Citation

Casella C, Buccelli C, Niola M, Di Lorenzo P. Rivista Italiana di Medicina Legale e del Diritto in Campo Sanitario 2020; 42(1): 39-55.

Copyright

(Copyright © 2020)

DOI

unavailable

PMID

unavailable

Abstract

The work begins with the consideration that if on the one hand there is the unanimous agreement regarding the mandatory and binding nature of the favourable opinions issued by the Territorial Ethics Committees about the ethics and the scientific nature of a trial design, on the other we are still well away from reaching a sufficient degree of agreement on the identification of their legal status. This results in a situation of alarming uncertainty among operators, which this work aspires to find some remedies to, by conducting the survey not only in the light of international and national regulations, but also at the level of significant decisions passed by judges. At this point, some considerations will be shared regarding aspects of administrative, civil and/or criminal liability of Territorial Ethics Committees, or of their individual components, in the event of injury and/or death of a participant in a trial. Finally, a few words, about the attempt, detectable at international level, of radically downsizing the number and functions (including the consultative function recently requested by the Constitutional Court on assisted suicide) of local ethics committees, because of its numerous and disturbing impacts on the individual and social level, with predictable disastrous consequences on the protection of the values and rights of people with whom research is conducted. © 2020 Giuffre Editore SpA. All rights reserved.

Language: it

Keywords

Assisted suicide; Clinical trials; Liability; Naples Charter for protection of the person in clinical trials; Territorial Ethics Committees; U.E. Regulation n. 536/2014