Write IRB protocol narrative
AI creates complete IRB protocol narrative sections including background, objectives, study design, methods, risks/benefits, and data analysis plan.
Write IRB protocol narrative
River's IRB Protocol Narrative Generator creates complete protocol narrative sections for Institutional Review Board submissions. You provide study information (research question, design, methods, population), and the AI generates comprehensive protocol narrative including background and significance, study objectives and hypotheses, detailed study design and methodology, participant recruitment and consent procedures, data collection and management, risk/benefit analysis, and data analysis plan. The narrative is organized, thorough, and meets IRB requirements. Perfect for clinical researchers writing protocols, principal investigators preparing IRB submissions, research coordinators developing study documents, or anyone conducting human subjects research.
Unlike incomplete or poorly organized protocol narratives, this tool creates systematic, detailed protocols that address all IRB requirements. Complete protocol narratives ensure IRB reviewers understand your study design and participant protections, support efficient IRB review without endless revisions, demonstrate scientific rigor and ethical conduct, and serve as roadmap for study conduct. The AI structures narratives with appropriate scientific detail, clear methodology, and thorough consideration of participant safety. When protocol narratives are complete and well-written, they facilitate IRB approval and successful research conduct.
This tool is perfect for clinical researchers preparing IRB submissions, principal investigators writing grant proposals requiring IRB protocols, research fellows developing dissertation protocols, clinical trial coordinators creating study documentation, or any researcher conducting human subjects research. If your protocol narratives lack organization or completeness, this creates professional, thorough narratives. Use it for any research study requiring IRB review and approval.
IRB Protocol Requirements
Complete IRB protocols include essential sections: background and significance (why is this research important and what's known), specific aims and hypotheses (what questions will you answer), study design (type of study: observational, interventional, randomized controlled trial, cohort, etc.), participant population (inclusion/exclusion criteria, number of subjects, vulnerable populations), recruitment methods (how you'll identify and approach potential participants), informed consent procedures (how consent will be obtained and documented), study procedures (exactly what will happen to participants, visit schedule, data collected, interventions performed), risks and risk minimization (potential harms and how you'll minimize them), benefits (to participants and to society), data and safety monitoring, data management and confidentiality, statistical analysis plan, and study timeline.
Write protocols clearly and completely. IRB reviewers come from diverse backgrounds; write for general scientific audience, not just specialists in your field. Define medical terms and acronyms. Explain your rationale: why this design, why this population, why these measures? Be specific about procedures: not just 'blood draw' but 'one 10 mL blood draw from antecubital vein at baseline and 3 months.' Detail your consent process: who will obtain consent, where, how much time will participants have to decide, how you'll assess understanding. Address vulnerable populations appropriately (children, prisoners, pregnant women, decisionally impaired). If your study poses more than minimal risk or involves vulnerable populations, provide extra justification and protections.
IRB approval requires that risks are minimized and reasonable in relation to anticipated benefits. Thoroughly analyze potential risks: physical (procedures, interventions), psychological (sensitive questions, emotional topics), social (breach of confidentiality, stigma), economic (time burden, lost wages), and legal risks. Explain how you'll minimize each risk. Discuss benefits realistically: direct benefits to participants (if any), benefits to society (advancing knowledge), and how benefits justify risks. Include data and safety monitoring plan appropriate to risk level (high-risk studies need data safety monitoring boards, lower-risk studies need principal investigator monitoring with stopping rules). Complete, thoughtful protocols that prioritize participant safety receive faster IRB approval.
What You Get
Complete IRB protocol narrative
Background and significance section
Study objectives and hypotheses
Detailed methodology and procedures
Participant recruitment and consent plan
Risk/benefit analysis
Data analysis plan
Professional scientific writing
How It Works
- 1Provide study informationShare research question, design, population, and methods
- 2AI writes protocol narrativeCreates complete IRB protocol narrative in 5-10 minutes
- 3Review and refineCustomize with study-specific details and institutional requirements
- 4Submit to IRBInclude protocol narrative in IRB application
Frequently Asked Questions
How detailed should study procedures be?
Very detailed. IRB needs to understand exactly what will happen to participants. Include: what procedures will be performed, when (visit schedule), how (specific methodology), how long each will take, who will perform them (PI, research coordinator, nurse), what data will be collected, what interventions given (dose, route, frequency), follow-up schedule, what happens if participant withdraws. Provide enough detail that IRB can assess risks and someone reading protocol could conduct study. Vague procedures lead to IRB questions and delays.
How do I justify risks when there's no direct benefit to participants?
Many studies (observational, survey research, biomarker studies) offer no direct benefit to participants. This is acceptable if risks are minimal and knowledge gained is valuable. Explain societal benefit: how will findings advance science, improve future patient care, or address important questions? Minimize risks as much as possible. Ensure burdens (time, procedures) are reasonable. Clearly disclose in consent that participants may not benefit directly but are contributing to science. IRBs approve many minimal-risk studies without direct participant benefit when knowledge gain is significant.
What constitutes adequate informed consent procedures?
Adequate consent includes: providing written consent form in language participant understands (appropriate reading level, translated if needed), giving participant adequate time to review and ask questions (not rushed decision), conducting consent discussion in private setting, ensuring person obtaining consent is knowledgeable about study, assessing participant understanding (teach-back or questionnaire), documenting consent (signatures, dates), and explaining that participation is voluntary and can be withdrawn anytime. For complex or high-risk studies, consider extended consent processes, decision aids, or cooling-off periods. Document your consent procedures thoroughly in protocol.
Do I need data safety monitoring board (DSMB)?
DSMB is required for NIH-funded clinical trials and recommended for any study with more than minimal risk, interventional studies, studies with vulnerable populations, or studies where interim data review could identify safety concerns or early evidence of benefit/harm requiring study modification or stopping. Lower-risk observational studies typically need only principal investigator monitoring with defined adverse event reporting procedures. Describe your monitoring plan appropriate to your study risk level. If DSMB not needed, justify why principal investigator monitoring is adequate.
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