Earlier this week, Kaiser Health News reported on a controversial effort to develop a herpes vaccine — funded by a group of libertarian businessmen, supported by an American university, and completely unmonitored by the FDA or any kind of IRB — being conducted on the Caribbean island of St. Kitts.
Now, KHN reports, the government of St. Kitts and Nevis has launched an investigation into the clinical trial because it says its officials were never notified the experiments were taking place within its borders.
"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," KHN quotes from a government press release. "By extension, none of these agencies has approved such a venture."
Agustín Fernández III, the cofounder of Rational Vaccines, the company that oversaw the vaccine testing, said his partner, William Halford, told him that he notified the St. Kitts government, KHN reports. Halford, was the lead investigator on the research but has since died of cancer. Southern Illinois University, the university where Halford was once a researcher, told a reporter previously that Halford was not doing the research as part of his job at the university, KHN adds.
Patrick Martin, St. Kitts and Nevis’ chief medical officer until June 2016, tells KHN that Halford might have been required to seek approval from St. Kitts customs officials depending on how he transported the vaccine to the country. Martin, who had been in that position since 2004, said he never heard from Halford or any other member of the company, although he should have been notified, KHN says.
"We are a country of rules and regulations. Researchers can't just do whatever they like without notifying the government or going to an IRB," Martin tells KHN.
Steven Joffe, chief of the division of medical ethics at the University of Pennsylvania Perelman School of Medicine, tells KHN that for research to be considered ethical, "the study must be conducted in accordance with international standards for human subjects research," including approval by an institutional review board or research ethics committee, and compliance with the laws and regulations of the country the research is taking place in.