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:
- Are the samples or data leaving Mayo Clinic? In what form?
- 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?
- How will the community view the project or results?
When making their decision, Biobank Access Committee members use principles that were developed by the Biospecimen Trust Oversight Group. The Rochester Community Advisory Board co-chair is also an active voting member of the Biospecimen Trust Oversight Group and the Biobank Access Committee. 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.
More than 280 projects have been approved to date.
The Biobank Access Committee has worked diligently 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.
The Biobank Access Committee comprises:
- James R. Cerhan, M.D., Ph.D. (chair), co-principal investigator, Mayo Clinic Biobank
- Mine Cicek, Ph.D., director, Biospecimens Accessioning and Processing
- Elena Anna (Eleanna) O. De Filippis, M.D., Ph.D., internal medicine physician
- Michael Frost, community member co-chair, Community Advisory Board
- Elizabeth (Liz) A. Gilman, M.D., medical director, Mayo Clinic Biobank; internal medicine physician
- Noralane M. Lindor, M.D., clinical geneticist
- Janet E. Olson, Ph.D., project director, Mayo Clinic Biobank
- Euijung Ryu, Ph.D., statistician
- Richard Sharp, Ph.D., co-chair, Community Advisory Board; bioethicist
- Joan M. Steyermark, M.S., LCGC, genetic counselor
- Paul Y. Takahashi, M.D., medical director, Mayo Clinic Biobank; internal medicine physician
- Stephen N. Thibodeau, Ph.D., chair, Biospecimen Trust Oversight Group
- Michael D. Van Norstrand, M.D., Ph.D., medical director, Mayo Clinic Biobank; gastroenterologist at Mayo Clinic Health System — Franciscan Healthcare in La Crosse, Wisconsin
Community Advisory Board Network
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 four days of 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 an advisory board in Rochester, Minnesota, in 2009, to ensure that the voice of the community continues to be heard.
In 2014, the Mayo Clinic Biobank formed a second community-based board in the Jacksonville, Florida, area to recognize contributors there and build community ties to Mayo Clinic Center for Individualized Medicine in Jacksonville.
A third advisory board was established in Phoenix, Arizona. It was created to provide guidance on the creation of the Sangre Por Salud (Blood for Health) biobank. The result of collaboration among Mayo Clinic, Mountain Park Health Center and Arizona State University, Sangre Por Salud aims to expand precision medicine research to include Latino communities, which are often underrepresented in biobanking research.
Sangre Por Salud contributors are patients at Mountain Park Health Center, a federally qualified health center that provides comprehensive health care to underserved populations.
Together, these comprise the three-site Community Advisory Board Network. Each board is composed of approximately 20 members chosen to reflect the diversity of community interests and backgrounds.
The three-site Community Advisory Board Network is facilitated by Mayo Clinic's Biomedical Ethics Research Program. The program's associate director for public engagement and the coordinator of the Community Advisory Board Network work together to streamline connections across the network. They work with the Center for Individualized Medicine staff, Biobank leadership and collaborators at all three sites to set community advisory board meeting agendas and facilitate meetings.
The Community Advisory Board Network 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 board members to the leadership are not binding, they are viewed with considerable respect and are often incorporated into leadership's and research teams' policies, actions and decisions.
The Biospecimen Trust Oversight Group has asked members of the Community Advisory Board Network 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. Each year the Biospecimen Trust Oversight Group has an annual retreat in which future priority areas are identified for the community advisory boards.
BioNews newsletters provide an archive of updates for Biobank participants about community advisory board activities and recent research projects.