The National Ethics Committee: a truly valuable asset for clinical trials?

Advances in biomedicine, increased patient autonomy, and higher average life expectancy, have contributed to raising a multitude of questions relating to Clinical Ethics. Though these aspects stand on their own, national or community-level legislation that is unable to meet Ethical demands, or satisfies them only partially, it will never be able to satisfy aims and interests of a rapidly changing society. The Ethical protection of the individual in the context of life and health has been entrusted to independent, impartial bodies: Territorial Ethics Committees. In 2015, Minacori et al1 posed the following question: Research Ethics Committees and clinical research in Italy: where are we going? After analyzing the Italian legislation regulating Ethics Committees and their practices, the authors noted that though the November 2012 Law had harmonized Territorial Ethical Committee activities at a national level, it neglected to address certain critical points such as the differing deadlines by which the Committees were required to present their opinions, and the drastic reduction of the Committees themselves which had, in fact, hampered their activity. What’s more, problems arose from the need for Committee members to receive specific training2 and delays in presenting opinions in research institutes extraneous to those in which the Ethical issue had originally arisen.