ABOVE: © ISTOCK.COM, RAZVANNISTOR
The World Health Organization did not follow the protocol of obtaining informed consent from parents in three African countries where children may have received an experimental malaria vaccine, sparking criticism from ethicists, according to a report published yesterday (February 26) in The BMJ. Rather than seeking informed consent from each parent in the participating communities, the WHO considered the consent “implied” because the malaria shots were given as part of routine vaccination programs.
“An implied consent process is no substitute for informed consent. Indeed, implied consent is no consent at all,” bioethicist Charles Weijer, the lead author of the Ottawa Statement that describes ethical guidelines for these types of trials, tells Gizmodo. “We have no assurance that parents in fact received information about the study let alone that they understood it. Parents attending a clinic for routine vaccination of their child may therefore be unaware of ...