The New 2019 IRB Common Rule Update: Implications for Plastic Surgery Research.

07:00 EST 10th February 2020 | BioPortfolio

Summary of "The New 2019 IRB Common Rule Update: Implications for Plastic Surgery Research."

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 towards human subjects. The establishment of federal regulations and the development of institutional review boards (IRBs) 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 its impact on plastic surgery research.


Journal Details

This article was published in the following journal.

Name: Plastic and reconstructive surgery
ISSN: 1529-4242


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Medical and Biotech [MESH] Definitions

Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.

The branch of surgery concerned with restoration, reconstruction, or improvement of defective, damaged, or missing structures.

Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.

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Plastic surgery of the eyelid. (Cline et al., Dictionary of Visual Science, 4th ed)

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