[Functioning of hospital Ethics Committee before and after entry in force of new Royal Decree 223/2004 on Clinical Trials with Drugs].
Correct functioning of the Ethics Committee (EC) guarantees respect to the rights of the subjects participating in clinical research. The European transposition of the clinical trial guidelines by the Royal Decree (RD) 223/2004 February 6 speeds up and simplifies the administrative procedures for the authorization of clinical trials. However, it is clear that it has meant a considerable effort on the work and administrative load of the ECs. An account is made on the adaptation procedures of the EC of the Hospital La Paz to apply the new Royal Decree and a short reflection is made on the most immediate consequences and repercussions in the EC activity.
Fernández de Uzquiano
E
E
Secretaría Técnica del Comité Etico de Investigación Clínica, Hospital Universitario La Paz, Madrid.
Lavilla Uriol
P
P
Alvarez-Sala Walther
R
R
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004358:Drug Therapy / Q000941:ethics*; D028741:Ethics Committees, Clinical; D013030:Spain