Acceso a la ficha clínica con fines de investigación biomédica

Abstract

The clinical information obtained from the clinical records is crucial for doing biomedical research. Up until some years ago a scarce limitation existed in the use of this information for research purposes. This situation has changed in nowadays because of the legal safeguarding of the privacy and confidentiality of personal data. In fact, article 13 of the Law 20.584 "Regulations of the rights and duties of health care users", states that people not related directly with patient care cannot have access to clinical records, with the exception of people with notarial authorization by the patient. Lately the following proposal has been done on this issue: in prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records; in retrospective studies, consent should be obtained from the patient if his/her personal information is going to be used; if the information is nameless, the consent can be disregarded after being reviewed the protocol by a Research Ethics Committee. Ethical requirements of the collections of anonymized data and use of historical records of deceased subjects are also discussed. The role of the Research Ethics Committees as well as the Editorial Boards in observing and respecting the ethical regulations in the approval of research projects and in the acceptance of biomedical research publications has a major importance.