IRB and Ethics Committee
Core summary
An IRB (Institutional Review Board) or REC (Research Ethics Committee) is an independent body that reviews research proposals to protect participant welfare. Review types range from exempt (minimal risk, de-identified data) to full board review (greater than minimal risk). Understanding the process saves time and prevents delays.
Detailed explanation
Detailed explanation
IRBs typically include scientists, non-scientists, community members, and legal/ethical experts. Their mandate is to ensure research protects participants' rights, safety, and welfare. Three review pathways exist: Exempt review — for studies involving minimal risk (surveys of adults, use of de-identified existing data, educational research). The IRB confirms exemption but does not conduct ongoing review. Expedited review — for minimal-risk studies that do not qualify for exemption but involve only minor changes to approved protocols or standard procedures (blood draws, non-invasive data collection). A single IRB member or chair can approve. Full board review — for studies involving greater than minimal risk (drug trials, surgical interventions, vulnerable populations). The full committee meets, discusses, and votes. Submission typically requires: the research protocol, informed consent documents, recruitment materials, data collection instruments, investigator qualifications, and conflict of interest disclosures. Common reasons for revision requests include: inadequate risk description, consent language too complex, insufficient data security plan, missing safeguards for vulnerable populations, or unclear inclusion/exclusion criteria.
Clinical example
You want to conduct a retrospective chart review of de-identified patient data. This likely qualifies for exempt review — minimal risk, no direct contact with subjects, existing data. You submit a brief application with your protocol and data security plan. The IRB confirms exemption within 1-2 weeks, and you can begin.
Research example
A multicenter RCT testing a new surgical technique requires full board review at every participating site. Each site's IRB may request different modifications — a common frustration that has led to the development of single IRB (sIRB) models, where one IRB serves as the reviewing authority for all sites.
Knowledge check
Q1. Which type of IRB review is appropriate for a survey of healthy adults about exercise habits?
Q2. What is a common reason IRBs request revisions?
Q3. What is the role of a community member on an IRB?