Presentation Transcript

1. Ethics, Trust, and HumanBiological Material

   John R. Stone, MD, PhD Center for Health Policy and Ethics Creighton University
2. Purpose With a community focus, address problems and strategies in ensuring trustworthy use of human biological material. Draw on community-based participatory research.
3. Trust & Perspective “What you see depends on where you stand.”* * Albert Einstein. Quoted in: Duster T. Explaining differential trust of DNA forensic technology: Grounded assessment or inexplicable paranoia? J Law Med Ethics. 2006; 34(2):293-300, (p. 293).
4. Tissue Donation to Biobanks Trust Low: indigenous & other populations with prior trust breaches (example: “parents whose children’s organs had been retained without consent ” ) Lipworth W, Forsyth R, Kerridge I. Tissue donation to biobanks: A review of sociological studies. Sociol Health Illn. 2011; 33(5):792-811, (p. 800).
5. Perspectives or InterestsGenomic Data Donors Families [Communities] Ancestral groups Investigators Funders Pharma Journals Clinicians Foster MW, Sharp RR. Share and share alike: Deciding how to distribute the scientific and social benefits of genomic data. Nat Rev Genet. 2007; 8(8):633-639.
6. Universal Declaration on the Human Genome and Human Rights 11 November 1997 (UNESCO) Article 10: “No research or research applications concerning the human genome… should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people.” UNESCO (United Nations Educational, Scientific and Cultural Organization) http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html (Accessed 12Sept2011) (Underline added)
7. Genomics & Communities “It is vital that members of communities of color are truly empowered to participate in providing guidance for genomics research and the policy-making process for science and biomedical research. …CBPR… has been recognized as a valuable model of conducting research to improve health and reduce health disparities.” Bonham VL, Citrin T, Modell SM, Franklin TH, Bleicher EW, Fleck LM. Community-based dialogue: Engaging communities of color in the united states' genetics policy conversation. J Health Polit Policy Law. 2009; 34(3):325-359, (p. 354). (Underlines added)
8. Benefits: Biological Material Improved diagnosis Better treatment Disease prevention Personalized healthcare
9. Harms: Biological Material General Privacy Employment/opportunities Insurance
10. Harms: Biological Material Populations Exploitation & other injustices Reification of racial/ethnic biases Stigma Violations of beliefs and traditions Achter P, Parrott R, Silk K. African Americans' opinions about human-genetics research. Politics Life Sci. 2004; 23(1):60-66.
11. TrustworthinessJudging Harms/Benefits What are harms and benefits? Who should decide?
12. Investigator/InstitutionEnsuring Trustworthiness Regarding the use of human biological material, targeted communities or populations are usually very involved in determining research design, implementation, and outcome implementation. True or False?
13. Investigator/InstitutionalTrustworthiness Regarding the use of human biological material, widely accepted and effective models of community involvement are available for ensuring trustworthy use. True or False?
14. Investigator/InstitutionEnsuring Trustworthiness Regarding the use of human biological material, Institutional Review Boards (IRBs) generally have sufficient community representation and input. True or False?
15. Communities & ResearchUse of Biological Material None (Individual informed consent) Consultation Advisory Board Institutional Review Board (IRB) Partnering Community-based Participatory Research Community Review Board (CRB)
16. Community Input Community advisory board Full “engagement” with researchers from design to dissemination. Fosters communication To whom? Researchers IRBs (Institutional Review Boards) Institutions McCarty CA, Chapman-Stone D, Derfus T, Giampietro PF, Fost N, Marshfield Clinic PMRP Community Advisory Group. Community consultation and communication for a population-based DNA biobank: The Marshfield Clinic personalized medicine research project. Am J Med Genet A. 2008; 146A(23):3026-3033.
17. IRBs & Communities “IRB/REB forms overwhelmingly … focused on assessing risk to individuals and not communities. …Their noninterest in community-level concerns, capacity building, and issues of equity situate them within a biomedical framework privileging “knowledge production” as the exclusive right of academic researchers.” Flicker S, Travers R, Guta A, McDonald S, Meagher A. Ethical dilemmas in community-based participatory research: Recommendations for institutional review boards. J Urban Health. 2007; 84(4):478-493, (p. 490).
18. Community InputIRBc/IRBC Moderate to major community involvement in the Institutional Review Board Institutional transformation
19. Community-based Participatory ResearchCBPR Full partnering (Community/Researchers) Full power sharing Collaboration to advance community good General knowledge is possible Cross-cultural challenges Moral anchors: respect, justice, beneficence (also care and solidarity)
20. CBPR Promise Better protection of individuals More community benefit Better design Better implementation Enhance trustworthiness Foster public support Resnik DB, Kennedy CE. Balancing scientific and community interests in community-based participatory research. Account Res. 2010; 17(4):198-210.
21. CBPR Conflicts Design Data interpretation (objectivity) Conduct Publication (Need for investigating best practices for resolution) Resnik DB, Kennedy CE. Balancing scientific and community interests in community-based participatory research. Account Res. 2010; 17(4):198-210.
22. CBPR/Transformation Communities Researchers Institutions/organizations
23. Trustworthiness and Communities IRBc: Institutional Review Board/strong community representation CRB: Community Review Board CAB: Community advisory board CBPR: Community-based Participatory Research Inst: Institution
24. Trustworthiness and Communities Community Community Researchers Institutional Researchers
25. Community-Academic Partnering Center for Promoting Health and Health Equality Community Partners Governing Board Academic Partners Administrative Core Intervention Training & Development Research
26. Community Relevance How does a particular community’s input matter if studies include many communities?
27. Ethics and HumilityResearcher CharacteristicsInstitutional Attitudes Knowledge/epistemological humility Conflict humility Cultural humility Stone, JR. Ethics and Community-Based Participatory Research. Focus. Spring 2011. http://chpe.creighton.edu/publications/focus/spring-2011/CBPR.htm.
28. HumilityKnowledge/epistemological Researchers’ ignorance Harm Potential Disrespect, injustice Power exercise Trustworthiness
29. Conflict Humility Career goals Funding priorities Institutional priorities (Usual conflicts) Trustworthiness
30. Cultural Humility* Disciplinary culture Institutional culture Personal culture Gender Race/ethnicity Nationality Biases, stereotypes Trustworthiness *Draws on: Tervalon M, Murray-Garcia J. Cultural humility versus cultural competence: A critical distinction in defining physician training outcomes in multicultural education. J of Health Care for the Poor and Underserved. 1998; 9(2):117-125.
31. Challenges: Community Collaboration Time Developing dialogues Employing appropriate frameworks Deliberative democracy Openness to & respect for diversity Fuse with CBPR methods  Bonham VL, Citrin T, Modell SM, Franklin TH, Bleicher EW, Fleck LM. Community-based dialogue: Engaging communities of color in the united states' genetics policy conversation. J Health Polit Policy Law. 2009; 34(3):325-359.