Using patient records for medical research.

1 addressed several issues concerning uses of patient data for medical research, which are important for general practice. The primary concern of GPs, with respect to uses of patient records, is to do nothing that jeopardises the trust of patients, which is partly based on assurances of confidentiality concerning the content of consultations. The Academy report quotes one submission in response to its call for evidence: 'When people go to their doctor or health professional, they are seeking treatment because they are unwell, and not to become subjects of research.' 1 Nevertheless, research is an important part of health care. To provide effective and equitable care for 100% of the population, the NHS needs research and intelligence based on 100% of the population, which is generally only available from studies of patient records. Many important research questions can only be addressed by combining data from large numbers of practices. Increasingly, such data are becoming available, and will need to be used imaginatively and effectively if primary care is to be recognised and supported in its capacity as a major force for health improvement. The general principle to be followed is that where records cannot be fully anonymised, the patient's informed consent must be sought. As the Academy's report illustrates, however, complete anonymisation is sometimes impossible (for example, for some types of record linkage), and may be counterproductive, in terms of the research questions being asked. Obtaining informed consent is desirable but can be prohibitively expensive, and involve predictable effects in terms of responders and non-responders, introducing serious bias to the research, and reducing the generalisability of the findings. Research ethics and governance committees have tended to take a strict line on these issues, putting protection of the individual above the public interest in high quality research. The Academy's report argues that ethics committees have been over-cautious, providing the public with a level of protection that patients may not want and that may be disproportionate to the risks involved in using patient records for epidemiological research. Research is needed on what people actually think. The limited research which exists suggests that while most people have never given any thought to such matters, they are generally understanding and supportive of the need for research based on medical records. A key consideration is that there should be 'no surprises'. If we have learned anything from such episodes as the Alder Hey affair it …