The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

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

PART 5 U.K. CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT

14.  The risk threshold and the degree of distress have to be specially defined and constantly monitored. U.K.