The University Dentistry Clinic’s Drug Research Ethics Committee (CEIm) receives accreditation
The Government of Catalonia’s Ministry of Health recently approved the accreditation of the Clinical Research Ethics Committee as the Drug Research Ethics Committee.
In December 2015, a Royal Degree (1090/2015, of 4 December) was published regulating clinical drug trials, drug research ethics committees and the Spanish Clinical Studies Registry. With this decree, the Spanish state aligned the legislative framework governing clinical trials with the provisions of European Union Regulation 536/2014. The revised text introduced a series of changes with regards to the composition, infrastructure, functions and operation of the committees responsible for assessing clinical drug trials and clinical research with medical devices. Since then, these committees have been known as Drug Research Ethics Committees (CEIm).
In addition to this, the Government of Catalonia’s Ministry of Health underwent a process of restructuring in 2017 (Articles 68 and 75 of Decree 6/2017, of 17 January). Since then, the competent body for accrediting Clinical Research Ethics Committees and, therefore, Drug Research Ethics Committees has been the Directorate-General for Healthcare Organisation and Regulation.
This made it necessary to accredit the Clinical Research Ethics Committee and the Drug Research Ethics Committee, as the former will soon disappear.
The CEIm is an independent body. Its mission is to ensure that the rights, security and well-being of any human beings who take part in biomedical research projects are protected and publicly guaranteed, assessing and monitoring the methodological, ethical and legal correctness of these projects. This ethics committee is also accredited to issue opinions on clinical drug trials and clinical research with medical devices.
The main functions of the CEIm are, therefore, to assess methodological, ethical and legal aspects and issue the relevant opinion; to assess any major changes in authorised clinical trials; and to monitor the trials from start to the final report.
The CEIm must consist of at least ten members: three medical practitioners, one clinical pharmacist, one primary care pharmacist, one hospital pharmacist, one nurse, two non-health professionals (one of which must be a lawyer), a member of a patient care committee, a member of the research committee, two members from outside the institution/centre, one member with certified training in bioethics, a patient representative and a user support representative.
In the case of the committee at UIC Barcelona, the president is Dr J. Manuel Ribera, the vice-president is Dr Pau Ferrer and the technical secretary is Noelia Nogales. These are the other members of the committee.