Ethical Issues in Community and Patient Stakeholder–Engaged Health Research

Emily E. Anderson, PhD, MPH, is Professor in the Neiswanger Institute for Bioethics and Healthcare Leadership at Loyola University Chicago’s Stritch School of Medicine. Dr. Anderson holds a PhD in health care ethics from Saint Louis University and an MPH from University of Illinois Chicago. She teaches courses on research ethics and responsible conduct of research to bioethics and biomedical sciences graduate students as well as medical students. In addition to the ethics of stakeholder engagement in research, her areas of interest and expertise include researcher and physician professionalism and misconduct; ethical issues in research with vulnerable populations; informed consent; institutional review board (IRB) policy; and the application of qualitative research techniques to the study of research ethics. She has published over 50 articles in top journals including the American Journal of Bioethics, Journal of Law, Medicine, and Ethics, Academic Medicine, and IRB: Ethics & Human Research. Dr. Anderson currently serves as associate editor of Narrative Inquiry in Bioethics. Dr. Anderson has been a co-investigator on several federally-funded research and educational projects and recently co-authored the book 100 Questions and Answers about Research Ethics (Sage Publications, 2018) with Dr. Amy Corneli (at Duke University).

• Chapter 1. Introduction (Emily E. Anderson).- Part 1. History, Codes of Ethics, Regulations.- Chapter 2. Theoretical roots of stakeholder-engaged research and reflections on CBPR and PCOR as a response to past research abuses (Meredith Minkler).- Chapter 3. A philosophical justification for stakeholder engagement and key principles/a conceptual model for ethical stakeholder-engaged research (Emily E. Anderson).- Chapter 4. Epistemology and stakeholder engagement/impact of diversity on ethical standards and practices (Kevin C. Elliott).- Chapter 5. The limitations of the Belmont principles for stakeholder-engaged research (Elisa Hurley).- Chapter 6. Canada’s approach to regulating research with indigenous peoples (Kim Anderson).- Chapter 7. The Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines and Stakeholder Engagement (Alex John London).- Chapter 8. History and philosophy of patient engagement in clinical research (Robert M. Califf).- Part 2. Promoting Equitable Collaboration.- Chapter 9. Who represents the community? Diversity and inclusion (Ann-Gel Palermo).- Chapter 10. Engagement for equity and sustainability; developing an equitable partnership; power-sharing, accountability, communication, conflict resolution, and trust (Giselle Corbie-Smith).- Chapter 11.- Capacity building and benefits to communities; Credit and compensation for community and patient stakeholders (Elizabeth Ripley).- Chapter 12. Engaging communities in agenda setting: deciding what questions get asked and how (Alice Ammerman).- Chapter 13. Conflicts of interest in research that engages stakeholders [individual and organizational] (Susannah Rose).- Part 3. Stakeholder Voices.- Chapter 14. “Crossing over” or “between two worlds” – The story of a someone whose engagement in research motivated them to get formal training in research or research ethics (Gigi McMillan).- Chapter 15. A community IRB member/member of a community-based ethics review board (Bronx Community Research Review Board).- Chapter 16. A stakeholder who has served as a PI (Sharon Terry).- Chapter 17. A stakeholder who has served as a community advisory board member (Sandra Crouse Quinn).- Chapter 18. The challenges of working in your own community.- Chapter 19. A patient advocate’s experience engaging in research.- Part 4. Human Research Protections and Research Ethics Review.- Chapter 20. Stakeholder engaged research and (the limits of) IRB review (Jennifer Cross).- Chapter 21. Community-level risks and benefits (Lainie Ross).- chapter 22. The principle of respect for community - a new principle (Nancy Shore).- Chapter 23. Challenges in the field and in interactions with research participants; challenges to voluntary informed consent, privacy, and confidentiality; Moral distress among lay stakeholders (Maghbooba Mosavel).- Chapter 24. The notion of community consent (Charles Weijer).- Chapter 25. Community-based research review processes (Hal Strelnick).- Chapter 26.Data ownership and deciding what gets published (Melody Goodman).- Part 5. Case Studies: Ethics of Stakeholder-Engaged Research Across Settings.- Chapter 27. Research in emergency settings: public notification and consultation (Ryan Spellecy).- Chapter 28. Engaging stakeholders in genomics research and the governance of biobanks (Michelle McGowan).- Chapter 29. Engaging online patient communities in research (Elizabeth Buchanan).- Chapter 30. Engaging patient advocates in research (Deborah Collyar).- Chapter 31. Engaging rare disease communities (Laura P. Forsythe).- Chapter 32. Engaging stakeholders in basic science research (Rhonda Kost).- Chapter 33. Engaging indigenous communities/ American Indian communities in Research (Bonnie Duran).- Chapter 34. North Americans engaging internationally (Amy Corneli).- Chapter 35. Engaging stakeholders in environmental health research (Doug Brugge).- Chapter 36. Engaging stakeholders in research on stigmatized health conditions (e.g., mental health, addiction, HIV) (Dennis Watson).- Chapter 37. Engaging youth in research (Celia Fisher).