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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.
Medical associations and advocacy groups are increasingly asking policymakers to ban such procedures on intersex infants until they can provide informed 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.
Consent occurs when one person voluntarily agrees to the proposal or desires of another. [1] It is a term of common speech, with specific definitions as used in such fields as the law, medicine, research, and sexual consent. Consent as understood in specific contexts may differ from its everyday meaning.
Consent is not defined but is granted or withheld after a process that involves consultation and participation. However, mere consultation by itself is not a substitute for actual consent. [5] The UN Working Group on Business and Human Rights notes that Indigenous Peoples "should determine autonomously how they define and establish consent." [6]
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