IRB Application for Initial Review

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IRB Application for Initial Review_draft to send 2025.pdf (3.2 MB)

SUMMARY

:memo: Purpose

This form is used for new study submissions requiring full board or expedited IRB review. It ensures compliance with ethical, regulatory, and institutional standards for human subjects research.

:open_file_folder: Key Sections Overview

  1. Study Information

    • Full and short study titles
    • Study type(s) (e.g., observational, interventional, device/drug-related)
    • Primary department and condition being studied

  2. Funding

    • Industry sponsor and CRO details
    • Additional funding sources

  3. Personnel

    • Principal Investigator (PI) details
    • PI mentor/advisor
    • Additional study personnel (sub-investigators, coordinators, assistants)

  4. Study Sites

    • Primary and additional sites
    • Other IRB reviews and approvals

  5. Study Details

    • Summary and objectives
    • Participant numbers
    • Payment details and methods

  6. Privacy & Confidentiality

    • Data identifiers
    • Protection of written and electronic data
    • Biospecimen and radiologic exposure

  7. Recruitment

    • Recruitment process and materials
    • Vulnerable populations and consent/assent plans

  8. Risk Assessment

    • Minimal vs. greater than minimal risk
    • Justification for risk-benefit ratio

  9. Special Populations

    • Children, pregnant women, neonates, prisoners, employees/students
    • Consent/assent procedures and waivers

  10. Informed Consent & HIPAA

    • Consent process and documentation
    • Waivers of consent and HIPAA authorization
    • Use and protection of PHI

  11. Device & Drug Information

    • HUD, investigational, and FDA-approved devices
    • Drug details, IND numbers, and accountability

  12. Data Management

    • Database formats, access, security, breach contingency plans

  13. Invoicing

    • IRB fee waiver requests
    • Contact and billing details

  14. Study Documents

    • Protocol, consent/assent forms, recruitment materials
    • Investigator’s Brochure, CVs, CITI training certificates

  15. Investigator Assurance

    • PI responsibilities and attestation
    • Data protection, compliance, and reporting obligations

:white_check_mark: Next Steps

Would you like help with any of the following?

  • Filling out specific sections
  • Reviewing for completeness or compliance
  • Drafting attachments (e.g., consent forms, recruitment materials)
  • Creating a checklist for submission