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Assent is defined as the affirmative agreement of an individual (usually a minor) to participate in research. Federal regulations require that assent be obtained from children who participate in research studies if they are capable of understanding what is being asked of them. Decisionally impaired individuals may also be asked to give their assent before joining a research study.
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Please note: Assent should never be used to replace the consent of a parent or legally authorized representative (LAR). Informed consent must be obtained from a parent or LAR in conjunction with assent from the child or decisionally impaired individual.
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Sterling IRB requires that assent be obtained from all children ages 7-11. The Sponsor may either increase the age of assent to older than 11 and/or decrease the age of assent to younger than 7.
Assent documents generally consist of 1 or 2 pages written entirely in the first person (e.g., "If I want..." and "I have been told..."). The assent document should be written in language appropriate to the age or cognitive ability of the person giving assent.
The assent document should contain the following elements:
A statement that the child/individual is agreeing to be in the study that was described in the informed consent document that his/her parent or legal authorized representative (LAR) signed.
A statement that the child/individual has been told what it means to volunteer for a research study.
A statement that the child/individual is making the decision on his/her own.
A statement that the child/individual can decide to quit the study at any time, and no one will be angry with him/her.
A statement that the child/individual has been told what will happen to him/her during the study.
A statement that the child/individual can ask any questions at any time, and the doctor will answer them.
A simple check box to let the child/individual check either that he/she agrees to be in the study or does not agree to be in the study.
A signature line for the child/individual to sign his/her name.
A place for the parent/LAR to document the child/individual's age.
A short statement that the parent/legal guardian believes that the assent document has been read by the child/individual, and that the child/individual seems to understand it.
A signature line for the signature of the parent/legal guardian.
Sterling IRB offers a template for the Assent Document (and the Participant Informed Consent Document). Please call 1-888-636-1062 (toll-free) or email to request a Sterling IRB template.
For further information or if you have any questions,
call 1-888-636-1062 (toll-free) or email .
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