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Table 6 Answers to question 7. “What are “compelling and scientifically sound methodological reasons” as outlined in paragraph 32 of the Declaration of Helsinki for your institution which would justify the use of placebo?”

From: Ethical principles and placebo-controlled trials – interpretation and implementation of the Declaration of Helsinki’s placebo paragraph in medical research

Compelling and scientifically sound methodological reasons

Country

Questionable effectiveness of standard treatment

Armenia, Canada, Cuba, Israel, Namibia

Assay sensitivity/ when placebo is the most rigorous test of efficacy

Germany, Ghana, USA, The EU

No current proven intervention exists

Namibia, Uganda, Zimbabwe

High placebo response rate

Canada, Chile, Cuba

None if effective treatment exists

Japan, United Arab Emirates, Zimbabwe

Standard treatment is too toxic

Ghana, Tanzania

Available treatment is too expensive

Botswana, Uganda

Non-responders

Israel, Tanzania

Add on

Ghana, Saudi Arabia

Size of placebo groups may be smaller than in active control studies

Saudi Arabia