Carla Saenz

Conducting health research with children is an ethical imperative that seeks to protect their well-being and advance their health and equitable treatment. An estimated 70 per cent of the drugs regularly administered to children have not been studied with them. Thus, children's health is regularly jeopardised: When children are given drugs without evidence of their safety and efficacy in this specific population, they are exposed to risks. Such exposure is usually not preceded by an informed consent process. Children are exposed to risks as part of their medical care without any additional safeguards (such as close monitoring) and without the prospect of learning from these risks.

Paradoxically, we ended up in this perilous situation because we wanted to protect children. We wrongly assumed that protecting them - along with other vulnerable populations - entailed their exclusion from research. Yet by excluding them from research, we fail to learn which medical interventions are safe and efficacious for children. We further fail to extend to children the benefits of science and research that should benefit them as well.

In 1970, the overall survival of children with acute lymphoblastic leukaemia (ALL), which is the most common cancer in childhood, was less than ten per cent. After conducting several clinical trials that together enrolled over 32,000 children in less than 40 years, ALL has become curable in over 90 per cent of patients. Conducting research with children has made this dramatic change possible. An ALL diagnosis is no longer a death sentence for a child.

Such rare accomplishments could not have been achieved, just by extrapolating from research with adults. Health research with children is indispensable to finding cures for them, because a child is not just a smaller 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 all types of health research on everything from nutrition to cancer. Such research should include studies with healthy children to prevent disease and with children suffering from chronic or acute, mild or severe conditions.

Including children in studies during the covid19 pandemic is critical. 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 ethics guidelines require that every research project with human participants undergoes rigorous ethics review by an independent committee to ensure, for example, that risks are reasonable and that participants are adequately protected. Committees reviewing research with under-age participants devote special attention to ensuring that their well-being and interests are protected. The acceptable level of risk for each study with children is meticulously assessed. Strategies to minimize

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