Where somebody does not have a legitimate relationship with a patient, explicit consent can provide another route for recruitment.
This might involve somebody who does have a legitimate relationship asking a patient whether they agree to another organisation accessing their confidential information to carry out more detailed screening.
Or people may proactively sign up to a register because they want to hear about research.
The report sets out what people should be told when giving this type of explicit consent to access their confidential patient information.
This includes:
- what information may be accessed
- who will access it
- whether access will be one-off or ongoing
- who may contact them and how
- how they can review or withdraw longer-term consent.
Where a commercial or other non-NHS organisation is involved, its role should also be clear.
The report also introduces standards for research sign-up registers.
These include:
- appropriate security assurance
- clear and maintained information about data flows and legal bases
- patient and public involvement
- controls to prevent people receiving excessive research invitations
- Research Ethics Committee approval as a sign-up registry research database
The intention is to allow a register to demonstrate centrally that it meets these standards rather than every individual study having to establish the same things again. This gives researchers another route to reach people who have actively chosen to hear about research, while providing assurance about the governance behind that route.
We are now beginning to see this approach put into practice through the Be Part of Research sign-up register