A controversial clinical trial for a herpes vaccine carried out in the Caribbean could cost US medical school researchers $15 million (£11.2 million) in funding, after a federal investigation was launched into potential research misconduct.
Southern Illinois University scientist Dr William Halford ran clinical trials in St Kitts and Nevis in 2016, using a weakened herpesvirus at a local hospital. According to local news sources, the lead researcher was initially unable to acquire government funding or approval from an institutional ethics review board – a legal requirement in the US – so flew the participants from the US out to the Caribbean islands instead.
Dr Halford, who died in June this year, had also co-founded an independent company, Rational Vaccines, SIU confirmed, and received financial backing for the trials from a group of wealthy independent supporters, including former PayPal boss Peter Thiel.
Some 20 participants were reported to have volunteered to take the vaccine, and at the end of 2016, Rational Vaccines issued a press release stating that the trial had seen “ground-breaking results”, outlining it as one of the most effective ever created for herpes sufferers.
Questions were raised, however, over the fact the trial had still not been approved by the university’s medical board, and an investigation was launched by the Department of Health and Human Services.
Issuing a statement on 20 November, SIU said the institution had no knowledge of or involvement in the trial other than the understanding that Dr Halford was co-founder of the independent company. Like the majority of US universities involved with medical research, SIU receives federal grant money, which could be jeopardised if the university is deemed to have violated federal rules by allowing the vaccine trials to go ahead.
A spokesperson for SIU School of Medicine said: “Because SIU was not involved in the St Kitts clinical trial in any way and viewed it as the business operations of a private company, SIU did not feel that any discussion with Dr. Halford about the trial was warranted.
“In summer 2017, concerns were raised about activities outside the St Kitts clinical trial. SIU Medicine takes these concerns very seriously.”
An internal review found that “serious noncompliance with regulatory requirements and institutional policies and procedures occurred”, they added, leading to further investigation by the US Office for Human Research Protections and the Food and Drug Administration into potential research misconduct.
“Once that investigation is completed and evaluated, we will provide more information, including any steps deemed necessary to ensure that research at SIU is both safe and compliant with all regulations,” the university added.