IRB Study

What is an IRB Study?

An Institutional Review Board (IRB) study refers to any research involving human subjects that must be reviewed and approved by an IRB (or Ethics Committee, EC, depending on the country).

The IRB ensures that the rights, safety, and welfare of participants are protected, and that the study complies with ethical principles (e.g., the Belmont Report: respect for persons, beneficence, justice) and regulatory guidelines (e.g., ICH-GCP, FDA, Health Canada, EMA).

Types of IRB Review

  1. Exempt Review
    • Minimal-risk studies, e.g., anonymous surveys, educational tests.
    • Still require IRB determination.
  2. Expedited Review
    • Minimal-risk research fitting specific categories (e.g., collection of blood samples, non-invasive procedures).
  3. Full Board Review
    • More than minimal risk, vulnerable populations (children, prisoners, pregnant women), or clinical trials of new drugs/devices.

IRB Submission for a Study Includes

  • Study protocol (objectives, design, methodology, duration).
  • Informed consent form (ICF).
  • Case report forms (CRFs)/data collection tools.
  • Recruitment materials (ads, posters, letters).
  • Investigator’s brochure (for drug/device trials).
  • Safety monitoring plan.
  • Budget and funding sources.

IRB Responsibilities in a Study

  • Review and approve/reject study before initiation.
  • Ensure risks are minimized and reasonable in relation to benefits.
  • Verify subject selection is equitable.
  • Ensure informed consent process is adequate.
  • Conduct continuing review (at least annually).
  • Review any protocol amendments, adverse events, or deviations.
  • Protect confidentiality and data integrity.

Examples of IRB-Reviewed Studies

  • Clinical drug/device trials (Phase I–IV).
  • Behavioral or social science studies involving human subjects.
  • Genetic testing studies (using identifiable samples).
  • Epidemiological studies with personal health information.

In short: An IRB study is any human-subject research that must be ethically reviewed to safeguard participants, with oversight continuing throughout the research.

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