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Trust & Community: Creating New Models of
Governance for Biobanks Barbara A. Koenig, Ph.D.
Department of Social & Behavioral Sciences University of California, San Francisco
University of Lausanne, Switzerland Feb. 20, 2012
Rapidly Changing Research Environment
• Static Regulatory Systems!
Premise
• Science is dynamic
• Ethics of human subject protection is “stale”
“Asking too much of consent”
Governing Biorepositories
• Is “consent” the correct starting point?
• Biobanks and tissue repositories present unique challenges to human subjects protection:
• How much “work” can informed consent do?
• Should we rely more on “governance” and best practices?
• If so, how implemented?
Overview
• Establishing Trustworthy Relationships with Communities
• Value of Empirical Research • Case Example: Deliberative
Community Engagement for the Mayo Biobank
• Challenges of “Adaptive” Governance
The Importance of Context
Expanded Views of Research/Therapy Continuum
• Technological change itself as a
challenge • DNA collection on every patient as
part of personalized medicine endeavors
Planning for new forms of research
Forms of Community Engagement
• Community-engaged research • Community-based participatory
research • Deliberative Community Engagement • ?????
Lessons from the HapMap Project
• Focus on “identifiable communities” • Internationally & in U.S.
• “Community engagement” (not consent)
• Without abandonment of individual informed consent
• Does not provide a model for engaging with citizens more generally
U.S. Empirical Studies to Advance our Understanding
• “Making Every Voice Count: Public Consultation on Genetics, Environment, and Health”
• Genetics and Public Policy, Johns Hopkins University
• eMERGE Network (NHGRI “u” award mechanism)
Mayo Clinic eMERGE Interview Study
• Prospective Interview Study • Method – In-depth, semi-structured
interview • Observation of the consent process
Data Sharing
• Most did not realize their data could be shared.
I: “So, do you think they were gonna use your blood samples for any... anything else besides your problems with your arteries? Do you think they might use it for other kinds of health problems?”
R: “I don’t think so. (PAD14)”
Data Sharing
R: “I guess whoever, um... Mayo Clinic would trust would be okay with me. (PAD05)”
Data Sharing
I: So that other researchers could include them in their own studies. You know, if they want bigger numbers. What do you think about that?
R: Fine. Good go ahead, doesn’t matter to me.
I: Okay. R: It’s fine with me. (PAD10)
Data Sharing I: So, that means that people that participate in
genetic research, their information could end up in a database, you know, on a computer, so that other researchers can include all that information in their own research. What do you think about that?
R: It would all be done by research people. I: Um hm. R: Then it would be okay. I: Okay. What kind of people would you NOT like
to have access to that? R: Well, I wouldn’t like it if anyone could just put a
computer on it and read it. (PAD14)
“A treatable disease like severe asthma”
“Having a bad reaction to certain types of medicine”
No Yes
“An untreatable disease like Alzheimer’s”
4
5
12
10
4
4
96
96
96
95
88
90
“Would you want to know if researchers found that you [have a/were]:”
‘Genetic risk factor for’
‘At increased risk of’
‘Genetic risk factor for’
‘Genetic risk factor for’
‘At increased risk of’
‘At increased risk of’
Courtesy of Joan Scott, Genetics & Public Policy Center
Deliberative Community Engagement
Planning the Deliberation, Nov. 2006
(with University of British Columbia Partners)
Advisors
• Susan Dodds, Applied Ethics, University of Wollongong, PI, Big Picture Bioethics
• Archon Fung, Kennedy School of Government, Harvard University
• John Gastil, Department of Communication, University of Washington (co-editor of The Deliberative Democracy Handbook)
Advisors, cont.
