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Ethics

Ethics

The safeguard of donors’ rights and, in particular the rights of vulnerable populations (children, ethnic groups etc.), is the main aim of the ethical conduction of the CNESPS Biobank.
The biological materials are collected from donors according to informed consent procedures.
The CNESPS Biobank makes use of study-specific consent forms and of a “broad consent” format. This latter providing the juridical basis for the re-use of the material, delimiting the biomedical area of interest, according to the scope of the specific studies which started each collections.
To implement the Biobank, ethical and legal procedures were designed according to a critical review of existing norms and recommendations at national and international level.

International reference documentation:


- Recommendation on research on biological materials of human origin. Council of Europe Rec 4/2006. read

- CIOMS and WHO. International Ethical Guidelines for Epidemiological Studies (2008). read

- OECD. Guidelines on Human Biobanks and Genetic Research (2009). read

- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (last update, Fortaleza Brasil 2013). read


Italian reference documentation:

- Informed Consent for Biological materials for research. Italy. National Bioethics Committee and Committee for Biosafety, Biotechnology and Life Science (2009). read

- Pediatric Biobanks. National Bioethics Committee (2014). read

Italian Law

- Legislative decree on Personal Data Protection n. 196, 30 June 2003. read

- Code of conduct and professional practice applying to processing of personal data for statistical and scientific purposes. Authority for Personal Data Protection (2004). read

- General Authorization to genetic data treatment. Authority for Personal Data Protection (last issued n. 8/2014). read

- General Authorization to personal data treatment for the scope of scientific research (last issued n. 9/2014). read


Our publications in this field

Toccaceli V, Fagnani C, Stazi MA. Medical records confidentiality and public health research: two values at stake? An Italian survey focus on individual preferences. J Pub Health Res 2015.4:19-22. read

Toccaceli V, Serino L, Stazi MA. Informed consent, and an ethico-legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study. Cell Tissue Bank. 2014 Dec;15(4):579-90. doi: 10.1007/s10561-014-9431-3. Epub 2014 Mar 5. read

Toccaceli V, Fagnani C, Gigantesco A, Brescianini S, D’Ippolito C, Stazi MA. Attitudes and willingness to donate biological samples for research among potential donors in the Italian Twin Register. J Emp Res Hum Res Ethics. 2014; 9: 39-47. read

Salvaterra E., Giorda R., Bassi M.T., Borgatti R., Knudsen L., Martinuzzi A., Nobile M., Pozzoli U., Ramelli G.P., Reni G.L., Rivolta D., Stazi M.A., Strazzer S., Thijs C., Toccaceli V., Trabacca A., Turconi A.C., Zanini S., Zucca C., Bresolin N. and Lenzi L. Research Biobanks in Pediatrics: Ethical, Legal and Social Issues under the Lens of Health Professionals. In: "Regulating Biobanks in Humans: the use of adult and children biomaterials for clinical and research purposes". Elena Salvaterra (ed.). Nova Science Publishers, 2014. p. 29-46.

Salvaterra E, Giorda R, Bassi MT, Borgatti R, Knudsen LE, Martinuzzi A, Nobile M, Pozzoli U, Ramelli GP, Reni GL, Rivolta D, Stazi MA, Strazzer S, Thijs C,Toccaceli V, Trabacca A, Turconi AC, Zanini S, Zucca C, Bresolin N, Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group L. Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries. Biopreserv Biobank. 2012 Feb;10(1):29-36. read

Toccaceli V. Population based Biobanks: participants’ understanding, attitude and awareness towards donation for research. In: Biobanche ed informazioni genetiche. Problemi etici e giuridici. A cura di Faralli C., Galletti M. Aracne Editore. 2011. Pagg. 51-58.

Toccaceli V, Fagnani C, Nisticò L, D'Ippolito C, Giannantonio L, Brescianini S, Stazi MA. Research understanding, attitude and awareness towards biobanking: a survey among Italian twin participants to a genetic epidemiological study. BMC Med Ethics. 2009 Jun 16;10:4. read

Toccaceli V. La conservazione del materiale biologico umano per la ricerca: riflessioni etiche sul consenso informato e l'anonimizzazione dei campioni. In: Borgia LM, Mazzarini L, Tagliabracci A, ed. Bioetica generale e clinica Torino: C.G. Edizioni Medico Scientifiche; 2009. p.418-422.

Toccaceli V, Nisticò L, D’Ippolito C, Cotichini R, Salemi M, Stazi MA. La Banca Biologica del Registro Nazionale Gemelli. Notiziario Istituto Superiore di Sanità, n 3, Marzo 2009. p 3-7. read

Toccaceli V. Dalla conservazione del materiale biologico per il singolo studio all’allestimento di una banca biologica: aspetti legali e spunti di riflessione etica. In: Registro Nazionale Gemelli: istituzione, linee di ricerca, procedure generali e strumenti operativi di gestione. A cura di Patriarca V., Fagnani C. et al. Rapporto ISTISAN, Istituto Superiore di Sanità, Rapporti ISTISAN 07/55. p. 34-39. read

Published 28-05-2010 in Ethics , last update 21-05-2015

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