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Federal Policy for the Protection of Human Subjects 45 CFR 46.116 which states that the nature of the study involves no more than minimal risk to subjects, research could not be carried out practicably without the waiver or alteration, and waiver will not adversely affect the rights and welfare of the subjects

The agency is now exploring ways to expand these efforts to educate individuals who can influence adults who smoke, such as encouraging cessation or raising awareness of harm-reduction strategies

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