Assent of Children
The FDA's Assent Requirements are slightly different than the Common Rule's and can be found in 21 CFR 50.55
45 CFR 46.402:
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
(d) Parent means a child's biological or adoptive parent.
(e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. (A guardian is the equivalent of a legally authorized individual acting on behalf of an incapacitated adult.)
Requirements for Permission and Assent
The regulations at 45 CFR 46.408 includes the requirements for obtaining or waiving parental permission and assent of child participants.
408(a) defines when assent of children will be required and when it can be waived. The IRB can waive the requirement of assent if either
some or all of the children will not be capable;
under some circumstances when the study holds out the prospect for direct benefit; or
the research meets the same requirements as waiver of consent
For more details, see related web page on Waiver of Assent.
408(b) requires just a single parent to provide permission for research approved under either 45 CFR 46.404 or 405 but ups the requirement to both parents for research approved under either 45 CFR 46.406 or 407.
408(c) allows the IRB to waive parental permission when it is not a reasonable requirement for the research, provided that there is an alternative mechanism in place to protect the participants. This is most frequently invoked for research involving adolescents but might also apply to research involving younger children such as those who are abused or neglected. Assent is usually sufficient as an alternative mechanism for protection for teenagers but some other substitute (e.g. an advocate) for a parent will generally be required for younger children.
408(d) the documentation requirements for parental permission are the same as for informed consent.
408(e) this part of the regulation is vague with regard to the details of documentation of assent. At CHOP, it is usually just documented on the Consent Form. However, investigators may propose alternatives, including a separate assent form, documentation in the study records or medical chart or no documentation.
How should assent be documented?
It is up to the IRB to determine when assent is required and when it is, the way it should be documented.
To document assent, some IRB's require the use of an assent form while some do not. The CHOP IRB's prefers that investigator document each child's assent on the consent form signed by their parent(s); the IRB prefers that investigators not use a separate form. The abilities and needs of children vary widely and investigators should provide the information in a format tailored to the child in front of them. In many cases, assent forms are simplified consent forms that include elements that are irrelevant to assent (e.g. risk assessment, confidentiality) and are rarely written with sufficient simplicity of style and readability to achieve their intended objective.
Does the child need to sign anything to indicate their assent?
The CHOP IRB does not require children to sign their name. On our template consent form signature pages, the signature of the child is left optional. Our preference is for investigators to focus on the assent process rather than on obtaining a signature for a form.