4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a
legally acceptable representative provided the following conditions are
fulfilled:
只要符合下列条件，非治疗试验可以在由合法可接受代表同意的受试对象中进行：
a) The objectives of the trial can not be met by means of a trial in subjects
who can give informed consent personally.
试验的目的不能通过在能亲自给出知情同意的受试对象中进行的试验达到。
b) The foreseeable risks to the subjects are low.
受试对象的可预见风险很低
c) The negative impact on the subject’s well-being is minimized and low.
对于受试对象健康的负面影响被减到最小，并且是最低的
d) The trial is not prohibited by law.
法律不禁止该试验
e) The approval/favourable opinion of the IRB/IEC is expressly sought on the
inclusion of such subjects, and the written approval/ favourable opinion covers
this aspect.
明确的寻求IRB/IEC对接纳这些受试对象的批准/赞成意见;书面的批准/赞成意见同意接纳这些受试对象。
Such trials, unless an exception is justified, should be conducted in
patients having a disease or condition for which the investigational product is
intended. Subjects in these trials should be particularly closely monitored and
should be withdrawn if they appear to be unduly distressed.
除非被证明是一个例外，这类试验应当在具有预期适用试验用药品的疾病或状况的病人中进行。这些试验中受试对象应当受到特别的密切检查，如果他们显得过分痛苦，应当退出试验。
