Informational

Guidance for Writing HUM Applications for Creating a Biorepository at the CBR

Central Biorepository
Dec 17, 2020 12:15 pm
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This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for creating a biospecimen collection. IRBMED may require more information from you depending on the specifics of your study.

  • HUM Application Guidance for Creating a Biospecimen Collection using the Central Biorepository

    • ​01. General Study Information
      • Question 1.1.2: As a related project enter “REP00000002 - University of Michigan Medical School Central Biorepository."
         
      • Question 1.8: Indicate proposed use of CBR resources in the project summary.
         
      • Question 1.11: Indicate 1.) duration of the collection (patient interaction) and 2.) that samples will be stored in the CBR long-term.
         
    • 01-1. Application Type
      • Question 1-1.1: Select “Human Subjects research Involving interaction or intervention" and indicate “Yes" for the research involving collection of biospecimens from subjects.
         
    • 0.3 UM Study Functions
      • Question 3.1: Select any services that will be performed by the CBR in addition to those of the study itself, and indicate these activities occurring at the University of Michigan in subsequent questions for “03-1 Performance Sites."
         
    • 0.7 Special Considerations
      • Question 7.1: Select “Yes" for the study involving biological specimens [Requires Section 18].
         
    • 10-1 Informed Consent
      • Question 10-1.1: CBR policy requires that two IRBMED repository consent templates be used together in addition to any informed consent documents that may be required for your study.
         
        • ​Biorepository Informed Consent Template (with instructions) — Required Reading
          1. ​​Indicate the name of the biorepository collection in the top paragraph – e.g., “the Ann Arbor Genomic Biobank, which takes part in the University of Michigan Medical School Central Biorepository."
             
          2. ​​Include the procedures by which the biospecimens will be collected and indicating whether these are additional to any clinical procedures.
             
          3. ​​Include contact information for both the PI and the CBR Director.
             
          4. ​​​Include/remove bullet point about surveys, as appropriate for your study.
             
        • ​Biorepository Informed Consent Informational Sheet
          1. ​​Page 1, middle panel, bottom: Include contact information for both the PI and the CBR Director.
             
          2. ​​Page 2, left panel: Include information about the collection procedures. If you are using a separate standard informed consent, it is appropriate to make reference to that document for procedural details.
             
          3. ​​Page 2, middle panel, bottom in Box numbered 2: Keep or remove the statement about informational surveys, as appropriate for your study.
             
          4. ​​Page 1, left panel, top: Describe the physical risks of any collection procedures that are additional to procedures that will be done for clinical purposes.
             
          5. ​​​Keep the language about the Certificate of Confidentiality.
             
        • ​Note: You may not need any additional consent documents beyond those above if your research falls in the following IRBMED guidelines: “Projects that include plans for no more than the following may seek consent under the single signature of the biorepository consent documents: (a) interactions and interventions reasonably designed to enhance the research value of the collection being assembled for future research; and (b) data generation and management with risks/benefits that fall within those of in vitro human research in general, as described in the documents."
           
      • Question 10-1.6: Select “Yes" specimens will be retained for future use.
         
      • Question 10-1.7: Select “Yes" the informed consent does specify specimens will be maintained for future research use.
         
    • 11. Confidentiality/Security/Privacy
      • Question 11.1: Most often, select “Yes" the study team will access data linked to the subject's identity [Requires Section 11-1]. 
         
      • Question 11.2: Indicate that all samples will be coded and stored in secured conditions in the CBR or in labs in which processing is occurring. The CBR Laboratory Information Management System contains a secure link to patient identifiers that only approved personnel are permitted to access. Key codes linking participants with their sample ID numbers are kept in a secure database.
         
      • Question 11.3: While the CBR employs most of these precautions, use this section to indicate those precautions this study will take independently.
         
      • Question 11.4: While the CBR's Certificate of Confidentiality protects biospecimens held at the CBR, answer this question regarding this study independently.
         
      • Question 11.6: Check "Retain for future research use [Requires Section 11-4]" and others as applicable.
         
    • 11-1 Identifiable Data (You will require this section if you indicated the study team will access any data that is linked to a subject's identity by name or other identifier or code.)
      • Question 11-1.1: Select “Coded or indirect identifiers - data record includes a link to direct identifiers (e.g., name, initials, phone number, SSN, or medical record number linked to data record but stored separately)" and others as applicable.
         
      • Question 11-1.3: Indicate how long the study team will maintain identifiers and that coded identifiers will be indefinitely maintained within the CBR.
         
      • Question 11-1.4: Select “Yes" to access, collect, use, maintain, or disclose identifying data.
         
      • Question 11-1.4.1, Question 11-1.4.2, Question 11-1.4.3, and Question 11-1.4.4: For CBR activities, the answer is “No." However, if these pertain to your study specifically, adjust the answer accordingly.
         
    • 11-4 Retention of Data and/or Specimens Details
      • Question 11-4.1: Indicate specimens will be stored for future research use.
         
      • Question 11-4.2: Check "Only at the University of Michigan" or "UM and Other Institutions" as applicable.
         
      • Question 11-4.3: The REP application comprehensively addresses these questions. You can find this information in the REP's space under “Related Projects" or in the HUM's space under “Document/Related Records" tab if you are a study team member on that REP. For the CBR REP, indicate that you will be following CBR procedures for samples going to CBR and specify who has access to the key for the coded data. For additional CBR-specific details refer to REP0000002 which can be found the CBR website.
         
    • 18. Biological Specimens
      • Question 18.1 subsections: Indicate which type of samples will be stored in the CBR under each sample type. (Note: Question 18.1.15 is only for using samples that are already stored in the CBR, not for creating a new collection.)
         
      • Question 18.2: Select “Yes" to receiving or recording direct/linked identifiers for biospecimens.
         
    • 20. Genetic Analysis (You will only require this section if genetic analysis is being performed on specimens acquired in this study.)
      • Question 20.4: Select “Yes" specimens may be shared with colleagues outside the study.
         
        • ​20.4.1: Indicate that for future studies that request samples from the CBR, biospecimens will be coded and identifiable information will only be available if approved by IRB. Additionally, an MOU will be supplied and required before transfer can take place.
           
    • 25. HIPAA Covered Components
      • ​Question 25.1: Select “Michigan Medicine Hybrid Covered Entity" for HIPPA-regulated data source and any others for your particular study.​
Units: Central Biorepository
Topic: eResearch Regulatory Management (eRRM) Repository
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Edited By: [email protected]
Last Updated: March 30, 2021 1:15 PM