Biospecimen Access and Utilization Policy

The University of Chicago Comprehensive Cancer Center (UCCCC)

Applicable Regulations & Guidelines:

1. All Human Tissue Resource Center guidelines including, but not limited to case law (Catalona vs Washington University) that ALL tissues collected using resources administered by the institution belong to the institution, regardless of the mechanism by which they were collected.
2. Report of the Biospecimen Collection and Allocation Working Group (9/30/11)
3. UCCCC Biobanking Policy

4. NCI Best Practices for Biospecimen Resources, March 2016 https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf

Definitions:

Biobank: Broad collection protocols for which the principal aim is to collect and store biospecimens for future undefined scientific purposes and are not linked to specific scientific or clinical aims in a research grant or clinical trial

CBRC: Cancer Biospecimen Review Coordinator

HTRC: Human Tissue Resource Center

Other biospecimen collection protocols: Biospecimen collection and storage protocols directly linked to specific aims of a clinical trial or research project

UCCCC Biospecimen Committee: Faculty committee responsible for all UCCCC biospecimen policies and procedures.

Background:

Cancer biospecimens are collected by UCCCC investigators for a variety of purposes to support their research. These broadly fall into two categories, limited collections for a specific project or trial, and broader biobanks for undefined future research. Regardless of the protocol’s purpose, the collected biospecimens are an extremely valuable, but limited resource. Additionally, a number of translational investigators desire access to biospecimens, but may not be affiliated with any collection protocols.

In order to support a broader range of translational cancer investigators, create equitable use of biospecimens, and assure that use of biospecimens is scientifically justified, a biospecimen access policy is necessary.

It is recognized that individual UCCCC PIs have created a number of biospecimen collection protocols, and as such these PIs have unique responsibilities and rights to collected biospecimens. Nevertherless, and as per case law, all collected biospecimens belong to the institution and the PI does not have perpetual exclusive access or any veto rights over how tissue will be distributed.

Scope: All biospecimen collection protocols for which a UCCCC member is the PI

Policy Statement:

1. 1. The UCCCC Biospecimen Committee will have ultimate authority to determine whether a collection protocol is defined as a “biobank” or “other biospecimen collection protocol.”
   2. Biobank protocol biospecimen withdrawal must undergo scientific review:
      1. The CBRC will corroborate the information provided on the request on specimen availability and how withdrawal impacts overall inventory.
      2. Biospecimen use that has undergone external peer review, will only require sign-off by the Biospecimen Committee Chair.
      3. Standard scientific review by Biospecimen Committee
         1. The Biospecimen Committee Chair will select at least three reviewers from the standing committee, including the PI (or co-I designee) of any relevant biospecimen collection protocol(s). Ad hoc reviewers will be used as needed.
         2. Reviewers will provide their assessment defined as “Approved”, “Disapproved” or “Revise and Resubmit Request”. Assessment will be based on scientific merit, impact on biospecimen resource and funding considerations.
         3. Investigators may revise and resubmit their proposals if recommended by the Committee. In the resubmission, they will be required to address the reviewers’ concerns specifically and how the proposal was amended. Appeals will be addressed by the larger Cancer Biospecimens Resource Committee, and the Committee’s decision will be considered final.
      4. Alternative scientific review by biobank protocol defined scientific committee
         1. The biobank PI will designate a scientific review process, which must be approved by the UCCCC Biospecimen Committee.
         2. Approvals under these processes will be forwarded to the UCCCC Biospecimen Committee Chair for sign-off.
      5. All reviews must be completed within two weeks.
   3. For non-biobanking protocol biospecimens, the PI and his/her designees will have exclusive access, but only for a specified time period from the initiation of the protocol. This period will generally be for the proposed duration of the research or associated clinical trial, must be designated by the PI, but cannot exceed 5 years. Exclusive access can be renewed, but only after review of a scientific justification by the Biospecimen Access Review Committee
      1. During the period of exclusivity, additional review for tissue access by the Biospecimen Access Review Committee is not required.
      2. Once exclusive access expires, these biospecimens and the associated protocol will be designated as “biobanks” and will become broadly available, but subject to any restrictions placed by the consent and the IRB.
   4. If a biospecimen protocol PI leaves the institution without transferring responsibility to another PI or otherwise relinquishes responsibility for the protocol, including allowing IRB approval for the protocol to lapse, the UCCCC Biospecimen Committee will inform the HTRC director who will take responsibility for the tissue and assure that it is as broadly available as possible.
   5. HTRC staff are responsible for handling the transfer of the biospecimens to the investigator. The investigator will complete a form upon transfer stating their compliance with Biospecimen Resource policies, including protecting patient data, agreeing not to distribute the biospecimens to other parties without prior approval, agreeing to acknowledge appropriate institutional Shared Resources and supporting grants, and confirming that they will publish or provide public information about the project outcome according to applicable NIH policies.