Assent

Federal regulations require the IRB to consider whether children participating in research are capable of providing assent and whether parental permission is required.

The IRB may waive the requirement for assent when:

• Some or all of the children are not capable of providing assent.
• The research offers the prospect of direct benefit that is important to the child's health or well-being and is available only in the context of the research.
• The research meets the regulatory requirements for a waiver of informed consent.

If you request a waiver of assent, describe the justification in your protocol and explain the circumstances under which assent will not be obtained.

Parental Permission

Depending on the level of risk and potential benefit, the IRB may determine that permission from one parent is sufficient or that permission from both parents is required, unless an exception permitted by the regulations applies.

For research conducted at NIH sites, both parents must provide permission when they share legal custody unless one of the regulatory exceptions applies.

The IRB may also waive parental permission under certain circumstances permitted by the regulations. This provision generally does not apply to FDA-regulated research.

Adults who lack the capacity to provide informed consent should still be given the opportunity to provide assent whenever they are capable of doing so.

Assent allows participants who cannot legally consent to express their wishes about participating in research and should be viewed as an ongoing process throughout the study. Participants should also be informed about important study changes that could affect their willingness to continue participation.

If your study will enroll adults who lack decision-making capacity, your protocol should describe:

• Whether participants are expected to be capable of providing assent.
• How the study team will assess a participant's ability to provide assent.
• Whether capacity will be reassessed during the study, if appropriate.
• How assent will be obtained and documented.
• How participant dissent will be handled.

If some or all participants will not be capable of providing assent, explain why in the protocol.

The assent process should be tailored to the participant's developmental level, cognitive abilities, and understanding.

Children

When obtaining assent from children:

• Present study information using language appropriate for the child's age and maturity.
• Describe in the protocol which children are expected to provide assent and which are not.
• Use written assent forms whenever appropriate.
• For younger children, use simplified language.
• Older children and adolescents may be able to use a modified version of the consent document as their assent form.

The NIH provides an assent template that investigators may adapt for their studies.

Adults Who Lack Capacity

When obtaining assent from adults who lack decision-making capacity:

• Use language appropriate for the participant's cognitive abilities.
• Assent may be obtained verbally or in writing, depending on the participant and the study.
• If written assent will be obtained, submit a separate assent form.
• If verbal assent will be obtained, submit the script or identify the document that will guide the discussion.
• Document the assent process and the participant's ability to provide assent in the medical record.

When appropriate, investigators should encourage participants to communicate their preferences using verbal responses, gestures, or other reasonable methods.

Assent is meaningful only if participants are free to express unwillingness to participate.

For adults who lack decision-making capacity, the protocol should describe how the study team will respond if a participant objects to study participation or to individual study procedures.

If the study proposes circumstances in which dissent will not be respected, the protocol should clearly justify those circumstances.

Assent is an important way to respect the autonomy of individuals who cannot legally provide informed consent. Investigators should describe in the protocol when assent will be obtained, how it will be assessed and documented, and when a waiver of assent is requested.