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PARENTAL OR LEGAL GUARDIAN INFORMATION & INFORMED CONSENT DOCUMENT FOR A MEDICATION TRIALConsent and assent: If there are children younger than 7 years in your study, the parents/ legal guardians
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How to fill out child assent and permission

01
Begin by obtaining the child's assent to participate in the activity or study. This can be done by explaining the study or activity in a language that the child can understand and ensuring that they agree to participate.
02
Provide a clear and simple consent form for both the child and their parent or legal guardian to sign.
03
Include all necessary information on the consent form, such as the purpose of the study or activity, any potential risks or benefits, and contact information for the researchers or organizers.
04
Ensure that the child and their parent or legal guardian have had the opportunity to ask any questions and have them answered satisfactorily before signing the consent form.
05
Keep a copy of the signed consent form for your records and provide a copy to the child and their parent or legal guardian.
06
Throughout the study or activity, regularly check in with the child to ensure their ongoing assent and comfort. If at any point the child expresses a desire to discontinue participation, respect their decision and notify their parent or legal guardian.

Who needs child assent and permission?

01
Child assent and permission are required in situations where minors (individuals under 18 years of age) are involved in research studies, clinical trials, or any activity that may involve potential risks or require informed consent.
02
Parents or legal guardians typically provide permission for their child to participate, but the child's assent is also necessary to ensure they understand what they are agreeing to and feel comfortable with their involvement.

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Child assent refers to the agreement of a minor to participate in research or decisions affecting them, while permission is the consent granted by a parent or guardian on behalf of the child.
Researchers, schools, or any organization conducting studies or activities involving children must file child assent and permission.
To fill out child assent and permission, provide clear information about the study, its purpose, any potential risks or benefits, and obtain signatures from both the child and the parent or guardian.
The purpose of child assent and permission is to ensure that children understand the research or activity and agree to participate, while also obtaining consent from a parent or guardian to protect the child's rights.
Child assent and permission forms must include the child's name, age, a description of the study, potential risks, benefits, and contact information for the research team.
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