⚠️ **Modal Warning**: These are the most predictable ethics review approaches:

| Modal Approach | T-Score | Limitations |
|----------------|---------|-------------|
| "Check Belmont 3 principles" | 0.90 | Formal checklist |
| "Confirm consent elements" | 0.85 | Ignores research specificity |
| "Judge Exempt/Expedited/Full" | 0.88 | Overlooks boundary cases |

➡️ Baseline established. Proceeding with research-specific ethical analysis.

**Direction A** (T ≈ 0.7): Standard Enhancement
- Belmont principles + research-specific risk matrix
- Suitable for: General research, expedited review candidates

**Direction B** (T ≈ 0.4): Proactive Analysis
- Anticipate unexpected ethical dilemma scenarios
- Stakeholder impact analysis
- Suitable for: Vulnerable population research, sensitive topics

**Direction C** (T < 0.3): Innovative Approach
- Analyze limitations of existing ethical frameworks
- Integrate emerging ethics issues (AI, big data, digital)
- Suitable for: Novel methodologies, emerging technology research

T > 0.8 (Modal - Needs Enhancement):
├── Generic Belmont principle application
├── Standard consent form templates
├── Binary Exempt/Expedited/Full judgment
└── Basic risk-benefit comparison

T 0.5-0.8 (Established - Needs Contextualization):
├── Ethics considerations by research design (RCT vs observational)
├── Special considerations by target population
├── Privacy analysis by data type
└── Cultural context consideration

T 0.3-0.5 (Deep - Recommended):
├── Unanticipated dilemma scenarios
├── Stakeholder impact mapping
├── Long-term impact analysis
└── Post-research obligation analysis

T < 0.3 (Innovation - For Leading Research):
├── Apply emerging ethical frameworks
├── AI/big data research ethics
├── Global research ethics harmonization
└── Researcher-participant power dynamics analysis

Required:
  - Research protocol: "Research purpose, methods, procedures"
  - Participant characteristics: "Age, vulnerability status"

Optional:
  - Data collection methods: "Surveys, interviews, experiments, etc."
  - Incentives: "Compensation type and amount"
  - Consent form draft: "If available"

## Research Ethics Review Report

### 1. Belmont Report Principles Review

#### Respect for Persons
| Item | Status | Notes |
|------|--------|-------|
| Voluntary participation | ✅/⚠️/❌ | |
| Adequate information | ✅/⚠️/❌ | |
| Right to withdraw | ✅/⚠️/❌ | |
| Vulnerable population protection | ✅/⚠️/❌ | |

#### Beneficence
| Item | Assessment |
|------|------------|
| Potential benefits | [List of benefits] |
| Potential risks | [List of risks] |
| Benefit/risk ratio | Adequate/Inadequate |
| Risk minimization measures | [List of measures] |

#### Justice
| Item | Status | Notes |
|------|--------|-------|
| Fair participant selection | ✅/⚠️/❌ | |
| Valid exclusion criteria | ✅/⚠️/❌ | |
| Benefit/burden distribution | ✅/⚠️/❌ | |

### 2. Ethical Risk Matrix

| Risk | Likelihood | Severity | Risk Level | Mitigation Measures |
|------|------------|----------|------------|---------------------|
| [Risk1] | High/Med/Low | High/Med/Low | | |
| [Risk2] | | | | |

### 3. Consent Form Review

#### Required Elements Checklist
- [ ] Study title and researcher information
- [ ] Research purpose explanation
- [ ] Participation procedures explanation
- [ ] Expected time commitment
- [ ] Potential risks and discomfort
- [ ] Expected benefits
- [ ] Confidentiality methods
- [ ] Compensation details
- [ ] Voluntary participation and withdrawal rights
- [ ] Contact information

#### Improvement Recommendations
1. [Recommendation 1]
2. [Recommendation 2]

### 4. Data Protection Plan

| Item | Current Status | Recommendations |
|------|----------------|-----------------|
| Anonymization method | | |
| Storage location | | |
| Retention period | | |
| Access control | | |
| Disposal plan | | |

### 5. IRB Review Level Determination

**Recommended Review Level**: [Exempt/Expedited/Full]
**Rationale**: [Judgment reasoning]

### 6. IRB Submission Checklist

- [ ] Research protocol
- [ ] Consent form
- [ ] Survey/interview protocol
- [ ] Researcher CITI certification
- [ ] Recruitment materials (if applicable)
- [ ] Other: [List]

You are a research ethics expert and IRB committee member.

Please review the ethical aspects of the following research:

[Research Protocol]: {protocol}
[Participants]: {participants}
[Data Collection]: {data_collection}

Tasks to perform:
1. Review according to Belmont Report principles
   - Respect for Persons
     - Autonomy protection
     - Vulnerable population protection
   - Beneficence
     - Benefit/risk ratio
     - Potential harm minimization
   - Justice
     - Fairness of participant selection
     - Equitable benefit/burden distribution

2. Ethical Risk Matrix
   | Risk | Likelihood | Severity | Mitigation Measures |

3. Consent Form Element Review
   - Research purpose clarity
   - Procedure explanation adequacy
   - Risk/benefit disclosure
   - Voluntary participation assurance
   - Withdrawal rights specification

4. Data Protection Plan Review
   - Anonymization/pseudonymization methods
   - Retention period and location
   - Access control management
   - Disposal plan

5. Generate IRB Submission Checklist

Applied Checkpoints:
  - CP-INIT-002: Select creativity level
  - CP-VS-001: Select ethics analysis direction (multiple)
  - CP-VS-003: Confirm final ethics review satisfaction
  - CP-FA-001: Select analogy source field

../../research-coordinator/core/vs-engine.md
../../research-coordinator/core/t-score-dynamic.md
../../research-coordinator/creativity/forced-analogy.md
../../research-coordinator/creativity/iterative-loop.md
../../research-coordinator/creativity/semantic-distance.md
../../research-coordinator/interaction/user-checkpoints.md