Calidad y Legibilidad de la Hoja de Informacion al Paciente en Estudios con Analisis Farmacogenetico

BACKGROUND AND OBJECTIVE: Pharmacogenetic studies have become in recent years a common practice in the development of new drugs, with the need to evaluate the information and readability of Informed Consent Forms(ICFs) to ensure compliance with the recommendations set by current legislation and expert groups. MATERIALS AND METHODS: Retrospective observational study that analyzes the content of ICFs received by participants of pharmacogenetic studies approved in a tertiary hospital. To evaluate the quality of the ICFs, a questionnaire of 42 questions was prepared (Table 1) with the elements that must contain the information given to subjects, while readability was assessed using different readability indices. RESULTS: The 31.5% of the 92 ICFs analyzed showed more than 75% of sections considered in the questionnaire. Sections with lower compliance were relative to risks and benefits (41.7%) and compensation for study participation (56.1%). None of the ICFs fulfilled with less than 50% of overall sections. Regarding legibility, about 90%, have a suitable degree for the most of population based on indexes used. CONCLUSIONS: Deficiencies were found in some parts of the information contained in ICFs, while the degree of legibility was high, being necessary for future studies to establish the degree of real understanding of patients.