In 'In the name of science: Ethical violations in the ECHO randomise trial', published in Global Public Health, Sathyamala argues that a clinical trial on 'Evidence for Contraceptive Options and HIV Outcomes' (ECHO), violated one of the central tenets of the Helsinki Declaration by privileging pursuit of knowledge over the interests of the girl/women trial participants from Africa.
It was in the 1990s, that the possibility of increased transmission of HIV with the use of injectable contraceptive Depo-Provera®, was first flagged in medical literature. This has posed a challenge for its use in countries, particularly in the African region, where the prevalence and transmission rate of HIV is high.
In 2015, a randomized ‘clinical’ trial, the Evidence for Contraceptive Options and HIV Outcomes (ECHO) was launched in four African countries to resolve the question whether the increased risk was causal. Contrary to expectations, the ECHO trial successfully recruited and randomized the specified number of girls/women participants.
Undue influence, incentives, coercive language and concealment
This paper argues that this was made possible by exercising undue influence, by using incentives, coercive language, and by concealing the real nature of the clinical trial during recruitment.
The ECHO trial is unique in subjecting a group of healthy girls/women knowingly to a contraceptive drug with an intention not of finding out whether it is efficacious as a contraceptive, but to find out how risky or life-threatening its use could be.
Thus, the ECHO trial has violated one of the central tenets of the Helsinki Declaration by privileging pursuit of knowledge over the interests of the girl/women trial participants from Africa.