Sen. Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, wrote to Acting Secretary Eric Hargan of the Department of the Health and Human Services (HHS), Commissioner Scott Gottlieb of the Food and Drug Administration (FDA) and Director Jerry Menikoff of the Office for Human Research Protections (OHRP) concerning news reports of apparently unsanctioned human research testing conducted by Southern Illinois University (SIU) professor William Halford which put individuals at extreme health risk. 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. Grassley wrote, “Halford reportedly administered an experimental vaccine to patients who were not enrolled in an approved study and therefore did not have the proper human subjects protections required by U.S. law…He also reportedly did not acquire written consent from the test subjects.”

Read full story...