Utilizzo del materiale biologico residuo nel laboratorio clinico
Use of residual biological material in the clinical laboratory.

AUTORI

ABSTRACT

Use of residual biological material in the clinical laboratory.

The clinical laboratory plays a central role in the evaluation of new diagnostic methods and procedures. It is common practice to use biological material from clinical practice for this purpose. The starting assumption is that the biological material is first of all used for the diagnostic and analytical procedures required by the medical prescription and that any further use must be subject to external authorization (Ethics Committee) and consent of the patient (where the Ethics Committee deems it necessary). Specific authorizations are required for the transfer of biological material to other researchers and/or industries. In any case, the use of the data is allowed provided that these are anonymous or aggregated. National and/or international laws and rules also govern BioBanks management; these are responsible for systematically collecting biological samples with a public service function and some of them have a research function. In all cases, it may be necessary to re-obtain or supplement the informed consent, i.e., when the study’s objectives for which the samples are to be analyzed have not been previously detailed. This Opinion paper deals with this complex and vast topic, considering that the prerequisite for using residual biological material is that was previously and adequately authorized. Some of the numerous regulations governing the use of residual biological material and sensitive data will therefore be mentioned. The purpose of the paper is to bring the issue to the attention of laboratory medicine professionals to stimulate the participation of scientific and professional associations in developing regulations and to provide tools for their optimal interpretation.

BIBLIOGRAFIA