1. The Royal Decree 561/1993 of April 16 establishing the requirements for the performance of clinical trials with medicines (in Spanish). Official reference: BOE, May 13, 1993: 14346–63.
2. World Medical Association Declaration of Helsinki: ethical principles for research involving human subjects. Adopted by the 18th WMA, Helsinki, Finland, June, 1964. Amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October, 2000,2000
3. The situation of clinical trials in Spain: year 2001 (in Spanish);Alés;Investigación Clínica y Bioética,2001
4. Research ethics committees and public dissemination of clinical trial results;Mann;Lancet,2002