Policies and Standard Operating Procedures (SOP)

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

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
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