The trial is reported to have taken place between April and August 2016 but the government claims that they were not notified of the trial.
If the reports are correct, the trial was seemingly conducted without obtaining ethical or regulatory approval in either St Kitts or the United States of America. It was not monitored or authorised by the St Kitts Medical Board or by the US Food and Drug Administration or an institutional review board (IRB), which are required in order to approve drugs for the US market.
Clinical trials involving live viruses can be dangerous if not conducted correctly as they can lead to outbreaks of infection or serious side effects in participants.
When announcing the investigation the St Kitts and Nevis Ministry of Health said that it will “always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved”.
“Reports of this trial make for shocking reading. Clinical trials are crucial to the development of new medicines and can produce huge benefits for wider society. However, they must be conducted in accordance with international standards in order to ensure the safety of participants and the general public.
“All clinical trials must be conducted in accordance with the Good Clinical Practice (GCP) guidelines, it is the only acceptable international ethical, scientific and practical standard. Compliance with the GCP guidelines is the only way to ensure that the rights, safety and wellbeing of research participants are protected and that the research data is reliable. It must be appreciated that the GCP guidelines trace their history back through the Helsinki declaration and the Nuremburg Code in a direct response to the atrocities committed by the Nazis in the Second World War.
“It is important that potential participants check that international standards are being observed before agreeing to take part in a clinical trial.”