Research involving medical records review

Abstract

Medical records review, or retrospective analysis of medical records, constitutes a significant part of medical research. Ethical concerns, especially issues of confidentiality, have resulted in the introduction of stringent regulations in doing this form of research. The merits and demerits of these new regulations are being debated all over the world. The introduction of regulations for individual informed consent will prove costly to Indian physicians. Attempts are being made to evolve a consensus in which ethical concerns are given due respect without discouraging research. Doctors of virtually all specialties have long used medical records for research. This practice has played a critical role in medical progress. Reviews of medical records and subsequent publication of these analyses are almost always done without revealing patients¡¦ identities. However, there is little debate about the need to obtain informed consent from patients when their identities must be revealed. This article refers to situations in which, although the patient¡¦s identity is not revealed in the publication, the investigator (who may not be the patient¡¦s treating physician), clinical research fellows and technical staff are privy to the patient¡¦s personal data. Historically, such research has been exempt from an ethics review and researchers have not been required to obtain informed consent from patients before using their records. Recently, however, a number of countries have introduced policies to regulate the use of medical records in research, effectively restricting the manner in which this type of research is conducted around the world (1-8). We suggest that the situation in India is different from the West and the international guidelines currently being formulated may prove deleterious to the Indian medical fraternity if applied here.