What is required when research involves children or cognitively impaired individuals?

When research involves children or cognitively impaired individuals, both assent from the participant and parental consent are required to ensure ethical standards are met. Assent is the agreement from the child or individual, which recognizes their developing autonomy and ability to understand the basic aspects of the research. This is crucial because even though children may not have the legal capacity to provide full consent, they should still be involved in the decision-making process regarding their participation.

Parental consent is necessary to ensure that a responsible adult is aware of the research and agrees to the child's participation, protecting the child's welfare and rights. This dual requirement reflects a careful consideration of the participants' vulnerabilities and rights, aligning with the ethical principles established in the Belmont Report, which emphasizes respect for persons, beneficence, and justice. Thus, both components serve to protect minors and cognitively impaired individuals in research settings.