IRB-Compliant Research Templates

Built by IRB experts, our templates ensure compliance with 45 CFR 46 (Common Rule), HIPAA, and institutional guidelines. Each template includes validated fields mapped to regulatory requirements.

CFR 46 Compliant
HIPAA Aligned
Real-time Validation

Survey Research

Minimal Risk - Expedited Review Eligible

9 Required Fields ~15 minutes

Meets 45 CFR 46.110 criteria for expedited review. Designed for anonymous or coded data collection with no more than minimal risk.

Common Applications:

  • Online & paper surveys, phone interviews
  • Educational assessments & opinion polls
  • Customer feedback & market research

IRB Requirements Covered:

  • Informed consent documentation (§46.117)
  • Data security & confidentiality measures
  • Risk-benefit analysis for minimal risk

Validation Includes:

Sample Size Justification Consent Protocol Data Protection

Vulnerable Populations

Full Board Review Required

11 Required Fields ~20 minutes

Comprehensive template ensuring compliance with Subparts B, C, and D protections. Addresses additional safeguards required for vulnerable subjects.

Vulnerable Populations Covered:

  • Children & minors (Subpart B: §46.404-407)
  • Prisoners (Subpart C: §46.305 requirements)
  • Cognitively impaired & economically disadvantaged

Additional Requirements:

  • Justification for inclusion of vulnerable groups
  • LAR/guardian consent & child assent protocols
  • Enhanced risk mitigation strategies

Enhanced Safeguards:

Risk Mitigation Plan LAR/Guardian Consent Benefit Justification

Observational Studies

Non-Interventional Research

11 Required Fields ~18 minutes

Structured for observational research with no manipulation of variables. Aligns with HIPAA privacy rules for secondary data use and PHI protection.

Study Design Types:

  • Cohort & case-control studies
  • Cross-sectional & ecological research
  • Medical records & registry data analysis

Privacy & Data Standards:

  • HIPAA-compliant data handling (§164.514)
  • De-identification protocols & limited data sets
  • Waiver of consent justification criteria

Data Source Options:

Medical Records Public Data Direct Observation

Not sure which template to choose?

Let us help you identify the right template for your research study. Get personalized recommendations based on your study design and participant population.

Built by IRB Compliance Experts

Our templates are developed with input from IRB administrators and regulatory specialists to ensure your submissions meet all institutional and federal requirements.

Regulatory Compliance

Templates map directly to CFR 46 requirements

Real-time Validation

Catch compliance issues before submission

Professional Export

IRB-ready PDF and Word documents

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