Declaration of Helsinki and Clinical Trial Regulations alignment

This guidance explains how the Declaration of Helsinki aligns with UK clinical trial regulations, ensuring ethical standards are maintained throughout research involving human participants. It highlights the principles of respect for individuals, informed consent, and prioritising participant welfare over scientific or societal interests. The document clarifies that UK regulations incorporate these principles into law, requiring trials to be scientifically sound, ethically approved, and conducted with transparency and accountability.

The guidance also addresses practical implications for sponsors and investigators, such as ensuring ethics committee review, safeguarding vulnerable populations, and maintaining data integrity. The alignment reinforces that compliance with UK regulations inherently satisfies the ethical obligations set out in the Declaration of Helsinki. This provides assurance to researchers and regulators that trials conducted under UK law meet internationally recognised ethical standards.