Brad Racino and Jill Castellano writing for inewsource reports that “banished blood stool samples from San Diego veterans [were] used in research article, despite federal probe.”
Questionable research practices, including ethical issues—are raised by this Southern California news. Apparently two University of California, San Diego (UCSD) associated investigators utilized blood and stool samples taken from sick veterans to support study findings published in an academic journal.
It is alleged that the two investigators were part of a study that “unethically collected biological samples from living subjects without their consent, which investigators called ‘serious non-compliance.’”
What are the Rules—Informed Consent
Researchers are expected to follow ethical guidelines to protect their patients. This absolute requirement for human research originates from the Helsinki Declaration.
Ethics Expert Comments
Ethics experts were consulted by the news source and they of course said that “academic papers based on unethical research is dangerous and encourages researchers to perform more problematic studies in the future.”
Cause for Even Greater Concern
There was a journalistic investigation into this exact issue by inewssource, (including VA repot finding violations of research practices), a local lawmaker got involved and even called for a hearing, and researchers were to cease all activities, but the paper was still published.
Who are the Investigators
How Did this All Come About?
The UCSD investigators had San Diego VA staff working on liver biopsies on alcoholic veterans—including the gathering of blood and stool samples as part of an international liver disease study during 2014-2016.
Apparently, whistleblowers contacted inewsource from the VA to report on what they believed were unnecessary liver biopsies. One of the whistleblowers was a VA physician and investigator and confided that in in one cases “a patient returned from the procedure ‘oozing with blood,’ with ‘stool scattered’ on his body in need of an emergency transition.”
The San Diego VA Investigation
The evidence piled in. inewsource reported that in fact the VA confirmed the researchers failed to secure consent for the removal of biopsies from liver. Moreover, other reports by federal agencies uncovered “privacy violations, shoddy recordkeeping, improperly trained staff, conflicts of interest and the lack of any investigation by the leadership after questions were first raised about the study six years ago.”
Dr. Ho, one of the investigators, resigned and turned up at the Mohammed Bin Rashid University of Medicine and Health Sciences. inewsource reports that in the published paper, Dr. Ho took credit for “enrolling subjects for bio-specimen collection.”
According to this article, a UCSD spokesperson noted, “The university is investigating the matter and will provide information once the investigation is complete.” At San Diego VA, another spokesperson said, “it would be a disservice to participants who allowed their specimens to be collected for research purposes to not publish valuable information on that participation.”
TrialSite News SiteWatch
TrialSite News SiteWatch monitors research sites (and their investigators) worldwide. We have a “Challenged” category and a “Leading” category. The former is for serious to really bad incidents, scenarios or practices that are exposed. In this case, this is the second time UCSD has shown up on TrialSite News SiteWatch in less than a month. Recently, we reported that they were stonewalling on sharing an information breach with actual research patients. See our article.
We must also call our readers attention to the investigators associated with his serious incident. We cannot be certain what has happened—we don’t know all of the facts. Certainly, Dr. Ho and Dr. Schnabl are accomplished and educated people, but their behavior, if this is true, must be corrected. Physicians acting as investigators have a moral, ethical and legal duty to comply with and adhere to fundamental principles such as informed consent. No amount fame, fortune or attention is worth violating the sacrosanct. If all of these allegations turn out to be true (and based on all of the reported public facts, we think that they are) they owe the clinical research community not only an apology but also public service. They should remind the rest of the world’s community the importance of fundamental research principles.