
Senator Demands Answers After Rogue Vaccine Research Compromises Patient Safety
Republican Senator Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, is calling on regulators and Southern Illinois University to account for reports that a researcher conducted rogue trials of an experimental herpes vaccine.
Republican Senator Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, is calling on regulators and Southern Illinois University (SIU) to account for reports that a researcher conducted rogue trials of an experimental herpes vaccine.
As Kaiser Health News
Grassley, in
“William Halford…may have violated almost every requirement of the Common Rule,” wrote Grassley. Under the rule, risks to participants must be minimized and reasonable in relation to anticipated benefits, selection of subjects must be equitable, informed consent must be sought and documented, researchers must monitor data to ensure participants’ safety, and participants’ privacy must be maintained. Grassley wrote that Halford did not have appropriate patient protections in place for his unapproved study, and that the researcher’s own emails “…stated that it would be ‘suicide’ if the manner in which he conducted the research were to be made public.”
Grassley has requested written responses from HHS, FDA, and OHRP detailing what—if any—investigations the agencies have launched into Halford’s conduct, and what corrective actions the agencies are taking to prevent similar violations from occurring.
Also in Grassley’s sights is SIU, itself. In a letter to the institution’s president, Randy Dunn, EdD, the senator asked for details of corrective action taken by the institution to prevent further noncompliance with regulatory requirements, the process SIU follows once a complaint about potentially unapproved research is received, the number of reports of unapproved research SIU has fielded over the past 5 years, and how many internal reviews and referrals to law enforcement were made during that period.
SIU’s official position, released in a November 2017
Grassley requested written responses to the questions posed in his letters by tomorrow, January 18, 2018.
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