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:
- 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;
- A description of the CBR resources approved for distribution under the use, including but not limited to their type, number, and quantity;
- Documented approval by a federally registered Institutional Review Board or other appropriate ethics committee;
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.
- 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.