Although the issue of informed consent for human research biobanks has been analyzed in a number of publications, revolving on speculative as well as empirical perspectives, it remains a critical matter within the ethical community globally. Considering that ethical requirements for information and consent vary widely, depending on the international, regional and national regulatory landscape, the development of a harmonized model of informed consent for research biobanks is today a huge challenge. After the analysis of the informed consent issue in pediatric biobanks, this chapter describes the variability of regulations addressing adult research biobanks on a global, regional and national level by focusing on the several consent standards reported into the literature. Afterward, this chapter proposes a template and procedure for developing unified informed consent forms for the storage and use of human specimens for research purposes, based on the experience of an inter- disciplinary group of professionals collaborating with a multispecialty biobank in the context of a public university hospital. Although local, this experience and the related consent template and procedure could serve as models suitable in similar research environments.
Research biobanks: A unified model of informed consent to collect, store, distribute and use human biological materials and data from adults / E. Salvaterra, L. Lecchi, S. Giovanelli, B. Butti, M.T. Bardella, P.A. Bertazzi, S. Bosari, G. Coggi, D.A. Coviello, F. Lalatta, M. Moggio, M. Nosotti, A. Zanella, P. Rebulla (BIOMATERIALS--PROPERTIES, PRODUCTION AND DEVICES SERIES). - In: Regulating Biobanks in Humans: The Use of Adult and Children Biomaterials for Clinical and Research Purposes / [a cura di] E. Salvaterra. - [s.l] : Nova Science Publishers, 2014 Apr. - ISBN 9781631176166. - pp. 47-62
|Titolo:||Research biobanks: A unified model of informed consent to collect, store, distribute and use human biological materials and data from adults|
|Settore Scientifico Disciplinare:||Settore MED/21 - Chirurgia Toracica|
Settore MED/08 - Anatomia Patologica
|Data di pubblicazione:||apr-2014|
|Tipologia:||Book Part (author)|
|Appare nelle tipologie:||03 - Contributo in volume|