What Is an Institutional Review Board?

An Institutional Review Board (IRB) is a committee that reviews research involving human participants to protect their rights and welfare. In many countries the equivalent body is called a research ethics committee (REC) or ethics review board; names and rules differ.

Purpose

IRBs assess whether the risks to participants are reasonable relative to the benefits, whether selection is fair, whether informed consent is adequate and documented, and whether privacy and confidentiality are protected. Foundational ethical documents include the Belmont Report (respect for persons, beneficence, justice) and the Declaration of Helsinki. In the United States, the Common Rule (45 CFR 46) sets requirements for federally supported research, and many institutions apply its standards more widely.

Who sits on it

Committees usually include members from different disciplines, at least one non-scientist and at least one person not affiliated with the institution, so that decisions reflect scientific, ethical and community perspectives.

What researchers submit

• A protocol with objectives, design, eligibility, procedures and analysis plan.
• Consent documents and information sheets.
• Recruitment materials and data collection instruments.
• Data protection and confidentiality plans.
• Investigator qualifications and training.
• Approvals from sites or other regulators if required.

Possible decisions

Approved, approved with modifications, deferred, not approved, or determined exempt or not human-subjects research, depending on the rules (see IRB Approval vs IRB Exemption).

Illustrative example

Invented for teaching. A student plans a questionnaire study of interns' stress. She submits the protocol, a participant information sheet, the questionnaire and a plan to store data without identifiers. The committee asks her to clarify how participation will remain voluntary and approves it after changes.

Common pitfalls

• Starting data collection before approval or a formal determination.
• Assuming that quality improvement or audit never needs review: ask the committee.

Key takeaways

• An IRB or ethics committee protects participants and reviews risk, consent and privacy.
• Ask early and follow its decisions.

This page is general educational information about research methods. It is not medical, legal or regulatory advice; follow your institution's ethics board and your target journal's instructions.