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KEY REGULATORY REQUIREMENTSOffice of Research (OR)OR Function Governing Regulatory Focus of StandardAuthorityStandard(s)Institutional U.S. Food & Drug 21 CFR 50 Protection of Human SubjectsReview Board Administration (FDA)(IRB) 21 CFR 56 Institutional Review BoardsOffice of Human 45 CFR 46 Protection of Human SubjectsResearch Protections(OHRP) Federal-wide Terms of Federal-wide AssuranceAssurance (FWA)Policy GuidanceProtection of Human SubjectsOffice of Civil Rights 45 CFR 160 HIPAA Privacy Rule:(OCR)Administrative Requirements45 CFR 164 HIPAA Security and PrivacyCode of <strong>Virginia</strong> §32.1-162 State Regulations Pertaining toResearchInstitutional United States Code The United States Federal Law Relating to AnimalAnimal Care and Animal Welfare Act UtilizationUse Committee(United States Code,(IACUC)Title 7, Sections 2131 to2156)U.S. Department of Animal Welfare Act, Federal Regulations Relating toAgriculture, Animal and 9 CFR AnimalsPlant Health InspectionServiceUSDA Animal andPlant HealthInspection AnimalCare Policy ManualUSDA Animal Care'sResearch ManualFederal Policies Relating to AnimalUtilizationFederal Policies Relating to AnimalUtilizationNIH Office of Laboratory Public Health Federal Regulations Relating toAnimal Welfare Service Policy on AnimalsHuman Care andUse of LaboratoryAnimals, HealthResearch ExtensionAct of 1985, Public Law171

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