Use of Patient Identifiable Data without Subjects' Consent

You may have to get support from Section 251 of the NHS Act 2006 to approve your study

Section 251 of the NHS Act 2006

Section 251 of the NHS Act 2006 replaces Section 60 of the Health and Social Care Act 2001. It provides relief from the common law duty of confidentiality which requires that patient identifiable data is only used with consent. Section 251 powers can only be used for medical purposes, where it can be shown that identifiable patient data is necessary and consent is not practicable.

If your study will use patient identifiable data from The NHS Information Centre, without the study subjects' consent, you will need to apply to the National Information Governance Board for Health and Social Care (NIGB) for approval. This could extend the application process.

The Health & Social Care Act 2008 establishes the National Information Governance Board for Health and Social Care (NIGB) as a statutory body with powers under the Secretary of State for health. They provide advice on the use of patient information and to oversee arrangements created under the NHS Act 2006. They assess applications for use of patient information, to make sure that it is in the interests of patients and wider public.


How to apply for S251 Support

Please make an application to the NIGB Ethics and Confidentiality Committee (ECC).

Information on Studies which have been given S251 NHS Act support will be placed on NIGB's publically available register of approved applications.

For more information on S251 NHS Act support please contact the NIGB Office.