Background Informed consent is a requirement for clinical trials.
Purpose Assessing the quality of the written informed consent form (ICF) that a patient signs to participate in a clinical trial.
Materials and methods Retrospective observational study. 50 ICF of clinical trials initiated in the HUP La Fe were chosen between March 2010 and January 2011. To assess the quality of the ICF, the ‘ Good Clinical Practice Guideline’ contained in the CPMP/ICH/135/95 the European Medicines Agency was used.
This guide contains 20 aspects. Data on the length and terminology were collected. In addition, the clarifications requested by the ethics committee (ECs) for these ICFs were reviewed.
Results Of the 50 ICFs analysed, 10% had all 20 aspects of the assessment correct. None of the ICFs were incorrect all sections. Four sections were correct in all ICFs: ‘trial involves research,’ ‘trials goals’, ‘participation is voluntary and the subject may withdraw at any time without penalty’ and ‘documents that identify the patient are confidential’. The aspect least mentioned in the ICFs was ‘the subject’s responsibilities' (50%). Understandability of the objectives, risks and inconveniences of the trial, the conditions under which it is to be conducted being informed of the right to withdraw from the trial at any time were properly included in more than 90% of the ICFs. These aspects are contained as requirements of Directive 2001/CE/CE. Aspects of terminology and extension were weak (34 and 33%) All ICFs required clarification by the ET, with a mean of 4.46 changes per ICF (CI95%: 3,82-5,10).
Conclusions Compliance with different aspects that must appear in the ICF is high. Aspects to improve are the structure and terminology, as they are essential to a proper understanding of the study. The evaluation of the ICF by the EC is of great importance to preserve patients' safety and rights.
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