Utilization of human tissue in breast cancer research

There is currently considerable debate regarding the retention and use of human tissue for research purposes. This debate has arisen partly because of the increase in public concern about this issue, but also because of the significant advances in both biotechnology and medical informatics that have taken place in recent years. Thus, potentially significant information regarding individuals is being increasingly generated in research laboratories, and these data are often stored on computerized databases with varying degrees of security. These factors raise issues of patient confidentiality, and the balance between this confidentiality and the need for progress in biomedical science must be carefully considered.One of the fundamental issues in the retention of human tissue for research purposes is the principle of abandonment. Until recently, most biomedical researchers have viewed excess tissue that has been removed for a diagnostic or therapeutic procedure as 'abandoned', and therefore such surplus material has been often used for research purposes without specific patient consent. This approach has recently been called into question [1,2], and it is likely that informed consent will be required in the future for a broader range of research involving human biological material than has been the case thus far. This has significant implications for research on human tissue and will necessitate alterations in the way that routine consent is obtained from patients. The central concept in this approach is that patients are asked to 'gift' their tissue for research.An important distinction when considering individual specimens is whether they can be viewed as 'identified' or 'unidentified'. Unidentified specimens, which can still be associated with clinically relevant data, are either anonymous (ie no individual identifiers were recorded at the time of collection) or anonymized (ie all specific patient identifiers have been irreversibly removed from previously identified