Consent, Data Sharing, and
Returning Results:
Decision Making in Managing Biobanks
Kelly A. Edwards, PhD
Associate Professor, Bioethics
Co-Director, Regulatory Support &
Bioethics Core, ITHS
1
Take Home Points
• Trustworthy practices in research are
going to be critical to long-term success
• Old practice paradigms may no longer
preserve public trust
– Upfront regulatory review
– Heavy burden on consent procedures
– Focus on individual privacy and identifiability
• Transformed data management and
research practices are needed
2
Ethics Issues and Questions
Consent:
– What information management systems will
best enhance or extend traditional consent
mechanisms?
Communications:
– In what ways might technical systems enhance
on-going engagement with participants and/or
the public?
Auditability:
– What are the benefits and risks of rich audit
trails and data use tracking systems? How
should we respond to errors or lapses?
3
Ethics Issues and Questions
Governance:
– How do we incorporate, and track, participant
preferences into research governance decisionmaking?
Sustainability:
– What are the best ways to engage the public
about the open-ended nature of translational
research?
4
CTSA Clinical Research Ethics Committee
Biobank Work Group
Goals: Serve as a resource to CTSAs and build
new knowledge and tools
• Progress:
– Building a google website to share governance
and community engagement materials
– Serving as a consult service for individuals and
groups with questions
– Applying for outside funding for demonstration
projects to assess outcomes
5
Bioethics Consult Service
• Questions about repository
governance?
• Contact our consult service:
– www.iths.org to bioethics consult request
– Seattle Children’s Operator: 206-9872000
6
What is Governance?
“The process of policy orientation that guides
research under ethical and scientific norms so
that the results can be used for the benefit
of population health.”
–P3G Consortium Lexicon: p3gobservatory.org
“The agreements, procedures, conventions, or
policies that define who gets power, how
decisions are taken and how accountability
is rendered.”
–Principles for Good Governance: www.iog.ca
7
Governance Decisions
• Purpose
• Consent
– Specific or broad
• Population
• Data Access
• Protections
• Return Results
• Participation
– By whom and how
– To participants?
– To repository?
• Oversight
– By whom and how
8
Step by step start-up guide
 What will you collect?
– Area of focus
– Study design
– Ownership and access
 How will you collect it?
–
–
–
–
Regulatory compliance
Operations and resources
Registry considerations
Repository considerations
 What else do you need?
– Public relations and materials
– Making samples available to researchers
http://resourcerepository.org/documents/1862/registry/repositorystart-upguide/
10
What are the risks?
•
•
•
•
•
Bad guys
Data invaders
Security breach
Carelessness
Forensic uses
• People doing things
we do not agree
with
• “Usual” harms:
– Violation of privacy
– Discrimination
• Less common harms:
–
–
–
–
–
–
Tying up resources
Self-concept damage
Group stigmatization
Perceived deception
Lack of respect
Lack of recognition
11
Current Public Climate for Research
“Where did you go with my DNA?” - NYT
Lessons from these Stories?
• Regulations are the floor
– We may need other standards to guide us
• “Business as usual” practices can cause harm
– We cannot anticipate what “harm” looks like
• Engage the public
– Be transparent about research practices and
intentions
– Communicate openly and clearly
– Ask permission before using samples if outside
original scope or intentions
13
Returning to Old Fashioned
Research Ethics
• Respect for Persons
– How can our research processes enact
respect?
• Beneficence
– How can we assure our research is achieving
benefits? And clear benefits for whom?
• Justice
– How can we proceed equitably and fairly while
addressing current injustices in the system?
14
Chain of trust:
Doing science without eye contact
15
Demonstrating Respect
What other ways can we use to
demonstrate respect?
– Increased communication
– Increased choice
– Benefit sharing
– Saying “thank you”
16
Informed Consent: Options
•
•
•
•
•
•
Opt-out
Opt-in
Specific designations of use
Consent at admission (if hospital-based)
Consent post-op
Re-consent for specific use
How should we decide what to use?
What will accomplish the goal of informed
choice?
