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Assent Guidelines
What is Assent in Human Subjects Research?
Assent is a child’s affirmative agreement to participate in research. For research involving minors (a person who is below 21 years of age and who has never been married), assent may be obtained out of respect a child as persons developing capacity.
Much like the informed consent process, assent is obtained by using an assent form which provides essential, simplified information about the study to the minors before they agree to participate.
Note: The terms “minor” and “child” are used interchangeably in this document.
When to obtain assent?
The decision on whether to obtain consent or assent depends on the level of understanding and intelligence of the minors.
Consent should be obtained from minors with sufficient understanding and intelligence to understand what is proposed in the research. (Refer also to our guide on consent requirements for research involving minors).
Assent should be obtained if the minors do not have sufficient understanding and intelligence to understand what is proposed in the research.
A good gauge on the level of understanding and intelligence of a minor is their age. As a general guide, consent should be obtained for minors 12 years and above if they have sufficient understanding and intelligence, whereas assent should be obtained for minors between 6 to 11 years of age. Minors below 6 years of age do not need to provide written agreement to participate in the research study.
| Does the child have sufficient understanding and intelligence to understand what is proposed in the research? | Requirements | |
|---|---|---|
| 12 to 20 years old (Secondary school and above) | To be determined by study team. | If “Yes”: Consent from both the minor and the parent If “No”: Assent from minor and Consent from the parent. |
| 6 to 11 years old (Primary school) | No | Assent from minor and Consent from the parent. |
| 0 to 5 years old (Pre-school and below) | No | Consent from the parent only. |
Note: In all scenarios, parental consent is always required when recruiting minors, unless a waiver of parental consent is approved by NTU-IRB.
The table above serves only as a general guide. There are other factors besides age that can influence a minor’s ability to understand the proposed research, including:
- The nature and complexity of the study: A complicated study (e.g. involving medical interventions and/or multiple procedures/study visits) may be harder for a minor to comprehend, as compared to a simple study (e.g. involving only a simple survey).
- The maturity, condition, and/or psychological state of the minor: Minors with cognitive disabilities (e.g. down syndrome) may not possess sufficient levels of understanding and intelligence as compared to other children of their age, thus affecting their ability to understand the proposed research.
PIs should consider all factors (not just age) when assessing whether obtaining assent would be appropriate, and if so, it should be stated in the IRB application that assent will be obtained from the minors and the assent form must be provided for review. If the study team does not intend to obtain assent from the minors, IRB reviewers may still request for the study team to do so after considering the aforementioned factors, so as to protect the rights and welfare of the minors.
Assent Form
An assent form is a simplified version of the consent form written to be understandable by the target children population. Please refer to the Assent Form Template which provides essential elements to be included in the form.
Things to note when developing an assent form:
- Avoid complicated language/ words. Write at a level appropriate to the child’s age and development.
- Complex terminology should be broken down and explained in layman’s terms.
- It is recommended for all sections found in the Assent Form Template to be included in the final version used by the study team.
Assent Procedure
Similar to the informed consent process, the assent form should be discussed and explained to the minors before enrolment. When giving assent, the minor should personally write his/her name and date on the assent form to document their assent. If the minor is unable to perform this action, they may affix their thumbprint instead, and the minor’s name and date can be written in the assent form on their behalf. In such cases, an impartial witness (not a study team member) should be present during the assent process to ascertain that assent was given voluntarily without coercion or intimidation. The impartial witness should also write his/her own name and sign in the assent form for documentation purposes.