Do I Need Regulatory Approvals and Sponsorship?

Sponsorship

Does my research need a sponsor?

A formal sponsor is required for all Health and Social care research falling under the remit of the Secretary of State for Health as set out in the UK Policy Framework for Health and Social Care Research. Some research taking place at the university that falls outside of this remit may also require advice and guidance, or a review from the Health and Social Care Research Sponsorship Committee, if it involves an intervention that is medical or impacts health.

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Regulatory Approvals

Does my research need NHS ethics approval?

Do find out if your research will need to be presented to an NHS REC for review and approval use the HRA ethics toolkit to help you understand.

If you need further help and advice contact your Faculty Ethics Officer.

What other regulatory approvals will I need?

All studies falling into the category of CTIMPs require authorisation by the Medicines and Healthcare Products Regulatory Agency. Application is via the Integrated Research Application System (IRAS).

You will need to pay a standard application fee and a fee for any amendments until trial completion.

All other clinical trials will need to obtain ethics approval from either Lancaster University or NHS Ethics. If you need further help and advice contact your Faculty Ethics Officer.

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