Paragraph 1

The conditions and principles specified in Part 2 apply to all clinical trials.

If F1any participant of a clinical trial is—

the conditions and principles specified in Part 3 apply in relation to F2that participant.

F3Subject to sub-paragraphs (6) and (7), if any participant of a clinical trial is a minor, the conditions and principles specified in Part 4 apply in relation to that participant.

F4Subject to sub-paragraphs (6) and (7), if any participant —

the conditions and principles specified in Part 5 apply in relation to that participant.

If any person—

that person cannot be included as F5a participant in the clinical trial.

Sub-paragraph (7) applies if treatment is being, or is about to be, provided for a participant who is F7a minor or an incapacitated adult as a matter of urgency and, having regard to the nature of the clinical trial and of the particular circumstances of the case—

Where this sub-paragraph applies, paragraphs 1 to 5 of F9Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult shall not apply in relation to F10the participant if the action specified in sub-paragraph (6) is carried out in accordance with a procedure approved by an ethics committee F11... at the time it gave its favourable opinion.