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“description”: “This SOP outlines the regulatory-compliant process for obtaining pediatric assent and parental consent in clinical trials, ensuring child welfare, parental involvement, and compliance with ICH GCP, FDA, EMA, CDSCO, and WHO guidelines.”,
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Published on 25/12/2025
Standard Operating Procedure for Pediatric Assent and Parental Consent in Clinical Trials
| Department | Clinical Research |
| SOP No. | CR/ICF/015/2025 |
| Supersedes | NA |
| Page No. | 1 of 24 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define the process for obtaining pediatric assent and parental/legal guardian consent for the participation
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
- Pediatric Assent Form Template (Annexure-1)
- Parental/Guardian Consent Form Template (Annexure-2)
- 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
| Prepared By | Rajesh Kumar, Clinical Research Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Pediatric Assent Form Template
| Section | Description |
|---|---|
| Study Title | [Insert Title] |
| Why the Study? | Explained in simple child-friendly language |
| What Happens? | Simple explanation of trial procedures |
| Choice | You can say yes or no. It is your choice. |
Annexure-2: Parental/Guardian Consent Form Template
| Parent/Guardian Name | Signature | Date | Child ID |
|---|---|---|---|
| Sunita Sharma | Signed | 10/09/2025 | CHD-011 |
Annexure-3: Consent Documentation Log
| Date | Child ID | Assent Obtained | Parent/Guardian Consent | Investigator |
|---|---|---|---|---|
| 12/09/2025 | CHD-012 | Yes | Yes | Dr. Meera Joshi |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
For more SOPs visit: Pharma SOP