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The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.
If an individual is considered unable to give informed consent, another person is generally authorized to give consent on the individual's behalf—for example, the parents or legal guardians of a child (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally disordered.
However, Subpart D of 45 CFR 46 marks several distinctions about obtaining consent/assent and the nature of the research involving children. According to the actual rules of informed consent given by the IRB for the research in question, child assent and parental consent may both be required to conduct research on minors.
In either case, "adequate provisions" must be made to allow the child to decide if they want to participate in the trial. The IRB must ensure that the assent process is appropriate for children. A child cannot legally give informed consent but they must be given the opportunity to decline.
Informed consent in medicine is consent given by a person who has a clear appreciation and understanding of the facts, implications, and future consequences of an action. The term is also used in other contexts, such as in social scientific research, when participants are asked to affirm that they understand the research procedure and consent ...
The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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Parental consent laws (also known as parental involvement laws) [1] in some countries require that one or more parents consent to or be notified before their minor child [2] can legally engage in certain activities. Parental consent may refer to: A parent's right to give consent, or be informed, before their minor child undergoes medical ...