What is the role of informed consent in research involving children?

Informed consent plays a crucial role in research involving children by ensuring that the rights and welfare of the child participants are protected. The correct answer highlights that parents or guardians must provide consent, which is a fundamental requirement in research ethics. This is because children, due to their developmental stage, may not fully understand the implications of their participation in research and therefore cannot provide legally valid consent.

Additionally, the concept of "assent" is important. Assent is the process of seeking agreement from the child. It recognizes the child's developing capacity to understand the research and provides an opportunity for them to voice their willingness to participate. This dual requirement of parental or guardian consent combined with child assent honors ethical principles such as autonomy and respect for persons, ensuring that children are not just passive subjects but active participants in the decision-making process regarding their involvement in research.

The other options misrepresent the process; they either suggest that children can solely decide their participation without adult guidance, which overlooks the necessity of protective consent from responsible adults, or they imply that consent is not required, which is not consistent with ethical research standards.