April 2018: Portugal Regulatory Update

CEIC – National Ethics Committee for Clinical Research

National Ethics Committee for Clinical Research

National Ethics Committee for Clinical Research (CEIC) is the REC responsible for assessing Clinical trials with investigational medicinal products applications and also studies with intervention of medical devices. Nevertheless, CEIC may delegate this assessment to a local health research ethics committee The requirements for these ethics committees to be competent to do such evaluation have to be defined, by law, by the National Ethics Committee (CEIC).

Members of the National Ethics Committee are appointed by the Health Minister and the law has established that CEIC is independent and multidisciplinary and that all the members must declare publicly their conflicts of interest (all this information is available in the CEIC webpage).

The National Ethics Committee for Clinical Research has 35 members: a president, a vice-president, seven executive committee members and 28 other members. Members have recognized qualifications on medical sciences (medical doctors, pharmacists, nurses, psychologists), ethics, theology, epidemiology and pharmacoepidemiology, sociology and philosophy. CEIC members include also lawyers, mathematicians, laymen and a patient’s representative.
By law, and whenever necessary CEIC may ask for independent external expertise.

There are no formal training requirements for RECs members Nevertheless there are in each plenary meeting a training session in different areas. New members are trained and helped with the old ones whenever they have to evaluate clinical trials proposals.

CEICs meetings may only occur when the majority of its members are present. If a quorum is not reached at the 1st call for the meeting, a new one must be called and then a quorum is constituted as long as one third of the voting members are present.

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