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 a proposed study. This protocol must be approved by the Mayo Clinic Institutional Review Board and the Biobank Access Committee.
The Biospecimen Trust Oversight Group controls all access to the Biobank, while the 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 and regulating access to biospecimens collected at Mayo.
Biobank 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:
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 a valued Biobank participant, with confidence that your samples and information are effectively used toward a goal of improving health care.
Biobank Access Committee principles
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