Assent

When a participant may not be able to legally consent to research participation, a Legally Authorized Representative (LAR) provides the consent for the participant. However, WCG IRB usually also requires that participants who are not able to consent for themselves assent to participation if possible. “Assent” means a participant’s affirmative agreement to participate in research. An investigator should not interpret a participant’s failure to object as “assent” unless the participant has also affirmatively agreed to be in the research.  

Assent is usually required for research involving underage participants and research involving adults with diminished capacity. Assessing an adult’s capacity to consent may be somewhat difficult, depending on the participant’s medical/mental condition and the requirements of the protocol. If the investigator anticipates that some participants may be able to consent while others may not, the investigator should establish a process to assess capacity.

Whenever there is doubt about capacity, the participant is best protected by involving a LAR who knows the participant and is willing and able to participate in the informed consent process with the potential participant.

In order to assent, a participant must have at least a basic understanding of what might be asked of them in the research and what might happen to a level consistent with the participant’s capacity to understand. 

The additional challenges an investigator faces in the assent process depend on the level of understanding the participant may be able to achieve. This will vary with each individual potential participant. An investigator may be able to obtain information about the participant’s ability to understand from the person providing consent.

Recognition of the potential for unintended “coercion or undue influence” or “intimidation” is essential for the assent process. The person obtaining assent must take extra care to minimize these aspects of the communication between participant and researcher. At times this may mean having a different individual conduct the assent process to optimize the communication.

WCG IRB initial review submission forms ask sites if they plan to enroll wards of the state. Federal regulation 45 CFR §46.409outlines special requirements for the involvement of wards in research. Sites that plan to enroll wards may be required to provide a plan for appointing an advocate for each participant. Some state and local laws also further restrict enrollment of wards in research. 

If the parent(s) of a minor child pass away after providing consent, the child can remain in the study without additional re-consent if guardianship is transferred to the state or a relative and the child’s caretaker(s) agree to the child’s continued participation in the research study.