In brief

On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.

The National Ethics Committee, which replaces the Ethics Committee of the NIH, is responsible for clinical trials and performs the functions of the territorial ethics committees as well as those relating to research bodies and public bodies of a national nature.

The establishment of the National Ethics Committee is part of the reform of the organization of ethics committees and the regulatory framework for clinical trials, also for the purposes of adapting to the provisions of Regulation (EU) 536/2014, which will apply from 31 January 2022.