Research Ethics Protocol Reviewer
Review healthcare research protocols for ethical compliance and vulnerable population protection
What You Can Do
You can systematically analyze research protocols against ethical principles, regulatory frameworks, and IRB standards to identify risks before submission. Claude reviews your protocol to ensure vulnerable populations receive appropriate protections, verify informed consent meets regulatory adequacy, detect conflicts of interest and bias, and generate actionable recommendations for strengthening ethical safeguards.
Features
Verifies your protocol meets ICH-GCP, Belmont Report, Common Rule, and applicable institutional ethics standards for research compliance
Identifies at-risk groups (children, pregnant women, prisoners, cognitively impaired) and evaluates whether protections are appropriate and adequate
Reviews consent forms for clarity, completeness of risk disclosure, readability for target population, and regulatory compliance per Common Rule §46.116
Ranks identified ethical concerns by severity, probability, and potential harm to provide clear prioritization for remediation before IRB review
Flags financial, personal, and institutional conflicts that could compromise research integrity or participant welfare
Verifies all required safety protocols, monitoring plans, and ethical documentation address known risks to study population
Provides specific, implementable improvements to increase likelihood of approval and reduce revision requests from ethics review boards
Example Output
Protocol Ethical Compliance Review
Overall Risk Level: Moderate | Regulatory Compliance: 87%
Key Findings:
- ✓ Study population and inclusion criteria clearly defined
- ✗ Informed consent form lacks quantitative adverse event rates
- ✓ Adequate protections implemented for pediatric participants
- ⚠ Conflict of interest disclosure insufficient for PI's consulting relationship
Critical Recommendations:
- Revise consent form to include specific adverse event incidence rates from prior studies
- Add principal investigator conflict of interest mitigation strategy and data safety monitoring
- Clarify participant exit criteria and withdrawal procedures in protocol and consent form
Regulatory Citations:
- 45 CFR 46.111 (IRB review criteria)
- ICH-GCP E11 (pediatric ethical considerations)
- Belmont Report (beneficence and justice assessment)
What's Included
- Regulatory Compliance Checklist: Comprehensive framework covering Common Rule, ICH-GCP, Belmont Report principles, and other applicable ethics guidelines
- Vulnerable Population Matrix: Decision tool to identify at-risk groups relevant to your study and determine appropriate ethical safeguards for each
- Informed Consent Review Template: Structured evaluation assessing consent document clarity, completeness, readability level, and regulatory requirements
- Ethical Risk Assessment Tool: Scoring system to quantify and prioritize identified ethical concerns by severity, likelihood, and potential impact
- IRB Submission Preparation Checklist: Step-by-step guide to address common IRB concerns and revision requests before initial submission
Who It's For
- Institutional Review Board (IRB) members and reviewers
- Clinical trial coordinators and research project managers
- Healthcare compliance and regulatory affairs officers
- Bioethics consultants and research ethics specialists
- Academic researchers and principal investigators
Best For
- Pre-submission protocol ethical review and strengthening
- Vulnerable population protection assessment and planning
- Informed consent adequacy and clarity evaluation
- Regulatory compliance verification against ethical frameworks
- Conflict of interest and research integrity risk detection
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