It is often necessary for clinical research and trials to involve children so that the effects of medicines on children can be more clearly understood, or to conduct studies on the mental or physical well-being of children. However, the involvement of children must be undertaken in accordance with international ethical standards, including key principles of respect for persons, beneficence (the ethical obligation to do good and avoid harm) and justice (ensuring a fair distribution of burden and benefits of research).
Children have a right to be treated with dignity and for their well-being to be protected, which means that children should not be subjected to medical or scientific experimentation without their informed consent or that of their legal representative. A child’s ability to consent to be the subject of research is dependent on complex questions of capacity and maturity. Different jurisdictions may have different laws governing this and these should be carefully considered before conducting any research involving children.
The ethical considerations of utilizing children in research are complicated, being a delicate balance between ensuring the child’s well-being and the greater good that can be gained from research. Children require special and more stringent protection when participating in research than do adult subjects, due to their developmental, physiological and psychological differences. This includes taking steps to minimize the child’s fear, pain and distress, ensuring appropriate pediatric expertise is available at all trial sites, and providing access to their caregiver when requested.