What is the term for the agreement required from a person unable to give legal consent to participate in a study?

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The correct answer is informed assent. Informed assent refers to the process of obtaining agreement from individuals who are unable to give full legal consent—such as minors or individuals with certain cognitive impairments—to participate in a study. This process typically involves providing the individual with age-appropriate information about the study, ensuring that they understand what participation involves, and confirming that they are willing to participate to the best of their ability.

Parental consent is needed for individuals who cannot legally consent but does not specifically address the individuals themselves. Informed consent, on the other hand, is the process used when an individual is able to give legal consent themselves, while voluntary consent emphasizes the requirement that participation is free from coercion. Informed assent bridges the need for ethical research practices by recognizing the capacity of individuals to affirmatively agree to participate, even when they are not legally allowed to provide consent themselves.

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