IRB Protocol Drafting
Draft Institutional Review Board (IRB) protocol documents from research descriptions. Produces structured templates that researchers can customize for their institution's specific requirements.
IMPORTANT DISCLAIMER: Output is a draft template for the researcher to review and adapt. This is not legal advice. All protocols must be reviewed and approved by your institution's IRB office before beginning research.
When to Use This Skill
Trigger when user:
- •Says "IRB protocol", "IRB application", "ethics review"
- •Asks about "informed consent" form drafting
- •Needs a "human subjects protocol" or "ethics application"
- •Wants to determine "exempt vs expedited vs full review"
- •Says "write my IRB" or "draft protocol"
Workflow
Phase 1: Determine Study Type
Use AskUserQuestion to clarify:
- •Study type: Survey, interview, experiment, secondary data analysis, mixed methods?
- •Population: Adults, minors, vulnerable populations?
- •Data type: Anonymous, confidential, identifiable?
- •Risk level: Minimal risk or greater than minimal risk?
- •Institution: Which IRB? (different institutions have different forms)
Phase 2: Determine Review Category
| Category | Criteria | Typical Studies |
|---|---|---|
| Exempt | Minimal risk, no identifiers, educational/survey/public data | Anonymous online surveys, analysis of public datasets |
| Expedited | Minimal risk, identifiable but not sensitive | Interviews with adults, identifiable survey data |
| Full Board | Greater than minimal risk, vulnerable populations, sensitive topics | Studies with minors, prisoners, or topics involving trauma |
Phase 3: Draft Protocol Sections
3a. Study Information
- •Protocol title
- •Principal Investigator and co-investigators
- •Funding source (if applicable)
- •Expected start and end dates
3b. Study Purpose
- •Research questions and hypotheses
- •Background and significance (brief, 1-2 paragraphs)
- •How this study addresses a gap in knowledge
3c. Participant Selection
- •Target population and eligibility criteria
- •Inclusion and exclusion criteria
- •Recruitment methods and materials
- •Expected sample size and justification
- •Compensation (if any)
3d. Study Procedures
- •Step-by-step description of what participants will do
- •Duration of participation
- •Location (online, in-person, etc.)
- •Data collection instruments (surveys, interview guides)
3e. Risks and Benefits
- •Potential risks to participants (psychological, social, economic, physical)
- •Steps to minimize each risk
- •Potential benefits to participants (if any — "none" is acceptable)
- •Potential benefits to society/knowledge
3f. Data Security
- •How data will be collected (platform, tools)
- •Where data will be stored (encrypted, institutional servers, cloud)
- •Who will have access to data
- •How long data will be retained
- •De-identification procedures
- •Data destruction plan
3g. Informed Consent
- •Consent process (written, verbal, online click-through)
- •Key elements to include:
- •Purpose of the study
- •What participation involves
- •Voluntary nature and right to withdraw
- •Risks and benefits
- •Confidentiality protections
- •Contact information for questions
Phase 4: Generate Templates
Produce:
- •Protocol document (main IRB application narrative)
- •Informed consent form (participant-facing, plain language)
- •Recruitment materials (email/flyer text, if needed)
Study-Specific Templates
Survey Research
- •Online platform details (Qualtrics, SurveyMonkey, etc.)
- •IP address collection settings
- •Attention check and bot detection
- •Data download and storage procedures
Interview Studies
- •Recording consent (audio/video)
- •Transcription procedures (human vs. automated)
- •Member checking plans
- •Quote approval process
Secondary Data Analysis
- •Data source and access agreement
- •De-identification verification
- •Data use agreement requirements
- •Variables to be analyzed
Key Principles
- •Use plain language — IRB reviewers and participants should both understand
- •Be specific about data security (name the encryption, name the platform)
- •Address every risk honestly, even if minimal
- •Consent forms should be at 8th grade reading level
- •When in doubt, err on the side of more protection
- •Always note that this is a DRAFT requiring institutional IRB review