• Simon Niemeyer, Deliberative Democracy, Australian National University
• Mark Warren, Harold & Dorrie Merilees Chair in the Study of Democracy, Political Science, UBC
Key Questions in Event Design • Who deliberates • How selected • Length of event • Use of “experts” • Background materials • Use of visual aids • Small vs large group time • Specific questions (framing)
Deliberative events
Salmon Genomics, Vancouver November 2008
RDX Bioremediation, Vancouver April 2010
Rochester Epidemiology Project, Mayo
November 2011
BC Biobank deliberation April/May 2007
Mayo Clinic, Minnesota, United States September 2007
Western Australia, Office of Population Health Genomics, Department of Health
Stakeholders: August 2008 Public: November 2008
BC BioLibrary, Vancouver March 2009
A Practice with Roots in Political Theory • Attempt to compensate for a deficit in
direct participation in contemporary democracies
• Not mediated by political parties, or organized lobbies or interests, or any form of expertise
• Assumes that individual actors with divergent interests can reach a productive exchange of ideas, not merely restate entrenched positions
Deliberative Democracy Examples
• Roots in Athens • Trial by jury (citizens’ jury)
• public works, urban renewal, ecological impacts
• Extended to inquiry into contentious issues in science and technology
• U.S. Centers for Disease Control on avian flu pandemic
Deliberative Democracy Goals
• Goal is not just to “inform” or “educate” the community
• Seeks genuine discussion among representative community members, and,
• Make recommendations about implementation, governance, & long term community oversight
Summary: Deliberative Community Engagement
• Provides a substitute for “expert knowledge”
• Goal is to make real trade-offs and compromises, encouraging the formulation of policy recommendations
Summary: Deliberative Community Engagement
• Key conditions for meaningful deliberation
• Time • Information • Atmosphere of Mutual Respect
Procedures • A “representative” sample of 30
Olmsted County residents deliberate over 2 weekends (4 full days)
• Two weeks before, they receive a mailing with basic information
• Website allows further interaction • Stakeholders available to provide
their perspective and to answer questions
21 Demographically Stratified
Participants
Start
Pre-circulated website & materials
Website mediated dialogue & information
Second Weekend Deliberation
Task: Rank values, rate policy choices and
identify persistent controversies
First Weekend Information
Task: Identify the interests & values
related to biobanking
Expert & Stakeholder
Q & A
Reports, Print & online
materials
Policy Uptake
Media and Public Uptake
Website Homepage
Panel of Expert Speakers
Large Group Deliberation
Small Group Sessions
Procedures
• Sample Selection • Main variables: sex, age, educational level,
ethnicity, religious beliefs, immigration status
• Selected minorities (such as Native Americans) over-sampled
• N=30
Definitions of “Disinterested” (not uninterested)
• Legal Definition Neutral, impartial; lacking a financial
interest in, or other predisposition toward, a particular resolution of a controversy or issue. (fluoridation of water)
Involvement of “Stakeholders” Stakeholders inform the debate but
do not deliberate Avoid “hijacking” of the event to
further specific agendas 5 speakers present a range of views
about biobanking
Summary of Deliberation
• Participants compensated ($400.) • Professional moderators (leaders) • Balance of large & small group (7-8)
deliberation, to allow all voices to be heard
Results of Engagement
Results of Engagement: Recruitment
• Payment
• unpaid donor preferred
Results of Engagement: Informed consent
• Format • simple language • multiple media
Results of Engagement: Informed consent
• Persistent disagreement over
releasing to donor’s family
Results of Engagement: Access and sample control
• Control • oversight by Mayo Clinic regardless
of where research is performed • return of excess to Mayo
• Establish a process dealing with misuse
Results of Engagement: Informing and involving the community
• Keep the community informed • newsletter, website, etc.
• Change Biospecimen Trust Oversight Group
• add community liaison members • establish community outreach program
Results of Engagement: Informing and involving the community
• Inviting community involvement • regular open forum • additional engagement events
What Worked? What Failed?
Interim Community Advisory Board
Summer 2008 • Reviewed both the long and short informed
consent forms, recruitment documents
• Unexpected feedback: • Favored omitting an opt-out regarding
sample-sharing outside Mayo • Were comfortable with few details
Mayo Clinic Biobank Community Advisory Board
• 20 members • Meets every two months • Half the members were deliberants • Half chosen from the local
community • Co-chaired by an elected community
member & a bioethics faculty member
Community Advisory Board
• Activities of CAB: – Advise on management and operation of
biobank(s) – Review policies governing access to research
samples – Evaluate patient materials – Suggest plans for community education – Consider complex policy decisions such as
return of results to participants. SLIDE Courtesy of Ms. Kiley Johnson,
Mayo Clinic Genetic Counselor
Excerpt from Biobank Consent form:
“9. What if researchers discover something about my health?
