Adaptação cultural do instrumento The Process and Quality of Informed Consent (P-QIC) para o português brasileiro

Abstract

In the health area research that prioritizes the human being as an object of study and involves the collection of evidence is considered as Clinical Research. The Resolution 466/12 of the National Health Council (CNS) determines the guidelines and regulatory norms for research involving human beings, considering that these correspond to any research that individually or collectively has as a participant the human being, in part or in total, involving you directly or indirectly, either by manipulating your data or biological materials. This resolution deals with item IV of the Informed Consent. It is expressed that the process must be conscious, autonomous, free and informed by the individuals or groups invited to participate in a research. The present study was developed in order to question what the volunteers understand about their participation, responsibilities, procedures and the purpose of Clinical Research in which they participate. And for this assessment, a measurement tool culturally adapted to Brazilian Portuguese is required: The Process and Quality of Informed Consent (P-QIC). It was a methodological study of cultural adaptation that involved the following steps: translation of The Process and Quality of Informed Consent (P-QIC) into Brazilian Portuguese; organization of a Committee of Judges to verify the semantic, idiomatic, conceptual and cultural equivalences of the P-QIC instrument adapted for Brazilian Portuguese; execution of the P-QIC reverse translation and semantic evaluation of the P-QIC instrument adapted to Brazilian Portuguese. The cultural adaptation process took place in approximately six months. Few modifications were observed between the versions, and adaptations were made. The semantic evaluation stage was effective and allowed the necessary adjustments to facilitate the target audience's understanding of the instrument. The P-QIC instrument was culturally adapted to Brazilian Portuguese and reached the semantic, idiomatic, conceptual and cultural equivalences of the instrument, in addition to face and content validity and can be validated for use in Brazilian Clinical Research centers.