ETHICS COMMITTEE AND CLINICAL TRIALS

The clinical trial of new drugs is the first main step for the development of new therapies against new diseases or illness which tend to become chronic and/or debilitating; furthermore, it is necessary to evaluate the efficacy of a drug, the risks it implicates, and definitively, decide if it is appropriate to make it available for the population.

The article 32 of Italian Constitution says as follows: “The Republic protects the health as a fundamental right of the person and as interest of the community, and guarantees free medical treatments to indigent. Nobody can be forced to a particular health treatment unless required by law. Law can never violate the limits imposed by respect for the human being”. In light of this article of the Constitution, the green light to lead a clinical study in Italy, can take place just after the promoting of the experimentation has earned the authorization of the competent authority, the Ministry of Health (that is the Italian Institution of Drug), and it has gained a positive opinion from the Ethics Committee to whom is referred the experimental centre, generally hospitals of IRCCS (Research and Treatment Institution of Scientific Nature).Moreover the AIFA (Italian Medicin Agency), is provided of an operational unity called National Observatory on Clinical Experimentation (OsSC), whose role is to monitor clinical experimentations approved by Italians Ethics Committee.

In this article we will try to better understand  how is structured an Ethics Committee and how it works.

What is an Ethics Committee?

It is an independent entity formed by both healthcare professionals and not, with the task of evaluate the protocols of every experimentation, from a scientific point of view, ethical and of the ethical and economical feasibility. For its decisions and activities it refers to the Helsinki Declaration of 1964, complying with the laws of “Good Clinical Practice”, to national and international laws and, where it is possible, to the recommendations of Bioethics National Committee.

In Italy you cannot lead any experimentation on man, unless this has been evaluated and approved by an Ethics Committee. Today there are more than 200 of them, placed in hospitals and Local Health Companies (ASL).

What are the tasks of the Ethics Committee?

 Referring to the realization of the directive 2001/20/CEE, related to the application of Good Clinical Practice, in the executions of clinical experimentations of drugs for medical use, in 2003 has entered into force the administrative order on clinical experimentation that has highlighted different critical points on which the Committee must focus the attention when it examines the protocol of a clinical study.

In other words:

• To control the evolution of studies, verify that the protocol is complete in all its sections, evaluating correctly the benefits and the risks of the drug that is being studied. Moreover, it has to evaluate if the end-points indicated in the protocol are appropriates in order to measure the achievement of the objectives.
• To promote the information and the vocational training for doctors and patients, in order to provide them accurate and appropriate information, so that the person could express an aware agreement, and without being influenced; all this is made to give opinions and indications in case of specific applications, for either individual (in case of uncertainties about treatments to adopt), or generic level (in case of you have to take a decision on groups of patients);
• To verify the economic coverage of finances linked to experimentation;
• To verify that in the protocol of experimentation is guaranteed the right of diffusion and publication of results from experimenters, independently by the opinion of the promoter, even if the results of the study are negatives, and in compliance with applicable laws on  confidentiality of sensitive data and intellectual protection.

What are the essentials of an Ethics Committee?

 The main prerequisite that allows an Ethic Committee to work correctly is to be truly independent. At least a half of the members must not be dependent from the organization, the experimenter must not participate to the vote of the committee on the project and the members of the committee must not have interest conflicts on the experimentation.

The second requirement is related to the multidisciplinary aspect of the committee, and thanks to its competences covers every aspect of Bioethics. For this reason, it has to include at least two clinicians, a doctor (or a pediatrician if minors are involved), a biologist, a statistician, a pharmacologist, a pharmacist belonging to the company (or belonging to the Regional health caring service), the chief medical officer( or the scientific director or a manager of the Councillor of the related healthcare), an expert in the legal and insurance field (or a coroner, an expert in bioethicist and a representative of an association for patient protection).

If the study is a single institution type, which means that it involves a single experimental centre, it is the job of the Ethics Committee to which it refers, to express study’s opinion (Article 6, law 211/2003). In case of multi-centre experimentations, more experimental centres involved, the documentation will be sent to all the ethics committees of the centres which participate to the study, identifying one of them, as the coordinating study centre.

The Unique Opinion will be sent both to the promoter of the experimentation and to the other ethics committees of the satellite experimental centres. These have a period of 30 days, to accept or decline the participation to the study.

Dr. Claudio Pio Clemente