Assent Template and Assent Information
Assent from minors under Subpart D of 45 CFR 46 and 21 CFR 50
The regulations define when assent of children will be required and when it can be waived. The IRB can waive the requirement for assent if either:
- some or all of the children will not be capable; or
- under some circumstances, when the study holds out the prospect for direct benefit that is important to the health or well-being of children, and is available only in the context of research; or
- the research meets the same requirements as waiver of consent.
If an investigator wishes for the IRB to waive assent for some or all of the participants, this should be described in the protocol and the conditions under which the waiver will apply. In the absence of a waiver, the investigator must obtain assent.
Per 45 CFR 46.408(b) and 21 CFR 50.55(e), the IRB may find that the permission of one parent is sufficient for research approved under either 45 CFR 46.404/21 CFR 50.51 or 405/52; but permission from both parents is required for research approved under either 45 CFR 46.406/ 21 CFR 50.53 or 407/54 (unless certain exceptions are met). Note that regardless of the IRB determination, for research taking place at an NIH site, when parents share joint legal custody for medical decision-making of a child (e.g., by a custody agreement or court order), both parents must give their permission unless specific exceptions are met.
45 CFR 46.408(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 minor participants. This waiver is most frequently invoked for research involving adolescents. However, it 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. However, for younger children, some other substitute for a parent (e.g., an advocate) will generally be required. This provision does not apply to FDA regulated research.
The 45 CFR 46.408(d) and 21 CFR 50.55(f) documentation requirements for parental permission are the same as for informed consent of adult subjects.
45 CFR 46.408(e) and 21 CFR 50.55(g) are vague with regard to the details of documentation of assent. At the NIH, we encourage investigators to develop a written assent that is appropriate to the age and condition of the children being studied. The method of obtaining assent and how it will be documented should be described in the protocol. Investigators will be expected to follow what is in the IRB approved protocol.
How should assent be documented?
The IRB recognizes that the abilities and needs of children vary widely, so investigators, when obtaining assent from a minor, should provide study information in a format tailored to the child that is in front of them.
The IRB expects that the investigator will submit a proposal in the protocol, 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.
At the NIH, the IRB prefers that investigators develop an age-appropriate written assent form. The template below is designed for children approximately ages 7-13. Note that there are no regulatory requirements for what information is included in an assent document, so there is no need to include elements that are irrelevant. Be sure to write the assent form in a simple style to make it readable and understandable to your intended audience.
The regular consent document should be written as close to an 8th grade reading level as possible. As such, you may consider having older children (ages 14 and up) sign the regular consent as their assent document, as they are able to read and understand that document.