A call by the Wellcome Trust for clearer guidance for GPs to ensure medical records can be safely used in research has been backed by two leading bodies representing GPs in the UK.
Patient records in general practice surgeries are a unique resource of information which can help medical researchers improve their understanding of disease, develop potential new treatments and improve patient care. The increasing use of electronic records should make it easier for researchers to use this information.
The public are generally supportive of this research: two-thirds of people would consider allowing personal health information to be shared for research purposes. However, this information is both sensitive and private and the public, patients and healthcare professionals must all have confidence that the security of personal information is safeguarded.
Today, the Wellcome Trust, the UK's largest medical research charity, publishes guidelines for best practice in the use of patient records for research purposes. The report was reached during a national consensus meeting held in 2008 with GPs, researchers and patient groups.
The guidelines - Towards Consensus for Best Practice - have been endorsed by the British Medical Association (BMA), the independent trade union and professional association for doctors and medical students, and the Royal College of General Practitioners (RCGP), the professional membership body for family doctors in the UK and abroad.
Three overarching principles form the basis on which the guidelines were agreed. They are:
- Patient confidentiality and privacy must be safeguarded
- GPs and healthcare professionals should play the role of patient's advocate
- Public awareness and understanding of the use of records in research should be improved.
"We welcome the endorsement by the BMA and the Royal College of General Practitioners of the guidelines for the use of patient records from general practice for research," says Sir Mark Walport, Director of the Wellcome Trust. "There are over 44,000 GPs in the UK, and their support is essential if we are to maintain trust in how patients' medical records are accessed for research purposes. The public strongly support medical research and researchers in turn must support the public by working to the highest standards."
"This report provides valuable guidance to GPs," says Dr Vivienne Nathanson, Head of Science and Ethics at the BMA. "The first priority of GPs must be to deliver high-quality healthcare. But they must also protect patients if their records are to be used in research and ensure that the confidentiality of patient data is safe and secure at all times."
RCGP Chairman Professor Steve Field said: "Quality research has enabled us to make some amazing advances in the treatment and care of our patients. GPs and researchers need to work in partnership to ensure that we gain the best evidence to guide future improvements .GPs will find these new guidelines extremely useful, they are an excellent first step towards ensuring best practice."
The report includes guidelines on the use of anonymised, coded and identifiable data from patient records, and the use of privacy-enhancing technologies, including safe havens, encryption and honest brokers. It also sets out recommendations on how to identify potential participants for a particular study, how they should be approached, the level of consent required and the provision of sufficient information that a potential participant may make an informed decision on whether to participate.