The goal of this assignment is to get hands-on experience creating Policies and SOPs for the Biospecimen
Repository.
Each biorepository is different and the Policies will reflect the uniqueness of the Biorepository. A policy is an
“internal rule” as well as a “promise and an obligation to follow applicable regulations.” The SOP (standard
operating procedure), on the other hand, describes HOW, by WHOM, and by WHAT means the policy will be
followed. Several SOPs may be needed to fulfill the same policy.
The National Cancer Institute (NCI) Biorepository and Biospecimen Research Branch (BBRB) website has a
comprehensive set of policies at: http://biospecimens.cancer.gov/bestpractices/elp/ (Links to an external site.).
Similarly, the Canadian Tissue Research Network (CTRNet) has posted a full set of policies and procedures,
https://www.ctrnet.ca/en/resources/national-standards/ (Links to an external site.)that could be used as
templates and adjusted to fit any Biorepository needs. Thirdly, most major biorepositories have transparent
policies and SOPs that could be found on their websites.
This and next module we will look at the Mayo Clinic Biobank. This is a relatively newly established U.S. based
biobank and we will study the paper published by Olson et al., (2013), “The Mayo Clinic Biobank: A building
block for individualized medicine”. We will retrace their steps in building the biobank.
1. Based on the information found in the paper, or on the Mayo Clinic website
(http://www.mayo.edu/research/institutional-review-board/policy-manual (Links to an external site.) ) or on the
Mayo Clinic Biobank website (http://www.mayo.edu/research/centers-programs/mayo-clinic-biobank/forresearchers (Links to an external site.) ), create one document of your choice that describes a policy set by
Mayo Clinic Biobank, as it pertains to one of the following principles:
Principles of Responsible Custodianship
Informed consent
Privacy Protection
Access to Biospecimen and Data
Intellectual Property and Resource Sharing
Conflict of Interest
Governance
Emergency Preparedness
Biobank Planning
When creating your policy document, please use the fictitious name “THE Biobank,” in other words, refer to the
biobank with a hypothetical name. I think we should do this out of respect to the “real” Mayo Clinic Biobank
documents. (30 points)
2. Prepare an SOP for the “Withdrawal of consent” for “THE Biobank,” based on the information for the Mayo
Clinic Biobank. (25 points)
3. Prepare an SOP for “Emergency Procedure for Power Failure” for “THE Biobank”, based on the Mayo Clinic
Bioservices Policies found on their website at: https://www.mayo.edu/research/documents/bioservices-2015-
business-continuity-plan/doc-20461849 (Links to an external site.) (25 points)
Reference:
Olson, J. E., Ryu, E., Johnson, K. J., Koenig, B. A., Maschke, K. J., Morrisette, J. A., … Cerhan, J. R. (2013).
The Mayo Clinic Biobank: A building block for individualized medicine. Mayo Clinic Proceedings, 88(9), 952–
962. doi:10.1016/j.mayocp.2013.06.006 Accessed at June 21, 2015
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4258707/ (Links to an external site.)
The National Cancer Institute (NCI) Biorepository and Biospecimen Research Branch. Accessed on February,
2016 at:  http://biospecimens.cancer.gov/bestpractices/elp/ (Links to an external site.)