Evaluation of the written informed consent form in clinical trials

Purpose: To assess the quality of the written informed consent form (WICF) in clinical trials. Material and methods: Retrospective observational study was performed on 50 WICF of clinical trials started between 2010 and 2011. The quality of the content of the WICF was assessed using the Guideline for Good Clinical Practice'' contained in the CPMP/ICH/135/95 of the European Medicines Agency. Legibility indexes were applied to the WICF. Results: The WICF was correct in all aspects in 10% of the clinical trial; five sections were correct in all WICF: trial involves research'', trials goals'', participation is voluntary and the subject may withdraw at any time without penalty'', study personnel with access to medical records'' and documents that identify the patient are confidential''. Aspects less present were the subject's responsibilities'' and available alternatives''. All WICF required clarification by the Ethics Committee (EC), with a mean of 4.24 (SD = 1.87) changes per WICF. The WICF showed good results in the indices of readability. Almost all (98%) of WICF were considered with an acceptable readability. Conclusions: Compliance with different aspects that must appear in the WICF is high. Aspects to improve are the subject's responsibilities and available alternatives to the clinical trial. The complexity of reading the WICF is suitable for the average population. The review of the WICF by the EC guarantees the access to comprehensive and appropriate information. (C) 2012 SECA. Published by Elsevier Espana, S.L. All rights reserved.