17
Public Opinion
• 72% wanted to know about research being done
with anonymous samples; 81% with identifiable samples
• 37% of reasons for wanting to know about what research
was done were curiosity-based.
• 57% would require researchers to seek permission, whereas
43% would be satisfied with notification only.
Phone interviews 2002
1,193 clinic patients
Hull et al. 2008
18
Public Opinion
• 90% were concerned about privacy protections
• 60% would participate in a biobank if asked
• 48% would provide consent for all research
if approved by an oversight board, 42% wanted
to be asked for each
2008 public survey
N= 4659 (58.4% response)
Kaufman et al. 2009
19
Re-Consent Prior to Data Sharing
% Agree
IRBs
n=199
Genetics
n=346
12
46
10
43
Neutral
Very/Somewhat
%
Disagree
40
% Don’t
Know
44
Very/Somewhat
Lemke et al, 2010; Trinidad et al, 2011
3
3
DK
20
Re-contact, Re-consent
We should explore new methods of recontact (automated, electronic
communication), which:
– Keep participants engaged and informed about
research activities
– May contribute to science literacy
– Builds and sustains relationships, which are
important to trust
– Creates good will in public programs and
research enterprise
21
Managing Choice Dynamically
22
Returning Results:
Current Consensus (NHLBI)
• Results should be offered if:
– there is established analytic validity.
– the associated risk for disease is replicable and
significant.
– the disease has important health implications, such as
premature death or substantial morbidity.
– proven therapeutic or preventive interventions are
available.
• Assuming that participants have agreed to
receive results.
• Results should never be forced on research
participants.
Bookman et al. (2006) Am J Med Genet
23
Disclose or Not: Barriers Remain
Conceptual:
– What is the fundamental purpose of research?
Should disclosure be part of research practice?
– What counts as a benefit? A harm? How much
certainty do we need to act?
Practical:
– CLIA-certified laboratories
– Paid staff to follow up
– Finding participants over time
24
Different Kinds of Results
• Already in clinical use
– Example: BRCA1 mutation (Breast/ovarian
cancer risk)
• Potential clinical use
– Example: Association of gene variant with
prostate cancer risk
• Clinical interest
– Example: Association of gene variant with
cardiovascular disease risk
• Research/general interest
– Example: Association with height
25
Cloud Sourcing Data
• Return all data – raw data – to
patients for further, independent use
26
Benefits of Public Participation
Public participation in research can:
– Improve recruitment
– Enhance data collection
– Focus analysis and interpretation
– Facilitate dissemination
– Creates trust
Staley K. (2009) Exploring Impact: Public involvement in NHS,
27
public health and social care research. INVOLVE, Eastleigh.
Resources
 ISBER
– http://www.isber.org/ibc.html
 NCI Best practices
– http://biospecimens.cancer.gov/practices/default.a
sp
 NCRR Clinical Translational Science Award
– Biobank Working Group. Resource share site TBA.
 ITHS Bioethics Consult Service
– www.iths.org
Acknowledgments
Center for Genomics & Healthcare Equality
(NHGRI)
– Wylie Burke, Malia Fullerton, Rose James, Helene Starks (UW)
– Bert Boyer & Scarlett Hopkins (University of Alaska, Fairbanks)
Genetic Alliance
– Sharon Terry, CEO and Liz Horn, Director of Biobank
Institute for Translational Health Sciences
(NCRR)
– Nick Anderson, Sarah Greene, Holly Tabor, Ben Wilfond, Jen Wroblewski
Testing Justice Project
(Greenwall Foundation)
– Sara Goering and Suzanne Holland
TIES Project
(UCD and Office of Research Integrity)
– Gail Geller (Hopkins), Rich Sharp (Cleveland), Mark Yarborough
(Colorado), and several community health leaders (Alok Sarwal, Grant
Jones, et al)
29
Challenges of Biobanking Research
• Who owns the data?
• How do we continue to have stewardship
over data collected in good faith?
• How can we get meaningful consent?
• How should we weigh the trade-offs of
privacy risks against research utility?
• When, if ever, should results be returned?
30