The Research Approvals System

Introduction

If you wish to do any research in the NHS involving NHS Patients, Staff, Samples, Data or resources you will need as a minimum approval from:

• an NHS research ethics committee (REC), and
• NHS Permission from the NHS organisation responsible for the research site or PIC¹
  (for independent contractors such as GP practices, dentists and pharmacists this will be the Primary Care Trust).

Depending on your research you may also need approval from:

• MHRA approval - for research involving investigational medicinal products or medical devices
• Ministry of Justice Approval - for research in prisons
• NIGB - for research involving collection of identifiable data where consent is not practical.

Why do I need these approvals?

The approval system for NHS research is there to safeguard participants in research, researchers and Trusts hosting research. They provide assurances that your research proposal is scientifically sound, is feasible, is of value to the NHS and its patients, and respects the rights, safety and dignity of participants.

NHS Research Ethics Committees provide an independent review of your research to ensure that it respects the rights, safety and well-being of participants. They will pay particular attention to the materials provided to participants and the recruitment and consent process.

NHS Permission from the NHS Organisations hosting the research is usually facilitated by the R&D office at each Trust. The NHS Organisation is interested in project feasibility and how your proposal fits with the services offered by the host Trust as well as other research already ongoing. They will also look at resources and capability of the Trust to host the research, data protection and confidentiality as well as what happens at the end of the study.

Timelines for approval

It is generally advised that you need to factor in a minimum of 3 months to gain NHS REC approval and NHS Permission; this will be more if other approvals are needed.

Please note – approval is an ONGOING process, continued approval of your project is dependent on submission of annual progress reports to the reviewing bodies and submission and approval of all amendments. See post approval section for more details.