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

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

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

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

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

Planning for an Institutional Biorepository

• Specimen collection and the creation and maintenance of

research biorepositories are “research” activities

– To the extent they include individually identifiable information, they

are “human subjects research” under the Common 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”)

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

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)

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

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

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

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

Questions

Kate Gallin Heffernan

Verrill Dana LLP

(617) 274-2858

kheffernan@verrilldana.com