Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR

Central Biorepository

| Approval Date:

December 17, 2020 11:30 am

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 secondary use of biospecimens. IRBMED may require more information from you depending on the specifics of your study. Please reference the CBR MOU and/or Use Proposal Form you filled out previously to assist with your HUM application.

HUM Application Guidance for Recontacting Subjects for Either Additional Sample Collection or New Study Enrollment

01. General Study Information
- Question 1.1.2: As a related project enter “REP00000002 – University of Michigan Medical School Central Biorepository” and HUM(s) of any primary studies that collected the samples being requested.
- Question 1.8: Indicate proposed use of CBR resources in the project summary.
01-1: Application Type
- Question 1-1.1: Select “Human Subjects research involving interaction or intervention”
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 for “03-1 Performance Sites”.
0.5 Research Design
- Question 5.3: Select “Yes” the study will involve recruitment and/or participation of subjects to produce new data [Requires 8-1 and 11-3].
0.7 Special Considerations
- Question 7.1: Select “Yes” for the study involving biological specimens [Requires Section 18].
  - 7.1.1: If your study involves new genetic analysis of biospecimens, select “Yes” [Requires Section 20].
- Question 7.2: Almost always you will select “Yes,” your study involves the secondary analysis of pre-existing data associated with biospecimens (i.e. used as a screening component, incorporated into analyses, etc.) [Requires Section 24].
0.8-1 Subject Recruitment
- Note: For this section you do not need to describe the previous recruitment methods for specimens already stored in the CBR. Instead, focus on your study’s unique recruitment procedures.
- Question 8-1.2: Select “Other UM subject pools (describe below)” in addition to any other relevant items for this study. Provide the HUM(s) of the previous study whose biospecimens you will access.
10. Informed Consent
- Note: If your study is planning on recruiting participants in addition to utilizing CBR resources, use this section to indicate your specific recruitment protocol. If you plan to store your newly collected samples in the CBR, also reference the CBR’s “Creating a Biospecimen Collection using the Central Biorepository (CBR)” for detailed description of the requirements for consenting subjects.
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/certain 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. Explain your study’s specific precautions.
- Question 11.3: While the CBR employs most of these precautions, use this section to indicate those precautions this study will take independently.
- Question 11.6: Check “Retain for future research use (Requires Section 11-4)” if you plan to store new samples in the CBR. Otherwise, indicate how you plan to handle any remaining sample from aliquots received by CBR.
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. If you are storing new samples in the CBR, indicate 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.
Question 11-4: Retention of Data and/or Specimens Detail (You will only require this section if you indicated data and/or specimens would be retained for future research use.)
- If you are planning on collecting additional biospecimens for your study in addition to those you’re pulling from the CBR:
  - Question 11-4.1: Indicate that some specimens were previously collected and stored by the CBR. At the time of collection subjects were consented to enable for broad, future research use in a variety of settings. For new samples, indicate specimens will be stored for future research.
  - 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 for existing samples 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 on the CBR website.
18. Biological Specimens
- Question 18.1.15: For CBR-banked specimens, check “Other” and specify “UM Central Biorepository.”
- 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 in this study.)
- Question 20.1: Indicate what type of samples from which primary study (HUM) will undergo genetic analysis.
- Question 20.4: If you are planning on collecting additional biospecimens for your study that will be stored in the CBR long-term, then 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 (You will only require this section if you indicate that you will be accessing or using PHI.)
- Question 25.1: HIPAA-regulated data used source “Michigan Medicine Hybrid Covered Entity” and any others for your particular study.
25-1 Protected Health Information (You will only require this section if you indicate that you will be accessing or using PHI.)
- Question 25-1: If you are recontacting subjects from CBR-housed cohorts, include “Personal identifiers” unless you are using the Data Office as an Honest Broker for recruitment. Include any additional PHI accessed for your study specifically.
- If all biospecimens in your study were collected under standard CBR informed consent:
  - Question 25-1.3: Select that authorization was/will be obtained from all subjects.
  - Question 25-1.3.1: Select “integrated with” or “separate from” informed consent document, as applicable to original authorization
If any biospecimens are collected outside of the standard CBR informed consent, refer to the IRB for the best way to answer the questions in this section.

