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This document outlines the procedures for obtaining assent from minors for participation in research studies, including guidelines for parental consent and the risks associated with such research.
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How to fill out obtaining and documenting assent
How to fill out Obtaining and Documenting Assent from Minors
01
Begin by explaining the purpose of the study in age-appropriate language.
02
Ensure that the minor understands the information being presented.
03
Clearly outline what participation entails, including any risks and benefits.
04
Ask the minor for their agreement to participate after providing sufficient information.
05
Document the assent verbally or in writing, depending on the requirements of the study.
06
Ensure that there is a mechanism for the minor to withdraw assent at any point.
Who needs Obtaining and Documenting Assent from Minors?
01
Researchers conducting studies involving minors.
02
Ethics committees reviewing proposals involving research with children.
03
Institutional review boards (IRBs) that oversee research ethics.
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What is the meaning of assent for children?
Assent is an agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7-17 or cognitively-impaired person) to participate in research. Please review the Research Guidance Document on Assent for more information about requirements, etc.
What is an example of child assent?
Parental consent is usually a prerequisite to the recruitment of human research participants who are children. However, parental consent constitutes only half of the consent process. Assent, the agreement of a child to participate in research, is the second component of the informed consent procedure for children.
What does obtaining assent mean?
Sample Child Assent Forms I have been told that my parents (mom or dad) have said it's okay (or, have given permission) for me to participate, if I want to, in a project about _. I know that I can stop at any time I want to and it will be okay if I want to stop.
What is the requirement for documentation of minors assent to participate in research?
Assent is an agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7-17 or cognitively-impaired person) to participate in research.
What is obtaining assent from children?
The IRB presumes that minors ages 7 and older should be given an opportunity to provide assent. Written assent using a physical document is usually sought in these cases. For children (typically ages 3 to 6), specific considerations should be made to ensure that they understand what is asked of them.
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What is Obtaining and Documenting Assent from Minors?
Obtaining and Documenting Assent from Minors refers to the process of gaining agreement from minors to participate in research or studies, ensuring that they understand what participation involves, in addition to obtaining parental consent.
Who is required to file Obtaining and Documenting Assent from Minors?
Researchers conducting studies that involve minors are required to file Obtaining and Documenting Assent from Minors as part of the ethical guidelines and regulatory requirements governing research involving human subjects.
How to fill out Obtaining and Documenting Assent from Minors?
To fill out Obtaining and Documenting Assent from Minors, researchers must provide clear information about the study, including its purpose, procedures, potential risks, and benefits, and ensure that the minor signs or indicates their understanding and willingness to participate.
What is the purpose of Obtaining and Documenting Assent from Minors?
The purpose of Obtaining and Documenting Assent from Minors is to respect the autonomy of minors and ensure they are informed about their participation in research, thereby promoting ethical standards and protecting vulnerable populations.
What information must be reported on Obtaining and Documenting Assent from Minors?
The information that must be reported includes the minor's understanding of the study, any potential risks and benefits, the procedure for participation, and the minor's signature or other indication of assent.
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