Whistleblower Alleges Major Problems with Clinical Research Program at UCSD

Aug 19, 2019 | Challenged Sites, Conflict of Interest, Human Protection, Informed Consent, Site Challenges, Site Watch, UCSD

Whistleblower Alleges Major Problems with Clinical Research Program at UCSD

UC San Diego, an elite research center, is putting thousands of people a year at risk because they don’t follow basic human protection and safety rules according to an anonymous whistleblower. The allegations were delivered in a letter to top University of California officials on Monday warning “What is going to happen is someone will get hurt.”

Apparently, the letter’s author alleges that UCSD’s Human Research Protections Program is not doing its job to ensure that clinical investigators and staff follow ethical and legal guidelines when conducting clinical trials with human participants.

Serious Allegations

The whistleblower, and we must remind the readers this is not proven but simply allegations from an anonymous whistleblower, that the UCSD program is “the most serial noncompliant” throughout the University of California System, “if not the country.”

inewsource Identifies Whistleblower

inewsource, a San Diego-based investigative, data-driven journalistic publication, reports that they now know who the whistleblower is but agreed not to reveal any names. They noted that the individual apparently was associated with UCSD’s medical research oversight.

UCSD Officials Pursuing an Investigation

Scott Lafee, a UCSD spokesperson, reports that “a formal whistleblower investigation has been opened and the allegations will be investigated through an official process.

Heart of the Complaint: UCSD Leadership Promoting Expediency over Safety in Human Trials

The crux of the complaint rests on the allegation that UCSD senior leadership seeks clinical program expediency and efficiency over human safety and associated federal, state, and local regulations. From there, a predictable set of charges follow from insufficient informed consent to looking past conflict of interest matters to failure to follow the law when serious events require notice to the authorities.

Competitive Pressures Mounting

Researchers must stay relevant in their investigations or risk not attracting funding and lose economic and political clout within their institutions. A true-quality-driven culture is absolutely vital for a vibrant, dynamic and sustainable research program. The quality cannot be a checklist used as an afterthought to cover the read-ends, but rather it must be infused into a culture that embraces quality, which of course includes adhering to all the fundamental principles of research such as informed consent for starters.

But culture changes over time and if not re-grounded in the legal, ethical, and moral foundations required for success, institutions can start to lose their way.

Final Comments

We cannot be sure what is really going on in UCSD till the official investigation produces final findings. We have reported on a few troubling matters at UCSD often courtesy of inewsource. UCSD is a fine institution with an international reputation for excellence, however we cannot ignore the seriousness of the allegations in the whistleblower’s letter. We place UCSD on SiteWatch and monitor with the hopes that many of the allegations turn out to not be true.


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