Use and Distribution of Biospecimens and Data Policy

CBR program: A U-M research effort that participates in the CBR by collecting biospecimens and storing all or some of those biospecimens in the CBR.

CBR resources: Biospecimens collected under a CBR program and data associated with or derived from those biospecimens for research.

Collection: All the CBR resources comprised by a single CBR program.

Primary Use: A specific research use (i.e., testing of a specific hypothesis or set of hypotheses, creation of a biorepository) for which a resource was initially acquired in compliance with all applicable legal requirements.

Secondary Use: Any other research use, whether proposed by the investigator who acquired and/or deposited the resource into the CBR or by any other investigator.

Use Proposal: An application to the CBR or CBR program seeking approval for a Secondary Use of CBR resources.

Oversight Committee: A committee for review of Use Proposals concerning a particular Collection. Oversight Committees for Collections sponsored by Michigan Medicine faculty are subject to standards established in the Research Biorepositories Policy. Synonyms for “Oversight Committee” may be “Steering Committee”, “Governance Committee”, or another title, as long as the Committee is chartered with the same responsibilities as those outlined for an Oversight Committee in the Research Biorepositories Policy.

A. In accordance with the Research Biorepositories Policy, CBR resources are donated by patients and research participants to the University, with the University retaining the ownership of these biospecimens and any derivatives, unless stipulated otherwise by research agreements for which biospecimens are collected.

B. Meritorious Secondary Uses of CBR resources are valuable opportunities for collaboration among investigators, strengthen the research portfolio of the University of Michigan Medical School, and speed the pace of research.

C. The investigators who deposit any particular biospecimens into the CBR are typically in the best position to assess the merit of Use Proposals pertaining to those biospecimens.

D. The CBR Advisory Committee is chartered to act as an Oversight Committee under the Research Biorepositories Policy.

A. Distribution Requests will be fulfilled only for:

1. Primary Uses; and
2. Secondary Uses that have been approved by either:

            a. the CBR Advisory Committee, acting as an Oversight Committee;

                                or

            b. the otherwise designated Oversight Committee(s) for the Collection(s) from which the requested resources originate.

B. Any Use Proposal seeking CBR resources from multiple Collections must be reviewed only by the CBR Advisory Committee if there are conflicting approvals from the multiple designated Oversight Committees.

The CBR director has administrative discretion to steer a given Use Proposal towards one CBR Program over another if the number of CBR resources sought can be adequately managed via that one Program, and it makes sense to do so.

When other agreements require a particular Oversight Committee (e.g., one defined by the National Institutes of Health) also review such a Use Proposal, the contributing investigator will notify the CBR of this requirement. 

C. When the CBR Advisory Committee acts as an Oversight Committee, each principal investigator who deposited any of the CBR resources subject to the Use Proposal under review will be included as a voting member of the Committee.

D. Any change in the scope of a use approved under Section IV(a)(2), above, must be approved by the Oversight Committee(s) that granted the initial approval.

E. Decisions made on Use Proposals under Section IV(a)(2)(b), above, may be appealed to the CBR Advisory Committee by any involved party.

Decisions made by the CBR Advisory Committee (acting as an Oversight Committee) on Use Proposals may be resubmitted with changes or, thereafter, appealed to the Dean of the Medical School or the Dean’s designee. Appeals must be submitted in writing and must present the appellant’s specific disagreements with the judgment of the committee.

F. The CBR Advisory Committee may suspend or terminate approval of access to CBR resources if an investigator fails to comply with applicable policies or procedures or to exercise his/her access within a reasonable period of time. If the research has IRB oversight, compliance issues will be reported to the IRB.

A. Designation of Oversight Committees. Any investigator depositing materials into the CBR must designate an Oversight Committee to meet the standards established in the Research Biorepositories Policy. 

B. Use Proposals. Investigators interested in Secondary Uses of CBR Resources must prepare and submit a Use Proposal, which will be shared with the designated Oversight Committee. Researchers may contact the CBR at any time for assistance, such as a request for study contact information, or what information each Oversight Committee requires for its review.

Investigators and Oversight Committees are encouraged to keep CBR staff as informed as possible as Use Proposals develop so that issues can be anticipated and managed, necessary documentation can be prepared timely, and CBR staff can assemble any additional materials to assist in Oversight Committee review. 

