Institutional Review Board (IRB)
An IRB (also called Ethics Committee or Institutional Ethics Committee) is a committee that reviews research involving human subjects to ensure ethical conduct and participant protection.
1Detailed Explanation
IRBs were established under the Common Rule (US) and similar regulations worldwide to protect human research participants. Key functions include: reviewing study protocols, assessing risk-benefit ratio, ensuring informed consent, protecting vulnerable populations, and monitoring ongoing research. IRB approval is required for most human subjects research before enrollment begins. Key documents include: protocol, informed consent form, recruitment materials, and data collection instruments. Continuing review is required at specified intervals. IRB review can be expedited for minimal risk research or full board review for higher risk. The Helsinki Declaration, Belmont Report, and CIOMS guidelines provide international ethical frameworks.
2Examples
- A.An IRB approval statement: 'The study was approved by the XYZ University Institutional Review Board (IRB# 2024-001) on January 15, 2024.'
- B.A multi-center study requiring IRB approval at each participating institution
3Why It Matters in Research
IRB approval is mandatory for human subjects research. Its documentation in the manuscript is required by most journals and is a CONSORT and STROBE requirement.
4Related Terms
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