The trial received financial backing from from eccentric tech billionaire and Donald Trump supporter Peter Thiel.
The American Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 American human subjects. The researchers also did not officially seek permission from any of the Caribbean Islands’ medical or government authorities to test the vaccine, which took place from April to August 2016.
“The Ministry of Health states categorically that neither the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on this project,” said the government press release sent out Wednesday night. “By extension, none of these agencies has approved such a venture.”
U.S. researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.
In the St. Kitts press release, the Ministry of Health and Social Services said it “will always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved.”
To ensure this happens, an ethics review committee is supposed to vet medical research protocols “in keeping with international best practices.”
The St.Kitts-Nevis Government as well as citizens have been outraged by the revelation of the Herpes Vaccine Trials which operated unknown to any government or local medical officials.
The alleged Trials took place under no approval, oversight or authority of neither the US FDA or St.Kitts Medical Board.