Med school updates investigation into late researcher

Dr. William Halford Dr. William Halford

SPRINGFIELD, Ill. (WAND)- Leaders at SIU School of Medicine say a committee is still investigating “irregularities” in research done on human subjects by a now-dead professor at the school, research that is also under investigation by Federal authorities.

Dr. William Halford, who died in June 2017, worked for years to develop a vaccine to treat and prevent genital herpes. Halford also co-founded Rational Vaccines in 2015 to further his research.

After Halford’s death, a colleague from Rational Vaccines told SIU’s Institutional Review Board of “irregularities” in Halford’s research on human subjects, some of whom were subjects from SIU School of Medicine, according to SIU Dean Jerry Kruse. Those irregularities included treating patients with vaccines that had not been approved by the FDA and doing research without oversight from an Institutional Review Board.

According to reporting by Kaiser Health News, Halford vaccinated at least eight patients at hotels in Springfield in 2013 and later ran a clinical trial for his company out of a house in St. Kitts and Nevis without alerting authorities in that country or the U.S.

Kruse said the School of Medicine’s Institutional Review Board launched an investigation after the conversation on July 31. In September, the Office of Human Research Protection asked for a report from SIU, which it provided to both the office and the FDA. Kruse said the school has been in “frequent communication” with those agencies as the school’s Misconduct in Science Committee continues an investigation.

“We will be awaiting (the committee’s) recommendations regarding both what happened with Dr. Halford’s research and where we are with our standard operating procedures,” Kruse said. “We want them to be as thorough as they need to be … so that we get the whole story and get a good look at ourselves.”

On Jan. 4, Iowa Senator Chuck Grassley mentioned the matter in a letter to the Acting Secretary of Health and Human Services, the FDA Commissioner and the director of the Office for Human Research Protection.

In that letter, Grassley posed several questions:

  • Has HHS, OHRP, or the FDA performed a formal investigation and review into the

reported research? If so, what were the results? If not, why not?

  • Has HHS, OHRP, or the FDA found SIU to be culpable for Professor Halford’s reported

research? If so, what steps were taken to make sure SIU properly oversees its research

professors? If not, why not?

  • Did HHS, OHRP, or the FDA find SIU’s response to Professor Halford’s work to be

adequate? Please explain.

  • Since SIU found “serious noncompliance with regulatory requirements...”
  • What corrective action did HHS, OHRP, or the FDA take to ensure that noncompliance does

not occur again?

  • Has HHS or the FDA ever reported research malpractice to federal or state law

enforcement for potential prosecution?

  • Please explain, in detail, the process OHRP follows once a complaint about potentially

unapproved research is received.

  • How many reports of unapproved clinical trials have been received by OHRP in the past

5 years?

  • Of the reported cases, how many resulted in an internal review by the institution in


  • Of the reported cases, how many resulted in referral to federal or state law enforcement?

Grassley’s letter asked for responses by Jan. 18. Grassley’s staff could not immediately confirm Monday whether the senator received those responses. Press officers for HHS and FDA did not return calls for comment Monday, although those offices may be affected by the Federal government shutdown. An SIU spokesperson said the school responded to Grassley's letter on Jan. 18. 

The spokesperson also said three people with knowledge of Halford's work have left the medical school. 

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