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Information for researchers

The primary aim of research governance is to ensure the safety and wellbeing of all research participants. Research governance also aims to improve research quality and prevent research misconduct and fraud.

Research governance:

• sets standards,
• identifies ways to deliver standards,
• describes monitoring and assessment arrangements, and
• applies to all staff and participants involved in research, including those who conduct, manage or fund research.

If you wish to carry out research involving NHS Direct, please contact the NHS Direct Research and Clinical Audit Team as early as possible in the process. The team can guide and advise you on next steps and provide you with the necessary forms and information to progress your project.

NHS Direct research approval process

In order to conduct research you will need approval from both a Research Ethics Committee and the NHS Direct Research Office. Research cannot commence until both approvals have been granted.

The NHS Direct research governance approval process is concerned with ensuring the safety and wellbeing of all participants. The proposed study must offer solid research evidence based on sound methodology and clear adherence to all regulations and principles. It will normally fit with service priorities. Furthermore, it should demonstrate good value for money for the organisation.

To obtain research governance approval, researchers must supply evidence that all the appropriate regulatory approvals have been granted. These include:

• funding approval,
• approval from the appropriate management department,
• finance department confirmation that the costings are correct,
• confirmation that Intellectual Property issues have been considered and managed, and
• evidence that the study meets the requirements of the Caldicott Principles and the Data Protection Act.

Core documents

The following documents are normally required when applying for NHS Direct research governance approval:

• Research Ethics Committee application (and notice of approval, when granted)
• Research protocol
• Participant information sheets (where applicable)
• Consent forms
• Any questionnaires, interview schedules etc.
• Confirmation of research sponsor
• Regulatory approvals
• Confirmation of funding

Honorary contracts

Those not currently working in the NHS may need a Research Passport or Honorary Contract before commencing their study. Please contact the Research Office for further advice.

Monitoring and completion

During the process of any study, chief investigators should normally submit six-monthly progress reports and notify the Research Office immediately of any change to the protocol or timescale, or of any concerns with the study.

Final reports, potential journal articles or abstracts should also be submitted to the Research Office prior to publication.

Researchers may find the following links useful:

Is it research?

R&D Forum: Research Governance Documentation and Information Guide

NRES Guidance