Informed Consent in Research with Minors and the Mentally Disabled
A. Consent of the Guardian or Legally Authorized Representative
B. Child Assent
A. Consent of the Guardian or Legally Authorized Representative
When research is conducted with minors and the mentally incapacitated, informed consent must be sought and documented from a parent/guardian (in the case of a minor), or legally authorized representative (in the case of persons who are mentally incapacitated). Both groups are thought to lack the cognitive abilities necessary to make decisions on their own. Thus, in both cases informed consent must be sought from a third party. In the case of children, the third party would be the parent(s) (or guardian). In the case of mentally disabled persons the third party is usually the caregiver, whether a family member, friend, or even an institution.
Written documentation of informed consent is required for research involving minors under the age of 18 and all mentally disabled persons. As previously discussed, the procedures employed to obtain consent should also be viewed as a process. The parent or representative should be given ample opportunity to ask questions, consider what is involved, and discuss participation with those whom they are consenting for, or others, as appropriate. When constructing the consent document, investigators should include all the content requirements listed in Informed Consent. The form should be constructed using language which conveys that consent is being sought on behalf of another individual (e.g. “your child’s participation will involve”, “your child will be asked to…”, etc.).
Note about Parental Consent: If the research involves no more than minimal risk, the consent of one parent is sufficient. However, if the research involves greater than minimal risk, the consent of both parents is necessary except in unusual circumstances (e.g., the second parent is deceased or unknown, or one parent has sole custody).
B. Child Assent
Federal regulations state that in addition to parental consent, a child’s agreement to participate should be sought whenever possible (45 CFR 46.401). Attaining the agreement of a minor to participate in research is referred to as the process of “assent”. This should be done, of course, in a manner that is consistent with the age and developmental level of the child. The IRB typically requires that all children from age 7 through age 17 be given an opportunity to assent to their participation in research. In most cases, their assent is documented by using a written form, similar to a consent form, that presents information about the study in a child-friendly and age appropriate manner. When the reading level of the children is a concern, a verbal assent script may be used to convey what their participation would involve. All assent materials must be reviewed and approved by the IRB. Although Federal Regulations do not specify that assent be sought from mentally disabled participants, there may be cases where it would be appropriate.