Check research ethics compliance for human subjects research. Covers consent, confidentiality, risk assessment, and approval requirements.
Ensure compliance dengan research ethics untuk human subjects research.
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: _________
| 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:
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:
Risk Mitigation:
Groups requiring extra protection:
Special Requirements:
Need approval:
May be exempt:
Check your institution's guidelines!
Protocol Summary
Risk/Benefit Analysis
Consent Procedure
Data Protection Plan
Researcher Credentials
Problem: Students feel pressured to participate Solution: Alternative activities, no grade impact, third-party recruitment
Problem: Withholding true purpose Solution: Debriefing essential, justify necessity, IRB approval
Problem: Participant wants to quit mid-study Solution: Honor immediately, destroy data if requested, no penalty
Problem: Discovering participant needs help (e.g., depression symptoms) Solution: Protocol for referral, resources list
Problem: Confidential data compromised Solution: Incident reporting, mitigation plan
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.].
Before starting data collection:
"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.