Detection of West Nile virus RNA (lineages 1 and 2) in an external quality assessment programme for laboratories screening blood and blood components for West Nile virus by nucleic acid amplification testing.

BACKGROUND: A second Italian external quality assessment programme was run in 2011 to assess the performance of blood transfusion centres in detecting West Nile virus RNA in plasma. MATERIALS AND METHODS: Each participant received two panels containing negative samples and samples positive for West Nile virus lineages 1 and 2, some of which with a viral concentration close to or below the 95% limit of detection of the respective commercial nucleic acid amplification test assay: the PROCLEIX WNV assay or the Cobas TaqScreen West Nile virus test. RESULTS: Eleven laboratories took part in the external quality assessment programme. All of them correctly identified the positive samples with a viral concentration above the 95% limit of detection. No false positive results or pre-/post-analytical errors were observed. DISCUSSION: The External quality assessment programme run in 2011 allowed participants to assess the performance of the nucleic acid amplification test methods applied in their seasonal routine screening of blood donations. The results confirm the 95% limit of detection reported by the test kits' manufacturers for both West Nile virus lineages.

[Consulting an ethics committee, when is it necessary? Two examples]. / Ricorso al comitato etico, quando è necessario? Due esempi.

We described the indications of laws and the commitment of researchers on the decision to submit two projects regarding observational studies to the ethics committee. Out of the two studies, the first one shows problems on data confidentiality and privacy, while the other one entails a risk, even though minimum, of physical damage for the study subjects. In Italy, the laws foreseeing the submission of research projects to the ethical committee are the Code for Personal Data Protection (Dlgs 196/2003), and the Good Clinical Practice regulations for the protection of research subjects (DM 15 luglio 1997); other provisions tied to such basic laws are also mentioned in the article. The laws on the protection of personal data tend to simplify prescriptions when the research relates to public health issues; the laws on the protection of the research subject do not almost totally pertain observational studies. We concluded that the researchers are free to submit or not both projects to the ethics committee. We underlined that the sensitivity of researchers on the endorsement of the same ethical principles can be different. We would think convenient also for epidemiological research, as well for clinic research, to establish an uniform approach. The recent issuing of the Additional Protocol on biomedical research to the Oviedo Convention may provide an opportunity.

[Italian regulation on the protection of human subjects participating to clinical studies, from the Nineties to 2004]. / La normativa sulla protezione dei soggetti partecipanti a studi clinici in Italia: dagli anni Novanta al 2004.

In chronological order, and in the light of bioethics principles, the authors describe the Italian regulation which concerns the protection of human subjects participating in clinical trials from 1990 to July 2004, the related institution of Ethical Committees and the adoption of the tool of the informed consent. The publication includes the ties that have connected the Italian regulations to the European one since the beginning. During such period, the reception of the Good Clinical Practice guidelines - which occurred in 1992 first, and finally in 1997 - has led to the establishment and the fostering of such important institutions as well as to the shaping of a network of Ethical Committees working on clinical trials and coordinated at a central level. In this paper the authors examine in particular: clinical trials of medicinal products, of medical devices and of ionizing radiations. Some implications of ethics are also discussed.

[The informed consent procedure in epidemiological research]. / Procedure di consenso informato nella ricerca epidemiologica.

After a brief introduction on the beginning and subsequent developments of informed consent (IC), this paper analyses its ethical, legal, medical and scientific implications and its specific applications to epidemiological research. The aim is to highlight how IC principles should be fulfilled through different procedures responding to the ethical and scientific requirements of epidemiological research. At least two improper applications, in fact, can deprive IC of its meaning: referring to ethical principles without discernment, or following IC guidelines without critical evaluation. Attempts to improve IC procedures adapting them to specific needs and scientific developments should be evaluated carefully and without preconceptions.