Chuck Grassley

United States Senator from Iowa

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Grassley Seeks Answers and Accountability Following Reports of Unsanctioned Human Research Testing

Jan 05, 2018
Serious Noncompliance Put Individuals at Extreme Health Risk
 
WASHINGTON – 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. Grassley also wrote to President Randy Dunn of the Southern Illinois University System regarding the matter.
 
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.
 
In his letter to Hargan, Gottlieb and Menikoff, Grassley is seeking information about the status of any ongoing investigation, if any determination has been made as to Halford’s culpability, what corrective action is being taken to ensure proper oversight of research on human subjects, an explanation of the reporting process for potentially unapproved research and data about complaints of unapproved research.
 
Grassley wrote, “[T]his entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff. The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed him, has put individuals at extreme health risk.”
 
In his letter to Dunn, Grassley is seeking information about corrective action SIU is taking to ensure noncompliance does not occur again, SIU’s process for reporting complaints about unapproved research and data about complaints of unapproved research.
 
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.”
 
Grassley requested a written response to each of his letters by January 18, 2018.
 
Grassley’s letter to HHS, FDA and OHRP can be found here and below.
 
Grassley’s letter to SIU can be found here and below.
 
 
January 4, 2018
 
Eric D. Hargan                                                                                                  
Acting Secretary
Department of Health and Human Services
Washington, DC
 
Dr. Scott Gottlieb
Commissioner
Food and Drug Administration
Silver Spring, MD
 
Dr. Jerry A. Menikoff
Director
Office for Human Research Protections
Rockville, MD
 
Dear Mr. Hargan, Dr. Gottlieb, and Dr. Menikoff:
 
            As you know, testing involving the use of human subjects in the U.S. is regulated by Title 45 CFR Part 46.  The regulation is codified in separate regulations by 15 Federal departments and agencies known as “The Common Rule” – three other departments and agencies comply with all subparts of 45 CFR Part 46.  Pursuant to the Common Rule, research must be reviewed and approved by an Institutional Review Board (IRB) using the following criteria:  1) risks to subjects must be minimized; 2) the risks to subjects must be reasonable in relation to anticipated benefits; 3) the selection of subjects must be equitable, with attention to the special problems of research involving vulnerable populations; 4) informed consent must be sought and appropriately documented if the risk is greater than minimal; 5) researchers must continually monitor the data collected to ensure safety of subjects; and 6) the privacy of subjects must be maintained.[1]  In effort to make sure results are widely available and can be subjected to public scrutiny, Title 21 CFR Part 50, Subpart B (Informed Consent of Human Subjects), requires a description and summary of the results for applicable clinical trials involving human subject testing be posted to ClinicalTrials.gov.[2]
 
            Recently, investigative news reports have indicated that a Southern Illinois University (SIU) professor, William Halford, may have violated almost every requirement of the Common Rule.  For example, Professor 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.[3]  The vaccine was allegedly administered in a Holiday Inn Express and a Crowne Plaza Hotel near the SIU lab.[4]  He also reportedly did not acquire written consent from the test subjects.  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.[5]  His research was later moved out of the continental United States.  SIU claims that is was unaware of the research practices.[6]
 
The Department of Health and Human Services “demanded the university account for the research.”[7]  In response, the university found “serious noncompliance with regulatory requirements and institutional policies and procedures.”[8]  Furthermore, the U.S. Food and Drug Administration (FDA) reportedly did not monitor this research.[9] 
 
If the reporting is accurate, this entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff.  The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed him, has put individuals at extreme health risk. 
 
In order to better understand the situation, please provide the following:
 
  1. 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?
 
  1. 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?
 
  1. Did HHS, OHRP, or the FDA find SIU’s response to Professor Halford’s work to be adequate?  Please explain.  
 
  1. Since SIU found “serious noncompliance with regulatory requirements…”[10] what corrective action did HHS, OHRP, or the FDA take to ensure that noncompliance does not occur again?
 
