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The New 2019 Institutional Review Board Common Rule Update: Implications for Plastic Surgery Research
Dustin T Crystal1, Nicholas G Cuccolo1, Ahmed M S Ibrahim1
1From the Division of Plastic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School; the Division of Plastic Surgery, University of Washington; and the Department of Plastic Surgery, The Ohio State University.
Abstract:
Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.
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