Comment News Day 3 hours agoCarla Saenz –
Conducting health research with children is an ethical imperative that seeks to protect their well-being and advance their health and equitable treatment. It is estimated that 70% of medications given regularly to children have not been studied with them. Therefore, children’s health is regularly endangered: when medicines are given to children without evidence of their safety and effectiveness in this specific population, they are exposed to risks. This exposure is not usually preceded by an informed consent process. Children are exposed to risks as part of their medical care without any additional safeguards (such as close follow-up) and without the opportunity to learn from those risks.
Paradoxically, we ended up in this dangerous situation because we wanted to protect children. We mistakenly assumed that protecting them, along with other vulnerable populations, entailed their exclusion from research. However, by excluding them from research, we do not know which medical interventions are safe and effective for children. In addition, we stop extending to children the benefits of science and research that should also benefit them.
In 1970, the overall survival of children with acute lymphoblastic leukemia (ALL), which is the most common cancer in childhood, was less than ten percent. After conducting several clinical trials that enrolled more than 32,000 children together in less than 40 years, ALL was cured in more than 90% of patients. Research with children has made this dramatic change possible. A diagnosis of ALL is no longer a death sentence for a child.
Such rare achievements could not have been achieved, just by extrapolating the research with adults. Health research with children is essential to find remedies, because a child is not just a younger adult: children are physiologically different, so diseases and drugs affect them differently. Therefore, the only way to know if a health intervention is safe and effective in children is to include them in clinical trials and in all kinds of health research, from nutrition to cancer. This research should include studies with healthy children to prevent disease and with children suffering from chronic or acute, mild or severe conditions.
The inclusion of children in studies during the covid19 pandemic is crucial. Their health and well-being are also affected by covid19. Like adults, they should benefit from global efforts to quickly conduct rigorous research to find interventions to prevent and treat this disease.
International ethical guidelines require that each research project with human participants be subjected to a rigorous ethical review by an independent committee to ensure, for example, that the risks are reasonable and that the participants are adequately protected. Committees reviewing research with underage participants pay special attention to ensuring that their well-being and interests are protected. The acceptable level of risk for each study with children is thoroughly assessed. Strategies are introduced to minimize each of these risks (e.g., through strict monitoring by health professionals or gradual dose increases). Ethics committees ensure that parents or guardians provide informed consent for their children’s participation.
However, they also ensure that the children themselves are involved in the decision to participate in the research, as this involvement is appropriate for their ages.
Participating in research is beneficial for children: having interventions that we know are safe and effective for children is in their best interest. And there are already solid mechanisms in place to ensure that their participation in research is ethical. In addition, studies of the experiences of children who have participated in research reveal that children themselves are really concerned about their contribution to finding a cure or medical intervention that can benefit other children, including new vaccines or tests to diagnose children. .
The exclusion of children from health research not only undermines the protection of their well-being; it is also unfair. Children deserve access to safe and effective interventions supported by scientific evidence. We have a moral duty to extend to them the benefits that result from research.
The covid19 pandemic has drawn attention to the value of research. To promote this and promote responsible inclusion in research of all populations, we must foster dialogue between the research community and society. Public engagement is key to trust, which is essential to catalyze ethical research that benefits us all.
Carla Saenz is the regional bioethics advisor of the Pan American Health Organization (PAHO)