Informed Assent for Clinical Trials for Children/Minors

Summary

This template can be used as an informed assent for clinical trials when the subjects are children/minors. It is intended as a general drafting aid and will require modification for the specific clinical trial. This template includes practical guidance, drafting notes, and alternate clauses. Informed consent involves many factors, including: • Providing a potential subject with enough information to allow for an informed decision about the subject's participation in the clinical trial • Facilitating the potential subject's understanding of the information • Providing opportunity for the potential subject to ask questions and to consider whether to participate • Obtaining the potential subject's voluntary agreement to take part in the clinical trial and • Continuing to provide information as the clinical investigation moves forward Children are those persons who have not yet reached the legal age for consent to treatments that are a part of research (45 C.F.R. § 46.402(a)), and this age can vary by jurisdiction. When the clinical trial involves children/minors, you must obtain the child's assent as well as the permission of the child's parent or legal guardian. Since children cannot legally give their consent to participate in the clinical trial, they may instead give their assent. Therefore, their template should use the word assent. Assent is defined as a child's affirmative agreement to take part in the research. Researchers should give the assent template to the child to read, if they are literate, and, depending on the reading ability of the child, the researcher may decide to read the template aloud to the child. The child must then be given the opportunity to ask questions and have anything explained before making a decision. In terms of parental permission, the parent or legal guardian must, too, learn about the study, have the opportunity to ask questions, and either agree or decline their child's participation in the research. The parental permission can take the form of a typical informed consent; however, the language will refer to ""your child"" instead of ""you."" If there are two parents or legal guardians, permission should come from both unless the institutional review board (IRB) has determined that permission from one parent or legal guardian suffices. For certain types of trials, the IRB may waive the parental permission component if the study is examining conditions in children for which parental or legal guardian permission is not a reasonable requirement to protect the subject (e.g., a study examining neglected or abused children). To help provide guidance, the following lists the category of permitted research involving children and the corresponding parental permission requirement: • Minimal risk (45 C.F.R. § 46.404). One parent/legal guardian may suffice. • Greater than minimal risk (45 C.F.R. § 46.405). One parent/legal guardian may suffice with IRB decision controlling. • Greater than minimal risk, no direct benefit to subject, likely to yield generalizable knowledge (45 C.F.R. § 46.406). Both parents/legal guardians unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the child. • Greater than minimal risk, no direct benefit to subject, results may alleviate serious problems knowledge (45 C.F.R. § 46.407). Both parents/legal guardians unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the child. A simple, short assent template may be used for children. A longer assent template for children can also be used and can be modeled off of the Informed Consent for Clinical Trials Form and modified (if necessary) for children to understand. For a full listing of related content about clinical trials, see Clinical Trials Resource Kit. For more on healthcare generally, see Healthcare Fundamentals Resource Kit. For additional informed consent templates, see Informed Consent for Clinical Trials Form and Informed Consent for Clinical Trials for People with Disabilities.