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Standard Operating Procedure for Pediatric Assent and Parental Consent in Clinical Trials

Purpose

The purpose of this SOP is to define the process for obtaining pediatric assent and parental/legal guardian consent for the participation of children in clinical trials. This ensures the rights, safety, and well-being of minors are protected and that participation is ethically and legally sound, in compliance with international and national regulations.

Scope

This SOP applies to all investigators, sub-investigators, study coordinators, and site staff responsible for enrolling pediatric participants in clinical trials. It covers age-appropriate assent, parental/legal guardian consent, documentation, and ethical considerations for involving children in research.

Responsibilities

• Principal Investigator (PI): Ensures child assent and parental consent are obtained in accordance with regulatory guidelines.
• Study Coordinator: Facilitates age-appropriate communication with children and manages documentation.
• Parent/Legal Guardian: Provides informed consent on behalf of the child.
• Ethics Committee/IRB: Reviews and approves assent and parental consent forms.
• Quality Assurance Officer: Audits consent documentation during trial monitoring.

Accountability

The Principal Investigator is accountable for ensuring that no child participates in a clinical trial without both parental/legal guardian consent and, where applicable, the child’s assent. This dual consent process reflects ethical obligations under ICH-GCP and other guidelines.

Procedure

1. Age Determination and Assent Requirement
Children above 7 years (or as defined by local law) must provide assent in addition to parental consent.
Children below this threshold require only parental/legal guardian consent.

2. Development of Assent Forms
Draft child-friendly assent forms with simplified language.
Translate into local languages where necessary.
Obtain EC/IRB approval for assent and consent forms before use.

3. Obtaining Parental/Guardian Consent
Provide parents/guardians with full study information: purpose, risks, benefits, and procedures.
Obtain signed consent from at least one or both parents, depending on national regulations and trial risk profile.

4. Obtaining Pediatric Assent
Explain study details to the child in age-appropriate language.
Confirm the child understands participation is voluntary.
Obtain written assent (signature or mark) for older children, or verbal assent recorded for younger ones.

5. Witness Requirement
If the child is unable to sign, obtain thumbprint or verbal assent in presence of an impartial witness.
Document witness details on assent form.

6. Documentation and Filing
File original signed assent and parental consent forms in site records.
Provide a copy to parent/guardian.
Record consent in Consent Documentation Log.

7. Re-consent
Re-consent required when the child reaches the legal age of consent during trial.
Re-consent also applies when new information affects participation.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• EC: Ethics Committee
• IRB: Institutional Review Board
• ICF: Informed Consent Form
• QA: Quality Assurance

Documents

1. Pediatric Assent Form Template (Annexure-1)
2. Parental/Guardian Consent Form Template (Annexure-2)
3. Consent Documentation Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Pediatric Research Guidance
• EMA Clinical Trial Regulation (EU No. 536/2014)
• WHO Guidelines on Ethics in Health Research
• CDSCO Clinical Trial Rules, 2019

Version: 1.0

Approval Section

Annexures

Annexure-1: Pediatric Assent Form Template

Annexure-2: Parental/Guardian Consent Form Template

Annexure-3: Consent Documentation Log

Revision History

For more SOPs visit: Pharma SOP