Consent
			16.5.2 Data Collection Methodology
			16.5.3 Protection of Participants
			16.5.4 Removing “Non-traditional” Identifiers from the Dataset Before Sharing
		16.6 The Road to Responsibly Shared Data: Roles and Responsibilities
			16.6.1 Role and Responsibilities of the Principal Investigator
			16.6.2 Role and Responsibilities of Funders
			16.6.3 Roles and Responsibilities of Nonacademic Stakeholders
		16.7 Conclusion and Recommendations
			16.7.1 Ethically Guided Solutions: Memorandum of Understanding and Partnership Agreements
		References
Part IV: Research Ethics Oversight
	Chapter 17: Applying the Belmont Principles to Stakeholder-Engaged Research: Adaptions and Limitations
		17.1 The Belmont Report in Context
		17.2 Applying Belmont’s Principles to CEnR: Flexibility in the Applications
		17.3 The Limitations of Belmont: Communities as Research Partners
		17.4 Conclusion
		References
	Chapter 18: Stakeholder Engagement and (the Limits of) IRB Review
		18.1 Whence the Divide?
			18.1.1 Differences in Ethical Frameworks
			18.1.2 Differences in Meaning and Purpose of Research
			18.1.3 Different Assumptions About the Relationship Between the Researcher and the Researched
			18.1.4 Different Methodological Assumptions
			18.1.5 Potential Bridges of the Divide
		18.2 Structural Adaptations: Flexibility in IRB Processes
			18.2.1 Recognition and Oversight of Stakeholders as Part of the Research Team
			18.2.2 Managing the Review of Emergent Research Designs
		18.3 Content Adaptations: Communication and Representation
		18.4 Limitations and Conclusion
		References
	Chapter 19: Community Research Ethics Oversight: Place, Experience, and Expertise
		19.1 Introduction
		19.2 Case Studies
			19.2.1 The Bronx Community Research Ethics Review Board
			19.2.2 Research 101: A Manifesto for Ethical Research in the Vancouver Downtown Eastside
			19.2.3 The Philadelphia Promise Zone Research Connection
		19.3 Discussion
			19.3.1 Community and the Shared Experience of Place
			19.3.2 “Community Expertise” and the Epistemological Significance of Place
		19.4 Conclusion
		References
	Chapter 20: Introducing the Downtown Eastside Community Research Ethics Workshop: Notes on a Process for Community Ethics Review
		20.1 Research in the DTES and Our Experiences with “Research 101”
		20.2 What Is a Community Ethics Review Process and Why Is It Important?
		20.3 Introducing the CREW
		20.4 Research Ethics Training for Community Reviewers
		20.5 Piloting Practice Reviews
		20.6 The Potential of Community Ethics Review: Notes from Three Pilot CREW Reviews
			20.6.1 Identifying Inaccessibility and the Need for Language and Formats That Everyone Can Understand
			20.6.2 Critiquing Institutional Assumptions About Quantifying Risk and Vulnerability on Behalf of Communities
			20.6.3 Noticing Unintentional Stigmatization in Research Design
			20.6.4 Conceptualizing and Advocating for Strong Approaches to Ongoing Consent
			20.6.5 What Lived Experience? Clarifying Researchers’ Vague Understandings of Key Community Roles
			20.6.6 Sustaining Community Oversight When Community Connections Grow Fuzzy
			20.6.7 Other Potential Benefits of Community Ethics Review in the DTES
		20.7 Authority, Community Ethics Review, and the Possibility of Real Accountability in Research
		20.8 Unresolved Challenges: Funding, Ownership, and Community Representation
		20.9 Conclusion
		References
Index