Research Ethics Compliance
Navigate research ethics requirements with confidence using this all-in-one compliance assessment tool. Designed for researchers and students, it guides you through project details, ethics considerations, and regulatory requirements while automatically identifying potential compliance issues. Generate professional reports, consent form templates, and export documentation ready for IRB submission.
Key Features
- Interactive project information and ethics assessment forms
- Real-time compliance scoring and risk level assessment
- Automatic identification of critical, major, and minor issues
- Vulnerability population and data protection checks
- Informed consent template generator
- Professional HTML/PDF report generation
- JSON data export and import for project continuity
- IRB submission package preparation
- Color-coded severity indicators and recommendations
- Comprehensive audit trail documentation
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Frequently Asked Questions
What is IRB approval and do I need it for my research?
IRB (Institutional Review Board) approval is required for research involving human participants to ensure their rights, safety, and welfare are protected. You need IRB approval if your research collects data from people through surveys, interviews, observations, or medical procedures. Even minimal risk studies require review. This tool helps you assess whether IRB approval is needed and prepares documentation for submission.
What are vulnerable populations in research ethics?
Vulnerable populations include groups with limited autonomy or increased susceptibility to coercion: children, pregnant women, prisoners, individuals with cognitive impairments, economically disadvantaged persons, and terminally ill patients. Research with these groups requires additional protections, specialized consent procedures, and stricter IRB review. This tool identifies when your research involves vulnerable populations and provides appropriate safeguards.
What should be included in an informed consent form?
Informed consent must include: study purpose and procedures, duration of participation, risks and benefits, alternatives to participation, confidentiality protections, voluntary nature of participation, right to withdraw without penalty, contact information for questions, and compensation details. The form must be written at 8th-grade reading level. This tool generates consent templates meeting federal regulations.
How long does IRB approval take?
Expedited review typically takes 2-4 weeks, while full board review can take 4-8 weeks or longer. Timeline depends on study complexity, institutional processes, and whether revisions are requested. Plan IRB submission at least 2-3 months before you need to begin data collection. This tool helps you prepare complete, high-quality submissions that minimize delays from revision requests.