Assent Document Guidelines
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.
Please note: Assent should never be used to replace the permission/consent of the parent or legally authorized representative. The permission/consent of a parent or LAR must be obtained in conjunction with the assent of a child or decisionally impaired individual.
Minors and individuals who are not competent to provide consent should be given the opportunity to assent (affirmational agreement) to participate in the research study. Sterling IRB usually requires that individuals who are unable to provide legally effective informed consent on their own, assent to participation whenever possible, and also sign and date a written informed consent / assent document. For research involving minors, Sterling's policy is that a separate documented assent must be obtained from all children ages 7-11; verbal assent must be obtained from all minors. The Sponsor may increase the required age range for a separate assent to either younger than 7 or older than 11. All other minors will document assent using the consent form.
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/permission document that his/her parent or legally 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 short statement that the parent/LAR 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/LAR.
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