Child Assent Procedure
Georgia State University Procedure:
No assent is required. Provide to the IRB information about how you will ensure that the children want to participate and are not getting upset.
Verbal assent must be obtained and documented by PI. Submit an assent script to the IRB for review. The assent script must be age and cognition appropriate for the population.
This age group must sign a separate assent document. The document will explain what will happen, and why, risks involved, any benefits, and the option that they could withdraw e.g., “you don’t have to be in this study, and your parent(s)/legal guardian(s) cannot make you be in it.” Also, a statement which would in effect say that they can “stop being in the study at any time” It does not necessarily need to contain other standard items like alternatives, cost/compensation and disclaimers, new findings, contacts, and confidentiality, but must be age and cognition appropriate for the population. Once the study is explained to the child, he or she should be asked to sign the assent. if signing a form is too intimidating or not appropriate for the population, the researcher can request a waiver of documentation of consent.
Consent must be obtained from the parent or legal guardian of children involved in research through a Parent Permission Form. This document needs to be in the format of an informed consent, but should be in third person (i.e. your child). The title of the document should the Parent Permission Form. Only a parent or legal guardian can sign a parental permission form for a child participating in research. A care giver, nanny, or grandparent cannot sign the form unless he/she is the child’s legal guardian.
Should the assenting child decline participation in this study, the PI, the parent(s), or legal guardian(s) cannot force the child to participate.
The Georgia State University IRB may determine that a waiver of consent is appropriate for parental permission for some studies. A waiver of consent for parental permission could also be requested for children 17 years old depending upon the type of research being conducted (i.e., the research study is conducted on a University campus, is a survey or questionnaire, and is determined to be a minimal risk.) The waiver must be requested and justified in the IRB application.