Ethics

All health research involving NHS service users, identifiable data or tissue require a favourable opinion from the Research Ethics Service (RES). The Research Ethics Service is a core function of the Health Research Authority (HRA) and is committed to enabling and supporting ethical research in the NHS. Studies involving anonymised data or tissue, or research involving NHS staff and NHS facilities may not always need ethical review, please see the guidance on the HRA.

The Research Ethics Service will review the study ensuring that it is worthwhile, of value and ethical. They are particularly interested in protecting the rights and safety of any potential research participants.

To go through the ethics approval system, several items need to be in place prior to submission. All research studies require a sponsor, funding and the scientific value of the research assessed by means of independent external peer review.

This process is managed through a single on-line system based on the national Integrated Research Application System (IRAS) application form. This system, which replaced the previous NRES forms, captures all the necessary information needed by different agencies.

When the ethics application form is complete, the investigator needs to approach the local allocation system of the National Research Ethics Committees for an appointment to present their research proposal. For studies sponsored by CPFT, researchers should not book in their study until they have had confirmation from the R&D department to do so.

Certain types of study require approval by a committee which has recognised expertise in certain types of research. The central allocation system of NRES ensures that your study is sent to the right committee. It is likely that you will need to go this route if your study:

  • Is a clinical trial of a medicinal product or medical device
  • Involves vulnerable people (eg, prisoners or adults with incapacity)
  • Involves children
  • Involves setting up a tissue bank
  • Is happening on a number of different sites

The process of getting an opinion from an ethics committee takes time and needs to be planned early. Contact the R&D office early for guidance and support.

Additional approvals

Additional external approval is required from the MHRA if the research involves the use of medicines and the practical and safety issues will need to be addressed before the project starts with the Trust’s Pharmacy department which is responsible for these aspects of safety. It is best to consult pharmacy at an early stage when designing a study. Contact clare.mundell@cpft.nhs.uk

The page was last updated on 27 March 2018 by aient.

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Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital
Cambridge, CB21 5EF

T 01223 219400 (open 8:30am to 5pm)
F 01480 398501

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