Governance and Oversight

Institutional Review Board

The Mayo Clinic Institutional Review Board (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

The Biospecimen Trust Oversight Group 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 and regulating access to biospecimens collected at Mayo.

Biobank Access Committee

Read the access principles.

The Biospecimen Trust Oversight Group 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 Biobank 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, Biobank Access Committee members use principles that were developed by the Biospecimen Trust Oversight Group. If needed, the Community Advisory Board 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 Biobank Access Committee denies the researcher's request for samples, the researcher is sent a denial letter, and no samples or information are provided.

As of April 2014, more than 110 projects have been approved, while two have been denied or tabled for revisions or consideration at a later date.

The Biobank 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 valued Biobank participants with confidence that their 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
  • W. Edward Highsmith Jr., Ph.D., director, Biospecimens Accessioning and Processing
  • Mark Liebow, M.D., medical director, Mayo Clinic Biobank; internal medicine physician
  • Noralane M. Lindor, M.D., clinical geneticist, Mayo Clinic in Arizona
  • Jennifer B. McCormick, Ph.D., bioethicist
  • Janet E. Olson, Ph.D., project director, Mayo Clinic Biobank
  • Gail Onderak, community member co-chair, Community Advisory Board
  • Alexander S. Parker, Ph.D., co-principal investigator, Mayo Clinic Biobank, Florida
  • Douglas L. Riegert-Johnson, M.D., clinical geneticist, Mayo Clinic in Florida
  • Euijung Ryu, Ph.D., statistician
  • Richard Sharp, Ph.D., co-chair, Community Advisory Board; bioethicist
  • Paul Y. Takahashi, M.D., medical director, Mayo Clinic Biobank; internal medicine physician
  • Stephen N. Thibodeau, Ph.D., chair, Biospecimen Trust Oversight Group
  • Erin M. Winkler, CGC, genetic counselor

Community Advisory Board

In September 2007, Mayo Clinic held a deliberative community engagement event. Twenty citizens, chosen to represent the population of Olmsted County, Minnesota, took part in in-depth conversations about biobanking and issues surrounding genetic and genomic research.

Citizens read background material; heard from scientists, patient advocates, legal experts and other stakeholders; and deliberated with one another over two weekends. On the final day of the event, the participants created recommendations for the design of the Mayo Clinic Biobank.

The hopes and values expressed by the community guided Mayo Clinic's development of the Biobank, particularly procedures and practices to protect the individuals donating to the Biobank. One recommendation voiced by the participants was the need for ongoing community guidance and involvement in Biobank governance. Therefore, Mayo Clinic established a Community Advisory Board (CAB) to ensure that the voice of the community continues to be heard.

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

The CAB provides community input to the Mayo Clinic Biobank leadership about current and future plans for maintenance and growth of the Mayo Clinic Biobank. While the recommendations provided by the CAB members to the leadership are not binding, they are viewed with considerable respect and are often incorporated into policies, actions and decisions that leadership make.

The CAB is co-chaired by a community member (elected by CAB members) and a member of the Mayo Clinic Biomedical Ethics Program. The co-chairs work with Biobank staff to set meeting agendas and facilitate CAB meetings. Both co-chairs are also active voting members of the Biospecimen Trust Oversight Group and Biobank Access Committee. A community vice chair (elected by CAB members) is also part of CAB leadership and helps with co-chair responsibilities.

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, the Biospecimen Trust Oversight Group 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 meets every other month to learn about, discuss and develop recommendations to help guide the Biobank leadership.

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

  • Jan. 24, 2013 — Updates on Biobank activities and review of educational material
  • March 16, 2013 — Ethical and policy challenges of whole-exome and whole-genome sequencing of Biobank samples
  • July 11, 2013 — Psychiatric and disease-specific biobanking
  • Sept. 5, 2013 — Biobanking and consent issues in pediatric populations
  • Nov. 7, 2013 — Recommendations for the development of the Mayo Clinic Biobank business plan

The 2014 CAB meeting schedule is:

  • Jan. 23, 2014 — Recommendations for the development of the Mayo Clinic Biobank business plan (continued)
  • March 13, 2014 — Recommendations for the implementation of a Florida Community Advisory Board
  • May 8, 2014 — Updates on the Mayo Clinic Biobank communication plan
  • July 10, 2014
  • Sept. 4, 2014
  • Nov. 6, 2014