[Authorization Processes for Access to Hospital Clinical Records: The Case of a Multicenter Study].

Abstract

Clinical practice generates a wealth of data daily, collected for the purpose of providing healthcare. However, this data holds the potential to contribute to the generation of knowledge. The aim of this study was to describe the process of submitting requests for access to clinical records for research and the heterogeneity in the evaluation of a national research project by the boards of directors and ethics committees of hospitals, hospital centers, and local health units within the Portuguese national health service. The procedures and waiting times are described. The results of this study highlight considerable variability in the process of submitting requests for access to clinical data and the evaluation of research protocols. They also reveal lengthy waiting times for obtaining authorizations. This study underscores the urgent need to continue the discussion on the ethical and legal issues involved in studies requiring access to clinical records or other health data.