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Compliance with National Norms of Human Subjects Protections

Under the U.S. Department of Health and Human Services (DHHS) human subjects protection regulations at 45 CFR 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). This compliance is called a Federalwide Assurance. CDPHEs Federalwide Assurance Number is FWA 00003044.

 

All of the Departments human subjects activities and the activities of our Institutional Review Board designated under our Federalwide Assurance, regardless of funding source, are guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research pdf file

 

Federal human research subjects protection policy is defined in 45 CFR 46,including conflict of interest and protection of special populations:

 


The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. Documentation of informed consent must comply with 45 CFR 46.117. A checklist and tips on informed consent are available at the OHRP website.