* Assent: The child must be given an age-appropriate explanation of the research, including what will happen to them, why it's being done, and what the risks and benefits are. They then must agree to participate. This is called assent. The level of understanding required for assent varies with the child's age and maturity.
* Parental/Guardian Permission (Informed Consent): A parent or legal guardian must give informed consent. This means they must be given a complete and understandable explanation of the research, including the risks and benefits, and they must voluntarily agree to allow their child to participate. They also need to understand they can withdraw their child at any time without penalty.
The specifics of what information is provided and how assent and consent are obtained vary depending on the age of the child, the nature of the research, and the institutional review board (IRB) overseeing the study. IRBs are crucial in protecting children's rights and well-being in research.