The Biosample Repository Facility at Fox Chase Cancer Center

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The Biosample Repository Facility (BRF) staff consents patients/donors for the collection of biospecimens including blood, urine, bone marrow and tissue and from large cohorts of individuals affected and unaffected with cancer. The potential risks and benefits of participation are fully explained and discussed with each potential participant through a process of informed consent and they are given multiple opportunities to ask questions and withdraw from the study. All key personnel involved in the design or conduct of the research involving human tissues have received the required education on the protection of human research participants. The collection of biospecimens for the BRF is approved by the Fox Chase Cancer Center (FCCC) Institutional Review Board (IRB).

Due to the sensitive nature of family and personal medical information, the BRF takes precautions to protect the privacy of participants. Each participant is given a unique study code. All demographic, questionnaire data and biosamples are identified by the individual-specific code number and date of collection. Additionally, blood and tissue specimens are assigned a sample-specific number at the time of collection. The sample number is printed on the label in a legible form and all references to the participant's name and address are removed. The information collected is handled according to the strict guidelines of a monitored research environment and does not become part of a permanent medical record nor is it made available to other individuals or institutions. Access to confidential information, such as names and addresses and other personal information are limited to the staff of the BRF and Population Studies Facility (PSF). Hard copies of signed informed consent forms are stored in secure file cabinets in the Facility. The FCCC computers used for storing the information are protected from inappropriate outside access by the FCCC firewall provided by the Research Computing Services Internet Working Facility at FCCC. All BRF personnel are instructed in the ethics of data access.

The BRF has a well-established system in place designed to contact patients prior to surgery. Patients coming to FCCC for pre-surgical evaluation are approached by BRF patient recruiters for consent in Pre-Admission Testing (PAT). Patients not seen in PAT prior to surgery are contacted by telephone. Each patient is asked to read and sign two documents: 1) Informed Consent Document and 2) Authorization (Permission) to Use or Disclose (Release) Protected Health Information (PHI) for Research. Over the past year, the BRF staff recruiters obtained consent from 2,193 individuals to participate, which resulted in the collection of 2,822 blood specimens and 929 tissue specimens for the Repository.

From donated blood samples, the BRF can provide whole blood, serum, plasma, lymphocytes and/or DNA for IRB-approved studies. Tissues specimens are stored in the facility as snap frozen and/or formalin fixed paraffin embedded (FFPE) specimens. Tumor samples are frequently collected together with benign tissues from the same patient. In addition to FFPE tissue sections and snap frozen tissues, the BRF offers tissue microarray (TMA) services including sections from an existing collection of TMAs and/or customized design and construction of TMAs. BRF staff can also provide immunohistochemical staining and evaluation of tissue and TMA sections.

Data on participants, including diagnosis, clinical treatments, outcomes and information on personal family histories of cancer, clinical intervention and lifestyle factors, are collected from Health History Questionnaires (HHQ) for male and female patients.. This information is stripped of all protected health information (PHI) by BRF staff and made available to IRB approved investigators in a completely de-identified format.

Collections

The BRF collects and banks biospecimens and tissues for its general collection. In addition, the BRF also processes and banks biosamples for individual investigator initiated tumor registries and clinical protocols. These targeted collections generally fall into two broad categories: 1) collections that are shared with the general collection of the BRF and 2) collections for an individual project or PI that are not shared with the BRF.

BRF oversight and process to review requests for specimens and data

Operation of the Biosample Repository is the responsibility of Dr. Denise Connolly who provides overall direction and supervision of the individuals in charge of collecting, processing and distributing the biospecimens and the epidemiologic data donated by eligible research participants. Dr. Hong Wu, a Board Certified Anatomic Pathologist, reviews all tumor tissues that are deposited in the BRF and used for TMA construction.

The BRF has a Faculty Advisory Committee (FAC) that is directly involved in the development of BRF policies and procedures to accommodate the unique resources and needs of individual investigators. The FAC meets with Dr. Connolly annually to review all issues related to the BRF and provide advice for new policies and procedures proposed for the BRF. The BRF FAC provides an annual summary report to the Facilities Parental Oversight Committee that in turn reports to Dr. Jonathan Chernoff, the Chief Scientific Officer.

The BRF acts in the capacity to collect, process, bank and distribute human biospecimens. It is clear that the biosamples obtained by the BRF will be finite in quantity. To prioritize the distribution of this limited resource, FCCC investigators interested in using the BRF resources, a Tissue Request Review Committee (TRRC) reviews investigator requests for BRF biospecimens. To obtain biospecimens, investigators are required to submit a detailed research proposal, which is first reviewed by the TRRC to ensure feasibility and availability of the requested materials. The TRRC is comprised of faculty members including Pathologists, Medical Oncologists, Basic Scientists and Behavioral Scientists. Once requests are approved, they are then evaluated by the Research Review Committee (RRC) and the Institutional Review Board (IRB) at FCCC for scientific merit. These independent methods of review help to optimize use of this precious resource. Once IRB approval has been obtained, the approved protocol is submitted to the BRF and the request is fulfilled.

The BRF was encouraged by the National Cancer Institute (NCI) to make services available to external users. External applicants are required to fill out an application (instructions are posted on the BRF website or they can contact the BRF directly for assistance). Applications are sent to the BRF's TRRC for evaluation. Priority is given to investigators who have received peer-reviewed grant support. External investigators will have access to the biospecimens once the IRB (at the requesting institute) and the BRF's TRRC have granted approval of the proposed studies. On approval of the BRF Director and TRRC, the BRF staff assembles the material from the sample library, aliquots the appropriate amount and ships to the requesting investigator. Pre-surgical serum/plasma and primary tumor samples have in the past been the most commonly depleted resource. In such cases, the following guidelines are followed: