Governing the Biobank

The Biospecimen Trust Oversight Group has developed a detailed governance structure for the Mayo Clinic Biobank. All researchers wishing to use the Biobank must submit a protocol that addresses the scientific, legal and ethical components of the proposed study. This protocol must first be approved by the Mayo Clinic Institutional Review Board. The Biospecimen Trust Oversight Group controls all access to the Biobank, while a Community Advisory Board provides an important component of Biobank governance.

The Biobank's governing bodies are:

Institutional Review Board (IRB)

The Mayo Clinic IRB is a governing body of scientists, doctors and representatives of the community who review research projects in order to protect study participants. Research institutions, including Mayo Clinic, are required to have an IRB. Every study is reviewed by an IRB before it begins. The federal government monitors IRBs, though each IRB operates independently. IRBs ensure that researchers and institutions abide by federal regulations and guidelines so that risk to human research participants is minimized.

Biospecimen Trust Oversight Group (BTOG)

The BTOG is a committee of scientists, physicians, lawyers and ethicists charged with overseeing the operations of the Mayo Clinic Biobank and other biospecimen collections at Mayo. Its duties include creating and implementing policies concerning the storage of donor samples and health information, evaluating and approving potential research studies, and regulating access to biospecimens collected at Mayo.

Access Committee

The BTOG has formed a smaller group known as the Mayo Clinic Biobank Access Committee. This group makes decisions about how Biobank samples and information are used. When a researcher asks to use the Biobank for a new study, the Access Committee reviews the request. The committee approves the request, denies it or makes suggestions for revisions.

As committee members make these decisions, they consider several things:

• Is the research important?
• Does the Biobank have enough samples to honor the request?
• Is it necessary to contact Biobank participants for additional information or samples?
• Will research results be generated that require contacting participants?

When making their decision, Access Committee members use principles that were developed by BTOG. When the committee has a complex request, it invites the co-chair of the Community Advisory Board (CAB) to attend meetings to offer advice. If needed, the full CAB may review the project. This ensures that the views of the community are included as decisions are made.

If the research project is approved, the researcher receives an approval letter and the requested information and samples are provided. If the Access Committee denies the researcher's request for samples, the researcher is sent a denial letter and no samples or information is provided.

As of October 2011, 28 projects have been approved, while two have been denied or tabled for revisions or consideration at a later date. The Access Committee has worked feverishly to review projects and ensure that only high-quality research projects are being approved for Biobank sample use. This process provides you, a valued Biobank participant, with confidence that your samples and information are effectively used toward a goal of improving health care.

Membership

• James R. Cerhan, M.D., Ph.D., chair — principal investigator, Mayo Clinic Biobank
• Scott A. Beck — administrator, Mayo Clinic Biobank
• Zachary S. Fredericksen — statistician
• W. Edward Highsmith Jr., Ph.D. — director, Biospecimens Accessioning & Processing
• Kiley J. Johnson, CGC — genetic counselor
• Karla J. Kopp — Biospecimens Accessioning & Processing
• Mark Liebow, M.D. — medical director, Mayo Clinic Biobank, and internal medicine physician
• Karen J. Maschke, Ph.D. — The Hastings Center
• Janet E. Olson, Ph.D. — project director, Mayo Clinic Biobank
• Paul Y. Takahashi, M.D. — medical director, Mayo Clinic Biobank, and internal medicine physician
• Stephen N. Thibodeau, Ph.D. — chair, Biospecimen Trust Oversight Group

Access principles

• The Mayo Clinic Biobank is a resource to be used to address important research and clinical questions.
• All projects that use the Mayo Clinic Biobank require full evaluation by Mayo Clinic scientists. Sometimes, scientists and physicians from outside of Mayo Clinic who are experts in the diseases being studied also evaluate projects. If a project has not been formally reviewed before a researcher requests Biobank samples for it, the Access Committee will require such a review prior to approving the request.
• All research projects must be reviewed by the Mayo Clinic IRB, which ensures high-quality, ethically sound research is being performed.
• Community Advisory Board advice will be requested as needed.
• Contact with Biobank participants, when necessary, will be coordinated through the Access Committee.
• A Mayo researcher must be included in any proposal submitted to the Access Committee.
• In general, patient identifiers will not be provided to investigators. Under certain circumstances, however, patient medical records may be allowed to be reviewed under strict surveillance by Biobank staff. Once records are reviewed, any identifying information (such as name, Mayo Clinic number or date of birth) will be stripped from the data that the researcher was collecting so that no researcher will have identifying information on a Biobank participant.
• The Access Committee will help determine if the study request might generate important research results and if these results should be provided to participants. Any return of research results will be coordinated and approved by the Access Committee.
• Any policies that require data to be shared with national research funding agencies must be described in the request.
• Biobank samples will be provided only for the specific uses mentioned in the access request, and any change in the project must be approved by the Access Committee. Samples will not be provided for unspecified uses.
• Data generated from the use of Mayo Clinic Biobank samples will be deposited into the Mayo Clinic Biobank database to expand the information available for future use. If a researcher does not want to return data to the Biobank, then an exception would need to be made and approved by the Access Committee.
• If there are significant costs associated with the request beyond the scope of the Biobank's resources, those costs will be the responsibility of individual investigators.

Community Advisory Board (CAB)

The Mayo Clinic Biobank CAB is composed of 20 members chosen to reflect the diversity of community interests and backgrounds. Nine of these members participated in the Biobank's deliberative community engagement event.

The purpose of the CAB is to ensure that the community's voice is heard in shaping the current and future plans and maintenance of the Mayo Clinic Biobank.

Members elect a community representative who co-chairs the board with a Mayo Clinic co-chair — a member of the Mayo Clinic Program in Professionalism and Ethics staff. The Mayo Clinic co-chair attends all CAB meetings and updates BTOG on the board's progress and recommendations. The community member co-chair attends BTOG meetings and facilitates CAB meetings when appropriate.

In 2008, CAB members met with Mayo Clinic Biobank staff members to assist in creating the Biobank's informed consent procedures and review recruitment materials and methods. Many of the improvements and suggestions generated by the CAB were adopted by the Mayo Clinic Biobank before it began operations in April 2009.

Since then, BTOG has asked the CAB to review and recommend policies and procedures on issues arising in Biobank research, such as return of research results, data sharing with other researchers, procedures used to recruit Biobank donors, and many other topics. The CAB is convened once every two months.

The following are listings of previous and future CAB meeting dates and agenda topics. For detailed summaries from previous meetings, please see the CAB columns in the BioNews newsletters.

• Sept. 8, 2011 — Electronic Medical Records and Genomics (eMERGE) recap by co-chair; presentation of final return of results letters; update on Biobank shortened consent form project; five-year plan for the Biobank; topics for future discussion; private CAB-only discussion
• June 28, 2011 — Book discussion of "The Immortal Life of Henrietta Lacks"; introduction of the CAB blog; eMERGE discussion
• May 5, 2011 — Return of results letter drafts reviewed and revised by CAB; suggestions for newsletters and website by CAB
• Jan. 27, 2011 — Polycystic kidney disease project overview and discussion of return of results
• May 13, 2010 — Tour of Mayo Clinic Biobank laboratories; data sharing and confidentiality; question-and-answer session with Mayo legal counsel; review of new projects
• Jan. 28, 2010 — Biobanking initiative progress report; overview of the Marshfield Clinic biobank

The 2012 CAB meeting schedule is:

• Jan. 26
• March 1
• May 3
• July 12
• Sept. 6
• Nov. 1