Ethics, Trust, and HumanBiological Material
John R. Stone, MD, PhDCenter for Health Policy and Ethics
Creighton University
Purpose
With a community focus, address problems and strategies in ensuring trustworthy use of human biological material.
Draw on community-based participatory research.
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).
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).
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.
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)
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)
Benefits: Biological Material
Improved diagnosis Better treatment Disease prevention Personalized healthcare
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.
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?
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?
Investigator/InstitutionEnsuring Trustworthiness
Regarding the use of human biological material, Institutional Review Boards (IRBs) generally have sufficient community representation and input.
True or False?
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)
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.
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).
Community InputIRBc/IRBC
Moderate to major community involvement in the Institutional Review Board
Institutional transformation
Community-based Participatory Research CBPR
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)
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.
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.
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
Community-Academic Partnering
Center for Promoting Health and Health Equality
Governing Board
Academic Partners
Community
Partners
AdministrativeCore
Intervention
Training &Developme
ntResearch
Community Relevance
How does a particular community’s input matter if studies include many communities?
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.
HumilityKnowledge/epistemological
Researchers’ ignorance
Harm Potential Disrespect,
injustice Power exercise
Trustworthiness
Conflict Humility
Career goals Funding priorities Institutional
priorities (Usual conflicts)
Trustworthiness
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.
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.