SCHEDULE 1CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS
PART 1APPLICATION AND INTERPRETATION
3
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.