Table 7 Answers to question 8. “How does your institution define “serious harm” as outlined in paragraph 32 of the Declaration of Helsinki for a patient which would restrict the use of placebo?”
Definition of serious harm | Country |
|---|---|
Persistent or significant disability/incapacity | Armenia, Botswana, Germany, Ghana, Japan, Latvia, Malaysia, Namibia, Republic of Belarus, Saudi Arabia, Slovakia, The EU, The Netherlands, USA |
Life-threatening events | Botswana, Cuba, Czech Republic, Germany, Ghana, Hungary, Israel, Namibia, Republic of Belarus, Saudi Arabia, Tanzania, The EU |
Death | Botswana, Ghana, Namibia, Republic of Belarus, Saudi Arabia, Tanzania, The EU, USA |
Inpatient hospitalization or causes prolongation of existing hospitalization | Germany, Ghana, Namibia, Saudi Arabia, The EU, United Arab Emirates |
Congenital anomaly/birth defect | Germany, Ghana, Namibia, Saudi Arabia, |
Requires intervention to prevent permanent impairment or damage | Saudi Arabia, The EU |
Maintenance therapy for schizophrenic patients | Hungary |