Institutional Review Board (IRB) protocol narratives are comprehensive research documents describing study purpose, design, procedures, risks, benefits, and protections for human subjects. According to OHRP guidance on IRB requirements, inadequate protocol documentation causes most IRB application delays and rejections. Complete initial submissions with all required elements accelerate approval, enabling research to begin sooner.
What 12 Sections Must Every IRB Protocol Include?
Every complete IRB protocol must include 12 essential sections. Missing any section triggers revision requests that delay approval by weeks or months.
IRB Protocol Section Checklist
| # | Section | Key Content |
|---|---|---|
| 1 | Title & PI Info | Study title, principal investigator, co-investigators |
| 2 | Research Objectives | Hypotheses, specific aims, research questions |
| 3 | Background & Significance | Literature review, scientific justification |
| 4 | Study Design | Methods, randomization, blinding, controls |
| 5 | Subject Selection | Inclusion/exclusion criteria, sample size, power |
| 6 | Recruitment | Methods, materials, compensation |
| 7 | Study Procedures | Timeline, visits, interventions, assessments |
| 8 | Risks & Benefits | Risk assessment, mitigation, benefit analysis |
| 9 | Informed Consent | Process, documentation, ongoing consent |
| 10 | Privacy & Confidentiality | Data protection, storage, access controls |
| 11 | Data Safety Monitoring | DSMB, adverse event reporting, stopping rules |
| 12 | Statistical Analysis | Analysis plan, power calculation, handling missing data |
How to Write Study Procedures Clearly
Study procedures must be described in sufficient detail for IRB to assess participant burden and risk. Use specific times, durations, and sequences:
**Visit 1 (2 hours):** - Consent process (30 min) - Baseline questionnaires (45 min) - Blood draw (10 min) - Physical measurements (15 min) **Visit 2 at 4 weeks (1 hour):** - Follow-up questionnaires (45 min) - Repeat blood draw (10 min) **Visit 3 at 8 weeks (1 hour):** - Final questionnaires (45 min) - Repeat measurements (15 min) - Compensation provided
Include specific questionnaire details: "Demographics questionnaire (10 items, 5 min). Depression screening using validated PHQ-9 (9 items, 5 min). Quality of life assessment using SF-36 (36 items, 10 min)."
How to Document Risks Comprehensively
Comprehensive risk assessment covers 5 risk categories: physical, psychological, social, economic, and legal. Even minimal-risk studies require documenting considered risks.
Risk Documentation Template
| Risk Category | Example Risk | Mitigation Strategy |
|---|---|---|
| Physical | Blood draw may cause bruising | Trained phlebotomist, sterile technique |
| Psychological | Depression questions may cause discomfort | Skip option, counseling referrals available |
| Social | Participation disclosure could cause stigma | Confidential enrollment, private meeting rooms |
| Economic | Time away from work | Evening/weekend appointments available |
| Legal | Sensitive data could be subpoenaed | Certificate of Confidentiality from NIH |
Quantify risks when possible: "Serious adverse events occur in less than 1% of participants. Most common side effects are mild headache (15%) and fatigue (8%)."
How to Describe Informed Consent Process
Consent process description must be detailed:
- Potential participants approached in private area
- Coordinator provides consent form and verbal explanation
- Covers: purpose, procedures, risks, benefits, voluntary nature, right to withdraw
- Opportunity to ask questions without time pressure
- Only after questions answered and understanding demonstrated: signature obtained
- Participant receives copy of signed form
For vulnerable populations: "Children ages 7-17 will provide written assent after developmentally appropriate explanation. Parent or legal guardian must provide written permission. Assent and permission obtained separately."
How to Document Privacy Protections
Data protection plans must be specific:
- Coding: Data coded with participant ID numbers; master key stored separately
- Electronic storage: Password-protected encrypted server behind institutional firewall
- Physical storage: Locked cabinet in locked office; access limited to study team
- Retention: 7 years per institutional policy, then secure destruction
- Destruction: Paper records shredded; electronic files securely deleted
Frequently Asked Questions About IRB Protocols
How long should an IRB protocol be?
Complete protocols typically span 20-40 pages depending on study complexity. Simple survey studies may require 15-20 pages. Complex clinical trials may need 40+ pages. Follow your IRB's template and page limits if specified.
What's the difference between exempt and expedited review?
Exempt studies involve minimal risk and fit specific categories (surveys, educational research, existing data). Expedited review applies to minimal-risk studies not qualifying for exemption. Full board review is required for greater-than-minimal-risk studies or vulnerable populations.
What causes most IRB rejection/revision requests?
Top 5 causes: (1) Vague procedure descriptions, (2) Inadequate risk assessment, (3) Consent forms at inappropriate reading level, (4) Missing vulnerable population protections, (5) Unclear data security plans. Address these areas thoroughly.
How long does IRB approval take?
Exempt: 1-2 weeks. Expedited: 2-4 weeks. Full board: 4-8 weeks. These timelines assume complete submissions. Revision requests add 2-4 weeks per cycle. Complete initial submissions with all required elements accelerate approval.
Can AI help write IRB protocols?
Yes, AI tools like River's IRB Protocol Generator can create comprehensive protocol narratives. You provide study design details, and the AI generates properly formatted protocols covering all 12 required sections. Always have your protocol reviewed by your institution's IRB before submission.
AI IRB protocol narrative generation accelerates protocol development, ensuring all required elements are included in well-organized submissions. Use River's IRB Protocol Generator to create comprehensive research protocols that meet regulatory requirements while clearly communicating study design and human subjects protections.