Seeking Approvals: Section 251 approval

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Informed consent is the fundamental principle governing the use of patient identifiable information within health or social/community care research. It is recognised that there are situations where informed consent cannot be obtained. In England and Wales, Section 251 of the NHS Act 2006 (originally Section 60 of the Health and Social Care Act 2001) provides the statutory power to ensure that NHS patient identifiable information needed to support essential NHS activity can be used without the consent of patients. The power can be used only to support medical purposes that are in the interests of patients or the wider public, where consent is not a practicable alternative and where anonymised information will not suffice. Separate arrangements are in place in Scotland and Northern Ireland, see Central NHS and other data approvals for further information.

In England and Wales, Section 251 approval provides a reliable basis in law to permit the disclosure and temporary use of identifiable NHS patient information for:
  • Those wishing to obtain identifiable NHS patient information without consent; or
  • Data controllers who are asked to supply identifiable patient information without consent.
Section 251 approval is considered by the Confidentiality Advisory Group (CAG) in order to advise the Health Research Authority (HRA) whether there is sufficient justification to access data without consent. Please see 1st and 2nd resources below for further information and details on how to apply.
Part of the approval process is to provide assurance that good Information Governance practices are in place. This will usually involve completion of the research module of the NHS Information Governance Toolkit (see the 3rd resource below).
It should be noted that although Section 251 approval can temporarily set aside the common law duty of confidentiality, compliance with the Data Protection Act (1998) must still be maintained and data must still be fairly collected – i.e. individuals have a right to know who holds information about them and why. Appropriate fair processing information (that includes the use of patient data to support research), should be made available in hospitals and GP surgeries, to ensure this requirement is met.