Valoración de las hojas de información al paciente en subestudios farmacogenéticos: aspectos éticolegales

Abstract

The information provided during the informed consent process is crucial to respect research participants’ autonomy. Consent forms should include the information that is most relevant to make an informed decision and in an accessible language. In Spain, the Biomedical Investigation Law (2007) specifies the items that consent forms have to include about the uses of the biological samples and the genetic information. The main purpose of our study was to conduct a content analysis of consent forms for pharmacogenetic studies to determine what written information is provided and the readability of this information. We included all available consent forms approved by a Research Ethics Committee between 2004 and 2009. A data collection sheet with 61 questions was designed based on the Spanish law and a review of ethical recommendations. For each consent form, information was recorded about the general aspects of the study and the conditions of use of both the biological samples and the genetic information. We also analysed the readability of the information using the Flesch-Szigriszt score. Logistic regressions were performed to identify factors associated to the quantity of information provided and the level of readability. The number of consent forms analysed was 158. We found that general information related to the study was given in a high percentage (above 90% of the consent forms). Information related to the samples was given in a lower percentage: 11 out of 19 questions were included in less than 50 % of the consent forms. And the information about genetic information was even lower: 8 out of 12 questions were mentioned in less than 30% of the consent forms. The Spanish Law did not have a significant impact to improve the information provided to patients. The level of readability of the consent forms was normal or slightly difficult. The source of founding and the pathology studied were factors associated to the quantity of information provided and the level of readability. In conclusion, there are significant deficiencies in the information provided in the consent forms for pharmacogenetic studies. The implementation of the recent Spanish legislation was not associated with a significant improvement.