EVOLVING CONSENT:

Broad and Informed Consent

Challenges in 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

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

1. Havasupai community experience

New York Times 2010

• A genetic study of diabetes

• Approval from the ASU Institutional Review Board (IRB)

• An informed consent process was conducted for studies on “behavioral / medical problems”

• Blood samples were collected from ~400 tribal members

Objections to misuse of DNA samples

• Inconclusive results 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 Times 2010

The aftermath of the settlement

• Media attention, important ethical issues raised, and an impact on tribes

• No legal precedent after the case settled

• Questions remained:

• What is the impact on IRBs and human genetic researchers?

• Has this case challenged the way that we think about informed consent?

New York Times 2010

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.

Broad Consent Language

• Confusion about the case and acceptability

• “Whether they went and got subsequent IRB permission to do this or whether they felt the consent was sufficiently broad to allow it, based on the consent that 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 appropriate and what’s not, because these situations come up that you just can’t anticipate in advance.” (Researcher)

Concerns about Data Sharing

• Many researchers desired sharing to advance science

• “[Samples are] so expensive to collect, so if it can be useful in other research, it’s really encouraged to share anonymous information.” (Researcher)

• Feeling external pressures to share

• “What I have felt recently though is that we’ve been strong-armed a little bit more by the government, by this requirement of data sharing.” (Researcher)

• Understanding participants’ concerns • “Occasionally somebody’s worried that their genetic data is going

to be in a government database 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 study anyway.’” (IRB Chairperson)

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

• Broad consent: an agreement to unspecified future use

• Data sharing: 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

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 costs of maintaining large biobanks

• When privacy concerns were adequately addressed

• If participants have trust in the institution

Broad Consent Preferences

Study (Sample Size) Population Favor Broad Consent

Kaufman 2009, Murphy 2009, Platt 2013 (n = 4,659)

US adults (nationwide) 46%

Simon 2011 (n = 751)

Community members (northern Iowa)

41%

(n = 48) Community members

(northern Iowa) 54%

Kaufman 2009 (n = 931)

Veterans (nationwide) 47%

Pentz 2006 (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-Mansilla 2010 (n = 28)

Breast cancer or cystic fibrosis patients (U.S.)

39%

Data Sharing Preferences

Source Sample Population Data sharing preference

Brothers et al, 2011

88% (of n=4050)

Vanderbilt faculty/staff

Willing to have data deposited into a national database

Goddard et al, 2009

82% (of n=500)

Kaiser patients in OR

Agreed to have their information posted in a US government database

Kaufman et al, 2009

80% (of n=4659)

US adults Willing to grant access to government researchers

Kaufman et 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)

Kaiser patients in CO

Would provide a sample

Beskow & Dean, 2008

50% (of n=40)

NC community members

Concerned about government researchers having access

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

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?

Acknowledgements

• Impact of the Havasupai case • Stanford Center for Biomedical Ethics: Mildred Cho, Sandra Soo-Jin Lee, Lauren Milner • Funding: NIH Postdoctoral Fellowship (F32 HG005931), Center for Integration of

Research on Genetics & Ethics (CIRGE) grant (P50 HG003389)

• Systematic Literature Review • Vanderbilt: Ellen Wright Clayton Melissa McPheeters, Nila Sathe, Rachel Walden

• eMERGE Consent, Education, Regulation, and Consultation (CERC) working group and grant supplement

• eMERGE Network:

• The eMERGE Network and the Patient Perspectives on Broad Consent in Biobank Research in the eMERGE Network was initiated and funded by NHGRI through the following grants: U01HG006828 (Cincinnati Children’s Hospital Medical Center/Harvard); U01HG006830 (Children’s Hospital of Philadelphia); U01HG006389 (Essentia Institute of Rural 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 University serving as the Coordinating Center).