• During individual studies, researchers could find out important information about your health. They might discover something about your health right now, or about your risk of getting sick in the future. Researchers will not discover something about every donor, so you are not guaranteed to receive results.
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Excerpt from Biobank Consent form:
• Since decisions about health and disease are very personal, no one can predict which results donors will want in the future. One of the important jobs that BTOG has is to decide which research results, if any, will be returned to Biobank donors. They will make this decision for each individual study after consulting with the appropriate researchers, doctors, and the Community Advisory Board. Names will not be mentioned during this process.”
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Process Used for Determining If/What Results are Returned
PROCESS SLIDES are courtesy of Ms. Kiley Johnson,
Mayo Clinic Genetic Counselor
Biobank Access Process
Researcher fills out Access Request
form
Researcher meets with Dr. Olson; Mses. Johnson and
Kopp; Mr. Fredericksen
Request to full Access Comm. (CAB as needed)
Approve study.No results returned
Approve pending return of results discussion/plan
Deny/table
1. Answers questions; fills in details2. Determine if study is a possible return of results scenario
Biobank Access Process
Approve study.No results returned
Approve pending return of results discussion/plan
Deny/table
Samples distributed
Study results deposited in Biobank
database once complete
Convene expert panel (CAB co-chair, Access Comm., subject experts MDs, PhDs) to discuss when to return results
Determine no return of
results
Determine return of results
necessary
Return of results plan developed by GC/Access Comm.
Modification and materials submitted
to IRB for review
Return of Results Questions • No National Guidelines available to follow • Convene an expert panel to consider:
– Does the genetic finding: • have important health implications for the
participant? • are the associated risks both established and
substantial?
– Is the genetic finding actionable? • Are there established therapeutic or preventive
interventions or other available actions that have the potential to change the clinical course of the disease?
Taken from Fabsitz, et. al, Ethical and practical guidelines for reporting genetic researcher results to study participants: Updated guidelines from a National Heart, Lung, and Blood Institute Working Group, Circulation: Cardiovascular Genetics. December, 2010
Panel of Experts Dominant PKD: Discussion
• Does the genetic finding: – have important health implications for the participant:
Yes – have established and substantial risks? Yes- genetic testing and management is undertaken
routinely in clinic for this disease.
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Panel of Experts Dominant PKD: Discussion Is the genetic finding actionable?
– Are there established therapeutic or preventive interventions or other available actions that have the potential to change the clinical course of the disease
Yes • Medication to control high blood pressure • Medication or surgery to reduce pain • Antibiotics to resolve infections • Dialysis to replace functions of failed kidneys, or kidney
transplantation • Management/Screening/surgery for aneurysms
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
•
PKD – Dominant Outcome
• Polycystic kidney disease: Dominant – Possible implications in Biobank participants:
• 1 or 2 persons (if any) may be found to carry a gene mutation known to cause Autosomal Dominant PKD
– PROPOSED ACTION: Biobank would contact them to offer return of results (details provided later)
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Discussion with Community Advisory Board
• January 27, 2011 meeting – Orientation to the specific disease – Small group discussion of return of results – Generally recommended return of results
• May 5, 2011 meeting
– Reviewed first draft of letters to return results – Made many substantive suggestions
• September 8, 2011
– Reviewed final draft of letters to return results SLIDE Courtesy of Ms. Kiley Johnson,
Mayo Clinic Genetic Counselor
CAB comments – hopes • Personal and family well-being/Advanced planning and
Preparation – Early detection: “If I was informed I had a gene with an unknown
variation, I could watch my symptoms and possibly be diagnosed and receive treatment earlier.”
– Family well-being: “Can help family members be aware of disease so they can be checked”
– Reproductive planning and choices: “If I learned I was a recessive carrier. I could receive genetic counseling to possibly avoid having a child with Disease X and “[prevent] Pass[ing] this on to my offspring.”
