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Universities are doing more and more clinical trials, and the dual oversight by the FDA and OHRP adds confusion.
(Clinical trials performed to support a new drug or device application are regulated by the FDA; some centers have dual oversight for everything).
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Coordinated risk regulation in advance of product development would encourage America's innovators to more aggressively explore low-risk/high-potential-value terrain while freeing up resources to move dual use oversight into the 21st century.
And "the letter rejects, out of hand, the need for enhanced biosafety, biosecurity, and dual-use oversight, and, instead, maintains that all that is needed is an opportunity for researchers 'to assure the public' and 'to clearly explain the benefits of this important research and the measures taken to minimize its possible risk.'" The letter is "strictly symbolic," he writes.
If they do, I am confident that more attention will be paid to smart proposals for dual-regime oversight such as the one put forward by CFTC Chairman Gary Gensler.
Although the NSABB has played an important role in providing advice, guidance and leadership regarding biosecurity oversight of dual use research, this advisory committee empaneled by the US Department of Health and Human Services has no direct authority over dual use research in other countries.
The biosecurity board does not approve particular experiments but offers policy advice on, among other things, oversight of "dual use" studies, meaning research that could be used for biowarfare or bioterrorism as well as for legitimate purposes.
Oversight of dual practice varied by department in H1.
Accordingly, we suggest that an advisory panel with a mission similar to that of the NSABB, designated Science Advisory Board for Biosecurity (SABB), be formalized by each of other countries, which act at the national level to provide advice and guidance regarding biosecurity oversight of dual use research projects in their own countries.
Nevertheless, the central point is this: In the 8 years since that report, no coordinated system for oversight of dual-use research, either national or international, has been implemented.
Dutch parliamentarians have asked the government for stricter oversight of dual-use research, and health minister Edith Schippers has hinted she may support the creation of a European version of the NSABB.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com