| 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.
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
ETHICAL REQUIREMENTS CHECKLIST
A. Informed Consent
Required Elements:
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:
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
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
-
Protocol Summary
- Research question
- Methodology
- Participant characteristics
-
Risk/Benefit Analysis
- Potential risks
- Risk mitigation
- Expected benefits
-
Consent Procedure
- How consent obtained
- Form attached
-
Data Protection Plan
-
Researcher Credentials
- Qualifications
- Training certificates
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
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.].
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
CHECKLIST
Before starting data collection:
PROCESS
- Identify risks → What could harm participants?
- Plan mitigation → How to prevent/minimize?
- Prepare consent → Clear, comprehensive
- Set up data protection → Security measures
- Submit for approval → IRB/Ethics committee
- Wait for approval → Never start early!
- Train team → Everyone understands protocol
- Monitor during study → Watch for issues
- Debrief participants → After completion
- Retain records → Approval, consent forms
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.
