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- MHRA and REC requesting modifications post-approval
- Approvals lapsing for trials with no recruitment
- The approvals process for Phase 1 healthy volunteer trials
- Target timeframes that RECs will work towards for all Phase 1 healthy volunteer applications submitted through the fast-track research ethics review service - long description
- Target timeframes that RECs will work towards for modifications to Phase 1 healthy volunteer trials - long description
- Simplified arrangements for consent in clinical trials
- Research Ethics Committees that review clinical trials
- Research transparency requirements for clinical trials
- Registering a clinical trial
- Publishing trial results
- Offering to share a summary of results with participants
- How CTIMP sponsors can share a summary of results
- Deferrals
- Deferrals in Phase 1 trials
- Automatic deferral scenarios for Phase 1 healthy volunteer trial applications - long description
- Waivers
- Clinical trials regulations news and updates
- Simplified arrangements for seeking and evidencing consent in clinical trials survey results - 5 August 2025
- Medical devices and software applicationsUnder the Medical Devices Regulations 2002, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another commercial company in order to demonstrate the safety and performance of a non-CE marked medical device, or a CE-marked device that has been modified or is to be used for a new purpose.
- Gene therapyIf your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).