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Part of National data opt-out guidance for researchers

4. Section 251 and the application of national data opt-outs

National data opt-outs apply to a disclosure when an organisation such as a research body confirms they have obtained an approval from the Confidentiality Advisory Group (CAG) for the disclosure of CPI held by another organisation responsible for the data (the data provider) such as an NHS Trust.

A CAG approval is an approval made under section 251 of the NHS Act 2006 and its current regulations, the Health Service (Control of Patient Information) Regulations 2002 (see appendix 1), which enable the common law duty of confidentiality to be temporarily lifted so that CPI can be disclosed without the data provider being in breach of the common law duty of confidentiality. In practice, this means that the person responsible for the information (data provider) can, if they wish, disclose the information to the data applicant e.g. research body without being in breach of the common law duty of confidentiality.

CAG consider a number of section 251 applications each year. The CAG Registers give details of approvals under section 251 (regulation 2 and 5) which cover both non-research and research applications. 

It is only when a section 251 is relied on to obtain CPI that national data opt-outs apply. National data opt-outs do not apply where information being disclosed is anonymised in accordance with the Information Commissioner’s Office (ICO) anonymisation code of practice or the individual has given their consent for their information to be used for a particular purpose, for example a specific research study.

Where a patient has set a national data opt-out it does not stop that patient from giving their consent for a specific use of their data. It is important that patients continue to be offered the opportunity to participate in medical research studies, provided this is done in a way that does not breach their confidentiality, i.e. it addresses the Common Law Duty of Confidentiality.

Visit the NHS Health Research Authority website for more information about CAG and the section 251 approvals process.

Last edited: 2 October 2019 5:06 pm