PT  - JOURNAL ARTICLE
AU  - Carlo Petrini
TI  - What is the role of ethics committees after Regulation (EU) 536/2014?
AID  - 10.1136/medethics-2015-103028
DP  - 2016 Mar 01
TA  - Journal of Medical Ethics
PG  - 186--188
VI  - 42
IP  - 3
4099  - http://jme.bmj.com/content/42/3/186.short
4100  - http://jme.bmj.com/content/42/3/186.full
SO  - J Med Ethics2016 Mar 01; 42
AB  - EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a ‘single decision’. This raises the problem of identifying: (1) the facility designated to express this ‘single decision’ and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a ‘single decision’ by the Member State concerned. Three possible approaches to the procedures for expressing that ‘single decision’ and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option.