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 the study and the fact that they can decline.”
Malaria has a devastating impact on people living in tropical regions, with an estimated 200 million cases each year, leading to 400,000 deaths in Africa, according to the WHO. When it was announced last spring that the first malaria vaccine, called Mosquirix, was going be trialed in Malawi, Kenya, and Ghana, experts understood that it would not be “a silver bullet,” but instead could be a positive addition to other preventive measures, such as bed nets and insecticides.
The plan was to inoculate 720,000 children in these three countries over the first two years. The design of the study is a randomized cluster trial, in which community groups, rather than individuals, are randomly assigned to either the experimental intervention or another arm.
The trial was set to follow in the footsteps of a Phase 3 test that involved giving multiple doses of the vaccine to close to 15,500 children between ages six weeks and 17 months over a five-year period. While malaria cases decreased by about one-third, there were some worrisome side effects. Children who received the vaccine were 10 times more likely to develop meningitis in cerebral malarial cases compared to those who didn’t get the shots. Girls in the test cohort, overall, were twice as likely to die from any cause compared to girls in the control group, according to WHO’s proposed framework of the trial.
In the latest study, “information on vaccination is provided to the community and to parents through health talks and community outreach—among other methods, and parents who present for vaccination do so with the option to vaccinate their children or not,” a WHO spokesperson tells the BMJ. Therefore, parents who opt to vaccinate “imply consent.”
Weijer counters that there is no guarantee parents knew of the trial or the possible side effects that were observed during the previous study.
From WHO’s perspective, this was a “pilot study,” meant to determine the feasibility of the vaccine and wasn’t technically official research, thus limiting the amount of red tape and regulations they need to abide by. Outside experts disagree about that definition.
“If an activity is classified as research, then all sorts of rules and oversight mechanisms are activated. For example, the activity must receive prospective ethical review. Unless certain conditions are met, human subjects must provide informed consent,” Johnathan Kimmelman, a bioethicist at McGill University, comments to the BMJ. “The fact that the activity has been registered in clinicaltrials.gov amounts to an open declaration that this is research.”