The Medicinal Research Ethics Committee of the Quirón Hospital Group in Barcelona has adapted its procedures to the new legal regulations for clinical trials and health products (RD 1090/2015 of 4 December).
The fundamental mission of the CEIm of the Quirónsalud Hospital Group in Barcelona is to ensure that clinical research is carried out properly and the subjects participating in the research are properly protected, as well as to ensure compliance with the methodological and ethical aspects stipulated in the Good Clinical Practice Regulations currently in force in the European Union and in other legally applicable standards and guidelines, such as Royal Decree 1090/2015, of 4 December, which regulates clinical drug trials, and the Biomedical Research Act 14/2007 of 3 July, among others.
Its role and functions are defined in autonomous community, Spanish, EU and international legislation, in which it is obliged to carry out rigorous assessments and monitoring of each of the projects in terms of the methodological, ethical and legal aspects, and risk-benefit analyses of all protocols of clinical trials and studies which are planned to be carried out within the scope of the following private hospitals in Barcelona:
- Teknon Medical Centre
- Dexeus University Hospital
- Hospital Quirónsalud, Barcelona
Similarly, the legislation requires that the observational, post-authorisation studies are also evaluated by the CEIm. In accordance with internal standards, Quirónsalud Hospital Group’s CEIC in Barcelona assesses the studies to be implemented in our hospitals.
The CEIm of the Quirónsalud Hospital Group in Barcelona is governed by its Standard Operating Procedures which ensure it operates properly, meets the applicable legal requirements and has the necessary means to reach its objectives.
The committee currently has 15 members:
- 5 doctors
- 2 clinical pharmacologists
- 1 primary care pharmacist
- 1 hospital pharmacist
- 2 trained nurses (with university diplomas)
- 1 law graduate (lawyer)
- 3 members who are not healthcare professionals (including the lawyer)
Research Management Unit – CEIC Technical Secretary’s Office
Vilana, 12 - 08022 Barcelona
Tel. +34 932 906 268