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. Operationalizing Institutional Research
Biorepositories: A Plan to Address
Practical and Legal Considerations
Kate Gallin Heffernan, J.D.
kheffernan@verrilldana.com
(617) 274-2858
November 16, 2015

2. Chapter Co-Authors
• Kate Gallin Heffernan, J.D.
• Mark A. Borreliz, J.D.
• Emily Chi Fogler, J.D.
• Marylana Saadeh Helou, J.D.
• Andrew P. Rusczek, J.D., M.Bioethics

3. Scope of Chapter
• Introduction
• Planning for an Institutional Biorepository
– Protocol
– Informed Consent Process
• Planning for Third-Party Interests in the
Biorepository
– Rights of Specimen Donors
– Rights of Investigators
– Rights of Commercial Sponsors and Third Parties
• Education Efforts

4. Introduction
• Evolution of biorepositories from de-centralized lab- or
study-specific efforts to a recognized and regulated field
of science
• Benefits of centralized institutional biorepositories
• Chapter explores practical and legal issues institutions
need to consider before operationalizing an institutional
research biorepository
• Chapter aims to highlight operational hurdles and
recommend best practices for institutions

5. At a Cross-Roads: the NPRM
• We are on the brink of regulatory change that might
heighten the value and relevance of the learning gained
from the operation of institutional biorepositories
– NPRM, if implemented, would broaden the concept of human
subjects research to encompass research involving human
specimens, regardless of identifiability
– Driven by autonomy more than a change in the standard of
identifiability
• Final rule will most likely require institutions to obtain
some form of broad consent before storing or using
many, if not most, specimens for research purposes

6. Planning for an Institutional Biorepository
• Specimen collection and the creation and maintenance of
research biorepositories are “research” activities
– To the extent they includeindividuallyidentifiableinformation, they
are “human subjects research”undertheCommon Rule
• The requirements for IRB oversight and informed consent
will generally apply to the development of an institutional
biorepository, unless a determination can be made that the
biorepository is exempt from such requirements or consent is
otherwise waived
• A biorepository may also be required to comply with HIPAA
and its privacy regulations (if “protected health information”)

7. The Protocol
• Topics an institution should address:
1. Purpose and management of the biorepository;
2. How specimens and information will be accepted,
initially and with respect to any updates;
3. How informed consent will be obtained;
4. Storage and other operational considerations, including
the mechanics of how information and specimens will be
maintained and protected, and any quality assurance
procedures; and
5. How specimens and information will be released from
the biorepository for secondary research uses

8. The Informed Consent Process
• Chapter focuses on the process challenges
• Mechanisms:“front door” consent, EMR-embedded
requests for participation, electronic kiosks, identifying
opportunities of patient interaction, etc.
• Nature and scope: broad, protocol-specific, tiered,
dynamic, or based on an opt-in or opt-out premise
• Source of materials: approach to consent may differ for
various sources of specimens and information (e.g., for
non-identifiable clinical excess: research consent, opt-in
or opt-out process, or continued reliance on existing
procedure consent form)

9. Kick-Off Meeting Checklist
• Chapter includes a general checklist
(Appendix A) to help institutions focus their
initial thinking and planning for the creation
of biorepositories
• The checklist identifies practical questions and
topics for an institution to cover at an internal
meeting to discuss the possibility of
establishing a biorepository

10. Planning for Third-Party Interests
in the Biorepository
• Rights of Specimen Donors
– Specimen science depends on the willingness of subjects to
donate of themselves to science
– No consensus around legal rights to own one’s excised
specimens (despite some state legislative efforts and cases
seeking to establish such a right)
– Importance of informed consent to set appropriate expectations
• Rights of Investigators
– Clear policies articulating IP rights and institution’s interests
– Materials Transfer Agreements when sharing the resource
• Rights of Commercial Sponsors and other Similarly Situated
Third Parties

11. Education Efforts
• Patients:
– Informed consent process alone may not optimize patient
education or engagement in the biorepository
– Other educational tools: a website dedicated to the
biorepository; videos; frequently asked questions; newsletters;
press releases; posters, pamphlets, and displays throughout the
institution; institution-wide “research notification”
• Clinicians:
– Education may be accomplished though many of the same
mechanisms as may be utilized for patients
– In addition: clinician-focused communications and materials;
in-person informational sessions; regular updates about research
conducted using biorepository resources

12. Conclusion
• Establishing a compliant, smoothly functioning institutional
biorepository demands forethought and expertise of many
disciplines
• Early commitment to designing a comprehensive protocol,
implementing ethical, carefully chosen informed consent
procedures, and crafting a superstructure of policies and
contracts to anticipate and avoid misaligned expectations
• Challenges to operationalizing successful institutional
biorepositories may increase if NPRM is finalized in its
current form, but the collective lessons already learned by
host institutions will retain much of their fundamental value
as this evolving and inestimably vital research tool enters new
regulatory terrains

13. Questions
Kate Gallin Heffernan
Verrill Dana LLP
(617) 274-2858
kheffernan@verrilldana.com