FDA Opens Criminal Investigation Into Unauthorized Human Research Following Grassley Oversight Inquiry
WASHINGTON – Following a January 2018 letter sent by Sen. Chuck Grassley of Iowa to the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS) and the Office for Human Research Protections (OHRP), the FDA has reportedly opened a criminal investigation into research by Southern Illinois University (SIU) professor William Halford, now-deceased, who conducted unauthorized human research testing in 2013 and 2016 which put individuals at extreme health risk. The response from HHS on behalf of all three recipients of Grassley’s letter can be found here. Grassley also wrote to SIU in January. SIU’s response can be found here.
Grassley issued the following statement on the reported opening of a criminal investigation into the research.
“I’m glad FDA appears to be taking this matter seriously. We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye. Human research testing should only be conducted in limited and highly regulated circumstances that are as safe as possible. This research broke just about every rule in the book and put human subjects at extreme health risk. That it was allowed to take place at all represents a failure on multiple levels. The government is tasked with oversight of this type of research and I await its results.”
Testing involving the use of human subjects in the U.S. is regulated by what is known as the “Common Rule.” Among other regulations, these include minimizing risk to the subject, selecting subjects equitably, receiving informed consent, continual monitoring and respecting privacy. News reports indicate that Halford may have violated nearly every requirement of the Common Rule. Emails from the professor reportedly stated that it would be “suicide” if the manner in which he conducted the research were to be made public.