C. Approval and Distributions. Secondary Uses will be considered fully approved and actionable when the following have been provided to CBR staff:

1. Documented approval of the Use Proposal by the designated Oversight Committee(s) for the CBR resources sought, including a clear statement of the approved aims and hypotheses to be tested;
    
2. A description of the CBR resources approved for distribution under the use, including but not limited to their type, number, and quantity;
    
3. Documented approval by a federally registered Institutional Review Board or other appropriate ethics committee;
   
   or
   
   ​Sufficient detail (including all data elements that will be combined and associated with the biospecimens sought) for the CBR to determine that the proposed project is not regulated by human subjects protections regulations.  As a best practice, U-M investigators should complete a brief not-regulated application in eResearch in order to obtain a not-regulated IRB determination.
    
4. Signed copies of required Memoranda of Understanding.

The CBR may provide letters of conditional approval, such as for grant applications, when one or more of the above elements has not yet been completed. However, such conditional approval will not permit distribution of CBR resources.

D. Recording approved uses. The CBR will maintain records of the uses for which CBR resources may be distributed. CBR staff will provide investigators with copies of any such records relevant to their approved uses. In addition, the CBR maintains records of

• The HUM number for the approved use
• The name of the Oversight Committee
• Relevant Memoranda of Understanding

E. Distribution of biospecimens. CBR staff will distribute requested biospecimens, and will track these distributions, after receiving the following information from the requestor:

• The approved uses for the resources
• The HUM number for the approved use
• The specific resources being requested, with reference to Sample IDs, including alternates if necessary
• Any sample processing requirements
• Shipping address

F. Distribution of biospecimen-associated and biospecimen-derived data. Requested data accommodated by the CBR laboratory information management system (LIMS) will be transferred to approved users. CBR staff will provide approved users with available information about how CBR-resource data accommodated by systems other than the CBR LIMS can be accessed.

G. Amendments. Investigators must contact CBR staff or CBR Programs to seek approval for changes to the scope of a previously approved project (e.g., any change to hypothesis being tested, or to type, number, or quantity of biospecimens sought), via a new Use Proposal, which references the first. CBR staff will route the amendment to the appropriate Oversight Committee(s) for review and approval, as necessary. No distributions will be made beyond the terms of the documented approval. IRBMED amendments may also be necessary. IRB approval of amendments can be sought contemporaneously with CBR and/or CBR Program approvals. CBR staff and requesting Study Team staff will work together to develop the IRB amendment as necessary. Distributions will take place when all necessary approvals are obtained. 

H. Suspension or termination of committee approval. The CBR Director may, after exhausting reasonable efforts to resolve perceived investigator compliance issues, suspend distribution of CBR resources to the investigator. Any such case will be brought to the CBR Advisory Committee for resolution no sooner than seven days and no later than forty-two days from the date of suspension. In resolving any such issues, the Advisory Committee will follow institutional policies and procedures and report cases to other institutional entities, including IRBMED as appropriate.

45 CFR Part 46 

University of Michigan Medical School Policy for Governance of University of Michigan Medical School Research Biorepositories

A. Original Approval Date: 03/10/2015

B. Revisions

1. 05/19/2015: Reformatted with no substantive changes.
2. 06/15/2017: Scope of this policy harmonized with that of the CBR Certificate of Confidentiality; removed references in procedures section to specific actions in the LIMS that are no longer being used.
3. 03/19/2018: Minor clarifications made in §§IV(B), V(B)(4) and V(E).
4. 6/18/2020: Updated title Medical School Governing UMMS Research Biorepositories Policy (“Research Biorepositories Policy”) throughout; Added permission for CBR Director to route certain multi-collection Use Proposals towards one Program vs. another (§IVB); Divided §B into two sections, creating a new §C Approvals and Distributions; added clarifying language throughout; added clarifying statements in the definition of Oversight Committee.
5. 08/29/2023: Updated references, formatting, header and footer. Removed reference to CBR Governance Committee, replaced by the CBR Advisory Committee.

Signed by: Victoria Blanc, Director of University of Michigan Medical School Central Biorepository on 29 August 2023
(original signed document on file at CBR)