Consent, Data Sharing, and Returning Results:

Decision Making in Managing Biobanks

Kelly A. Edwards, PhDAssociate Professor, Bioethics

Co-Director, Regulatory Support & Bioethics Core, ITHS

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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

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Ethics Issues and QuestionsConsent:

– 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?

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Ethics Issues and Questions

Governance:– How do we incorporate, and track,

participant preferences into research governance decision-making?

Sustainability:– What are the best ways to engage the

public about the open-ended nature of translational research?

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CTSA Clinical Research Ethics Committee

Biobank Work GroupGoals: 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

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Bioethics Consult Service

• Questions about repository governance?

• Contact our consult service:– www.iths.org to bioethics consult

request– Seattle Children’s Operator: 206-

987-2000

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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.ca7

Governance Decisions

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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/http://resourcerepository.org/documents/1862/registry/repositorystart-upguide/

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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

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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

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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?

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Chain of trust: Doing science without eye contact

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Demonstrating Respect

What other ways can we use to demonstrate respect?– Increased communication– Increased choice– Benefit sharing– Saying “thank you”

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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 20021,193 clinic patients

Hull et al. 200818

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

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Re-Consent Prior to Data Sharing

IRBs

Genetics

% Disagree

% Agree

Very/SomewhatNeutral

% Don’t Know

4612

4310

40

44

DKVery/Somewhat

3

3

n=199

n=346

Lemke et al, 2010; Trinidad et al, 2011

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Re-contact, Re-consent

We should explore new methods of re-contact (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

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Managing Choice Dynamically

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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

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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, public health and social care research. INVOLVE, Eastleigh.

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Resources ISBER

– http://www.isber.org/ibc.html

NCI Best practices

– http://biospecimens.cancer.gov/practices/default.asp

NCRR Clinical Translational Science Award

– Biobank Working Group. Resource share site TBA.

ITHS Bioethics Consult Service

– www.iths.org

AcknowledgmentsCenter 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?

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