title: [Consulting an ethics committee, when is it necessary? Two examples].
abstract: 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.
authors.affiliation: Centro nazionale di epidemiologia, sorveglianza e promozione della salute, Istituto superiore di sanità, Roma. rosmini@iss.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Rosmini
authors.forename: Gabriella
authors.initials: G
authors.lastname: Scuderi
mesh_terms: D003219:Confidentiality; D028744:Ethics Committees, Research; D033061:Ethics Consultation; D032984:Ethics, Research; D006801:Humans; D007558:Italy; D008499:Medical Records; D018907:Privacy; D011634:Public Health; D012107:Research Design; D035842:Research Subjects