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Consent, Data Sharing, and Returning Results: Decision Making in Managing Biobanks

Feb 02, 2016




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. Take Home Points. Trustworthy practices in research are going to be critical to long-term success - PowerPoint PPT Presentation

  • Consent, Data Sharing, and Returning Results: Decision Making in Managing BiobanksKelly A. Edwards, PhDAssociate Professor, BioethicsCo-Director, Regulatory Support & Bioethics Core, ITHS*

  • Take Home PointsTrustworthy practices in research are going to be critical to long-term successOld practice paradigms may no longer preserve public trustUpfront regulatory reviewHeavy burden on consent proceduresFocus on individual privacy and identifiabilityTransformed data management and research practices are needed*

  • 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? *

  • 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?*

  • CTSA Clinical Research Ethics CommitteeBiobank Work GroupGoals: Serve as a resource to CTSAs and build new knowledge and toolsProgress:Building a google website to share governance and community engagement materials Serving as a consult service for individuals and groups with questionsApplying for outside funding for demonstration projects to assess outcomes*

  • Bioethics Consult ServiceQuestions about repository governance?Contact our consult to bioethics consult requestSeattle Childrens Operator: 206-987-2000


  • 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.orgThe agreements, procedures, conventions, or policies that define who gets power, how decisions are taken and how accountability is rendered.Principles for Good Governance:*

  • Governance Decisions*

  • Step by step start-up guideWhat will you collect?Area of focusStudy designOwnership and accessHow will you collect it?Regulatory complianceOperations and resourcesRegistry considerationsRepository considerationsWhat else do you need?Public relations and materialsMaking samples available to researchers

  • *

  • What are the risks?Bad guysData invadersSecurity breachCarelessnessForensic uses

    People doing things we do not agree withUsual harms:Violation of privacyDiscrimination Less common harms:Tying up resourcesSelf-concept damageGroup stigmatizationPerceived deceptionLack of respectLack of recognition


  • Current Public Climate for ResearchWhere did you go with my DNA? - NYT

  • Lessons from these Stories?Regulations are the floorWe may need other standards to guide usBusiness as usual practices can cause harmWe cannot anticipate what harm looks likeEngage the publicBe transparent about research practices and intentionsCommunicate openly and clearlyAsk permission before using samples if outside original scope or intentions*

  • Returning to Old Fashioned Research EthicsRespect for PersonsHow can our research processes enact respect?BeneficenceHow can we assure our research is achieving benefits? And clear benefits for whom?JusticeHow can we proceed equitably and fairly while addressing current injustices in the system?*

  • Chain of trust: Doing science without eye contact*

  • Demonstrating RespectWhat other ways can we use to demonstrate respect?Increased communicationIncreased choiceBenefit sharingSaying thank you


  • Informed Consent: OptionsOpt-outOpt-inSpecific designations of useConsent at admission (if hospital-based)Consent post-opRe-consent for specific useHow should we decide what to use?What will accomplish the goal of informed choice?*

  • Public Opinion72% wanted to know about research being done with anonymous samples; 81% with identifiable samples37% 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 patientsHull et al. 2008*

  • Public Opinion90% were concerned about privacy protections60% would participate in a biobank if asked48% 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*

  • Re-Consent Prior to Data SharingLemke et al, 2010; Trinidad et al, 2011*




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  • Re-contact, Re-consentWe should explore new methods of re-contact (automated, electronic communication), which:Keep participants engaged and informed about research activitiesMay contribute to science literacyBuilds and sustains relationships, which are important to trustCreates good will in public programs and research enterprise


  • Managing Choice Dynamically*

  • 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*

  • Disclose or Not: Barriers RemainConceptual: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 laboratoriesPaid staff to follow upFinding participants over time*

  • Different Kinds of ResultsAlready in clinical useExample: BRCA1 mutation (Breast/ovarian cancer risk)

    Potential clinical useExample: Association of gene variant with prostate cancer risk

    Clinical interestExample: Association of gene variant with cardiovascular disease risk

    Research/general interestExample: Association with height*

  • Cloud Sourcing DataReturn all data raw data to patients for further, independent use*

  • Benefits of Public ParticipationPublic participation in research can:Improve recruitmentEnhance data collectionFocus analysis and interpretationFacilitate disseminationCreates trust

    Staley K. (2009) Exploring Impact: Public involvement in NHS, public health and social care research. INVOLVE, Eastleigh.*

  • ResourcesISBER Best practices Clinical Translational Science AwardBiobank Working Group. Resource share site TBA.ITHS Bioethics Consult

  • AcknowledgmentsCenter for Genomics & Healthcare Equality (NHGRI)Wylie Burke, Malia Fullerton, Rose James, Helene Starks (UW)Bert Boyer & Scarlett Hopkins (University of Alaska, Fairbanks)Genetic AllianceSharon Terry, CEO and Liz Horn, Director of BiobankInstitute for Translational Health Sciences (NCRR)Nick Anderson, Sarah Greene, Holly Tabor, Ben Wilfond, Jen WroblewskiTesting Justice Project (Greenwall Foundation)Sara Goering and Suzanne HollandTIES 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)*

  • Challenges of Biobanking ResearchWho 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?*

    *******Re-consent study invited first 400 mail consenters to participate in telephone interview91% (n = 365) completed the interview

    Was It Important We Asked?90% of participants said it was important that they were asked permission for data sharing69% rated it very important21% somewhat important

    JEHRE 2010****GRRIP SURVEYS: IDENTIFIABILITY**Pulled this in from final slidesTo what extent should participants want to be involved in the research process? Should participants be able to be involved in the oversight of a biobank? How much control is possible, or desirable, for participants? How could IT help to develop governance mechanisms for global data sharing?


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