title: [Obtaining informed consent and resorting to ethical committee in clinical and epidemiological research in Italy. A survey].
abstract: 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.
authors.affiliation: Centro nazionale di epidemiologia, sorveglianza e promozione della salute, Istituto superiore di sanitá, viale Regina Elena 299, 00161 Roma. rosmini@iss.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Rosmini
authors.forename: Luigina
authors.initials: L
authors.lastname: Ferrigno
mesh_terms: D004813:Epidemiology / Q000941:ethics*; D028741:Ethics Committees, Clinical; D006801:Humans; D007258:Informed Consent; D007558:Italy; D012106:Research / Q000592:standards*; D011795:Surveys and Questionnaires