[The informed consent procedure in epidemiological research].
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.
Rosmini
Francesco
F
Laboratorio di Epidemiologia e Biostatistica, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma. rosmini@iss.it
Scuderi
Gabriella
G
D002986:Clinical Trials as Topic / Q000941:ethics; D016021:Epidemiologic Studies; D017408:Guidelines as Topic; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D007558:Italy; D016743:Mental Competency; D011364:Professional Practice / Q000941:ethics / Q000592:standards; D012106:Research / Q000592:standards; D014342:Truth Disclosure