LA VALUTAZIONE DELLA "ETICITÀ" DEI PROTOCOLLI SPERIMENTALI

For the evaluation of the ethics of a study, the members of the ethics committee should consider all parts of the research protocol and various ethical issues could be raised. The ethical codes of conduct (Nuremberg Code, Helsinki Declaration, Belmont Report, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Good Clinical Practice, etc.) are the sources of international ethics of clinical trials but also of national and European laws but not always, on specific issues, these guidelines are accepted and shared, and none of these documents provides an ethical framework for the evaluation of the studies. Referring to these sources and relevant literature on the ethics of clinical research, we consider critical to the ethics of an research protocol, the following aspects: the value and scientific validity, the selection of subjects, the balance of risks and benefits for individuals, the informed consent, the confidentiality of data, the information on new data and the final results overall, the assistance in case of adverse events, the post-study arrangements, the insurance coverage. These requirements should all be considered and satisfied to judge a clinical trial ethically justified and acceptable, even if these may not always have unanimous interpretation. In this regard it is essential that the legislation provides clear and updated provisions on specific issues, and that the primacy of the dignity and fundamental rights of persons involved in trials than any other interest is accepted and shared among the members of the ethics committee