The BMJ: WHO’s malaria vaccine study represents a ‘serious breach of international ethical standards’
“A large scale malaria vaccine study led by the World Health Organization has been criticized by a leading bioethicist for committing a ‘serious breach’ of international ethical standards. The cluster randomized study in Africa is already under way in Malawi, Ghana, and Kenya, where 720,000 children will receive the RTS,S vaccine, known as Mosquirix, over the next two years. … Charles Weijer, a bioethicist at Western University in Canada, told The BMJ that the failure to obtain informed consent from parents whose children are taking part in the study violates the Ottawa Statement, a consensus statement on the ethics of cluster randomized trials, of which Weijer is the lead author, and the Council for International Organizations of Medical Sciences’ International Ethical Guidelines. … WHO contends that the study is a ‘pilot introduction’ and not a ‘research activity’…” (Doshi, 2/26).

Additional coverage of the bioethicist’s criticisms is available from CTVNews.ca and IFL Science.