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Policies and procedures of the UNC Lineberger Comprehensive Cancer Center Tissue Procurement Facility

Tissue is only procured after the pathologist has obtained the appropriate specimen information for patient care (e.g. diagnosis, inking of margins, etc.). TPF personnel must receive the specimen or receive approval for the specimen from the attending pathologist.

No specimen is distributed to any investigator until a final diagnosis has been received from pathology. No specimen is procured unless the patient has been appropriately informed and signed a consent form for such procurement. (note: for some protocols this consent may be the same as a clinical trial consent form).

Specimens collected using the TPF consent prior to June 19, 2009 cannot be distributed for germline studies (studies of inherited characteristics). Specimens can only be collected or distributed for germline DNA studies if the investigator has obtained a separate and specific informed consent from the patient or samples that are collected after June 19, 2009.

Specimens distributed to investigators cannot be sold or shared with any third party or other investigator. If there are other collaborators on the study for which specimens are being procured, those investigators need to be listed on the original study (include information in letter of research agreement). Specimens are distributed with a unique identification number generated by the laboratory. No patient identifying information is distributed with any sample unless the investigator receives the IRB approval and it is only for samples collected after June 19, 2009.

Patient privacy and confidentiality are essential and the investigator and TPF personnel must take all precautions to ensure compliance of our policies and protect against violation of patient privacy and confidentiality. The investigator must agree to abide by policies and procedures of the Tissue Procurement Facility and sign a letter of research agreement for ethical and appropriate conduct of their research that utilizes any specimen obtained from the TPF.