Policies & Procedures

BRF Process

The Biosample Repository Facility (BRF) staff consents patients for the collection of biospecimens including blood, tissue, urine, saliva and effusion fluids. The BRF also consents people without known cancer for donation of blood, typically to serve as normal controls. Patients coming to FCCC are contacted by telephone or approached by BRF patient recruiters for consent in Pre-Admission Testing (PAT) or at clinic visits. The potential risks and benefits of participation in the BRF are fully explained and discussed with each participant through a process of informed consent. Participants are given multiple opportunities to ask questions and may withdraw from the study at any time. Each patient is asked to read and sign two documents: 1) Informed Consent and 2) Authorization (Permission) to Use or Disclose (Release) Protected Health Information (PHI) for research. Participants are also asked to complete a health history questionnaire. Collection of biospecimens and associated data for research is approved by the FCCC Institutional Review Board (IRB). 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.

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 participant identification (ID) code number that is associated with all demographic, questionnaire data and biospecimens. In addition, all biospecimens are assigned specimen-specific ID numbers at the time of collection. Each sample barcode and ID number is printed on the label in a legible form and all participant identifiers 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 PHI are limited to the staff of the BRF and the Population Studies Facility (PSF). Computers used for information storage are protected from inappropriate outside access by the firewall provided by the TUHS IT Security Department. All BRF personnel are instructed in the ethics of data access.