Executive summary
This paper is for the Board’s information only to provide an overview of the Equality, Diversity and Inclusion in Health and Care Research Pilot Directions 2025 (Directions) issued to NHS England in September 2025 by the Secretary of State for Health and Social Care (SoS). These Directions have been issued under section 254(1) and associated provisions of the Health and Social Care Act 2012 (the 2012 Act), and section 13ZC and associated provisions of the National Health Service Act 20062 (the 2006 Act.)
The Directions have been issued under section 254 of the Health and Social Care Act 2012 (2012 Act), section 13ZC and 272(7) and (8) of the National Health Service Act 2006 (the 2006 Act) and Regulation 32 of the National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013.
Action required
The Board is asked to note the new Directions and the information provided in this Paper regarding their purpose, effect, and requirements.
Background
1. Under section 254 of the 2012 Act, the SoS may direct NHS England to establish and operate a system for the collection or analysis of information. These are functions exercisable in relation to the development or operation of information systems in connection with the provision of health services or of adult social care in England. Under section 13ZC of the 2006 Act, the SoS may give NHS England directions as to the exercise of any of its functions. The Directions are issued by the SoS to NHS England under these provisions.
Purpose of the Direction
2. The EDI Pilot is being established for the purposes of identifying variation in participation in health and care research, based on demographics, to assess and improve equality, diversity and inclusion in such research. NHS England will provide results of its analysis in the form of reports and dashboards, which will inform the Department of Health and Social Care’s (DHSC) strategy and policy decisions, with the support of the National Institute for Health and Care Research (NIHR). This is aligned with the “Best Research for Best Health: The Next Chapter” and as set out in the NIHR Research Inclusion Strategy 2022-2027.
3. The Pilot Directions will enable the collection of data by NHS England from participating health care organisations that are providing health research study projects (including clinical trials) funded by NIHR. The participant study data collected will be linked with certain personal demographic data held by NHS England to produce a derived dataset that will produce aggregated summary data about age, gender and geographic location (at Lower and Middle layer Super Output Area) of participants in those health research study projects. The EDI Pilot will include the development and implementation of an EDI dashboard by NHS England containing this aggregated summary data for DHSC and NIHR.
Effect and requirements of the Direction
4. From 3 September 2025, NHS England has a legal duty to comply with the Directions, which require it to establish and operate a system for the collection and analysis of information set out in the Requirements Specification which is published alongside the Directions. NHS England’s functions under the Directions are to be exercised in accordance with the Requirements Specification and other requirements set out in the Direction.
5. NHS England must also have regard to the statutory guidance issued by the SoS under section 274A of the 2012 Act: NHS England’s protection of patient data, 23 May 2023 when discharing its functions under the Directions.
Publication
6. NHS England is directed not to publish any data obtained by complying with the Pilot Directions.
Approval of acceptance of Directions and publication
7. The National Director of Transformation and National Medical Director approved acceptance of the Directions on behalf of the Accounting Officer as set out in the NHS England Scheme of Delegation. The Directions have been published on the NHS England website.