Biobanking 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 Biospecimen Access and Utilization Policy

Definitions:

Biobank: Broad collection of stored biospecimens for future undefined translational research

HTRC: Human Tissue Resource Center

Tier 1 Biospecimen Protocols: Biobank protocols incorporating multiple diseases/cancers for which the UCCCC maintains an inventory and that receive the highest level of UCCCC support

Tier 2 Biospecimen Protocols: Biobank protocols, typically for a single disease/cancer, for which an inventory is shared with the UCCCC and that receive the next highest level of UCCCC support

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

Background and Purpose:

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. For historical reasons, a number of biobanks have been created by individual faculty or disease oriented teams to focus on collections within a specific cancer. This has led to multiple cancer related biobanks of varying quality and robustness, with some disease areas having multiple investigators competing for similar specimens and other cancers having no organized biospecimen collection effort.

In order to support a broader range of translational cancer investigators, create a more representative collection of biospecimens across the cancer disease areas, create equitable use of biospecimens, and enhance efficiency of the UCCCC biospecimen banks, a limited number of more centrally aligned set of biospecimen collection protocols will be supported by the UCCCC.

Scope:

All biobanks that receive financial support from the UCCCC above and beyond the general support UCCCC provides to the HTRC.

Policy Statement:

1. The UCCCC will create a standing Biospecimen Committee with a named Chair and Vice-Chair. The Vice-Chair should be the HTRC Faculty Director and the other members must be full UCCCC members with research interests that include utilization of cancer biospecimens. Committee members should represent the breath and diversity of members and their research interests and inclusion of a patient advocate should be strongly considered.
2. Tier 1 biospecimen collection protocol PIs (or designated co-Is) must be and Tier 2 biospecimen collection protocol PIs (or designated co-Is) should be members of the UCCCC Biospecimen Committee.
3. The UCCCC Biospecimen Committee will have full authority over all UCCCC biospecimen policies and procedures and will report directly to the UCCCC Director.
4. The UCCCC Biospecimen Committee will select and approve biobank protocols for support. These will fall into two categories:
   1. Tier 1 protocols are defined as umbrella protocols which are not disease or project specific and for which the UCCCC will provide support for consenting, collection, tracking, and distribution of specimens. These will be fully subsidized for UCCCC members.
   2. Tier 2 protocols are defined as disease specific protocols that share their biobank specimen inventory with the UCCCC, and for which the UCCCC will provide support for tracking and distribution of specimens. These will receive a 30% subsidy in addition to the 10% discount already offered for UCCCC members.
5. Minimal criteria for a Tier 1 protocol include:
   1. Must support more than one cancer type or disease entity
   2. Must use the HTRC for biospecimen storage and their associated Laboratory Information Management System (LIMS) for tracking specimen details (e.g. specimen type, storage conditions, storage location, etc)
   3. Must have mechanisms for tracking
      1. consents, including whether permission is provided to obtain additional clinical information, re-contact the subject, and share specimens and data with outside entities
      2. basic clinical data including cancer subtype, stage, and subject demographic data
6. Minimal criteria for a Tier 2 protocol include:
   1. Must use the HTRC for biospecimen storage and their associated Laboratory Information Management System (LIMS) for tracking specimen details (e.g. specimen type, storage conditions, storage location, etc)
   2. Must have mechanisms for tracking
      1. consents, including whether permission is provided to obtain additional clinical information, re-contact the subject, and share specimens and data with outside entities
      2. basic clinical data including cancer subtype, stage, and subject demographic data
7. The UCCCC Biospecimen Committee will approve the standard set of specimens and the specific disease types to be collected for all Tier 1 protocols.
8. For Tier 1 protocols, collection of biospecimens beyond the standard set (e.g. fresh specimens sent immediately to an investigator’s laboratory) can be performed with Biospecimen Committee approval, unless the number of specimens is <20, in which case approval by the Biospecimen Committee Chair will suffice. The committee shall set a fee schedule for such collections.
9. The UCCCC Biospecimen Committee will provide advice to PIs of all Tier 2 protocols as to the standard set of specimens to be collected.
10. The UCCCC Biospecimen Committee will act as the scientific review committee for biospecimen requests from Tier 1 protocols. The UCCCC policy for scientific review of biospecimen distribution shall be followed.
11. The UCCCC Biospecimen Committee may act as the scientific review committee for biospecimen requests from Tier 2 protocols. In this case, the protocol PI (or their Co-I designee) should be part of the review. Tier 2 protocols may follow the alternative scientific review policy of the Biospecimen Access and Utilization Policy.
12. The UCCCC Biospecimen Committee will review the inventory and biospecimen utilization for all Tier 1 and Tier 2 biospecimen collection protocols at least annually and adjust the standard specimen and disease type collections accordingly.