Common Rule 2025

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Common Rule The Common Rule (45 CFR Part 46 of the Code of Federal Regulations) , regulates ethics for research projects involving human subjects that are funded by the United States Department of Health and Human Services and many other federal departments.
The HHS regulations for the protection of human subjects in research at 45 CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects.
This set of regulations aims to protect human subjects in federally funded research through three basic requirements. These include informed consent of research subjects; review of the proposed research by an Institutional Review Board (IRB); and assurances of compliance with regulations by the institutions involved.
The common rule can best be described by which phrases: Respect for persons, beneficence, and justice. Regulatory rules of ethics for human subjects protection. Guidance for biomedical and behavioral research involving human subjects.
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.
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The Common Rule is the popular term for the Federal (U.S.) Policy for the Protection of Human Subjects , 45 CFR part 46 , which outlines the criteria and mechanisms for IRB review of human subjects research.
The Common Rule (45 CFR part 46) is applicable to research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency in the United States that has signed onto the Common Rule.

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