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Sagot :
Federal regulations enforced by the Office for Human Research Protections, informed consent "shall be in language understandable to the subject or the representative," and 45 CFR 46.117 and 21 CFR 50.27 outline how the informed consent is to be documented.
The Code of Federal Regulations, which is codified in American law, contains all of the general and permanent rules that the executive departments and agencies of the federal government of the United States have issued. The key categories under which there is federal regulation are indicated by the 50 titles that make up the CFR.
Additionally, the Experimental Subjects Bill of Rights, which must be "prepared in a language in which the subject is fluent," must be given to all participants in any study that involves a real or foreseeable risk of biological harm, according to California state law (Health and Safety Code section 24172).
To learn more about Federal Regulations here:
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