Statement in Response to Rational Vaccines' Clinical Trial:
In 2015, a start-up company called Rational Vaccines was co-founded by Dr. Halford and Agustin Fernandez independent of SIU.
As is typical in the bio-research environment, Rational Vaccines licensed intellectual property from SIU through SIU’s Office of Technology Transfer. Within that license agreement, both Rational Vaccines and SIU are responsible for upholding all applicable laws and regulations associated with the license.
Rational Vaccines conducted its research and trials as an independent company. SIU is not responsible for trials and research conducted by independent companies. We refer all comments and questions about research and trials performed by Rational Vaccines to that independent company.
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. The SIU Institutional Review Board began investigating in July.
The initial IRB investigation has determined that serious noncompliance with regulatory requirements and institutional policies and procedures occurred. The IRB investigation has closed, and the IRB has submitted its report to Office for Human Research Protections and the Food and Drug Administration in accordance with the lRB's policies. As a result, an investigation under the Southern Illinois University policy on research misconduct has begun. That investigation is in process.
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.
Original statement posted 9/1/17. SIU Medicine will update this statement when more information is available.