Parental Permission and Participant Assent for Pediatric Clinical Research

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Parental Permission and Participant Assent for Pediatric Clinical Research

Study, Institution, and Participant Information

Voluntary Nature of Parental Permission

You are being asked to provide permission for your child to participate in a pediatric clinical research study. Your decision to permit participation is entirely voluntary. You may refuse to sign this form, and if you agree, you may withdraw your child from the study at any time without penalty or loss of standard pediatric medical care. Your child's relationship with their pediatricians, this hospital, or their school will not be affected by your decision. Your child also has a voluntary choice regarding participation, which will be respected.

Purpose and Pediatric Background

Children are not small adults. Their bodies process medications, react to therapies, and experience diseases differently. Pediatric clinical trials are essential to establish safe dosing, identify pediatric-specific side effects, and verify treatment efficacy in children. The purpose of this research study is to evaluate [insert specific pediatric study drug, medical device, or clinical protocol]. This study will enroll child participants within the age range of [insert age range, e.g. 2 to 17 years].

Clinical Study Procedures and Parent Commitments

Screening Exams: A complete pediatric physical examination, medical history review, and eligibility screening visits will be conducted to confirm safe trial enrollment.
Study Drug or Intervention: The study drug or device will be administered on the schedule defined in the protocol. Parents will be instructed on safe administration, tracking diaries, and dosing schedules.
Follow-Up Monitoring: Regularly scheduled clinic follow-up visits will measure safety variables, pediatric vital signs, blood draws, and development benchmarks.
Parent/Guardian Attendance: An adult parent or legal guardian must accompany the child participant to all scheduled clinical trial visits.

The Minor Participant Assent Process

Minors cannot legally consent to research. However, federal regulations require that children who are old enough to comprehend (typically age 7 to 17) actively agree to participate. This is called 'assent'. The study coordinator will explain the trial to your child in a simplified, age-appropriate manner. If your child is between 7 and 12, they will sign the simplified Assent section below. If they are between 13 and 17, they will review a youth-assent disclosure. If your child expresses verbal or non-verbal resistance to participation, they will not be enrolled, even if parental permission is granted.

Risk Categorization and Potential Benefits

IRB Risk Classification: Under federal pediatric research regulations (45 CFR 46 Subpart D), this study has been reviewed and classified as [insert classification: e.g. Section 46.405: Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects / Section 46.406: Research involving greater than minimal risk and no prospect of direct benefit, but likely to yield generalizable knowledge].
Potential Risks: Risks include side effects of the investigational drug (nausea, headache, skin rash, or specific safety alerts in the Investigator Brochure), pain or fear associated with blood draws, and the inconvenience of pediatric clinic visits.
Potential Benefits: Your child may experience direct clinical benefit if the investigational therapy stabilizes or improves their condition. Alternatively, participation may offer no direct benefit, but the generalizable knowledge gained will help future pediatric patients.

Privacy, HIPAA, and School Protections

Your child's identity and medical records will be protected under HIPAA privacy standards. Study records will be identified only by a secure participant code. No identifiable health information will be disclosed to your child's school, daycare, or teachers without your explicit, written consent. De-identified trial data will be shared with the sponsor and federal regulatory agencies. A federal Certificate of Confidentiality is active, shielding all pediatric records from subpoena or compelled disclosure in civil legal proceedings.

Compensation and Injury Protocols

Compensation will be provided to cover travel, parking, meals, and parent time commitments, structured as [insert compensation, e.g. $X per completed clinic visit]. Standard pediatric medical care that is not trial-related will be billed to your health insurance. In the event of a study-related injury, immediate medical care will be provided at no cost to you. Financial compensation for long-term complications or parent lost wages is not available.

Right of Parent and Minor to Withdraw

You can withdraw your parental permission and stop your child's participation in the clinical trial at any time. Your child can also withdraw their assent at any time. If you decide to withdraw, you must notify the Principal Investigator. Any study data collected up to the date of withdrawal will be retained to maintain clinical safety tracking and statistical validity in compliance with FDA requirements.

Parent / Guardian Permission Statement

I confirm that I have read this document. I have discussed the study with the principal investigator and the research team. All my questions have been answered. I give my formal permission for my child to participate in this pediatric clinical trial.

Signatures, Permission, and Assent Blocks

Parent / Legal Guardian Signature
Relationship (Parent 1)
Second Parent Signature (if required by IRB)
Relationship (Parent 2)
Minor Participant Assent Signature (Age 7 to 17)
Investigator Signature
Witness Signature (if required)
Date and Time of Permission
Document ID: CC-PENDING
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