Pediatric/Assent Form
Age-appropriate consent for studies involving minors. Includes parent/guardian consent and child assent sections.
Consent Form Sections
This template includes 9 sections covering all required elements
Parent/Guardian Information
Your child is being invited to participate in a research study. As their parent or guardian, you must provide permission for them to participate. Please read this form carefully and discuss it with your child.
What is This Study About?
This study is looking at [STUDY_PURPOSE_SIMPLE_LANGUAGE].
We are asking [NUMBER] children to be in this study. The study will last [DURATION].
What Will My Child Do?
If you allow your child to participate, they will:
- [ACTIVITY_1_SIMPLE_LANGUAGE]
- [ACTIVITY_2_SIMPLE_LANGUAGE]
This will take about [TIME] each time.
Are There Any Risks?
[RISKS_IN_SIMPLE_LANGUAGE]
If your child becomes upset or uncomfortable at any time, they can take a break or stop completely.
Will This Help My Child?
This study may not directly help your child. However, what we learn may help other children in the future.
Privacy
Your child's information will be kept private. We will not use their real name in any reports. Only the research team will see their answers.
Does My Child Have to Do This?
No. Being in this study is your choice and your child's choice. Your child can stop at any time. If your child decides to stop, nothing bad will happen.
Child Assent Section
FOR THE CHILD (to be read aloud if needed):
We want to tell you about a research study. Research studies help us learn new things.
We would like you to [SIMPLE_DESCRIPTION_FOR_CHILD].
You do not have to be in this study if you do not want to. If you say yes, you can still stop later. No one will be upset with you.
Do you have any questions?
Contact Information
If you have questions, please contact:
Researcher: [RESEARCHER_NAME] Phone: [RESEARCHER_PHONE]
For questions about your child's rights: [IRB_CONTACT]
Regulatory Compliance
- Includes all FDA-required elements per 21 CFR 50.25
- Complies with ICH-GCP E6(R2) guidelines
- Written at appropriate reading level (8th grade or below)
- Customizable for your study-specific requirements
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✓ 21 CFR Part 11 compliant
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