MHRA issues warning over patient data research

Research Access to database of GP patient information by unauthorised research teams puts confidentiality at risk.

Patient confidentiality could be compromised by researchers gaining unauthorised access to the general practice research database (GPRD), the MHRA has warned.

The MHRA's Independent Scientific Advisory Committee (ISAC) is reviewing access to the database, which contains anonymised data on more than four million patients.

In a report published last month on how the database was used in 2008/9, the committee expressed concern about 'growing misuse' of the data.

To maintain patient confidentiality, researchers must be approved by the ISAC. But the report found researchers had accessed data without permission.

'Committee members were concerned about the growing misuse of data by some users,' the report said. 'This was clearly reflected in some protocols in which researchers appeared to have sufficiently explored or potentially answered their study questions before protocol submission to the ISAC.'

The MHRA said there had been 'a very small number' of instances where this procedure has not been followed.

A spokeswoman stressed the importance of researchers seeking ISAC approval. 'This is to ensure the scientific rigour of the study, the appropriateness of GPRD as a data source, that patient and practice confidentiality is maintained and that the study falls within the overall purposes of the GPRD.'

The agency is developing guidance on the obligations associated with GPRD access, and will continue to monitor use of the data.

The ISAC report also expressed concern about researchers misrepresenting the type of study they planned to carry out when they apply for access to the GPRD. The committee may carry out an audit to assess the problem.

The ISAC will in future ask researchers for more detail of studies they are working on.

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Follow Us:

Just published

Viewpoint: GPs will be there for patients this winter, but at what cost?

Viewpoint: GPs will be there for patients this winter, but at what cost?

Rising to new challenges is in GPs' DNA and the profession has not let patients down...

GPs to be told 'shortly' how they can reclaim PPE costs

GPs to be told 'shortly' how they can reclaim PPE costs

Information on how practices will be reimbursed for PPE costs incurred during the...

GPs demand support as COVID hotspots sound alarm over rising workload

GPs demand support as COVID hotspots sound alarm over rising workload

GP leaders have accused the government of 'behaving as if the second wave is an unexpected...

Abusive graffiti daubed on side of GP practice in Bristol

Abusive graffiti daubed on side of GP practice in Bristol

GPs at a practice in Bristol arrived at work this week to find abusive graffiti daubed...

GP capacity hit hard as 60% lost colleagues to self-isolation in past fortnight

GP capacity hit hard as 60% lost colleagues to self-isolation in past fortnight

More than three in five GPs say they or clinical colleagues have been forced to self-isolate...

GPs feel like 'boiling frogs' as abuse over face-to-face appointments continues

GPs feel like 'boiling frogs' as abuse over face-to-face appointments continues

GPs are continuing to face unkindness, verbal abuse and complaints - leaving staff...