Libertà di scienza, ricerca biomedica e comitati etici. L'organizzazione amministrativa della sperimentazione clinica dei farmaci

In the presence of a science and technology characterized by the indefinite increase of the capacity to realize new purposes, a question tied to the complex relation between science, technology and society arises ever increasingly more often: Is scientific research (its aims, the manner in which it is performed, its acquisitions and its applications) in itself neutral and therefore free to be carried on in any direction, or is it necessary to make scientific inquiry subject to an assessment on the strength of the irrepressible link between freedom of science and safeguarding of the person? And, in the second case, what might be the instruments (including organizational) to ensure the proper balancing of scientific freedom with the need to guarantee basic personal rights? These questions are all the more cogent in a context highly conditioned by the logic of the market, tied to the private appropriation of knowledge as a conformational factor of scientific inquiry itself, in which development ‘does not derive from the technology per se’ and, therefore, innovation is not dictated just by a limitless utilization of freedom of research and the power of technology, but penetrates into society, above all in the name of the will to make possible the maximum commercial use of innovation. It is along this borderline that the freedom of science and of knowledge so- metimes ends up being questioned as one of the fundamental values of the individual, notwithstanding the constitutional guarantees with which it is surrounded (articles 9 and 33 of the Constitution). This question concerns biomedical research in an even more pronounced form owing to the immediate link with clinical testing and practice. The question of whether a regulation of science is imaginable and what might be the ambit thereof is posed again in this case in an immediate manner: What might be the public interests susceptible to such protection to be placed efficaciously as counter limits of a freedom so profoundly connected with the constitutional system? Can the need to prevent damage or harm, concretely likely, to others constitute the principle for limiting or abolishing the independence and freedom of the scientist and, therefore, his power of decision? What might be the organizational forms and procedures suitable for defining these counter limits in concrete terms? Through the analysis of the subjective profiles of biomedical research (the procedures for verification of the adequacy of the research scheme as necessary organizational modalities between self-regulation and normative regulation and the guarantees of the subjects involved in experimentation and consent in experimentation) and of the administrative organization of the same research (with particular reference to the regulation of ethics committees) the work reaches the conclusion that it seems the regulation of ‘dubious’ science and, therefore, the conformation of the single decisions cannot be entrusted to the acceptance of super principles, the nature and content of which and those to whom they are addressed may change depending on variables difficult to foresee or control, as such able to bear a priori on the lawfulness of science to explore everything possible. It seems that regulation, to the extent to which it appears configurable and admissible, will have to be tied, first of all, to agreed procedures for preliminary scientific risk assessment, able to allow a rational de- cision in conditions of uncertainty concerning the future state of things.