How to Deal with Regulation EU 536/2014 on Clinical Trials? A View from the Hospital Clínic Barcelona Research Ethics Committee

Abstract

A new legal development came into action on January 2016 to align the tasks and workflow of Research Ethics Committees (REC) with the Regulation EU 536/2014. We will show how our Hospital and our REC has adapted to the new rules. There are 125 REC in Spain. For each study, only one REC is responsible for issuing an opinion on the clinical trial (CT) application dossier. The RECs of other centres involved in the study are not entitled to contribute to the evaluation. This new paradigm implies that the REC responsible of the evaluation has to deal with local issues of each centre like investigator and facilities suitability. This new system requires a considerable harmonisation effort in order to secure that a reasonable consistent approach is adopted and that criteria for the evaluation of CT do not substantially differ between RECs. In early 2015 AEMPS set up a Clinical Trial Coordination Group (CTCG) chaired by the Head of Human Drugs Sector of the AEMPS and one member of each of approximately 25 RECs with higher experience in the evaluation of CT applications. Monthly meetings are held. We have created a Thecnical Secretary for Supporting the Research (TSSR) which includes a multidisciplinary working group in charge of:−Supporting the signature of the facilities suitability form of our centre.−Hospital Clínic research activity register.−Methodology, regulatory and ethical support to the investigators.−Supporting to the Technical Secretary of the REC.−Accelerating contract signature and other administrative procedures. The TSRS will allow us:−To know about the research activity in the Hospital, although our REC is not the one that evaluated the dossier.−To speed up bureaucratic procedures.−Keep the budget for the REC activities.