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ResourcesHuman Research Ethics(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)

 


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The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.



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