AMS calls for reform of personal medical data regulations 19/1/06. By the Public Health Genetics Unit The Academy of Medical Sciences has called on regulators to reform guidance on the use of personal medical data in research.

The newly published report, 'Personal data for public good: using health information in medical research,' by the Academy of Medical Sciences (AMS) outlines their concerns and makes recommendations for what they see as possible improvements to research practices.

Reform is needed, according to the AMS, because data protection and other related legislation has often been interpreted by regulatory bodies in contradictory and confusing ways. Because of the resulting uncertainty, researchers are often advised that personal medical data cannot be used in their research studies unless there is consent from the individual or the data has been anonymised.

For many research projects this might be impracticable and studies are either not done or delayed significantly while researchers try to meet these strict requirements. As a result, these contradictory interpretations are hindering research aimed at public health.

According to the report, "Identifiable data can be used for medical research without consent, provided that such use is necessary and is proportionate with respect to privacy and public interest benefits." This message needs to be made clear to researchers and the different bodies that approve research "…should accept this interpretation in their guidance and approval decisions".

The report makes several other recommendations. It calls for improvements in and a simplification of the regulatory process for approving research proposals. In addition, the Department of Health should make certain that research needs are fully integrated into the forthcoming National Programme for IT in the NHS, through the Connecting for Health electronic care record.

Additional research is also needed into determining how the public feels about research using their personal data. Anecdotal evidence appears to show that the public is supportive of this research and have confidence in the integrity of research practices. However, little empirical evidence is available to support this; the Academy has called on the Department of Health and the UK Clinical Research Collaboration to fund studies and public engagement activities around this issue.

Equally important, notes the report, is the need to ensure that researchers follow good practice in using personal medical data, to show they deserve the public's support. They must be made aware of relevant legislation, research governance policy and processes and their underlying ethical principles. The report recommends that good practice guidelines are developed to include data security, anonymisation, consent and the use of health records to identify potential research participants.

Research studies have been delayed or blocked by the regulators (see Research blocking 'costing lives', BBC news, 17/01/06) and the AMS sees the strict interpretation of the Data Protection Act 1998 as the major culprit. According to Professor Robert Souhami, chair of the working group, "Since the 1990s regulators have been taking a stricter line and this is making it hard for researchers to get permission to carry out studies using personal data. The UK used to be a world leader on this, but it is not any longer." The AMS hopes this report will raise awareness of these issues and prompt moves towards reform.

Article courtesy of the Public Health Genetics Unit.