generated from atomicai/getting-started
100 lines
4.0 KiB
Markdown
100 lines
4.0 KiB
Markdown
```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 | "" | "" | |