Assignment 5: Policies and Standard Operating Procedures (SOP)

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/for-researchers (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)