Evaluation of the clinical practice of Informed Consent in clinical trials

• Published in: Anales del sistema sanitario de Navarra Vol. 26; no. 1; pp. 35 - 42
• Main Authors: Gost, J, Silvestre, C, Ezpeleta, P, Astier, P, Díaz de Rada, O, Artázcoz, M T
• Format: Journal Article
• Language: Spanish
• Published: Spain 01-01-2003
• Subjects: Clinical Trials as Topic - standards; Cross-Sectional Studies; Evaluation Studies as Topic; Human Experimentation - standards; Humans; Informed Consent - standards; Research Design - standards
• ISSN: 1137-6627

On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.