Focus on the Activity of a Local Ethics Committee in Italy

Abstract

Background: The continuing evolution of medical treatments and the loss of neutrality of medicine with respect to morality of human values have represented the major tracking elements towards settings of sharing of choices between society and medicine. Several concerns have been raised upon links between pharmaceutical corporations and researchers. Moreover, being in a learning environment, we must pay even more attention to these items because students appear to be at risk for unrecognized influence by marketing efforts. The aim of this study is to focus on the activities of a local ethics committee (LEC) and the characteristics of the protocols discussed in an Italian LEC during a three year period (2001-2003).

Methods: Three years of activity of a LEC were analysed by a questionnaire registering: main sponsorship, setting, technical characteristics of trials, outcome of the submission to the LEC, state of progress. Approved trials were followed-up until April 30th, 2005.

Results: A total of 345 protocols were discussed. 67.8% (n = 198) of approved protocols were submitted by a pharmaceutical corporation. 72.6% (n = 212) of studies approved in 2001 were still in progress in 2005. 91.3% (n = 73) of closed trials had a pharmaceutical corporation as their main sponsor. None of the submitted studies focused on prevention strategies.

Conclusions: These results show how important grants offered by pharmaceutical industries are, the efforts spent on therapy and the lack of investors in prevention.