Informed Consent Form Automated Validation, The Brazilian Rare Disease Network Case Proposal

The informed consent form (ICF) is required for all observational studies involving human subjects in Brazil. Besides the existence of e-Consent technologies, Brazilian guidelines issued by the Ministry of Health, the ICF must be obtained in the physical form in face-face services. Furthermore, the Brazilian Network of Rare Diseases (RARAS) project was proposed in a context marked by a scarcity of structured data on Rare Diseases (RD). One of the main objectives of RARAS is to understand and expose the RD scenario in Brazil. Since one of the stages in the RARAS project requires data collected from a patient's interview, the ICF is mandatory. Therefore, the importance of completeness of participants' process aroused the need of the technical team of RARAS to propose a protocol to automate the validation of scanned physical ICFs. The purpose is based on applying image preprocessing methods and a deep learning model. Regarding previous results in the literature, the expected outcome is to achieve around 90% accuracy in the classification of ICF for the RARAS project.