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Researchers want access to patient data without consent

By Steve Nowottny

Exclusive: Medical researchers could gain access to fully identifiable patient records without GPs and patients even knowing, under proposals by the UK's two largest research organisations.

The hugely influential Wellcome Trust and Medical Research Council are lobbying the Government to allow authorised researchers to search GPs' records without explicit consent. Under the plans, patients eligible for clinical trials could be contacted directly by researchers and asked to take part.

The proposals raise the prospect of patients being invited to participate in a trial without being aware that information about their diagnosis had been passed on.

It is precisely the scenario Harry Cayton, chair of the National Information Governance Board for Health and Social Care, warned against last month. He said: ‘There is pressure from researchers and the Prime Minister to beef up UK research. They want a mechanism by which people's records could be accessed to invite them to take part in research. That would be a backward step.'

The Wellcome Trust, responding to a Connecting for Health consultation on the Secondary Uses Service, called for ‘approved' researchers to be given access to identifiable patient data to find potential candidates for trials.

The trust said access should ‘probably' be without explicit consent, provided researchers had undergone suitable vetting, and the study had research ethics committee approval. Consent would be assumed unless patients opted out. Access to records would need to include information recorded in ‘sealed envelopes', since without this ‘results of research may be invalid', its submission said.

The MRC also proposed access to identifiable data, and warned information governance could be ‘overly risk-averse'.

But doctors' groups warned giving researchers access without consent would undermine the trust of patients.

The BMA said explicit consent ‘should be the norm' for use of patient-identifiable data, and the RCGP warned ‘permission for use of identifiable data should never be assumed'.

The GMC said: ‘Disclosing personal information about patients without consent to allow others to invite them to join studies involves a breach of confidentiality.'

Dr Neil Bhatia, a GP in Yateley, Hampshire, said: ‘The Wellcome Trust does appear to think it has some God-given right to access everyone's data without consent. It comes across as supremely arrogant.'

Dr Trefor Roscoe, a GP in Sheffield, said: ‘If people were contacted out of the blue by researchers many would be astounded that third parties had access to their information.'

Bodies responding to the consultation were divided over other aspects of the Government proposals, including flagging the records of patients willing to be contacted by researchers and the use of pseudonymised data.

The BMA said there was a need for ‘better understanding' of pseudonymisation and warned: ‘Some NHS bodies and researchers interpret linked anonymised data very loosely, for example with name and address removed but still containing NHS number, date of birth and postcode.'

Divergent views on patient data

Anonymised data
Has general backing, but there is some disagreement over whether this should include sensitive information in ‘sealed envelopes'

Pseudonymised data
Cautiously backed, but the BMA warns researchers must not be able to reconstitute patient identities

Identifiable data
The Wellcome Trust and MRC argue for access on an opt-out basis, but the BMA, RCGP and GMC all want explicit consent

Contacting patients
Supported by the Wellcome Trust and MRC for ‘approved' researchers, but the BMA and RCGP are opposed

Sources: Submissions from the Wellcome Trust, MRC, GMC, BMA and RCGP

The Wellcome Trust wants the Government to allow authorised researchers to search identifiable patient records The Wellcome Trust wants the Government to allow authorised researchers to search identifiable patient records

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