Assent is defined as “a child’s affirmative agreement to participate in research.” Passive resignation to submit to an intervention or procedure is not considered assent. Federal regulations do not specify any of the elements of informed assent and do not provide an age at which assent ought to be possible. In determining whether children are capable of assenting, the IRB takes into account the ages, maturity, and psychological state of the children involved. The IRB determines whether all or some of the children are capable of assenting. The IRB also determines if written documentation of assent is required. The study team may document assent using the signature block for studies enrolling children in the HRP-502 TEMPLATE CONSENT DOCUMENT. The IRB also assess when parental permission is required, whether by one or both parents.

The assent of the children is not a necessary condition for proceeding with the research if the IRB determines 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. For more information on requirements for assent for children, see HRP 416 – CHECKLIST – Children, HRP-090 – SOP – Informed Consent Process for Research, HRP-091 – SOP – Written Documentation of Consent, and the Research with Children section.

As a general rule, all adults, regardless of their diagnosis or condition, are presumed competent to consent to participate in research unless there is evidence to the contrary. When investigators propose to include individuals with questionable capacity, you must provide a plan for assessing the participants’ decision-making capacity. Assessment is done on an individual basis and should determine the potential participants’ ability to understand and express a reasoned choice based on:

• The voluntary nature of research participation and the information relevant to their participation (research procedures);
• Consequences of participation for the participant’s own situation, especially with regard to the participant’s health condition;
• Consequences of the alternatives to participation;
• Potential risks and benefits involved in the study; and
• Procedures to follow if the participant experiences discomfort or wishes to withdraw.

If the assessment shows evidence that the participant is competent to consent, you must obtain valid informed consent directly from the participant. If the assessment determines that the potential participant does not have sufficient capacity to consent, you must do the following:

• Document the participant is incapable of understanding the information presented regarding the research in the participant’s research record;
• Document the information provided to the participant’s legally authorized representative regarding the cognitive and health status of the participant, the risks and benefits of the research, and the role of the legally authorized representative in the research record;
• Obtain the consent and signature of the participant’s legally authorized representative; and
• If ICH-GCP compliance is required, obtain and document the participant’s assent if the person with decisional impairment is capable of exercising some judgment concerning the nature of the research.

The verbal objection of an adult with decisional impairment is binding. If the participant, at any time, objects to continuing in the research study, they cannot participate in the research study. Situations may arise in which you could legitimately return to the participant at a later point to ascertain whether the previous objection still stands. The only exception will be research providing direct benefit only available in the context of the research, in which case you must submit a request to the IRB to enroll or continue the participant and provide written documentation of the agreement of the participant’s legally authorized representative. In this instance, the IRB may solicit advice of experts.

When appropriate, the consent process may be altered to allow for non-verbal or other alternative consent methods. Proposed alterations to the consent process are submitted for IRB review and approval.

For more information on consent and related requirements for enrolling adults with impaired decision-making, see HRP 013 – SOP – Legally Authorized Representatives, Children, and Guardians and HRP 417 – CHECKLIST – Adults with Impaired Decision-Making Capacity, HRP-090 – SOP – Informed Consent Process for Research, and HRP-091 – SOP – Written Documentation of Consent.