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The UK Data Protection Act 1998 is intended to accommodate medical research. The law allows personal information to be used and disclosed without explicit consent, subject to certain safeguards, when it is impractical to obtain consent and an important public interest is at stake.
Despite this, some data controllers continue to interpret the law in a restrictive way, write the authors.
They describe how such interpretation of the law currently threatens a planned study of UK military personnel who served in Bosnia so much that if it were to proceed, the results are likely to be too small and biased to reach useful conclusions.
They argue that adverse events or detriment from participation in epidemiological research are extremely rare and they call for a less rigid policy towards data sharing in this type of research.
"We are not arguing that epidemiological research should always proceed without consent. But it should be allowed to do so when the privacy interference is proportionate," they write. "Regulators and researchers need to improve their ability to recognise these situations and adjust their approach."
"With over 250 studies granted access to information without consent, the real issue is not that few studies have been given support to do this, but the stringency of the criteria for support," argues Peter Goldblatt of the Office for National Statistics. "What is needed to achieve a consensus on this issue is further evidence on when the effort and impact of seeking consent undermines the public interest in good quality research."
"We have an ethical responsibility to facilitate and not hinder research for the ultimate benefit of our patients," adds a senior doctor in an accompanying editorial. "We have to strike a balance between rights of the individual to privacy and needs of the community to answer important medical questions, and existing legislation allows that."
A new Academy of Medical Science report, which argues strongly for a clearer framework to deal with the use of personal health data in research, should be essential reading for data controllers and researchers, and will surely prompt more debate, he concludes.
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