Assent and consent

The Federal regulations regarding assent indicate that this must be obtained, but not at what age. The regulations indicate that assent from children must be obtained and documented when they are capable of providing it. See 45 CFR 46.408 and 21 CFR 50.55. These regulations also state that the IRB makes the determination, when reviewing a proposal, regarding whether assent is required and how this will be documented. Children's Wisconsin IRB takes into consideration age, maturity, and the psychological state of the children involved.

The default age at which the Children's IRB expects assent to be obtained, is age 7. The Principal Investigator should explain in the submission if they will be providing a separate assent form that the child signs to document assent, or whether assent will be documented on the parental permission consent form.

The process for obtaining assent should also be described, and the submissions should include any supplemental reference material that will be provided to the child. The Children's IRB will also review requests to waive assent for a particular subject, or group of subjects that the PI feels will not be capable of providing assent (for example, waiving assent for children under the age of 14.)

The requirement to obtain assent, from all children anticipated to be involved, or for each child as appropriate, may be waived if:

• The capability of some or all of the children is so limited that they cannot reasonably be consulted;
• 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; or,
• The requirements for a waiver of informed consent found in 45 CFR 46.116 are met.

If there is a compelling reason to change this language, other than preference for word choice or style, you must request this change by submitting a petition to change consent required language request form. This should be done BEFORE submitting the project and the consent forms to Children's Wisconsin IRB for review. With initial submissions for new studies, you should have the project created and started in IRBNet as a work in progress so that an IRBNet Number is available for the form, but wait to submit until you receive a decision regarding requested ICF template changes.

This form should be emailed to the Children's IRB office for review and will be returned to the sender with the decision documented on the same form. The email should include the draft consent form so requested changes can be reviewed in context.

If the Children's IRB approves the request, we will return the draft consent with the appropriate section unlocked for editing. Approved changes are ONLY valid for the specific project for which they were requested. These changes should NOT be carried over to other studies without going through this process.