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Pediatric consent planning involves more than shortening the adult form. The site must explain the research appropriately, establish who can give permission and plan how a child's participation and understanding will be revisited.
Map permission and participation
TİTCK publishes pediatric ethics guidance alongside general ethics application and good clinical practice materials. Use the relevant current texts and ethics decisions to establish the study-specific approach. Do not invent a single assent age or signature rule applicable to every child and protocol.
Prepare age-appropriate materials
We recommend a discussion map covering representative identity, information appropriate to the child's understanding, the child's questions and the investigator's assessment. Document any separate materials and how disagreement or distress is managed. The form should support communication rather than turn the child's participation into a signature exercise.
Check the actual discussion pathway
- Verify the applicable representative permission pathway and unresolved legal questions.
- Check language, illustrations and procedure explanations against the planned age groups.
- Train staff to record the discussion, questions and any refusal or reluctance.
- Plan reassessment when capacity, age, study information or family circumstances change.
Plan for changing circumstances
Rehearse a difficult visit with the clinical team, including a child who does not want a procedure despite representative permission. Obtain the appropriate medical and ethical guidance before proceeding. Keep the documented rationale specific to the participant and study situation.
Frequently asked questions
- Does a parent's signature replace child-oriented information?
- No. The information and participation approach should reflect the applicable guidance and the child's situation.
- Can one universal age threshold be copied into every study?
- Use the relevant rules and ethics decision; do not substitute an unsupported operational convention.