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Section 251

From 04 March 2013 information on the ‘section 251’ approval process has been transferred to the HRA website and the NIGB website will no longer be updated. All current information on the application process and approved applications is now sited on the Health Research Authority website here Applicants should bookmark this link and use this to locate up to date information.

Section 251 of the NHS Act 2006 (originally enacted under Section 60 of the Health and Social Care Act 2001), allows the common law duty of confidentiality to be set aside in specific circumstances where anonymised information is not sufficient and where patient consent is not practicable.

For example a research study may require access to patient identifiable data to allow linkages between different datasets where the cohort is too large for consent. This would require time limited access to identifiable information where gaining consent from a large retrospective cohort would not be feasible and would require more identifiable data than would be necessary for linkage purposes.

An application for section 251 support requires explicit details about data flows and full justification about why each identifiable piece of information is required and how this allows the aims of the study to be met. Evidence that no other reasonable alternative, such as anonymisation or consent, exists will be assessed via the application form.

Any section 251 approval will be subject to an annual review in order to assess that the applicant has met the conditions or report plans, and/or action towards meeting them. It is the applicant's responsibility to ensure that this is submitted on the anniversary of approval.

For further information about applications for section 251 and for help regarding whether you need to make a section 251 application please see the How do I Apply section on this website and the pre application checklist.  For details on contacting the committee secretariat please see the Queries to the ECC Secretariat page.

For further detail about the detail of the enacting legislation please see the About section 251 page.

For details on the new role of the Health Research Authority please see the press release and the Section 251 transition pages.