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Resources :: Guide :: Vulnerable and risk sensitive participants :: Vulnerable participants :: Minors in research :: Consent

Consent

Parents should be contacted about the study before you can approach a child about participating in a study. In a general parent/ child consent process, the parent receives a parent version of the consent form, while the child receives an assent form. The parent should sign the consent form first before the child signs the assent form. Each form should be written to the comprehension level of the target audience. 

Determining capacity to assent: A child’s capacity to assent can depend on the complexity of the study and the maturity of the child, but as a general rule, the IRB-SBS requires that assent be obtained from all children ages seven and older. For children younger than seven, it is still appropriate to talk to the child about what they will do and to ask permission to go forward.

When can assent and/or consent be waived? If the child’s capacity to understand is so limited, assent can be waived but parental permission is still required. If the procedure provides a direct benefit important to the health or well-being of the child and it cannot be obtained otherwise, the researcher can proceed without assent though parental permission is required. If a protocol meets the requirements to waive documentation of consent or to waive consent, assent can also be waived.  In addition, if consent could be a risk to the child (i.e. abused or neglected child), consent can be waived but must be replaced with an adequate procedure to represent the child, including a procedure to obtain assent from the child where appropriate.

What forms should I use? For most studies, you will want to follow the Parent Consent/ Child Assent Template in the Forms section. In some studies, the parent may act as a participant in the study as well as allowing their child to participate.  If so, it may be necessary to provide a separate consent form document that more clearly explains what the parent will do as a participant in the study particularly if parent participation is optional; if you decide to use one form to describe the parent and child participation, make sure to use separate sections to describe what the parent will do and what the child will do. Also, if the study requires that you provide additional forms (i.e. materials release forms, debriefing documents), you should provide a parent version as well as a child version.

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