Researchers have failed to ease access to patients’ data for research

Researchers seem to have lost the battle for “bureaucratic” controls to be lifted on the use of data in which patients are identifiable.

The government is to go ahead with setting up research “safe havens,” bodies such as the NHS Information Centre that will be allowed to collect identifiable patient data, process it into anonymised and pseudonymised data, and provide data in both identifiable and non-identifiable form for use in research.

But the National Information Governance Board for Health and Social Care believes that under current legislation the safe havens will need the approval of its ethics and confidentiality committee to collect, store, and process identifiable data and to supply it to researchers.

And scientists wanting to use identifiable data without patients’ consent for a research project will still need to seek the approval of the committee, which replaces the outgoing Patient Information Advisory Group (PIAG).

Researchers have long complained that the bureaucratic hurdles of an application to PIAG, which is necessary if they want to use identifiable information without consent, are hampering life saving research. The research community has lobbied the government to lift the barriers, while patients’ groups insist that medical records should not be used without consent.

The result is a compromise in which, at least for the moment, researchers will still have to seek approval, although the process of making an application is expected to be made less burdensome.

Harry Cayton, chairman of the NIGB, said: “[Researchers] are not going to get a free for all. We have done a review of the bureaucracies around PIAG, and we’re hoping to find some improvements and economies in the way we do things to make it more efficient.

“It’s a continuing discussion. Patients’ rights remain intact while we seek to improve research.”

The NHS Information Centre is expected to be the first safe haven, but universities and other bodies could also apply for the status. Existing powers under section 251 of the National Health Service Act 2006 will be used to set up the safe havens system.

The government had tried to create sweeping data sharing powers under the Coroners and Justice Bill to make orders by secondary legislation. This would have allowed the removal of all barriers to data sharing “where the sharing is necessary to achieve a policy objective, where to do so is proportionate, and where it strikes a fair balance between the public interest and the rights of any individual affected by the data sharing.”

But ministers dropped the clause after an outcry from MPs, members of the House of Lords, and interest groups, including the BMA (BMJ 2009;338:b1237, 24 Mar, doi:10.1136/bmj.b1237).

A BMA spokesperson said: “The disclosure of any health information in situations where it is not possible to obtain patient consent is problematic.

“Obviously the idea of safe havens, which would provide a mechanism for controlled access to pseudonymised data, is preferable to the measures that were initially proposed in the draft Coroners and Justice Bill.

“However, more debate on this issue is likely to take place over the coming months, and the BMA continues to liaise closely with NHS Connecting for Health and the NHS Information Centre.”