From Bench to Bedside to Populations

Translation in Health CareExploring the impact of Emerging Technologies

Oxford, June 2015

Michael M. BurgessUniversity of British Columbia

Translation to “public”

• “Engage the public to stimulate their enthusiasm”

• Public health effects as the collective effects of health services delivered to individuals

• Translation? “creating public meaning”• How are health deficits relevant to direct

health system investment?

3 Translational Challenges

1. Individual informed consent, no matter how we tweak it, is not public engagement or governance

2. Influence of commercial and political enthusiasm for economic benefits

3. Transformative science requires transformative ethics and governance

The emperor has an embarrassingly small G-string on his corpulent body, and try as we might the little thing is not going to cover more. Worse, it might tear. . . .Ethical issues raised by health and social research constitute a vast body. Informed consent is a very modest little scrap of theory and policy. . . In practice informed consent is stretched beyond its capacity in an attempt to cover too many of the issues related to research ethics.

Burgess, M.M. Proposing Modesty for Informed Consent. Social Science and Medicine 65 (11) (2007): 2284 - 2295. Cf., Beyond consent: ethical and social issues in genetic testing. Nature Reviews: Genetics. 2 (2001): 9 - 14.

Proposing Modesty for Consent

Informed consent

• Authorizes the intervention as described and understood by the consenting person

• Reflects a relationship of trust and co-participation in the research enterprise (?)

• Does not:– Assure the conditions to fulfill consent– Provide input into direction of research– Constitute public participation in research

Consent to governance“creating governance schemes based on deliberative theory returns the consent concept to its original meaning in political philosophy. The focus turns away from a ceremony of individual control and choice. Instead, consent is about giving up control, agreeing to accept a set of procedures and practices created and interpreted by a group of fellow citizens; it is “consent to be governed.”

Barbara A. Koenig, “Have We Asked Too Much of Consent?,” HastingsCenter Report 44, no. 4 (2014): 33-34. DOI: 10.1002/hast.329

Trust and Commercial Influence

• Commercialization is a powerful engine to fund and develop health interventions

• Companies are obligated to find profitable targets

• Research funding is often directed to produce economic benefits

• How do these interventions relate to health inequities in the population?

EDRD: Compassionate and Fair

• E.g., What is the best blend of compassion for those with rare diseases and justice regarding funding for health disparities?

• Can we use big data or learning health systems to help inform these decisions?

• How do we rank the options and who should participate in the ranking?

Why consult the public?

• Better, more legitimate policy– Supplement expert, economic and stakeholder influence– Fair approach when reasonable people disagree– Increased legitimacy and compliance with policy

• Accountability to wide public– Big data-informed Health care policy

• shapes our future• has lost opportunity costs• creates new responsibilities

– Future individual choices constrained

Experiments in Trustworthy Governance

“. . .resolving the ethical problems inherent in biobanking lies in appropriate governance.”

“. . .assessment of experiments with different forms of governance holds the most hope for balancing protection of participants with the development and distribution of benefits derived from research using biobanks.”

T Caulfield, AL. McGuire, M Cho, et al (2008). Research Ethics Recommendations for Whole Genome Research: Consensus Statement. PLOS Biology 6.3: 430 – 435.

K O’Doherty, MM Burgess, K Edwards, R Gallagher, A Hawkins, J Kaye, V McCaffrey, D Winickoff (2011). Adaptive Governance for Biobanks. Social Science & Medicine. 73: 367-374.

Deliberative eventsBC Biobank deliberation

Vancouver April/May 2007

Mayo Clinic, Biobanks September 2007

Rochester Epidemiology Proj. November 2011

Western Australia Stakeholders: Aug 2008

Public: November 2008

Salmon Genomics Vancouver November 2008

BC BioLibrary Vancouver March 2009

RDX Bioremediation

Vancouver April 2010

Biofuels

Montreal Sept/Oct 2012

Biobank Project Tasmania

April 2013

California Biobanks

LA: May 2013

SF: Sept/Oct 2013

Priority setting in Cancer Control

Vancouver June, 2014

Newborn Screening

California Sept/Oct 2015

Participatory Governance• The “public” can incorporate technical and

social information and contribute to decisions– decision makers’ confidence in public’s capacity

• Direct representation for trustworthy governance: Advisories & engagement– Representation of diverse public interests– Resources to seek wider public input

MM Burgess (2014). From “trust us” to participatory governance: Deliberative publics and science policy. Public Understanding of Science.

Conclusion

• Translation of big data into public realm requires active participation of public in governance

• Informed consent is more appropriately considered within the negotiation of a new social license, with trustworthy and participatory governance as an enabling context

• Participatory governance requires resources, development and assessment

From Bench to Bedside to Populations

Translation in Health CareExploring the impact of Emerging Technologies

Oxford, June 2015

Michael M. BurgessUniversity of British Columbia