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