El acceso a la historia clínica en la investigación observacional

Abstract

In accordance with current Spanish legislation, patient consent is required without exception in order to access their medical records for research purposes, which is not the case in other countries of the European Union or as established in the Declaration of Helsinki.The various international ethical regulations require observational studies to be reviewed by an Independent Ethics Committee to guarantee confidentiality and respect of the participants’ rights.The objective of this paper is to review the legal requirements to access medical records for research, regarding both the ethical review and the request for informed consent.Tools should be developed that facilitate access to electronic medical records for research purposes in compliance with legal requirements pertaining to data protection. The new European Regulation allows the Member States to establish legal exceptions to the data protection rights of subjects to facilitate scientific research.