PR 680 Lecture Notes - Lecture 26: Common Rule, Belmont Report

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Hhs regulations are sometimes referred to this, which is the location in the code of federal regulations. The common rule wasn"t really changed until 2017 when the hhs and 15 other federal agencies issued a final rule to update the regulations. Revisions were made to strengthen the protections for human subjects and reduce any burdens to administration and create more flexibility for the research environment today. There were three subparts added: b, c & d. Subpart b: involves pregnant women, human fetuses, and neonates. Who has to review the research with the human subjects. What questions should be talked about during a review. What review needs to happen during a project or course. When deciding if a project should be reviewed, you have to determine if it falls in the research definition with human subjects. If it doesn"t fall under the definition, it doesn"t need an irb review, however, there could be ethical issues that should be addressed.

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