The Belmont Report was authored by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Formed through the National Research Act of 1974, the Commission was tasked with identifying the basic ethical principles that should govern biomedical and behavioral research involving human subjects and with developing guidelines to ensure such research meets those principles.
Core Principles of the Belmont Report
The National Commission published this cornerstone document, establishing foundational research ethics principles for investigations involving human subjects.
1. Respect For Persons
Researchers must treat individuals as autonomous agents. People experiencing diminished autonomy require additional protection. This concept forms the basis for informed consent.
2. Beneficence
Investigators hold an obligation toward maximizing possible benefits while minimizing potential harm. Ethical study design requires assessing risks against anticipated benefits carefully.
3. Justice
Society should distribute scientific burdens and trial advantages fairly. Scientists cannot exploit vulnerable populations or exclude eligible groups without justifiable cause.
Frequently Asked Questions
What is the Belmont Report?
This report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Drawing on nearly four years of monthly discussions, this framework outlines key ethical issues and considerations rising from research with human subjects. Institutional boards use these directives today.
How does this apply to clinical trials?
Organizations conducting human research must adhere strictly to established standards that reflect the Belmont principles. Compliance protects participant rights and welfare, as required by agencies like the Food and Drug Administration (FDA).
How can I learn more about ethical review
Explore our “What Is an IRB” guide that details what an IRB is, its key functions, and much more.
Ensure Ethical Compliance With WCG
With nearly 60 years of IRB experience, WCG is a trusted leader in ethical review and regulatory compliance. Our commitment to safety and security is demonstrated by our dedication to maintaining industry-recognized certifications, ensuring our processes meet the highest standards for protecting research participants. We support biopharmaceutical companies and research sites in navigating complex regulatory landscapes efficiently and with confidence. Connect with one of our IRB experts today to learn how we can help you ensure ethical compliance for your next study.
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