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Consent to Clinical Research

Informed consent practices have evolved over time after instances were documented in which research participants were not treated fairly or respectfully, were not informed, or were subjected to unnecessary harm. Current federal regulations support the ethical treatment of persons in the research setting in that the participation is voluntary, that the risks outweigh the benefits, and that all people are given an equal chance to participate. When a researcher invites a participant into the research setting, the researcher is required to provide the necessary information, to ensure that the participant fully understands the information, and to stop the research if it is felt that these standards have not been met. Prior to enrollment in a research study, that candidate must provide valid consent for participation. ...

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