EVOLVING CONSENT:
Broadand InformedConsent
Challengesin the Age of Data Sharing
Nanibaa’ Garrison, Ph.D.
Treuman Katz Cent...
Overview
• Proposed changes to the Common Rule will
require consent for research using de-identified
human data and specim...
1.Havasupai community experience
New York Times2010
• A genetic study of diabetes
• Approval from the ASU
InstitutionalRev...
Objectionsto misuseof DNA samples
• Inconclusiveresults for Diabetes
study
• Samples were shared with other
researchers; u...
The aftermath of the settlement
• Media attention, important
ethical issues raised, and an
impact on tribes
• No legal pre...
2.Researcher and IRB perspectives
• Impact of the Havasupai lawsuit
• Interviewed 26 IRB chairs and Researchers at top NIH...
Broad Consent Language
• Confusion about the case and acceptability
• “Whetherthey went and got subsequentIRB permission t...
Concerns about Data Sharing
• Many researchers desired sharing to advance science
• “[Samples are] so expensiveto collect,...
3.Biobank Participants’Perspectives
• What factors are associated with willingness / unwillingness to
provide broad consen...
Factors affecting Preferences
• Criteria affecting increased willingness to provide
broad consent vs. tiered or study-spec...
Broad Consent Preferences
Study (Sample Size) Population Favor Broad Consent
Kaufman 2009,Murphy 2009,
Platt2013
(n = 4,65...
Data Sharing Preferences
Source Sample Population Data sharing preference
Brotherset al,
2011
88%
(of n=4050)
Vanderbilt
f...
Data sharing preferences
• Willingness to share data:
• Varied by data type and who will access it
• Data (biospecimens vs...
Conclusions
• Havasupai case demonstrated communication gaps
• Old broad consent may not necessarily work for new
studies
...
Acknowledgements
• Impactof the Havasupaicase
• StanfordCenterfor Biomedical Ethics: Mildred Cho, SandraSoo-Jin Lee, Laure...
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Nanibaa’ A. Garrison, "Evolving Consent: Insights from the Havasupai Case in the Age of Broad Consent and Data Sharing"

From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015. This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University. For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
Published on: Mar 3, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


Transcripts - Nanibaa’ A. Garrison, "Evolving Consent: Insights from the Havasupai Case in the Age of Broad Consent and Data Sharing"

