hollywoodtone.blogspot.com Spanish researcher fined for unauthorized HIV research
hollywoodtone.blogspot.com Spanish researcher fined for unauthorized HIV research
A Spanish researcher faces a penalty after conducting an HIV study. The researcher, Vicente Soriano, did not obtain proper approvals or insurance.
Vicente Soriano, of Hospital Carlos III in Madrid, has been charged for conducting a clinical trial involving a new HIV drug without getting the appropriate approvals from Spain’s Agency for Medicines and Health Products. Soriano was additionbally charged with failing to obtain proper insurance for the trial and for informing trial participants that he had secured the hospital’s ethical clearance when he had in fact not done so. After a hearing. a court of appeals levied a hefty €210,000 ($283,689) fine against Soriano. However, Soriano is appealing the fines. The aim of the trial was to determine if HIV patients with undetectable levels of the virus in their blood could swap out one type of viral inhibitors for another, in order to improve their outcomes and suffer fewer side effects. More than 300 subjects enrolled in the trial. Some of the research was published in the journal HIV Clinical Trials. The problem was, no approval was obtained for the trial and it was not subjected to the usual ethical oversights. According to Science Insider, Soriano’s main defense was that the study was not a clinical trial, but rather an observational and retrospective study, and therefore was not subject to the approvals of regular clinical trials. The appeal is set to run.
hollywoodtone.blogspot.com Spanish researcher fined for unauthorized HIV research