Assent is defined as an “agreement by an individual not competent to give legally valid informed consent to participate in research” (e.g. an individual under the age of 18 or cognitively impaired to a point that it interferes with decision making). An assent form must be created for any research that includes individuals who are not capable of granting informed consent. Principal investigators need to be aware that assent forms are used in addition to consent forms. For any individual who would be asked to give assent, the principal investigator must also obtain consent from that individual’s guardian.
Assent Guidelines
- Participants between the ages of 6 and 17 are asked to sign assent when taking part in any research project. If a child refuses to sign an assent form, the research cannot proceed even if consent has been granted by the child’s guardian.
- Participants who are over the age of 18 but cognitively disabled must also give assent to take part in a research project. If a cognitively disabled individual refuses to sign an assent form, the research cannot proceed even if consent has been granted by the individual’s guardian.
- In all cases where assent may be needed a separate assent form must be created and that form must include the same information as the consent form presented to the guardian (although the language may be changed so that the form reads at the appropriate education/ability level of the individual granting assent).
- Individuals who are too young or too cognitively disabled to sign their own names should be granted the opportunity to give a verbal assent. This verbal assent must be recorded by the researcher and maintained in the same manner as a written assent or consent form.
- Individuals who are too young or too cognitively disabled to give assent should be considered “a special population” that is at high risk of manipulation by the research process. Any research that includes these populations must be recorded and the materials must be maintained in the same manner as other research materials. If a participant who falls into this category shows discomfort or displeasure at the research process, this should be interpreted as revoking of assent even if the guardian has given consent for the research to continue, and the research session with that participant should be terminated.
- The language of the assent form must be appropriate for the population of interest and the mental abilities of the participants involved. If needed, the assent form can be read aloud to the participant.
Assent forms should include the following:
- The title of the research project
- The purpose of the research project
- The procedures that the participant will be undergoing
- A description of how the participant can stop the research if he/she wants to withdraw (including a very clear explanation that he/she will not experience negative consequences for withdrawing)
- Statements about confidentiality using language that corresponds to the education/ability level of the participant and that includes how, where, and how long the data will be kept and how it will be destroyed
- Signature lines for assent, date, and principal investigator
