Create sop: Procedure for Calming a Distressed Toddler During Eye-Tracking Assessments

SOPs/LAB/SOP-LAB-001-calming-distressed-toddler-eye-tracking.md

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+```yaml
+---
+title: "Procedure for Calming a Distressed Toddler During Eye-Tracking Assessments"
+author: ""
+date: 2026-01-02
+version: "1.0"
+status: "Draft"
+---
+```
+
+## 1. Purpose
+This Standard Operating Procedure (SOP) defines a standardized, ethical, and child-centered approach for calming a distressed toddler during eye-tracking assessments conducted at PNRL. The purpose is to ensure participant safety, data integrity, and compliance with Institutional Review Board (IRB) requirements.
+
+## 2. Scope
+This SOP applies to all eye-tracking assessment sessions involving toddlers conducted by PNRL research staff. It is intended for use before, during, and immediately after assessment activities when a toddler shows signs of distress.
+
+## 3. Audience
+- Research Assistants
+- Study Coordinators
+- Principal Investigator (oversight)
+
+## 4. Regulatory and Ethical Compliance
+This SOP is designed to comply with:
+- Institutional Review Board (IRB)–approved study protocols
+- Ethical principles for research involving children
+- ISO 9001 Quality Management Systems (documentation and process control)
+- ISO 13485 principles where applicable to research devices
+- FDA 21 CFR Part 11 (where electronic records or signatures are used)
+
+## 5. Definitions
+| Term | Definition |
+|------|------------|
+| Toddler | A child typically aged 12–36 months |
+| Distress | Observable signs of discomfort, fear, crying, refusal, or agitation |
+| Eye-Tracking Assessment | A non-invasive procedure measuring visual attention using eye-tracking equipment |
+
+## 6. Roles and Responsibilities
+| Role | Responsibility |
+|-----|----------------|
+| Research Assistant | Implement calming procedures, monitor child welfare, document events |
+| Study Coordinator | Ensure staff training and SOP adherence |
+| Principal Investigator | Ensure IRB compliance and approve deviations |
+
+## 7. Procedure
+*Follow the steps sequentially. Progress to the next step only if the toddler remains distressed.*
+
+### Step 1: Pause the Assessment
+- Immediately stop the eye-tracking task.
+- Lower or turn away visual stimuli and dim screens if applicable.
+- *Ensure the toddler is not restrained and has freedom of movement.*
+
+### Step 2: Assess the Source of Distress
+- Observe verbal and non-verbal cues (crying, pushing away equipment).
+- Ask the caregiver about possible causes (fatigue, hunger, fear).
+- *Document observations after the session.*
+
+### Step 3: Provide Comfort and Familiarization
+- Allow the caregiver to hold or comfort the toddler.
+- Use a calm voice and neutral facial expressions.
+- Introduce familiar or approved comfort items if allowed by IRB protocol.
+
+### Step 4: Offer a Brief Break or Distraction
+- Provide a short break away from the equipment.
+- Use age-appropriate, IRB-approved toys or songs.
+- *Do not coerce or pressure the toddler to continue.*
+
+### Step 5: Decide to Resume or Terminate the Session
+- Resume only if the toddler appears calm and willing.
+- If distress persists, terminate the session respectfully.
+- Thank the caregiver and toddler for participation.
+
+## 8. Documentation Requirements
+- Record occurrence of distress in the study log.
+- Note actions taken and outcome.
+- Ensure records are stored in accordance with IRB and data protection requirements.
+
+## 9. Training Requirements
+- All research assistants must be trained on this SOP prior to conducting assessments.
+- Training completion must be documented.
+
+## 10. Deviations
+- Any deviation from this SOP must be documented and reported to the Study Coordinator.
+- Significant deviations may require IRB notification per protocol.
+
+## 11. References
+- IRB-approved study protocol ""
+- Ethical Principles for Research with Human Subjects
+- ISO 9001: Quality Management Systems
+- FDA 21 CFR Part 11 (if applicable)
+
+## 12. Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2026-01-02 | Initial draft | "" |
+
+## 13. Approval Signatures
+| Name | Role | Signature | Date |
+|-----|------|-----------|------|
+| "" | Principal Investigator | "" | "" |
+| "" | Quality/Compliance | "" | "" |