What is IRB (Institutional Review Board)?

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Research & Regulatory

Research use only

IRB (Institutional Review Board)

An ethics committee that reviews and monitors research involving human subjects to ensure participant rights and safety.

Reference / Full Definition

Research & Regulatory

An Institutional Review Board (IRB) is an ethics committee designated to review, approve, and monitor biomedical and behavioral research involving human subjects. IRB approval is required before any human clinical trial can begin.

IRB review evaluates: scientific merit, risk-benefit ratio, informed consent procedures, participant selection criteria, data confidentiality protections, and ongoing safety monitoring plans. Federal regulations (45 CFR 46 and 21 CFR 50/56) govern IRB operations.

All Healthy Aminos products are for research use only and are not intended for human clinical trials without appropriate regulatory approvals.

Cross-Reference / Related Terms

FDA (Food and Drug Administration)The United States federal agency responsible for regulating food, drugs, medical devices, and biological products.PreclinicalThe stage of research conducted before human clinical trials, encompassing in vitro studies and animal model experiments.In VivoResearch conducted within a living organism, such as animal models, to study biological processes in their natural context.

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Research Use Only

FOR RESEARCH USE ONLY. Products sold by Healthy Aminos are intended strictly for in-vitro research and laboratory use. Not for human or animal consumption. Not FDA approved. By purchasing from Healthy Aminos, the buyer acknowledges that these products are not intended to diagnose, treat, cure, or prevent any disease. All products are sold as reference standards and research chemicals only.