In a small number of situations, researchers can access identifiable confidential patient information when it is not possible to seek consent, and consent cannot be inferred. There are different arrangements in each nation in the UK to lift the common law duty of confidentiality, or give permission on behalf of NHS organisations.
Example
In England and Wales, the Confidentiality Advisory Group of the Health Research Authority advises whether it would be in the public interest to support access to identifiable confidential patient information without consent. This advice is given under section 251 of The Health Service (Control of Patient Information) Regulations 2002. Any cases that receive support under section 251 must follow standard conditions of transparency, public involvement, notification and opt-out.
Even where this permission is given, people should have the opportunity to proactively refuse access to their identifiable confidential patient information, unless researchers can justify that this will significantly distort the results of their research. This refusal by patients to allow access to their identifiable confidential patient information without their consent is called an opt-out.
The report concludes that it is appropriate for patients to be able to choose to opt-out of allowing access to their identifiable confidential patient information without their consent separately for specific research studies as well as more generally. Allowing these separate choices means that where patients specifically object to a particular research study, their opt-out will not prevent access to their identifiable confidential patient information for other research.