Policy guidelines for the utilization of formalin-fixed, paraffin-embeddedtissue sections: the UNCSPORE experience

Paraffin blocks represent a valuable resource that has allowed investigator s to apply today's technology to address scientific questions in a shorter period of time and in more diverse populations than would have been possibl e with fresh or frozen tissue. However, in addition to being an exhaustible resource, there is concern regarding the appropriate use of these tissues, both with respect to medical or legal considerations and quality control a nd quality assurance practices. We describe policy guidelines to address th ese concerns, including: safeguards to address medical/legal and patient co nfidentiality issues, quality control and quality assurance for tissue sect ioning, processing and storage, database management for sample tracking, an d scientific review for utilization of specimens. These policies and proced ures have been developed and implemented by the University of North Carolin a (UNC) Specialized Program of Research Excellence (SPORE) in the Breast Ca ncer Immunohistochemistry (IHC) Core laboratory, in collaboration with our study pathologists, participants, and research investigators. It is our hop e that the information and experience described here may stimulate discussi on that can ultimately lead to a uniform policy for handling formalin-fixed paraffin-embedded tissues in research.