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 General

Privacy Employment/opportunities Insurance

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.

TrustworthinessJudging Harms/Benefits

What are harms and benefits? Who should decide?

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.

CBPR/Transformation Communities Researchers Institutions/organizations

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

Trustworthiness and Communities

Community

InstitutionalResearchers

CommunityResearchers

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.