Paragraph 12 Principles
Informed consent given by a legal representative to an incapacitated adult in a clinical trial shall represent that adult’s presumed will.
Notes on Schedule 1
Textual amendments
- F1
Word in Sch. 1 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(2)