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The Medicines for Human Use (Clinical Trials) Regulations 2004

Status:

This is the original version (as it was originally made).

1.—(1) The conditions and principles specified in Part 2 apply to all clinical trials.

(2) If any subject of a clinical trial is—

(a)an adult able to give informed consent, or

(b)an adult who has given informed consent to taking part in the clinical trial prior to the onset of incapacity,

the conditions and principles specified in Part 3 apply in relation to that subject.

(3) If any subject of a clinical trial is a minor, the conditions and principles specified in Part 4 apply in relation to that subject.

(4) If any subject—

(a)is an adult unable by virtue of physical or mental incapacity to give informed consent, and

(b)did not, prior to the onset of incapacity, give or refuse to give informed consent to taking part in the clinical trial,

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

(5) If any person—

(a)is an adult unable by virtue of physical or mental incapacity to give informed consent, and

(b)has, prior to the onset of incapacity, refused to give informed consent to taking part in the clinical trial,

that person cannot be included as a subject in the clinical trial.

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