Seven years after investigations uncovered “serious noncompliance” in the collection of biological samples at a California VA hospital, the original whistleblowers say several papers related to the work use these problematic samples and should be retracted. But the principal investigator of the work says there’s no reason to question the findings.
The VA San Diego Health Care System was one of 12 institutions involved in the InTeam Consortium, a research initiative between 2013 and 2019 focused on alcohol-related liver inflammation. In 2016, two whistleblowers — Mario Chojkier and Martina Buck — alleged staff at the VA hadn’t obtained proper consent to perform biopsies on critically ill patients and use the samples for research related to the project.
Subsequent investigations — including one by VA San Diego’s institutional review board — have confirmed violations of policies, primarily related to a lack of informed consent. Ramon Bataller, the principal investigator of the InTeam Consortium, told local media outlet inewsource in 2019 the samples collected at the VA would be “banished” from any academic papers.
But several published studies seem to be linked to those samples, according to Chojkier, a gastroenterologist at the University of California, San Diego, and Buck, a former associate professor of medicine at the same institution. They say these studies should be retracted.
For a study published in 2018 in the Journal of Hepatology, patients were enrolled from the InTeam Consortium from the 12 participating centers – of which VASHDS is one. The paper lists Samuel Ho as one of the authors responsible for collecting human samples. Ho codirected the clinical study at the VA San Diego when the problematic samples were collected. Until 2018, he was also a professor of medicine at UCSD and division chief at the VA San Diego Health Care.
Similarly, for four other papers — a 2017 study in the Journal of Clinical Investigation, a 2017 study in Hepatology, a 2019 study in Nature, and a 2019 study in Digestive Diseases and Science, Ho is one of the authors responsible for sample collection.
Vlad Ratziu, the editor-in-chief of the Journal of Hepatology, said the manuscript raised no issues when it was handled by the journal, and no issues since it appeared in print. Editors do not have the capacity to review where liver samples came from, “other than through the information the authors disclose,” he wrote in an email to Retraction Watch.
A representative from Springer Nature wrote they were “looking into the matter.” Ann Haran, the director of publications at the American Association for the Study of Liver Diseases and managing editor of Hepatology said the journal would follow up with the authors as per COPE guidance. Editors at the Journal of Clinical Investigation have not responded to requests for comment.
In an email to Retraction Watch, Ho — who has been at Mohammed Bin Rashid University of Medicine and Health Sciences in Dubai since leaving San Diego in 2018 — wrote that none of the samples related to the earlier inquiries were used for any research and all were destroyed in compliance with the IRB. “There is no published research that was ever done with any of the samples in question and the case was resolved by the IRBs and regulating bodies,” he said. “There is no reason to question any of the published research.”
Ho said the current PI, Bernd Schnabl, a professor of medicine at UCSD and a coauthor with Ho on several of the papers, could confirm his claim that none of the implicated samples appear in published research. Schnabl, who also codirected the clinical study with Ho, declined to comment, citing his status as a federal employee.
Bataller, the InTeam Consortium PI, did not respond to requests for comment for this story, nor did two individuals we contacted in public affairs for VA San Diego. David Brenner, vice chancellor of health sciences at UCSD at the time, also did not respond to requests for comment.
Chojkier and Buck say the papers should be pulled because of “serious violations of [informed consent], serious violations of IRB, and other serious ethical violations in clinical research.” They called for the confiscation and destruction of all remaining samples, and urged journals to investigate the samples used in each study.
The 2018 inquiry by the VA San Diego’s IRB found “serious noncompliance” in the research, which was on finding molecular targets for alcoholic hepatitis. Researchers collected fresh liver tissue for research instead of using archival samples, per the approved protocol. The IRB also found the informed consent documents did not disclose to patients additional liver tissue would be taken, or explain the risks associated with those procedures.
A year later, another review found these additional procedures increased the risk of bleeding and pain. It also found a liver biopsy specimen was obtained from a participant before informed consent had been obtained. The report recommended that the San Diego VA should “consult with the VA National Center for Ethics in Healthcare concerning the research use of liver tissue samples obtained without appropriate consent.” The inquiries were the subject of a Congressional hearing in October 2019, during which a health representative from the Department of Veterans Affairs presented findings of “egregious research misconduct” to the Committee on Veterans Affairs. Two of the reviews also found the research records for the San Diego InTeam study were poorly maintained and incomplete.
In February 2019, the San Diego VA sent letters to the four living participants of the sample collection performed there, notifying them of the unconsented collection of an additional liver biopsy sample for research purposes.
“These patients were violated … it still makes me nauseous,” Buck said. “I have given a large part of my life to the pursuit of scientific research. It’s a core value to me. To see it continue to be violated is repulsive.”
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