Damage to clinical research participants: the nature of the civil liability of researchers, sponsors, and institutions involved

Abstract

This study has as its theme the civil liability of researchers, sponsors, and institutions, before clinical research participants. In view of the absence of a specific formal law regulating the subject, its general objective is to identify the type of civil liability of each clinical research executing agent and, as specific objectives, to analyze the normative panorama on the matter, to clarify the main characteristics of objective, subjective, and solidary liabilities, and point out whether the rules already edited are sufficient to assign, with legal certainty, the liability of the respective executors. As for the methodology, the argumentative construction is carried out with the use of documentary and bibliographic techniques, adopting a qualitative approach. The main results indicate that, despite the incidence, in all phases of clinical research, of the norms of the Federal Constitution, of the Civil Code, and of the items of Resolution n. 466/2012 of the National Health Council, in addition to, in phase IV (post-marketing), of the Consumer Defense Code, it would be safer for everyone involved if there were a specific formal law on the subject. The conclusion demonstrates, in summary, that (a) researchers are subjectively responsible for their own actions and objectively responsible for the actions of auxiliary researchers and the technical support team; (b) the sponsor and the institutions involved respond objectively; and (c) at all stages of the research, the executing agents are jointly liable.