How does the ethical review process work in Portugal and which are the designated ethics committees?
Created in January 2005, the “Comissão de Ética para a Investigação Clínica” (CEIC) is endowed with independent technical and scientific experts who work in the dependence of the Minister of Health. During the following seven years, CEIC evaluated about 840 requests for an opinion relating to new trials and 2640 relating to requests for substantial amendments to the previously approved trials.
CEIC is a multidisciplinary ethics committee, consisting of about three dozen individuals with recognized expertise and experience in clinical trials and ethics, which meet monthly in plenary sessions under the direction of its Chairman or his Vice-chair. The Executive Committee is composed of the Chairman, the Vice-Chair and five to seven members selected from among other members of the CEIC; the Executive Committee meets weekly. The experts who evaluate clinical trials are chosen from the members of the CEIC, according to their area of expertise. CEIC has a secretariat composed by specialized technicians and administrative staff, whose procedures are properly defined.
CEIC issues this note on procedures for obtaining the single opinion for clinical trials, having in mind a clarification of the procedures.
Procedures of CEIC for issuing the single opinion:
The request for authorization to conduct a clinical trial is submitted to CEIC, with an application form, proof of payment of fees to Infarmed and with the required documentation. CEIC then triggers a number of procedures for issuing the single opinion, with a final decision taken in the plenary session.