  1. Has HHS or the FDA ever reported research malpractice to federal or state law enforcement for potential prosecution?
 
  1. Please explain, in detail, the process OHRP follows once a complaint about potentially unapproved research is received.
 
  1. How many reports of unapproved clinical trials have been received by OHRP in the past 5 years?
 
  1. Of the reported cases, how many resulted in an internal review by the institution in question?
 
  1. Of the reported cases, how many resulted in referral to federal or state law enforcement?
           
A written response to these questions is requested by January 18, 2018.
 
Sincerely,
 
Charles E. Grassley                            
Chairman                                
                                                                        Committee on the Judiciary
 
 
January 4, 2018
 
Dr. Randy J. Dunn
President
Southern Illinois University System
Carbondale, IL 62901
 
Dear President Dunn:
 
            As you know, testing involving the use of human subjects in the U.S. is regulated by Title 45 CFR Part 46, which encapsulates the Common Rule. The responsibilities of researchers applying for an investigational new drug application (NDA) at the U.S. Food and Drug Administration (FDA) are regulated at Title 21 CFR 312. The National Institutes of Health (NIH) website has posted the public policy requirements, objections and other appropriation mandates to which NIH grants are subject.[11]  Both FDA and NIH are operating divisions within the U.S. Department of Health and Human Services (HHS).
 
Recently, investigative news reports have indicated that a Southern Illinois University (SIU) professor, William Halford, may have violated almost every requirement of the Common Rule.  For example, Professor 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.[12]  The vaccine was allegedly administered in a Holiday Inn Express and a Crowne Plaza Hotel near the SIU lab.[13]  He also reportedly did not acquire written consent from the test subjects.  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.[14]  His research was later moved out of the continental United States.  SIU claims that is was unaware of the research practices.[15]
 
The Department of Health and Human Services “demanded the university account for the research.”[16]  In response, the university found “serious noncompliance with regulatory requirements and institutional policies and procedures.”[17]  Furthermore, the U.S. Food and Drug Administration (FDA) reportedly did not monitor this research.[18] 
 
If the reporting is accurate, this entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff.  The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed him, has put individuals at extreme health risk. 
 
In order to better understand the situation, please provide the following:
 
  1. Since Southern Illinois University found “serious noncompliance with regulatory requirements…”[19] what corrective action did you take to ensure that noncompliance does not occur again?
  2. Please explain, in detail, the process SIU follows once a complaint about potentially unapproved research is received.
  3. How many reports of unapproved research have been reported at SIU in the past 5 years?
  4. Of the reported cases, how many resulted in an internal review?  What were the results of each internal review?
  5. Of those cases reviewed, how many resulted in referral to federal or state law enforcement?
 
A written response to these questions is requested by January 18, 2018.
 
Sincerely,
 
Charles E. Grassley                            
Chairman                                
                                                            Committee on the Judiciary
 
-30-
 

[1] 45 C.F.R. 46.  https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.124.  U.S. Department of Health & Human Services (HHS), Information on Protection of Human Subjects in Research Funded or Regulated by U.S. Government, http://www.hhs.gov/1946inoculationstudy/protection.html
[2] U.S. Food and Drug Administration (FDA), 21 CFR Part 50, Subpart B, Informed Consent of Human Subjects, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25.
[3] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[4] Marisa Taylor, Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial, Kaiser Health News (Oct. 19, 2017).. Available at https://khn.org/news/desperate-quest-for-herpes-cure-launched-rogue-trial.
[5] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[12] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[13] Marisa Taylor, Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial, Kaiser Health News (Oct. 19, 2017).  Available at https://khn.org/news/desperate-quest-for-herpes-cure-launched-rogue-trial.
[14] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[15] Id.
[16] Marisa Taylor, Years Before Heading Offshore, Herpes Researcher Experimented on People in U.S., Kaiser Health News (Nov. 21, 2017).  Available at https://khn.org/news/years-before-heading-offshore-herpes-researcher-experimented-on-people-in-u-s/
[17] Id.
[18] Id.
[19] Id.