Genetic research: the role of citizens, public health and international stakeholders

Background: Genetic research has become an indispensable instrument for medical research, and the subjects involved have both divergent and convergent interests. Objective: The possibility of having more detailed genetic information undoubtedly offers benefits for the health of the subject, but could also pose risks and make the subject vulnerable to discrimination. Methods: The scientific community has viewed very favorably the public health utility of family history, in which data from a family whose members suffer from chronic pathologies is collected and filed, in order to develop a sort of “stratification of family risk.” Even though in the last decade the scientific and juridical literature has contributed greatly to the topic of biobanks, the perplexities that continue to surround this theme give the idea that current ethical protocols on research are inadequate. Results: Researchers, citizens, International stakeholders, mass media, Public Health and Governments play a key role in genetic research. It is obvious that the methods used for genetic research do not present intrinsic risks; they are much less dangerous than other activities of diagnosis and research. Before authorizing a research project, it is important to reflect on the responsibility and transparency of the studies to be conducted, and on the impact they may have on the interests of public health. Conclusion: We believe that the highest priority need is to develop a common language on the theme, as is the case in the sphere of clinical experimentation where rules of good clinical practice, albeit at times conflicting, have led to uniform convergences in the scientific world on the points to be actuated

Training of Ethics Committee Members

Research Ethics Committees (REC) carry out the important task of humanizing clinical trial. While current italian and international legislation dedicates considerable attention to REC composition with consensus on several vital guidelines no such univocal guidelines are available for REC training in Europe

La responsabilità amministrativa del medico dell'azienda ospedaliera

La responsabilità amministrativa del medico dell'azienda ospedalier

Le implicazioni bioetiche e medico-legali degli alimenti funzionali: l’esigenza di un coinvolgimento del Comitato Etico nella sperimentazione

E’ esponenzialmente aumentato, negli ultimi tempi la diffusione e il consumo dei prodotti salutistici, di conseguenza le industrie farmaceutiche stanno sviluppando nuovi componenti atti ad agevolare ed integrare l’uso di queste sostanze con la farmacopea attualmente utilizzata. L’intento di dimostrare effetti sulla salute deve, tuttavia, garantire al consumatore che le indicazioni di questi prodotti si basino su elementi scientifici generalmente accettati; si evidenziano i dati presi dal portale dell’AIFA dove sono presenti ventisette studi sponsorizzati aventi ad oggetto integratori alimentari, probiotici e prebiotici, in varie fasi di sperimentazione del 2006 al 2009. Il compito principale del Comitato Etico, ispirato ai copiosi riferimenti normativi vigenti in Italia, è quello di autorizzare la sperimentazione clinica di nuovi farmaci, di ogni sostanza o associazione di sostanze avente proprietà curative o profilattiche delle malattie umane allo scopo di ripristinare, correggere o modificare funzioni fisiologiche. Lo scopo del presente lavoro è quello di analizzare la normativa e le procedure di immessione, diffusione e utilizzazione di queste sostanze