Recent developments in genetics have furthered large-scale genetic research efforts as well as the creation of large biological banks at international, national and local levels.

The scientific value of biobanks is evident, in that the possibility of using a large number of biological samples will increase genetic knowledge and allow future studies on the same samples to be planned, which is not currently conceivable. The constitution of biobanks is of necessity based on human values; in fact, it is hoped that the progress of biomedical science and practice—which essentially depends on research involving human biological materials—can contribute to fighting diseases and improving the quality of human lives (Porteri and Borry 2008).

Nevertheless, the creation and management of biological banks raise profound ethical and legal issues concerning informed consent, confidentiality, the ownership of biological materials (and related information), access to the biobank, commercial interests and discriminatory use of the research results (Godard et al. 2002).

Sensitivity to the ethics of the issues raised by the creation and management of biobanks and by biological research in general has greatly increased in recent years, but regulations concerning the storage of human biological materials and genetic data are still evolving in most European countries; there are many variations in the definitions, scope and purposes of guidelines and legal instruments (Zika et al. 2008).

The need for a regulatory system for biobanks is clear, as is demonstrated by the efforts of committees and societies dealing with research on biological materials in different countries. In Italy, this is exemplified by the documents and guidelines of the National Bioethics Committee (Comitato Nazionale per la Bioetica—CNB), the National Committee for Biosafety, Biotechnology and Sciences of Life (Comitato Nazionale per la Biosicurezza, le Biotecnologie e le Scienze della Vita—CNBBSV), the Italian Society of Human Genetics (Società Italiana di Genetica Umana—SIGU) and the Telethon Foundation (Fondazione Telethon) (SIGU 2003; CNBB 2006; CNB 2006, 2009).

Gaps in the regulations pertaining to the collection and storage of biological materials in a biobank, at least in the European context, made the writing of local guidelines essential from an ethical point of view.

However, until very recently, the elaboration of local guidelines for obtaining, using and storing biological materials in a biobank has been an exception in Italy, as in all the European countries.

The aim of this chapter is to present a concrete experience of regulation of the ethical aspects related to the constitution and management of a biobank for research purposes in the field of neuropsychiatric disorders, as set up in an Italian institute for research and care.

The Scientific Institute San Giovanni di Dio Fatebenefratelli is a Scientific Institute for Research and Care (IRCCS) of national relevance. Its mission involves translational research (from bench to bedside) in the rehabilitation of patients with dementia or other psychiatric disorders.

A genetic and biological sample bank has been set up in the Institute. The collected biological material consists of DNA, RNA, plasma, serum, liquor and fibroblast (skin cell culture) samples.

Up to 2,500 samples have been collected in the field of neurodegenerative disorders: these come from donors affected by different forms of dementia, mainly Alzheimer’s disease. In the psychiatric field, the bank has collected 1,800 samples from donors affected by schizophrenia, depression, bipolar disorder and personality disorders. Six hundred samples come from subjects suffering from both dementia and behavioural disorders. Healthy controls have contributed almost 1,500 samples to the biobank.

The collected biological materials are used to identify genetic and/or biological patterns which could help in the early, differential diagnosis of neuropsychiatric disorders and in the discovery of novel and more precise treatment options, as well as in the assessment of genetic mutations and susceptibility genes that could be associated with the development of neuropsychiatric disorders. The peripheral tissues (plasma, serum, blood, RNA and fibroblasts) that are collected are employed in transcriptomic, proteomic and biochemical studies for the identification of biomarkers and in vitro models used for the personalisation of pharmacological and nonpharmacological therapies in patients with mental disorders.

From an ethical point of view, the biobank is regulated by the ethical code for the use of biological materials for research or experimental purposes, as elaborated by the ethics committee of the Institute (CEIOC; 21 March 2002).

The first draft of the ethical code for the use of biological material for research purposes was developed by an interdisciplinary working group that included members of the ethics committee as well as researchers from the Institute. The code was then discussed and approved in plenary meetings of the ethics committee. The interdisciplinary nature of the body developing the code guaranteed that both ethical and scientific issues were taken into consideration.