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Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

Articoli con TAG: consenso informato

Ricerca sul materiale biologico: ritorno al futuro
Research on biological material: back to the future
<p>Research using biological specimens and health data can accelerate the understanding of many diseases and the effectiveness of preventive, diagnostic and therapeutic interventions. However, researchers have to make a great effort to guarantee respect for transparency and protection of sensitive data of patients, or more generally, of donors whose biological material is collected and stored for future research purposes. Recently, the Committee of Ministers of the Council of Europe proposed new recommendations for the use of biological materials of human origin for future research purposes. The Recommendation CM/Rec(2016)6 focuses on the safeguarding of fundamental rights of the persons, whose biological materials are stored for biomedical research, with particular regard to frail people, unable to provide consent, to guarantee their dignity, integrity and privacy. Furthermore, attention is paid to the transfer of material and data, to the transparency of access policies and to the security in the governance of the collections, in a dimension of globalization and internationalization of research that is a powerful tool to improve human health and healthcare systems.</p>
Biochimica Clinica ; 45(3) 299-304
Opinioni - Opinions
Utilizzo del materiale biologico residuo nel laboratorio clinico
Use of residual biological material in the clinical laboratory.
<p>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&#39;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.</p>
Biochimica Clinica ; 45(4) 408-411
Opinioni - Opinion