Can children assent to participate in research?
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By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s).
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Informed Assent - A child's expressed willingness to participate in the research, given with the understanding of what is involved. Informed Consent - The legal agreement of a parent (s) or legal guardian for the child to participate in the research, given with the understanding of what is involved.
Authoritative international guidance requires that children provide assent for participation in research in addition to their parent's consent. However, as the concept of assent is not clear and may even be harmful, the guidelines need to be reformulated. Generally, competent adults consent to participate in research.
If by law a child is able to consent to treatment without parental permission, can they also consent to participate in research related to that treatment? What happens if a child reaches the legal age of consent while enrolled in a study? Are there special regulatory requirements for research involving children as subjects who are also wards?
Researchers should carefully consider and propose adequate provisions for obtaining the assent of children prior to their participating in research. The IRB application should address whether the intended subject population of children would be capable of understanding the nature of their participation in the research, and if so, whether or how assent will be obtained.
The process of asking a child to participate in research should be carefully planned and implemented, using age-appropriate language and methods, for any child who is considered capable of understanding and providing assent. This process should include a clear explanation (verbally, and in written form when applicable) that conveys:
Children are persons who have not attained the legal age for consent to treatments or procedures involved in research; in New York State anyone under the age of 18 is considered a child. When children are involved in a research activity it is necessary to obtain their assent and the permission of their parents.
Child assent to participate in research is required, in addition to parental consent, unless the IRB waives the assent requirement. As long as parental consent is obtained, the IRB can waive child assent in any of the following circumstances described at 45 CFR 46.408(a): a) The capability of some or all of the children is so limited that they cannot reasonably be consulted. As a general rule of thumb, the IRB considers child participants aged 7 (second grade) and older capable of giving ...
For a guardian to be able to grant permission for a child to participate in research, the guardian must either have authority to consent to a child's general medical care (where participation in...
While children are often not in a position to ‘consent’ to the research (i.e. they are not capable of making a truly informed decision), they should be told what is happening and what their rights are. In lieu of ‘consent’, minor children may sign documents indicating that they ‘assent’ to the research.
There are many ethical and legal issues to consider when involving children and young people in research. The requirements for consent, where participants are children and/or young people depend on the type of study and where in the UK it is taking place.
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