RT Journal Article
SR Electronic
T1 What is the role of ethics committees after Regulation (EU) 536/2014?
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 186
OP 188
DO 10.1136/medethics-2015-103028
VO 42
IS 3
A1 Carlo Petrini
YR 2016
UL http://jme.bmj.com/content/42/3/186.abstract
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.