```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 | "" | "" |