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Get the free Assent form for child between 13 and 17 years of age - radford

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This form is used to obtain informed consent from children aged 13 to 17 years for participation in a study, requiring a parent’s consent and a child's signature, along with a witness.
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How to fill out assent form for child

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How to fill out Assent form for child between 13 and 17 years of age

01
Begin by reviewing the Assent form to understand its purpose.
02
Fill in the child's basic information such as name, age, and date of birth.
03
Provide a brief explanation of the study or research in simple language that the child can understand.
04
Ensure that the potential risks and benefits of participation are clearly outlined.
05
Include a section for the child to indicate their willingness to participate, such as a checkbox or signature line.
06
Ask the child if they have any questions about the study.
07
Ensure a parent or guardian has reviewed and signed the consent form, if required.
08
Allow the child to sign and date the Assent form where indicated.

Who needs Assent form for child between 13 and 17 years of age?

01
The Assent form is needed for any research involving children aged 13 to 17, where their participation requires their agreement alongside parental consent.
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In general the Assent document should be less formal than the informed consent document (parental, caregiver, etc.). The important aspect is that the document can be clearly read and understood or that the text can be clearly read to and understood by the child or adult subject.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either decisionally or emotionally, of being reasonably consulted about participating.
If a minor who is 14 or over refuses treatment, a court order is usually required to provide that treatment against the minor's wishes, except in a small set of circumstances.
Children 7 to 12 years old In most cases, children this age will be able to participate in the assent process, using a simplified assent form (Assent Form). A separate, more detailed permission form will be needed for the parents or guardians (Parent Permission).
Consent/Assent: Permission from ONE parent/legal guardian may be sufficient. Assent of child (if child is 7 years of age or older). See the Waiver of Consent guidance for info on when the IRB may waive consent/assent for non-FDA-regulated research.
“Assent” is defined by the regulations as follows: “Assent” means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (45 CFR 46.402(b)).
Legally, children cannot give consent on their own behalf. The consent of their parent(s) or legal guardian is required before children can participate in research projects. In addition to obtaining parental/legal guardian consent, researchers must also obtain assent of children between the ages of 5 and 18.
Children 7 to 12 years old In most cases, children this age will be able to participate in the assent process, using a simplified assent form (Assent Form). A separate, more detailed permission form will be needed for the parents or guardians (Parent Permission).

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The Assent form is a document that indicates a child's agreement to participate in a research study or medical procedure, specifically for individuals aged between 13 and 17 years old. It is designed to complement parental consent by ensuring that the minor understands the study and voluntarily agrees to take part.
The Assent form must typically be filed by the researchers or investigators conducting the study, along with the parents or guardians who provide consent for the child's participation. The form ensures both the minor's understanding and agreement to participate.
To fill out the Assent form, the minor should read through the document carefully, with assistance as necessary, to understand the study's purpose, procedures, risks, and benefits. They then sign and date the form to indicate their consent. The form may also require a signature from a parent or guardian, depending on specific regulations.
The purpose of the Assent form is to ensure that minors aged 13 to 17 are informed about the nature of the research or procedure they are being asked to participate in and to confirm that they voluntarily agree to take part. It promotes ethical standards in research by acknowledging the minor's evolving capacity for decision-making.
The Assent form should report information including the study's title, purpose, procedures involved, any potential risks and benefits, confidentiality assurances, and the right to withdraw at any time without penalty. It may also include space for signatures of the minor and parent or guardian.
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