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.