• Benefit the social good. – “I could get involve in the community or institution [as a research
participant or disease advocate] that is interested to find a cure if any”
CAB comments – concerns • Personal and family well-being
– Undue stress and anxiety for both the individuals themselves and for their families.
– “People might … overreact and overestimate the risk and obsess over it, and it could lower their quality of life even if they don’t have or may never get disease.”
– Getting information about something for which they had little or no information. • “Some people don’t want to know.”
– Concerns about discriminatory use of the research findings by insurance companies/ potential employers:
• “Results could impact patients future related to insurance….” • Logistical process of returning results
– Recognized struggles that researchers and policymakers would have to grapple with:
• whether and what results to return • who makes the decisions and if returning findings does happen when, by
whom, and how. – Cost
• “If you tell someone they might have an increased risk or gene marker, they’ll need to be counseled about the implications – who, how or who pays?”
Process Proposed to Return Results
Flowchart of Biobank Return of Results (ROR)
Expert Panel Recommends Return
of Results
Patient wants more info?
Send R.O.R. letter
Resend letter at 4 weeks
Record in database NO (Returns
refusal letter)
No response
YES
1. Subject calls Biobank staff to set up 1st meeting with genetic counselor 2. Phone call/meeting #1 with Genetic Counselor
a. Discusses pros/cons/background information on results b. **no results given** c. Ask if patient wants to set up meeting #2
3. Mail follow-up meeting summary & disease-specific pamphlets 4. Record call/meeting in Biobank database
Wants to continue? Record in database NO
YES
Second call/meeting #2 with Genetic Counselor
1. Return results 2. Recommend CLIA confirmation 3. Mail follow up meeting summary to patient and M.D. if
requested 4. Record in database 5. Clinical follow-up as appropriate
SLIDES Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Upcoming Issues for CAB
• Whole exome/whole genome sequencing data
– What is returnable? – How to interpret large scale data for clinical use? – How/If to return results to participants for multiple genetic
variants of clinical relevance?
SLIDE Courtesy of Ms. Kiley Johnson, Mayo Clinic Genetic Counselor
Rochester Epidemiology Project
A Deliberative Community Engagement November, 2011
Adaptive Governance in Action Topics Addressed
• Hands on role in creating trustworthy practices
• Voice in “access committee” • Data sharing • Return of results • Poised to offer advice about the
implications of whole genome analysis
Special Issues for “Identifiable” Populations
• Genetics & Health Disparities • Racialization of biorepositories
• Distinguishing social categories from true genetic variation
• Protection from “group harms” remains a challenge
Adaptive Governance
• recognition of research participants and publics as a collective body
• trustworthiness • adaptive management • fit between the nature of a particular
biobank and the specific structural elements of governance adopted
• O’Doherty, et al. 2011
Challenges
• Current U.S. legal/regulatory framework does not encourage innovation or community-based approaches
• Focus remains on the individual • Deliberative Engagement is
expensive & time-consuming • Techniques of evaluation are needed
Fine-Grained Research on the Deliberative Process
• Studies of how “persistent disagreement” are handled by participants
• “can be creative of innovative governance solutions”
• Issue: Individual Compensation for tissue/blood donation
• Resolution of 3 competing perspectives: 1) the entrepreneur, 2) the communitarian, 3) the rights activist
Fine-Grained Research on the Deliberative Process
• Compromise: • Tax credits • High fees to corporations to fund
rare disease research • Right of return of health information
to donors
Heather Walmsley, “Stock Options, Tax Credits….The Value of Deliberative Public
Disagreement….” Soc Sci Med 2011
http://mayoresearch.mayo.edu/biobank/index.cfm
Mayo Clinic Biobank (see the video of the deliberation
accessible from home page)
Acknowledgements • Michael Burgess, Ph.D. (UBC) & Team • Mayo Biomedical Ethics Research
Program Staff (M. Robinson) • And thanks to:
The Greenwall Foundation National Institutes of Health NIH/NHGRI U01 HG004599 NIH/NIA R01 AG034676-45 NCI/NHGRI, R01CA154517
