From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015. This event is 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 is 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

1. Governance Issues for Biobanks and
Biospecimen Research
Karen J. Maschke, PhD
The Hastings Center
Specimen Science: Ethics and Policy Implications
November 16, 2015
Petrie-Flom Center, Harvard Law School

2. Biobank Governance: Key Themes
• Claim: that traditional research ethics
framework/human research protections
inadequate for research with biospecimens and
associated data because biobanks may involve:
– Broad consent for future unspecified research
– Long-term storage of biospecimens and associated
data
– Sharing biospecimens and associated data with many
investigators,including from commercial entities
– Genetic research: substance of research; identifiability
issue; research results; genetic privacy

3. Biobank Governance: Approaches/Models
• IRB review/approval only
• Additional internal committee(s) (e.g., oversight
committee,data access committee)
• External oversight committee(s)
• Public consultation based on surveys,interviews, focus
groups, deliberative democracy activities
• Biobank participants and general public: advisory role
only as members of selected committee(s)
• Biobank participants and general public: decision-making
role as voting members of oversight committee(s) or in
other capacity (e.g., wiki governance)

4. BiobankLandscape in U.S.
(Hendersonet al. 2013)
• Biobank: “repositories that assemble, store, and
manage collections of human specimens and
related data” (Henderson et al. 2013)
• Most affiliated with a larger organization – most
frequent affiliation: academic institution
• 36%: federal government provides largest source
of funding; 30% said largest source from larger
organization where embedded
• 75% obtain biospecimens from individuals; 57%
from clinical setting (leftover); 41% from both
sources

5. U.S. Personalized Medicine Initiative
Cohort Program (PMI-CP)
• Federally-funded research initiative (NIH): collect
and store biospecimens, genetic research data,
life-style information, and electronic health
records data from at least 1 million Americans –
adults and children
• PMI Working Group proposed a participatory
governance structure: biospecimen contributors
on various committees, and substantial number
of individuals from general public and
representatives of PMI-CP participant community
as members of a single IRB for the PMI-CP

6. Biobank Governance
• Governance issue for most biobanksin U.S. at
institutionallevel – not at “national” level as
for PMI-CP
• Repeated claim in biobankgovernance
literature: no “one size fits all governance
approach.”Why not?
• What about a standard, participatory
approachlike that proposed by the PMI
Working Group?

7. The Governance Bar: Where to Set?
• If a biobank’s materials are a “public resource” and a ”public good,” what
justifies not giving biospecimen contributors (and general public?) some
type of role in governance framework, especially if: biobank supported by
public funds; consent is for future unspecified research; genomic privacy
concerns; biospecimen and data shared with manyinvestigators, including
commercial entities?
• Should burden be on institutions and funders to justify why no
participatory role for biospecimen contributors? What about a
participatory role more than advisory, i.e., includes a decision-making
role?
• Normative arguments for PMI-CP approach at least for biobanks that
receive public funding:
– Individuals affected by a biobank’s decisions should have opportunity
to directly participate in decision-making
– Researchparticipants as “partners in science” requires more than
providing advice and feedback