Regulatory and ethical issues on the utilization of FFPE tissues in research.

Formalin-fixed, paraffin-embedded (FFPE) archival tissues and their associated diagnostic records represent an invaluable source of information on diseases where the patient outcomes are already known. Older archives contain many unique FFPE tissue specimens that would be impossible to replicate today due to changes in medical practice and technology. Unfortunately, there is no single regulatory or bioethical standard that covers research with FFPE tissue specimens. This makes it difficult for researchers to prepare protocols involving FFPE tissues and equally difficult for Institutional Review Boards to evaluate them. In this review, focused on US regulatory policy, the application of the Common Rule and the Privacy Rule of the Health Insurance Portability and Accountability Act to research involving FFPE tissue specimens will be discussed. It will be shown that the difficulty in applying regulatory and ethical standards to FFPE tissues results not from the tissues themselves, but from the personally identifiable health information associated with the tissue specimens.