Consent Procedures for Children and Youth
and Child Assent Information
Consent Procedures for Children and Youth
Parental permission. Federal regulations 45 CFR 46 Subpart D (Additional Protections for children Involved as Subjects in Research) require the permission of the parent when minors are involved in research for several reasons. With few exceptions (emancipated minor, mature minor), minors do not have the legal capacity to consent and, depending on their age and the complexity of the research context, may lack the cognitive capacity to comprehend the nature of the research and their research rights. Children may also lack the power or skills to refuse participation.
Permission of ONE parent is sufficient for research:
- Emancipated minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but are entitled to be treated as if they had such status by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation.
- Mature minor: Someone who has not reached adulthood (as defined by state law), but who according to state law may be treated as an adult for certain purposes (e.g., consenting to treatment for venereal disease, drug abuse, or emotional disorders).
a) involving no more than minimal risk; Cases of unclear custody and guardianship: Investigators should not assume that the adult living with the child is their legal guardian. This may be especially true when studying maltreated children or children in foster placements, who have unstable living arrangements.
b) involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects;
c) if one parent is incompetent or not reasonably available; or
d) only one parent has legal custody.
Out of respect for children as developing persons, federal regulations also require the assent of the child/adolescent.
Assent: A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402b]. Federal regulations do not specify the age at which assent must begin to be sought. Investigators and their IRBs must make that determination taking into account the nature of the research and age, maturity, and psychological state of minor involved [45 CFR 46.402(a)].
A minor's dissent (refusal to participate) overrides parental permission except when the research offers the child the possibility of a direct benefit that is important to his or her well-being and is available only in the context of the research [45 CFR 46.408(e)].
Waiving the Requirement for Parental Permission
The requirement for parental permission may be inappropriate if there is serious doubt as to whether the parents' interests adequately reflect the child's interests (e.g., research on child abuse or neglect; genetic testing of a healthy sibling to assist in understanding the disorder of a sibling) or cannot reasonably be obtained (e.g., research on runaways).
Participant Advocate: In such cases, consent may be waived if an appropriate mechanism for protecting the child participants is substituted. This usually entails appointment of an independent participant advocate who:
a) verifies the minor's understanding of assent procedures; Passive Consent: Difficulties in acquiring guardian consent is not in itself sufficient to waive the parental permission requirement. Passive consent (sending guardians forms asking them to respond only if they do not wish their child to participate) is not an ethical substitute for active consent. Such procedures can only be used if an IRB has approved a waiver of parental permission for reasons outlined above or if the research is eligible for exemption from IRB review (e.g., research conducted in established or commonly accepted educational settings involving normal educational instructional strategies or the effectiveness or comparison of curricula or instructional techniques [45 CFR 46.101 (b)].
b) supports their preferences;
c) ensures that participation is voluntary;
d) assesses reactions to planned procedures; and
e) ensures that adequate debriefing.
Model HIPAA Authorization Form for guardians of children and and developmentally disabled adults in research
Apply your knowledge of informed consent to the following case study: Development Differences in the Psychologial Sequelae of Rape Trauma.