IRB/Ethics Application Guide
Navigate research ethics approval with confidence. From protocol development to informed consent—everything you need for a successful application.
Review Categories
Understanding review categories helps you estimate timeline and prepare appropriate documentation.
Exempt
Risk Level: Minimal
Research involving normal educational practices, surveys/interviews with adults on non-sensitive topics, public observation, or analysis of existing data.
Examples:
- Anonymous surveys of adult professionals
- Observation in public spaces
- Analysis of de-identified existing datasets
- Educational research in normal classroom settings
Expedited
Risk Level: Low
Minimal risk research that doesn't qualify for exemption but uses standard procedures like surveys, interviews, or focus groups.
Examples:
- Interviews with adults on moderately sensitive topics
- Non-invasive physiological measurements
- Research with identifiable but non-sensitive data
- Surveys with minor vulnerable population involvement
Full Board Review
Risk Level: Greater than minimal
Research involving more than minimal risk, vulnerable populations, or sensitive topics requiring full committee deliberation.
Examples:
- Research with children or prisoners
- Sensitive topics (trauma, illegal behavior)
- Deception that may cause distress
- Collection of sensitive health information
Application Components
A complete IRB application includes these essential elements. Prepare them carefully to avoid delays.
Protocol/Research Plan
Detailed description of your study including background, objectives, methods, and timeline
Informed Consent Documents
Materials explaining the study to participants and documenting their voluntary agreement
Recruitment Materials
Flyers, emails, scripts, or social media posts used to invite participants
Data Collection Instruments
Surveys, interview guides, observation protocols, or other tools
CITI Training Certificates
Proof of research ethics training for all study personnel
Required Informed Consent Elements
Federal regulations require these elements in informed consent documents. Ensure your consent form addresses each one.
Additional elements may be required for specific populations (children, prisoners) or research types (genetic research, sensitive topics).
Common Application Mistakes
Vague or incomplete procedure descriptions
Describe exactly what participants will experience, minute by minute. Include time estimates, scripts, and all questions you'll ask.
Consent forms written at too high a reading level
Aim for 6th-8th grade reading level. Avoid jargon, use short sentences, and test readability with online tools.
Claiming 'no risks' when risks exist
All research has some risk, even if minimal. Address potential discomfort, time, privacy concerns. Be honest but not alarming.
Inconsistencies between application and materials
Ensure your protocol, consent form, and instruments all match. If you say 'approximately 30 minutes,' use that phrasing everywhere.
Missing or expired CITI training
Verify all team members have current, appropriate training before submission. Training expires—check dates.
Inadequate data security description
Specify where data will be stored, who has access, how long it's retained, and how it will be destroyed. Be specific about encryption and passwords.
Frequently Asked Questions
Need Help with Your Ethics Application?
Our research methodology consultants can review your protocol, help develop consent documents, and prepare you for IRB submission.
Related Resources
Explore more resources in our Research Methodology collection