Conditions to be met in emergency clinical study
| • Subjects affected by a life-threatening condition |
| • The treatment is experimental |
| • The clinical research allows verification of both the effectiveness and safety of the treatment |
| • It is impracticable to obtain consent |
| • The waiver of informed consent is needed for the clinical trial |
| • The researcher will contact the legally authorised representative |
| • The family members can decline the patient’s participation in the study |