Post

Categories of Research Eligible for Expedited IRB Review

This guidance outlines the categories of research that may be reviewed by Institutional Review Boards (IRBs) through an expedited review procedure. It applies to research activities that present no more than minimal risk to human subjects and involve only procedures listed in the specified categories. The guidance aims to streamline the IRB review process for qualifying research while maintaining appropriate human subject protections.

  1. Establish clear procedures to determine if research qualifies for expedited review based on risk level and categories
  2. Implement a screening process to verify research meets all applicability criteria before expedited review
  3. Document rationale for using expedited review procedures for each qualifying protocol
  4. Ensure appropriate protections for subject privacy and confidentiality are in place
  5. Maintain standard informed consent processes regardless of review type
  6. Create checklists to verify research meets specific category requirements
  7. Establish process for continuing review of previously approved research
  8. Train IRB members on proper application of expedited review procedures
  9. Develop documentation templates specific to expedited review process
  10. Implement monitoring system to ensure ongoing compliance with expedited review requirements

Key Considerations

Clinical testing

  • Clinical studies of drugs and medical devices only when:
    • Research on drugs not requiring an IND application
    • Research on medical devices not requiring an IDE or cleared/approved devices used according to labeling

Non-clinical testing

  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture with specific volume limits
  • Collection of biological specimens by noninvasive means
  • Collection of data through noninvasive procedures routinely used in clinical practice
  • Research involving materials collected for non-research purposes

Human Factors

  • Research on individual or group characteristics/behavior including:
    • Perception, cognition, motivation studies
    • Language and communication research
    • Cultural beliefs/practices studies
    • Social behavior research
    • Human factors evaluation

Safety

  • Research must present no more than minimal risk to subjects
  • Cannot be used for classified research
  • Must consider risks related to privacy and confidentiality
  • Must protect subjects from potential criminal/civil liability risks

Other considerations

  • 21 CFR Part 312: Investigational New Drug Application
  • 21 CFR Part 812: Investigational Device Exemption
  • 45 CFR 46.110: Expedited review procedures for certain kinds of research
  • 21 CFR 56.110: Expedited review procedures for certain kinds of research

Original guidance

  • Categories of Research Eligible for Expedited IRB Review
  • HTML / PDF
  • Issue date: 1998-11-09
  • Last changed date: 2023-03-24
  • Status: FINAL
  • Official FDA topics: Clinical Trials, Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics
  • ReguVirta summary file ID: a195a774f10ffaa656e9c35fa7b9b465
This post is licensed under CC BY 4.0 by the author.