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

---
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	""	""