1. New Developments in Biobank Governance: Domestic and International Issues TaSkR VI Sirikwa Hotel, Eldoret February 20, 2014 Eric M. Meslin, Ph.D. Director, IU Center for Bioethics Associate Dean and Professor of Bioethics Indiana University School of Medicine Director, Indiana-Moi Academic Research Ethics Partnership

2. Quick Review: DNA and Tissue Repositories Collections include  Large generic tissue banks, repositories  Materials collected in longitudinal studies  Unique collections (e.g., brain, Alzheimer)  Pathology specimens collected for clinical use  Newborn screening tests  Forensic DNA banks Materials include:  Biopsy tissue; Blood (and its parts); Tumor material; Umbilical cord blood; DNA

3. Definitions The term Biobank refers to collections of biological material, for example blood or tissue samples. These samples…can often be linked with information about the donor's health status.

4. Key Resource in Predictive Health Research: Human Biological Materials Source: NBAC 1998 +350million, Eiseman (2003)

5. Study Start Year # ParticipantsSponsor Samples/ DNA Health Records Framingham194814,428NHLBI/NIH Yes NHANES: I,II,III,IV1971 5,000 /yrCDC, DHHS Yes Nurses' Health Study1976122,000NINR/NIH Yes The Nun Study1986678 NIA/NIH, Kleberg Foundation Yes Multiethnic Cohort Study 1993 215,000+ NCI Yes Jackson Heart Study20006,500NHLBI, (NCMHD) Yes NUGene 2002 6,422Northwestern Yes Marshfield Clinic200240,000 Marshfield Medical Clinic Res. Foundation Yes Hispanic Community Health Study 200616,000NHLBI Yes Children's Hospital of Philadelphia 2006100,000JR Stokes RI Yes Examples of Predictive Health Studies with HBMs Principal governance regime: Regulations governing the protection of human subjects in research combined with the regime for clinical care follow-up Some studies pre-dated contemporary research governance regimes

6. The Accelerant Effect of the Genome Project New Emphasis in Predictive Health Identifying biological, environmental and genetic factors Studies that combine health data from medical records with genetic and other data from collected specimens, tissues, DNA

7. Three Governance Developments Informed Consent Ethics Review Connections to health information technology

8. Informed consent A legal and ethical concept intended to satisfy the requirements of providing sufficient information to allow choice Traditional governance approach to consent in biobanking involves  Identifying disclosures  Developing documents  Seeking ethics approval

9. ….Ambiguity FDA and Common Rule Consent requirements differ between Common Rule and FDA 1999 FDA Guidance did not require consent for unidentified samples 2004 OHRP Guidance resolves some but not all 2006 FDA Guidance resolves some but not all issues Still creates confusion in an attempt to satisfy both the Common Rule and FDA

10. Privacy and the Need to Identify Source: Altman, (2005)

11. Public Willingness to Participate in Biobanks

12. Public willingness to participate: Commercialization Varying resistance to the role of industry  The Moore objection  Commodification as a moral wrong  Source of sponsorship Human body has financial value  Tissue samples for research, esp. with rare diseases; health data linked to unique phenotypes Product development  Pharmacogenomics drugs  Tailored therapeutics  Device development

13. What Do We Know About Public Willingness to Participate? Physicians and Nurses—Pediatric Biobanking MD and RN attitudes toward pediatric biobanks are similar Broad support for a pediatric biobank from HCP, including support for unspecified use of samples  Denne, Wolf, Meslin et al (2008) [Unpublished] Women and Pregnant Mothers 77% felt predictive health research was worthwhile Most supported consent for future use  Haas, Renbarger, Meslin, Drabiak, Flockhart (2008) IU Cancer Patients ~85% agreed that stored tissue could be used in unspecified future research 60-70% would not require re-contact each time tissues were used  Helft, Champion, Eckles, Johnson, Meslin, (2007) Parental Attitudes-—Pediatric Biobanking 68% agree/strongly agree pts should have chance to be in research 81% somewhat/very likely to permit child’s blood to in biobank 91% have fair/great deal of trust in hospitals to protect confidentiality 62% oppose/strongly oppose commercialization  Harland, Miller, Meslin, Wolf, Denne (2010)

14. Debates about Consent Models Study specific Broad Blanket Opt-Out

15. Governance Developments: Informed Consent Witnessing an evolution in consent models  Stewardship  Dynamic

16. Good Governance: Public Engagement Simple engagement: public understanding  Provide information to public prior to consent Moderate engagement: deeper participation  Involve the public in discussions prior to developing a bank  Deliberative democracy models Complex engagement  Public given authority to develop priorities for bank  Determine benefit-sharing arrangements  Veto power?

17. Wiki- Governance Activities: Divide tasks Permit different audiences to work on different aspects of policy -Consent, privacy, commercialization Develop approaches to achieving consensus

18. Experience of the Western Australia Data Linkage Unit Administrative databases which collect: birth records, midwives' notifications, cancer registrations, inpatient hospital morbidity, in- patient and public out-patient, mental health services data and death records Used in combination with medical record audits to provide a comprehensive evaluation of health system performance. “When people in the general community were asked if they approved of their information being used in this way, they were found to be not only supportive of it, but they questioned why it was not already being done.” Source: Stanley and Meslin (2007)

19. Indiana Biobank: A New Approach Many U.S. biobanks are affiliated with universities and part of specific research programs IB concept began as a common platform for other BBs; now will be a statewide resource Building in community engagement from the start

20. Governance Steering Committee  Overall operational/ financial Subcommittees:  Phenotype  Biospecimen  Logistics/Governance  IT Community Advisory Board

21. Community Engagement… So Far Building Capacity CHEP/BSAP Working Group  Interdisciplinary members  Advice to IB Steering Committee Proposal:  Establish Community Advisory Board with diverse membership from various stakeholder groups and participants

23. The World of Biobanking

24. More…Ethics Review Committees National committees  200+ national bioethics committees  Policy development  Protocol Review Domestic committees  4500+ in USA/Canada  200+ in Africa NGOs, Philanthropies, Consortia  Number ???

25. An Easy Case: A large, multi-centre Phase I clinical drug trial is designed to be undertaken at sites in Kenya, Canada, and USA by university-based investigators from all three countries. It will be funded by KEMRI, CIHR, NIH. Personal health information also will be collected. What rules, regulations apply?

26. Challenges: IRBs IRBs are not fully familiar with the issues arising from studies involving HBMs Used to a “clinical trials” paradigm:  Timing  Intervention  Nature of risk  “dead or alive”

27. Required to at least comply with:  Canadian Tri-Council Policy  CIHR conditions of grant award  45 CFR 46 (“The Common Rule”)  FDA 21 CFR 50/56  The Privacy Rule (HIPAA)  Kenyan National Commission on Science, Technology and Innovation  KEMRI  Institution-specific SOPs, IRB requirements

28. Now Imagine a Harder Case: A genetic epidemiology study involving 25 countries in North America, Europe, Africa and Asia, with collected and stored biospecimens, common consent forms. Bioinformatic analysis of SNPs will be conducted at various labs throughout Europe and North America, and with longitudinal follow up of personal health data. The study will be funded by a consortium of venture capitalists, universities, drug companies, and NGOs. As a result, there will be MTAs, prior agreements about benefit sharing, and specific requirements for publication/authorship. What rules, regulations apply?

29. E-Governance and International Networking