1. From Bench to Bedside to Populations Translation in Health Care Exploring the impact of Emerging Technologies Oxford, June 2015 Michael M. Burgess University of British Columbia

2. 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. 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

4. 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

5. 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

6. 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?,” Hastings Center Report 44, no. 4 (2014): 33-34. DOI: 10.1002/hast.329

7. 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?

8. 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?

9. 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

10. 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.

11. Deliberative events BC 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  Vancouver November 2008 BC BioLibrary  Vancouver March 2009 RDX Bioremediation  Vancouver  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

12. 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.

13. 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

14. From Bench to Bedside to Populations Translation in Health Care Exploring the impact of Emerging Technologies Oxford, June 2015 Michael M. Burgess University of British Columbia