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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

UK authorities are preparing guidelines to implement new clinical trial rules in 2026 (Shutterstock)

The Health Research Authority has gone back to the drawing board to determine how best to roll out a key element in the new UK clinical trials law, relating to simplifying the process of seeking and recording informed consent in lower-risk clinical trials.

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