Ethics Committees in Italy: A Survey on a Sample of Oncologists

Abstract

Aims and background The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists’ opinions on Italian EC functioning. Methods and study design A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Results Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Conclusions Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers’ opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.