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In This Section
Assent of Children
Please note: 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 Waiver of Assent information below.
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.
The regulations for waiver of assent are contained in Subpart D which enumerates the special protections for children in research. There are three ways in which the IRB can waive assent for some or all of the subjects (45 CFR 46.408/46.116, 21 CFR 50.55(c)(1) and (c)(2)).
Waiver of Assent under the Common Rule
45 CFR 46.408:
Requirements for permission by parents or guardians and for assent by children
(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with #46.116 of Subpart A.
Waiver of Assent for FDA-regulated Studies
21 CFR 50.55:
Requirements for permission by parents or guardians and for assent by children
(c) The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines:
(1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or
(2) That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation.
Waiver of Assent Criteria
Some or all of the children aren't capable of providing assent:
- The default age for assent at CHOP is age 7 so if all subjects will be younger than 7 years, then the requirement for assent may be waived.
- The research may be complicated or the subject population may have limitations which make the likelihood that they can comprehend the research sufficiently to provide assent.
Research is approved under 21 CFR 50.52 or 45 CFR 46.405:
The research (1) holds out the prospect for direct benefit to the child, (2) the benefit is important for the child's health and (3) the benefit is only available in the research. This usually means that the investigational agent(s) are only available in the context of the research.
- All three conditions must be met;
- The most frequent use of this waiver is for clinical trials of investigational drugs or devices for life-threatening conditions such as treatment of cancer;
- The IRB will generally but not always require assent for a Phase 1 oncology trial. The prospect for direct benefit is often quite a bit less than for a Phase 3 trial and there are generally alternatives outside of the trial. However, there are situations where the trials in adults or other Phase I trials in children demonstrate substantial likelihood of clinical benefit which provides a basis for waiver of assent.
The research meets the criteria for Waiver of Consent under 45 CFR 46.116(d)
- Waiver of assent may be requested along with waiver of consent. The most frequent example for this waiver is for studies that are limited to the retrospective review of records.
- Waiver of assent may also be requested in situations where consent (parental permission) will be obtained. For example, it may not be practicable for the investigator to obtain the assent of the child for a telephone survey.
Frequently Asked Questions
Do the Regulations require the same elements for assent as they do for consent?
No, assent is not consent. At a minimum, the child should understand the purpose of the research (in age-appropriate terms), an explanation of the procedures, that their participation is voluntary and that they have the right to withdraw (change their mind) at any time. Assent must be affirmative. Failure to disagree is not evidence of assent. Children should not be asked to make risk-benefit assessments, nor should they have to deal with financial aspects (additional costs).
Should children be told how much money they will be paid?
It is respectful to be honest with all participants, especially children. If they are going to be compensated, they should be told how much and the basis for payment. Children younger than 9 can not understand payment based on effort and should receive a flat payment (if any). Children 9 and up can understand the concept of being paid more for more work/effort etc.
How must assent be documented (does the child need to sign the assent form)?
It is up to the IRB to decide whether or not assent must be documented and if it must be documented, the way in which it will be documented.
There is quite a bit of variability between IRBs ranging from no documentation - to documentation in the medical record - to documentation on the consent form - to documentation on an assent form. The CHOP IRB prefers that investigators document assent on the consent form using a separate assent documentation page that follows the consent signature/parent permission page. The CHOP IRB usually (but not always) makes the child's signature on the form optional. The Assent documentation page (available on the Consent Template page) includes a section for the investigator to indicate that the child was incapable of providing assent.
When does the IRB require children to sign the assent form or assent section of the consent form?
It is up to the IRB to determine whether or not the child must sign the form. The CHOP IRB takes into account the nature of the research, ages of the participants and other factors that might make signature more or less compelling.
When can the IRB waive the requirement for assent?
The IRB may waive assent for children in cases where the IRB determines that the child or children are incapable of providing assent. For example, an oncology study may be too complex for children younger than 12 or 14 to understand but a study limited to collecting a blood sample might be understandable to a 6 or 7 year old.
The IRB can also waive the requirement for assent under the following circumstances:
- the intervention offers a prospect for direct benefit ((e.g., a Phase III clinical trial) approved under 45 CFR 46.405/21 CFR 50.52));
- the benefit related to the intervention is important for the child's health (e.g., a novel chemotherapy drug or drug to treat a serious illness); and
- the intervention is only available in the context of the research (new drug or treatment regimen). See the Waiver of Assent accordion on the Assent of Children page for more information.
What if my study enrolls children ages 2 - 17 years; do I need assent of everyone?
Only children capable of providing assent should be both involved in the discussion and asked to provide assent. The IRB expects that the investigator will submit a proposal describing which age groups will be able to provide assent and which will not. This should be based on the type and complexity of the research and the population being enrolled. Children too young to assent should still have the research explained to them in terms appropriate to their level of understanding and maturity.