Ethics Risk Assessment
The Ethics Risk Assessment examines your study across eight categories of ethical concern, scores the risk in each, and produces an overall risk level with targeted recommendations.
How it works
You complete 45 questions grouped into eight categories. Every answer is a dropdown selection carrying a hidden risk weight (0-3). The module then:
- Sums risk weights within each category
- Normalises each category to a 0-100 score
- Classifies each category as low, medium, or high risk
- Averages category scores into an overall risk score
- Generates recommendations based on flagged issues
The eight categories
| # | Category | Questions |
|---|
| 1 | Participant Rights & Consent | Purpose explained, methods described, risks communicated, benefits explained, voluntariness, withdrawal rights, compensation, vulnerable groups, children's consent, consent language |
| 2 | Privacy & Data Security | Data protection (GDPR/KVKK), data minimisation, anonymisation, retention, access controls, encryption |
| 3 | Data Sharing & Publication | Result reporting, pre-registration, data/script sharing, open access, preprints, integrity measures |
| 4 | Secondary Data Use | Data source, original consent scope, ethics approval, DUA, re-identification risk |
| 5 | Conflicts of Interest & Funding | Financial conflicts, contracts, sponsor influence, data rights |
| 6 | Authorship & Originality | ICMJE compliance, contribution matrix, prior publication, thesis relation, gift authorship |
| 7 | Research Design & Risk-Benefit | Scientific validity, sample size, interim analysis, stopping rules, genetic data, incidental findings |
| 8 | Legal/Institutional Permissions | Ethics committee approval, institutional approval, regulatory approvals |
Scoring methodology
Risk weights per answer
| Weight | Meaning | Pattern |
|---|
| 0 | No risk | Best-practice (yes_detailed, full_anon, approved, na) |
| 0.5 | Very low risk | Slightly less than ideal (yes_basic, yes_major, minimal) |
| 1 | Low-moderate risk | Partial or standard (partial, yes_implied, adequate, pending) |
| 2 | Moderate-high risk | Unclear or limited (unclear, limited, basic, convenience) |
| 3 | High risk | Missing or non-compliant (no_clear, no_consent, duplicate, no_regulatory) |
Category normalisation
normalised_score = (sum of answer weights / category_max_score) * 100
Maximum scores per category:
| Category | Max |
|---|
| Participant Rights & Consent | 30 |
| Privacy & Data Security | 18 |
| Data Sharing & Publication | 18 |
| Secondary Data Use | 15 |
| Conflicts of Interest & Funding | 12 |
| Authorship & Originality | 15 |
| Research Design & Risk-Benefit | 18 |
| Legal/Institutional Permissions | 9 |
Risk level classification
| Normalised score | Risk level |
|---|
| < 33 | Low |
| 33 - 66 | Medium |
| >= 66 | High |
Overall risk score
overall_risk_score = average of all 8 normalised category scores
Issue flagging
Any answer with weight >= 2 is flagged as an issue for that category.
Recommendations
Category-driven
Every high risk category triggers: "HIGH PRIORITY: Address issues in [category]"
Trigger-based recommendations
| Trigger | Recommendation |
|---|
| Vulnerable groups: inadequate/standard | Ensure additional safeguards for vulnerable participants |
| Children's consent: no | CRITICAL: Obtain parental consent and child assent |
| Data protection: partial/planned/no | Ensure full GDPR/KVKK compliance before collection |
| Encryption: no | Implement encryption and logging measures |
| Integrity measures: no | Implement measures against p-hacking, HARKing, selective reporting |
| Re-identification risk: high | CRITICAL: Address high re-identification risk |
| Sponsor influence: yes | Ensure independence from sponsor influence |
| ICMJE compliance: unclear/no | Review authorship against ICMJE criteria |
| Prior publication: duplicate | CRITICAL: Duplicate publication violates ethical standards |
| Scientific validity: questionable | CRITICAL: Improve scientific validity and rigor |
| Ethics committee: none | CRITICAL: Obtain ethics committee approval |
Always included
- "Document all ethical considerations thoroughly in your protocol"
- "Maintain ongoing ethical review and compliance throughout the research"
The evaluation report
| Field | Contents |
|---|
| timestamp | When assessment was run |
| overallRiskScore | Averaged 0-100 risk score |
| categoryScores | Per-category: normalised score, risk level, flagged issues |
| recommendations | Generated recommendation list |
| details | Complete record of every answer |
Interpreting results
| Level | Reading |
|---|
| Low | Largely best-practice answers; few high-weight issues |
| Medium | Some partial or unclear answers; review flagged issues |
| High | Multiple high-weight answers; needs substantive attention before submission |
The risk score is a structured self-assessment aid, not a formal ethics approval. It surfaces issues committees will scrutinise so you can address them in advance.