The Ethics Committee for Research with Medicines, Health Products and Clinical Interventions (CEIm, from the acronym in Catalan) of the IRIS-CC gets ready to start its activity. In this first stage of the project, a total of 30 professionals from the different institutions that constitute the IRIS-CC have been selected in accordance with the regulations established by the Ministry of Health. The CEIm will be under the umbrella of the Clinical Trials Unit of the IRIS-CC, and Laia Ferré, head of the Allergology Unit at Althaia, will be the president.
The documentation to accredit the future IRIS-CC CEIm at the Generalitat de Catalunya is currently being processed. The CEIm will be an independent body with the main purpose of ensuring the protection of the rights, safety and well-being of the subjects participating in a biomedical research project and that these projects are carried out with guarantees and in compliance with good clinical practice in accordance with current legislation. In this regard, it will assess the methodological, ethical and legal aspects of all research projects involving patients, health data or biological samples from patients. Researchers wishing to launch a clinical research project must therefore have a favourable opinion from the CEIm, which is currently external.
In order to start working on the requirements that will have to be implemented as CEIm, a training course was held last October at the Hospital Sant Joan de Déu de Manresa. This training, aimed at the members of the future CEIm, focused on the functions of this body, discussed aspects related to the methodology and ethics of the clinical studies that will be analysed, and exercised the necessary skills for the evaluation of research protocols.
The course, organised by IRIS-CC and the Fundació Dr. Antoni Esteve, included plenary lectures and group work on practical exercises, with a total duration of 16 hours.