GuidanceMHRA
Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
First published: Jan 12, 2026Last updated: Apr 27, 2026Changes: 4
Latest change: Removed reference to specific version of Declaration of Helsinki in section 'Use of placebo or no intervention'. The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
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