Italy: a Coordination of the Ethics Committees

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IstitutoSuperioreSanita

Last year saw the installation in Italy of the new Centre for the Coordination of Italian regional ethics committees for clinical trials of medicines and medical devices for human use: the Centre is based at the Italian Medicines Agency and comprises 15 members.

On 24th July 2018 Maria Luisa Moro (Director of the health and social affairs agency of the Emilia-Romagna region) and our Academician Carlo Petrini (Chairman of the Ethics Committee and Director of the Bioethics Unit of the Istituto Superiore di Sanità, who had been unanimously designated as the Centre’s President but declined for institutional reasons) were unanimously elected President and Vice President respectively. The members remain in office for three years and can be re-appointed.

The Centre’s principle task is the publication of directives aimed specifically at ensuring homogeneity in the procedures relating to deadlines laid down by regional ethics committees and in their observance. It may also, at the request of individual committees, offer support and advice relating to the ethical aspects of clinical trials of medicines for human use (Article 7 of EU Regulation 536/2014). The Centre will also be responsible for monitoring the activities of regional ethics committees and reporting instances of failure to comply with the terms of the Regulation to the respective coordinators. It will also define the basic terms and conditions that must always be included in the contracts governing clinical trials drawn up between the promoter of the trial and the clinical facility involved.

Below and article of prof. Carlo Petrini about the Italian situation.