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Explanatory Notes

Stage 5: Ethics

Involve public contributors in development of study tools e.g. participant information sheets and consent procedures. Involve public contributors in the ethics application processes. See guidelines for Integrated Research Application System (IRAS).

As well as IRAS, approvals are required from Research & Development departments and there are other regulatory requirements especially for trials of medicines and medical devices.

Approval is only required when people are to have direct contact with the research participants. If access is only to anonymised data NHS ethical approval will not be required.