Consent Form Generator
A comprehensive informed consent form generator designed to help researchers create IRB/ethics-compliant consent documents for studies involving human participants. Build professional consent forms with all required elements including study information, procedures, risks with severity levels, benefits categorization, confidentiality statements, data storage details, voluntary participation rights, withdrawal procedures, and IRB contact information. Perfect for preparing ethics applications, IRB submissions, and research compliance documentation.
Key Features
- Comprehensive study information section
- Principal investigator details
- Institution and department information
- Funding source tracking
- Study duration specification
- Contact information management
- Detailed study purpose description
- Study procedures with duration and frequency
- Time commitment explanation
- Risk assessment with 4 severity levels (minimal, low, moderate, high)
- Risk mitigation strategies
- Benefits categorization (direct, indirect, societal)
- Compensation details
- Confidentiality statement customization
- Data storage and security protocols
- Voluntary participation rights
- Withdrawal process details
- Future contact permissions
- IRB/ethics committee contact information
- Multiple consent types (standard, minimal risk, online, parental, assent)
- Witness signature requirement option
- Preview mode with professional formatting
- Print-friendly consent form layout
- Export to text format for Word/PDF conversion
- Export to JSON for backup
- Import from JSON
- Browser localStorage persistence
- Statistics dashboard
- No login required
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Frequently Asked Questions
What elements are required in an informed consent form?
IRB-compliant consent forms must include: (1) study purpose and procedures, (2) time commitment, (3) risks and discomforts with severity levels, (4) benefits to participants or society, (5) confidentiality protections and data storage, (6) voluntary participation statement, (7) right to withdraw without penalty, (8) compensation if applicable, (9) researcher and IRB contact information. This tool ensures all required elements are included and properly formatted for ethics review.
What are the different risk levels in research consent forms?
Research risks are categorized as: Minimal risk (no greater than everyday activities like routine exams), Low risk (minor temporary discomfort like brief surveys), Moderate risk (more than minimal but reversible effects like stress from sensitive questions), and High risk (potential for serious harm requiring medical monitoring). Each level requires different mitigation strategies and IRB review procedures. This tool helps you accurately categorize and document risks.
Do online studies need consent forms?
Yes, online studies require informed consent, though the format may differ from in-person research. Online consent can use electronic signatures, click-through agreements, or documented consent statements participants review before proceeding. The same information elements are required (purpose, risks, benefits, confidentiality, voluntary participation, withdrawal rights), but delivery is adapted for digital formats. This tool generates online-appropriate consent language.