A. Designation of Oversight Committees. Any investigator depositing materials into the CBR may request, during the onboarding process or at any later time via the CBR Director, that the CBR Governance Committee designate a committee other than itself as the Oversight Committee for any Collection(s) contributed by that investigator. The CBR Governance Committee may so designate that committee if it meets the standards established for Oversight Committees in the UMMS Tissue Ownership Policy.
B. Use Proposals. In most cases, Use Proposals will be developed in collaboration with the investigators who contributed the CBR resources of interest. Investigators interested in preparing a Use Proposal for submission to an Oversight Committee 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. 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; 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;
Signed copies of required Materials Transfer Agreements and/or Data Use Agreements.
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.
Investigators 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 timely prepared, and CBR staff can assemble any additional materials to assist in Oversight Committee review.
C. 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.
D. Distribution of biospecimens. CBR staff will distribute requested biospecimens, and will track these distributions, after receiving the following information from the requestor:
- The approved use to which the resources will be put;
- The specific resources being requested, with reference to Sample IDs, including alternates;
- Any sample processing requirements; and
- Shipping address.
E. 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 in accord with the CBR’s current technical capabilities. CBR staff will provide approved users with available information about how CBR-resource data accommodated by systems other than the CBR LIMS can be sought.
F. Amendments. Investigators may contact CBR staff 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). 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 will be notified of any amendment to CBR approval, as necessary.
G. 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 Governance 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 Governance Committee will follow institutional policies and procedures and report cases to other institutional entities, including IRBMED as appropriate.