SCHEDULE 1CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS

PART 1APPLICATION AND INTERPRETATION

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1

For the purposes of this Schedule, a person gives informed consent to take part, or that a subject is to take part, in a clinical trial only if his decision—

a

is given freely after that person is informed of the nature, significance, implications and risks of the trial; and

b

either—

i

is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or

ii

if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.

2

For the purposes of this Schedule, references to informed consent—

a

shall be construed in accordance with paragraph (1); and

b

include references to informed consent given or refused by an adult unable by virtue of physical or mental incapacity to give informed consent, prior to the onset of that incapacity.