ethics-checker

name	ethics-checker
version	1.0.0
description	Check research ethics compliance for human subjects research. Covers consent, confidentiality, risk assessment, and approval requirements.
allowed-tools	["Read","Write","Edit"]

Research Ethics Checker

Ensure compliance dengan research ethics untuk human subjects research.

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CORE PRINCIPLES (Belmont Report)

1. Respect for Persons

• Autonomy: Participants can make informed decisions
• Protection: Special protection for vulnerable populations

2. Beneficence

• Do no harm (non-maleficence)
• Maximize benefits while minimizing risks

3. Justice

• Fair distribution of research burdens and benefits
• No exploitation of vulnerable groups

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ETHICAL REQUIREMENTS CHECKLIST

A. Informed Consent

Required Elements:

• Purpose of research explained
• Procedures described
• Risks disclosed
• Benefits explained
• Alternatives stated
• Confidentiality protections
• Voluntary participation emphasized
• Right to withdraw explained
• Contact information provided
• Questions invited

Consent Form Template:

TITLE: [Research Title]
RESEARCHER: [Your name], [Institution]

Purpose:
This study aims to [brief purpose]. You are invited to participate 
because [eligibility criteria].

Procedures:
Participation involves [describe activities, time required, sessions].

Risks:
Potential risks include [list any physical, psychological, social, 
economic risks]. Risk level: [minimal/moderate/high].

Benefits:
Direct benefits: [to participant, if any]
Indirect benefits: [contribution to knowledge]

Confidentiality:
[Explain data protection, storage, anonymization, who has access]

Voluntary Participation:
Your participation is voluntary. You may withdraw at any time without 
penalty or consequence.

Contact:
If you have questions, contact [researcher email/phone] or 
[supervisor/IRB contact].

Consent:
I have read and understand the above information. I agree to participate.

Signature: _________________ Date: _________

B. Confidentiality & Anonymity

Concept	Definition	How to Achieve
Anonymity	No way to identify participant	No names, no ID numbers
Confidentiality	Data linked but protected	Pseudonyms, secure storage

Data Protection Measures:

• Secure storage (password-protected, encrypted)
• Limited access (research team only)
• No identifying info in reports
• Data retention plan (delete after X years)
• Safe disposal procedures

C. Risk Assessment

Risk Categories:

Level	Examples	Approval
Minimal	Surveys, interviews, observation	Expedited/Exempt
Moderate	Sensitive topics, vulnerable groups	Full board
High	Experimental drugs, deception, trauma	Full board + extra

Common Risks to Address:

• Psychological distress
• Social/economic harm
• Loss of confidentiality
• Physical harm
• Legal consequences

Risk Mitigation:

• Screening for trauma history
• Debriefing procedures
• Referral resources
• Right to skip questions
• Immediate withdrawal option

D. Vulnerable Populations

Groups requiring extra protection:

• Children (under 18)
• Pregnant women
• Prisoners
• Cognitively impaired
• Economically disadvantaged
• Students (power differential)

Special Requirements:

• Parental consent + child assent (for minors)
• Independent advocate
• Enhanced confidentiality
• Minimal risk requirement

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IRB/ETHICS COMMITTEE APPROVAL

When Approval is Required

Need approval:

• Research with human participants
• Secondary use of identifiable data
• Observation in non-public spaces
• Access to private records

May be exempt:

• Publicly available data
• Educational tests (no identification)
• Observation of public behavior
• Benign behavioral interventions

Check your institution's guidelines!

Application Components

1. Protocol Summary

   • Research question
   • Methodology
   • Participant characteristics

2. Risk/Benefit Analysis

   • Potential risks
   • Risk mitigation
   • Expected benefits

3. Consent Procedure

   • How consent obtained
   • Form attached

4. Data Protection Plan

   • Storage
   • Access
   • Retention

5. Researcher Credentials

   • Qualifications
   • Training certificates

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COMMON ETHICAL ISSUES

Issue 1: Coercion vs. Voluntary

Problem: Students feel pressured to participate Solution: Alternative activities, no grade impact, third-party recruitment

Issue 2: Deception

Problem: Withholding true purpose Solution: Debriefing essential, justify necessity, IRB approval

Issue 3: Withdrawal

Problem: Participant wants to quit mid-study Solution: Honor immediately, destroy data if requested, no penalty

Issue 4: Incidental Findings

Problem: Discovering participant needs help (e.g., depression symptoms) Solution: Protocol for referral, resources list

Issue 5: Data Breach

Problem: Confidential data compromised Solution: Incident reporting, mitigation plan

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ETHICS STATEMENT TEMPLATE

For methodology chapter:

Ethical Considerations

This study was approved by the [Institution] Research Ethics 
Committee (Reference: [number], Date: [date]). All procedures 
followed the principles outlined in the Declaration of Helsinki.

Key ethical safeguards included:
1. Informed consent obtained from all participants prior to data 
   collection
2. Participation was voluntary with right to withdraw at any time
3. Data anonymized using participant codes; identifying information 
   stored separately
4. Data stored securely on password-protected devices with access 
   limited to the research team
5. No deception was used; full disclosure of research purpose
6. [Additional specific safeguards for your study]

For studies involving vulnerable populations:
Additional safeguards included [parental consent, child assent, 
enhanced confidentiality measures, etc.].

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MALAYSIAN CONTEXT

National Requirements

• MOHE (Ministry of Higher Education) guidelines
• NMRR (National Medical Research Register) for health research
• Institutional Ethics Committees

Cultural Considerations

• Respect for hierarchy and authority
• Community consent (for indigenous groups)
• Language-appropriate consent forms
• Gender-sensitive research practices

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CHECKLIST

Before starting data collection:

• IRB/Ethics approval obtained
• Approval number documented
• Consent forms prepared
• Consent procedure tested
• Data storage secured
• Risk mitigation planned
• Referral resources identified (if needed)
• Withdrawal procedure clear
• Debriefing prepared (if applicable)
• Research team trained on ethics

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PROCESS

1. Identify risks → What could harm participants?
2. Plan mitigation → How to prevent/minimize?
3. Prepare consent → Clear, comprehensive
4. Set up data protection → Security measures
5. Submit for approval → IRB/Ethics committee
6. Wait for approval → Never start early!
7. Train team → Everyone understands protocol
8. Monitor during study → Watch for issues
9. Debrief participants → After completion
10. Retain records → Approval, consent forms

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REMEMBER

"Ethics is not a hurdle to overcome but a framework to ensure your research is conducted with integrity and respect for those who make it possible."

When in doubt → ASK your ethics committee.