28 September 2012
The document deals with the ethical problems of randomised clinical trials on ill or injured patients, adults or minors, who are unable to give their timely informed consent. These are specific situations for which treatment exists but which is not very effective and not able to improve the prognosis. To take away the possibility of clinical trials from these subjects would mean on the one hand to reduce the hope that they might benefit from it and that their illness might be treated, and on the other to stop the therapies available from being improved for patients in the future too.
In the light of the analysis of the international and Italian regulations, the NBC considers a number of solutions emerging in this practice (reference to the members of the family and carers, opinion of the ethical committee, appeal to the state of necessity), showing their limitations.
In stressing the absolute need to safeguard the subject’s rights, safety and wellbeing, the Committee justifies the licitness of clinical trials in emergency situations, should the patient be unable to give his/her valid informed consent and in the absence of a legal representative, in specific conditions: the approval of a protocol – based on strong experimental evidence – by a national ethics committee set up ad hoc, independent, made up of doctors and nurses working in the specific sector, jurists, forensic scientists, patient rights representatives and bioethicists; the ascertainment of any possible desire to the contrary previously expressed by the patient; the request for consent deferred by the patient or his/her legal representative; the publication of the results of the trials to avoid unnecessary duplications.