Every human tissue collected from surgery or biopsy is formalin-fixed and paraffin-embedded (FFPE). A huge quantity of human tissues is preserved in hospitals, and it is possible to estimate that in Europe about three hundred million new specimens of tissues are stored in archives every year. These archive tissues (AT) represent any type of even rare pathological lesions with a number of cases sufficient for any possible study. Frequent evidence of acquired resistance to the new targeted therapies has posed clinicians new issues to be addressed, such as the need to go back to patients’ tissues. Increasingly more often we have to use ATs because of clinical research, which is now starting to be an integrated process with applied medicine. We cannot separate clinics from clinical research, it is a unique entity. This creates new necessities such as better quality ATs, more standardized methods, a careful choice of the tissues, and a better organization. The pathology archives of hospitals are clinical biorepositories that are different from a research biobank. The major difference is related to the clinical purpose of these archives; even though this may not seem to be an obstacle to their utilization for research purposes, it is perfectly fitted with the most recent necessities of a kind of clinical research that is strictly related to medicine and perfectly integrated into it. The use of AT biorepositories represents a peculiar type of tissue as a source that also needs a different bioethical approach.
