[Obtaining informed consent and resorting to ethical committee in clinical and epidemiological research in Italy. A survey].
OBJECTIVE
To describe how informed consent (CIn) and ethical review (CEt) are obtained in the Italian clinical and health research.


METHODS
survey


METHODS
6 Italian and 7 foreigner journals in the years 2001 and 2002.


METHODS
157 original or short articles, letters and case reports for which a member of an Italian institution was the corresponding author.


RESULTS
Mention in the text of CIn and CEt procedures.


RESULTS
In 42% of such studies (95% CI: 35-50%), informed consent was obtained; in 30% (95% CI: 23-37%), ethical committee approval was obtained, in 27% (95% CI: 21-35%) both had been obtained. The probability of informed consent and ethical review varied with type of data used (primary or secondary source). No significant differences, however, were noted based on the type of study population (vulnerable or non-vulnerable), the year, or the country in which the article was published (Italy or elsewhere). Keywords search in the articles text showed that ethical aspects of the study were not debated. Ethical procedures were synthetically reported as a rule, yet there were differences in their formulation.


CONCLUSIONS
The limited resorting to CIn and CEt procedures and the concision and variability of their description might depend on the plethora of the ethical, legal, editorial guidelines available for Italian researchers that partially overlap and partially present specific aspects whose interpretation is not free of niceties.
Rosmini
Francesco
F
Centro nazionale di epidemiologia, sorveglianza e promozione della salute, Istituto superiore di sanitá, viale Regina Elena 299, 00161 Roma. rosmini@iss.it
Ferrigno
Luigina
L
D004813:Epidemiology / Q000941:ethics*; D028741:Ethics Committees, Clinical; D006801:Humans; D007258:Informed Consent; D007558:Italy; D012106:Research / Q000592:standards*; D011795:Surveys and Questionnaires