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NHS R&D approval

 

The Department of Health’s Research Governance Framework for Health and Social Care (RGF) requires NHS organisations to ensure that before any research involving human participants, their organs, tissue or data commences:

Further Information on NHS R&D Approval

Further guidance on applying for NHS R&D approval is available on the website of the NHS R&D Forum website.

 

Questions about research governance policy should be directed to the R&D Directorate at the Department of Health. 

  • there are adequate arrangements and resources to meet the standards set out in the RGF;

  • an identified sponsor has taken on responsibility for the study;

  • the study has received ethical approval (where required);

  • there is a clinical trial authorisation in place for a clinical trial of a medicine;
  • the allocation of responsibilities is agreed and documented;
  • appropriate contractual arrangements are in place;
  • legislation relating to the research is followed within the organisation;
  • a person authorised to do so has given written permission on behalf of the NHS organisation.

 

The process of conducting the above checks and giving written permission is called NHS permission for research, often described as R&D approval. In most NHS organisations an R&D office or network is responsible for carrying out the relevant checks before permission is given by the chief executive or a delegated senior person.

 

The standards in the Research Governance Framework are applied in all countries of the UK.

 

Research requiring NHS R&D approval but not ethical review

The following types of research project do not require application for ethical review but still require NHS R&D approval:

 

  1. Projects limited to the use of samples/data samples provided by a research tissue bank (RTB) with generic ethical approval from a REC, in accordance with the conditions of approval. Samples / data must be non-identifiable to the researcher at point of access, otherwise further ethical review of the project is required. 

  2. Projects limited to the use of data provided by a research database with generic ethical approval from a REC, in accordance with the conditions of approval.  Data must be non-identifiable to the researcher at point of access, otherwise further ethical review of the project is required.

  3. Projects involving the use of NHS premises or resources but with no human participants or use of any samples / data from human participants.

 

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Applying for R&D approval

All applications for R&D approval from NHS organisations (or from health and social care organisations in Northern Ireland) are made using the Integrated Research Application System  (IRAS).

 

Applications should be made to each relevant NHS organisation. The application pack consists of:

 

  • the study-wide R&D form generated from the integrated dataset in IRAS;

  • the Site-Specific Information (SSI) Form providing specific information about the conduct of the research at the research site; and

  • supporting documentation as specified in the R&D submission checklist in IRAS.

 

Detailed guidance is available within IRAS on submission arrangements for R&D applications.

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Coordinated systems for gaining R&D approval

Coordinated systems are being implemented across the UK.  The system available to you will depend on where the lead NHS R&D office is based. The systems are compatible and have been designed to facilitate studies where sites are in different parts of the UK.

 

In England, the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP) is a new system designed to support the application and approvals process for NHS R&D approval for NIHR Clinical Research Network Portfolio studies, including commercially sponsored studies which are actively adopted into the NIHR Clinical Research Network Portfolio and studies funded through NIHR infrastructure.

 

For more information about studies able to use CSP, see the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission website.

If your study is potentially eligible for the NIHR Clinical Research Network Portfolio, you must indicate in the IRAS Project Filter that you wish to use NIHR CSP to obtain NHS R&D approvals for your study.  

 

For multi-centre research in Scotland, NHS Research Scotland (NRS) provides coordination of the process for obtaining NHS permission from Health Boards. Applications should be sent to the coordinating office. 

 

In Wales, a central Primary Care R&D Coordinating Office has been established. All R&D applications relating to primary care should be sent to the coordinating office. For further details see the All Wales Primary Care Research Management and Governance website. 

 

In all other situations, R&D applications should be made directly to the relevant R&D office. Contact details are available on the NHS R&D Forum website.

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Research tissue banks and databases

Under the Research Governance Framework, there is no requirement for NHS permission for research for the establishment of research tissue banks and databases in the NHS. Applications to NHS R&D offices through IRAS are not required as all NHS organisations are expected to have included management review in the process of establishing the tissue bank or database and, where applicable, applying for licensing of a tissue bank.

 

Research permission is also not required by collaborators at tissue / data collection centres (TCCs / DCCs) who provide tissue samples, other biological material and/or data under the terms of a supply agreement between the care organisation and the tissue bank or database. TCCs / DCCs are not research sites for the purposes of the RGF.