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Home » Ethical Biosafety Oversight of Gene Transfer Research
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Ethical Biosafety Oversight of Gene Transfer Research

Ethical Biosafety Oversight of Gene Transfer Research

The number of drug products under development that incorporate recombinant or synthetic DNA or RNA, viral vectors, and/or genetically-modified organisms (“GMOs”) continues to grow rapidly, and several such products have received marketing approval from the FDA. This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States. In particular, we focus on the roles of Institutional Biosafety Committees (IBCs) and Institutional Review Boards (IRBs) in approving and facilitating study startup.

The WIRB-Copernicus Group® (WCG) is the world’s largest and most trusted provider of regulatory and ethical review services for human research. For more information, visit www.wcgclinical.com/.

 

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