Investigation: SIU scientist’s herpes vaccine research violated rules
The initial investigation by SIU's institutional review board "has determined that serious noncompliance with regulatory requirements and institutional policies and procedures occurred,"
Details of the alleged noncompliance were unavailable, and though SIU has submitted a full report on its investigation to the federal government, SIU spokeswoman
The inquiry from the
If HHS determines that SIU violated any federal rules, that could jeopardize the medical school's
Rational Vaccines' chief executive officer, Agustin Fernandez III, didn't respond to a phone message or an email from the newspaper Wednesday but previously said no one was harmed in the clinical trial, held between
The fact that the clinical trial of a therapeutic vaccine for herpes patients took place without the oversight of an institutional review board at SIU or elsewhere to make sure patients' safety was safeguarded has raised concerns in the scientific community.
A prominent doctor from
Zenilman was unavailable for comment Wednesday. He also was unavailable when the newspaper tried to reach him in September.
The lack of institutional review board oversight was among concerns raised by reviewers of a scientific paper on the trial that was rejected for publication by the journal Future Virology before Halford's cancer-related death
The rejection came despite Rational Vaccines' news release, dated
The trial involving 17 patients suggested that a "functional cure" for herpes "may be on the horizon," according to the release.
Fernandez previously told
Kruse wrote in his letter to HHS that it was SIU's understanding that Rational Vaccines was responsible for the management and oversight of the trial, including work with a
SIU first learned about the trial on
"Because SIU was not involved in the trial in any way and viewed it as the business operations of a private company, SIU did not feel that any discussion with
However, Kruse indicated in his letter that SIU officials probably should have been aware of the
"I assure you that SIU takes this situation very seriously," he wrote, "and I am committed to identifying any missing controls that facilitated the conduct of a human subject trial without appropriate oversight."
Kruse added that he wants to ensure that future research at SIU "is both safe and in compliance with all regulations."
HHS apparently is trying to determine whether Halford, chief science officer and part-owner of Rational Vaccines, was "acting as an agent" of SIU when he conducted the
HHS spokeswoman
Halford told the newspaper before his death that he made sure his work with Rational Vaccines was separate from his work as an SIU researcher. If Halford intermingled that work on the medical school's campus, violations of internal or governmental rules may have occurred, Carlson said.
"Our understanding was that he was not conducting Rational Vaccines' research here," Carlson said.
Even if Halford portrayed himself as an SIU representative while conducting the trial or while trying to get the results published in a scientific journal, SIU probably can't be held liable in a lawsuit or by the federal government unless SIU officials gave their blessing to that behavior or exercised a major failure in expected oversight, Spector-Bagdady said.
Spector-Bagdady, who has not been involved in Halford's research, read a copy of Kruse's letter at the request of the SJ-R and said it appeared to be an "appropriate response."
The SJ-R reported in September that the government of
The status of the
It doesn't appear that Rational Vaccines broke any
Rational Vaccines may face a long road to convince scientists in
"It would be extremely hard to rebuild trust," she said.
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