ABSTRACT

Research conducted through the analysis of data contained in medical records (which, for ease of reference, will be called 'medical record research') has made many important contributions to medical knowledge. Unlike other forms of research, however, it has often been conducted with only limited legal and ethical controls, and without patients' knowledge or consent.1,2 Although there is no evidence that this practice has caused patients any harm, it is not acceptable under the Data Protection Act 1998. Having to comply with the data protection requirements may make it more difficult to obtain the data needed for medical record research, potentially reducing the quality of research that can be conducted.