Current functions of Italian ethics committees: a cross-sectional study.
BACKGROUND
The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion at a European level.


METHODS
A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.


RESULTS
Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.


CONCLUSIONS
A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models.
Caminiti
Caterina
C
Azienda Ospedaliero-Universitaria di Parma – Research and Innovation, Parma, Italy. ccaminiti@ao.pr.it
Diodati
Francesca
F
Gatti
Arianna
A
Santachiara
Saverio
S
Spinsanti
Sandro
S
D003430:Cross-Sectional Studies; D003657:Decision Making / Q000941:ethics; D028744:Ethics Committees, Research / Q000458:organization & administration*; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D007558:Italy; D008297:Male; D024382:Professional Role; D013647:Task Performance and Analysis