  • 1. EVOLVING CONSENT: Broadand InformedConsent Challengesin the Age of Data Sharing Nanibaa’ Garrison, Ph.D. Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Specimen Science: Ethics and Policy Implications Harvard Law School November 16, 2015
  • 2. Overview • Proposed changes to the Common Rule will require consent for research using de-identified human data and specimens in biobank research • Stakeholders 1. Communities (i.e. Havasupai Tribe) 2. Researchers, IRBs (An interview study) 3. Biobank Participants (A review) • Issues • Willingness to provide/accept Broad Consent • Considerations for Data Sharing
  • 3. 1.Havasupai community experience New York Times2010 • A genetic study of diabetes • Approval from the ASU InstitutionalReview Board (IRB) • An informed consent process was conducted for studies on “behavioral / medical problems” • Blood samples were collected from ~400 tribal members
  • 4. Objectionsto misuseof DNA samples • Inconclusiveresults for Diabetes study • Samples were shared with other researchers; used in studies on schizophrenia, inbreeding, and migration • Tribe sued ASU researchers over misuse of DNA samples • Out-of-court settlement • DNA samples were returned New York Times2010
  • 5. The aftermath of the settlement • Media attention, important ethical issues raised, and an impact on tribes • No legal precedent after the case settled • Questionsremained: • What is the impact on IRBs and human genetic researchers? • Has this case challenged the way that we think about informed consent? New York Times2010
  • 6. 2.Researcher and IRB perspectives • Impact of the Havasupai lawsuit • Interviewed 26 IRB chairs and Researchers at top NIH- funded medical schools in 2011 • Modified grounded theory approach for data analysis • Concerns were highlighted with broad consent, data sharing, and database oversight.
  • 7. Broad Consent Language • Confusion about the case and acceptability • “Whetherthey went and got subsequentIRB permission to do this or whether they felt the consent was sufficiently broadto allow it, based on the consentthat was signed, I don’t know. I think that, so much seems to depend on the language.” (IRB Chairperson) • Relying on the language of the consents • “Utilizing these genetic resources and trying to share your resources with others, you constantly have to look back at the language of the consents and talk to the IRB about what’s appropriateand what’s not, because these situations come up that you just can’t anticipatein advance.”(Researcher)
  • 8. Concerns about Data Sharing • Many researchers desired sharing to advance science • “[Samples are] so expensiveto collect, so if it can be useful in other research, it’s really encouraged to share anonymous information.” (Researcher) • Feeling external pressures to share • “WhatI have felt recently though is that we’vebeen strong-armed a little bit more by the government, by this requirementof data sharing.”(Researcher) • Understanding participants’ concerns • “Occasionally somebody’s worriedthat their genetic data is going to be in a governmentdatabase but when you probe that a little further, it’s not quite clear why they care. … We had one person who checked ‘no,’ and so I asked him … he said ‘no, no, I’d be in the studyanyway.’”(IRB Chairperson)
  • 9. 3.Biobank Participants’Perspectives • What factors are associated with willingness / unwillingness to provide broad consent for biobank research and data sharing? • Systematic Literature Review of original research in the US, published since 1990 • Broadconsent: an agreement to unspecified future use • Datasharing: transfer of biospecimens / data to other researchers or biorepositories • Articles evaluated by two investigators; disagreements were resolved through discussion • Final sample included 51 articles • Article in Press at Genetics in Medicine
  • 10. Factors affecting Preferences • Criteria affecting increased willingness to provide broad consent vs. tiered or study-specific • If the samples are de-identified • After learning more about the logistics and costsof maintaining large biobanks • When privacy concerns were adequately addressed • If participants have trust in the institution
  • 11. Broad Consent Preferences Study (Sample Size) Population Favor Broad Consent Kaufman 2009,Murphy 2009, Platt2013 (n = 4,659) USadults (nationwide) 46% Simon2011 (n = 751) Community members (northernIowa) 41% (n = 48) Community members (northernIowa) 54% Kaufman 2009 (n = 931) Veterans(nationwide) 47% Pentz2006 (n = 206) Cancer patients,university clinic (Atlanta, GA) 63%broad, 65%one-time (n = 109) Cancer patients,community clinic (Atlanta, GA) 45%broad, 38%one-time Valle-Mansilla2010 (n = 28) Breastcancer or cystic fibrosispatients (U.S.) 39%
  • 12. Data Sharing Preferences Source Sample Population Data sharing preference Brotherset al, 2011 88% (of n=4050) Vanderbilt faculty/staff Willingto have data deposited into a national database Goddardet al, 2009 82% (of n=500) Kaiserpatients in OR Agreed to have their information posted in a US government database Kaufmanet al, 2009 80% (of n=4659) US adults Willingto grant access to government researchers Kaufmanet al, 2009 71% (of n=931) US veterans Would participate if data are shared with government researchers Rahm et al, 2013 61% (of n=203) Kaiserpatients in CO Would provide a sample Beskow & Dean, 2008 50% (of n=40) NC community members Concerned about government researchers having access
  • 13. Data sharing preferences • Willingness to share data: • Varied by data type and who will access it • Data (biospecimens vs. data, identifiable vs. de-identified) • Researcher(local academic, non-local academic, governmental) • Institution(local, governmental, pharmaceutical, non-profit) • Varied across demographics • Under-represented minority groups tended to be less willing to have their data shared • Respondents cited privacy and confidentiality concerns
  • 14. Conclusions • Havasupai case demonstrated communication gaps • Old broad consent may not necessarily work for new studies • About half of Americans were okay with broad consent. What about the other half?
  • 15. Acknowledgements • Impactof the Havasupaicase • StanfordCenterfor Biomedical Ethics: Mildred Cho, SandraSoo-Jin Lee, Lauren Milner • Funding:NIH PostdoctoralFellowship(F32 HG005931),Centerfor Integrationof Researchon Genetics & Ethics (CIRGE) grant (P50HG003389) • SystematicLiterature Review • Vanderbilt:Ellen Wright Clayton Melissa McPheeters,Nila Sathe,Rachel Walden • eMERGEConsent, Education,Regulation,and Consultation (CERC) working group and grantsupplement • eMERGENetwork: • The eMERGE Network and the Patient Perspectives on Broad Consent in Biobank Research in the eMERGE Network was initiated and funded byNHGRIthrough the followinggrants: U01HG006828 (Cincinnati Children’s Hospital Medical Center/Harvard);U01HG006830 (Children’s Hospital ofPhiladelphia);U01HG006389(Essentia Institute ofRural Health); U01HG006382 (Geisinger Clinic); U01HG006375 (Group Health Cooperative);U01HG006379 (Mayo Clinic));U01HG006380 (Mount Sinai School of Medicine);U01HG006388 (Northwestern University);U01HG006378(Vanderbilt University);and U01HG006385 (Vanderbilt Universityservingas the CoordinatingCenter).

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