HUM Application Guidance for Secondary Analysis on Samples with No Patient Interaction or Intervention

01. General Study Information
- Question 1.1.2: As a related project enter “REP00000002 – University of Michigan Medical School Central Biorepository” and HUM(s) of any primary studies that collected the samples being requested.
- Question 1.8: Indicate proposed use of CBR resources in the project summary.
01-1: Application Type
- Question 1-1.1: Select “Secondary research use of private information of biospecimens”
01-1.2 Scope of Secondary Use Research
- Question 1: Select “Biospecimens [Require Section 18]” in addition to any others required for your study.
- Question 2: Select “No” if: the study is not regulated (meaning you will never have access to re-identify the subject through means such as: coded private information [Section 24], coded biological specimens [Section 18], de-identified biological specimens, or information that cannot be reidentified, or activities not engaged in human subjects research) or the study qualifies for exemption (meaning identifiers are viewed but never recorded or data is strictly within a U-M HIPAA hybrid covered entity such as the CBR.) Otherwise, select “Yes’, the study requires IRB review and approval.
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.”
0.5 Research Design (You will only require this section if the study requires comprehensive IRB review and approval.)
- Question 5.2: Select “Yes” the involvement of any subjects is limited to existing specimens.
- Question 5.3: Select “No” the study will not involve recruitment of subjects. (If the answer for your study is yes, please refer to this set of instructions for your HUM application).
10. Informed Consent (You will only require this section if the study requires comprehensive IRB review and approval.)
- Question 10.3: You will almost always select “Pre-existing consent(s) covers this activity.” As of 2020, residual samples in the COVID Biorepository are the only CBR biospecimens collected under a waiver of consent, so select “Request for waiver of informed consent/parental permission/legally authorized representative consent” if you are using those samples.
- Question 10.3.1: If all biospecimens were collected under CBR consent forms, include a statement that participants were consented with the understanding their samples would have broad future research use.
- Question 10.3.2: If all biospecimens were collected under CBR consent forms, upload blank copies of the two consent templates. If using a “legacy collection,” upload consent(s) from the original study.
11. Confidentiality/Security/Privacy (You will only require this section if the study requires comprehensive IRB review and approval.)
- 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. Explain your study’s specific precautions.
- Question 11.3: While the CBR employs most of these precautions, use this section to indicate those precautions this study will take independently.
- Question 11.6: Indicate how you plan to handle any remaining samples from the aliquots received by CBR once the study is completed.
11-1: Identifiable Data (You will only require this section if the study requires comprehensive IRB review and approval.)
- 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 11-1.4: 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 Detail (You will only require this section if you indicated data and/or specimens would be “Retained for future research use” in Section 11.6.) These questions pertain to your study’s specific protocol, not general CBR storage.
18. Biological Specimens
- Question 18.1 subsections: Indicate the type of samples being drawn from the CBR under the appropriate header and indicate the HUM of the study that originally collected the samples.
  - Depending on the nature of your sample, you’ll answer either 18.1.11 or 18.1.17: Check “Other” and specify “UM Central Biorepository” and indicate the HUM of the study that originally collected the samples.
- 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 in this study.)
- Question 20.1: Indicate what type of samples from which primary study (HUM) will undergo genetic analysis.
- Question 20.4: Answer per your study specifically. For reference, standard CBR consent templates do disclose the potential to share information/specimens with colleagues outside the study.
25. HIPAA Covered Components (You will only require this section if you indicate that you will be accessing or using PHI.)
- Question 25.1: HIPAA-regulated data used source “Michigan Medicine Hybrid Covered Entity” and any others for your particular study.
25-1 Protected Health Information (You will only require this section if you indicate that you will be accessing or using PHI.)
- If all biospecimens in your study were collected under standard CBR informed consent:
  - Question 25-1.3: Select that authorization was/will be obtained from all subjects.
  - Question 25-1.3.1: Select “integrated with” or “separate from” informed consent document, as applicable to original authorization.
If any biospecimens are collected outside of the standard CBR informed consent, refer to the IRB for the best way to answer the questions in this section.

UNIT: Central Biorepository

TOPICS: eResearch Regulatory Management (eRRM) / Repository

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Edited By: [email protected]
Last Updated: February 15, 2024 3:35 PM