What is the Ethics Module?
The Research Ethics Module helps researchers plan and evaluate the ethical dimensions of a study before submitting for review. It answers two questions:
- "How ethically sound is my study design?" — the Ethics Risk Assessment
- "Which ethics committee do I need?" — the Ethics Committee Navigator
The two tools
| Tool | What it does | Output |
|---|---|---|
| Ethics Risk Assessment | Assesses ethical risks through a structured questionnaire covering participant protection, data privacy, consent, vulnerable populations, and research integrity | Risk analysis (per-category and overall) plus actionable recommendations |
| Ethics Committee Navigator | Identifies which committee to submit to (IRB, IEC, IACUC, REB, or none) based on research type, jurisdiction, and study design | Committee assignment with submission requirements and regulatory references |
The two tools are complementary. The Navigator routes you to the correct review body; the Assessment ensures the study is ready.
Ethics Risk Assessment categories
| Category | What it examines |
|---|---|
| Participant Rights & Consent | Purpose, methodology, risks, benefits, voluntariness, withdrawal, compensation, vulnerable groups |
| Privacy & Data Security | Data protection, minimisation, anonymisation, retention, access control, encryption |
| Data Sharing & Publication Plan | Result reporting, pre-registration, data sharing, open access, integrity measures |
| Secondary Data Use | Data source, original consent, ethics approval, data-use agreements, re-identification risk |
| Conflicts of Interest & Funding | Financial interests, contracts, sponsor influence, data rights |
| Authorship & Originality | ICMJE compliance, contribution matrix, prior publication, gift authorship |
| Research Design & Risk-Benefit | Scientific validity, sample size, interim analysis, stopping rules, genetic data |
| Legal/Institutional Permissions | Ethics committee approval, institutional approval, regulatory approval |
Ethics Committee Navigator flow
Jurisdiction -> Research area -> Area-specific questions -> Committee assignment
| Step | Choices |
|---|---|
| Jurisdiction | FDA (United States), EMA (European Union), Other International |
| Research area | Medicine & Health, Science & Engineering, Education & Social Sciences, Arts, Survey Studies |
| Result | One of 8 outcomes: IRB, IEC, IACUC, REB, Scientific Ethics, Educational Ethics, Environmental Ethics, or no formal committee required |
Standards
Built around the Declaration of Helsinki, ICH-GCP, ICMJE authorship criteria, and data-protection regimes (GDPR/KVKK), alongside jurisdiction-specific references (FDA, EMA).
The module is a planning and self-assessment aid — it does not replace formal review.