An anonymous whistleblower is claiming that UC San Diego, one of the top research universities in the world, is putting at risk thousands of people each year because it’s not following basic rules meant to protect human research subjects and values grant funding over safety.
In a letter delivered to top University of California officials Monday, the whistleblower warns, “What is going to happen is someone will get hurt.”
The letter criticizes UCSD’s Human Research Protections Program, which ensures university researchers follow ethical and legal guidelines when conducting studies with human participants. Similar programs exist at universities that participate in human research across the country.
The whistleblower calls UCSD’s program “the most serial noncompliant” throughout the University of California system, “if not in the country.”
inewsource has verified the whistleblower’s identity and involvement in medical research oversight at UCSD, but we agreed not to reveal the person’s name because of the individual’s fear of reprisal.
“A formal whistleblower investigation has been opened and the allegations will be investigated through an official process,” UCSD spokesman Scott Lafee said Tuesday.
Millions of people around the world participate in research trials each year, whether for personal, financial or humanitarian reasons. They submit their DNA, organs, body chemistry or personal history to studies that aim to better society.
The complaint alleges UCSD senior leadership pressures staff to approve studies that run contrary to federal, state and local regulations. It also says the research protections program withholds risk information from research subjects, ignores concerns about conflicts of interest and fails to alert authorities to serious problems that occur as required under federal guidelines.
Those are "just a glimpse of the noncompliance issues that senior leadership purposefully neglects or perpetuates,” the letter says.
Dr. Michael Carome, who has worked in the field of research ethics for decades, told inewsource the letter “suggests that there are serious, systemic problems” with UCSD’s oversight of human research.
Carome is a former associate director at the U.S. Office for Human Research Protections, a federal agency charged with protecting human research subjects. He is now a director of the health research group at Public Citizen, a consumer advocacy nonprofit in Washington, D.C.
He compared the problems alleged in the letter to those uncovered 20 years ago at Rush-Presbyterian-St. Luke's Medical Center and Duke University Medical Center, as well as at Johns Hopkins University in 2001. Those cases resulted in “severe compliance actions” by the federal government, he said, which halted nearly all research at the institutions because of the violations.
Carome said the UCSD chancellor "needs to take the complaint seriously and fully investigate it, and assuming that the concerns raised are confirmed, take major action to remove and hold accountable individuals that have encouraged noncompliance here.”
In an ongoing investigation, inewsource has found shortcomings in the system meant to protect research participants across the country. Problems uncovered locally include:
— A renowned UCSD researcher who repeatedly put subjects in harm’s way.
— University officials stonewalling attempts to notify HIV-positive women about a data breach that exposed their personal information.
— A study involving both UCSD and the San Diego VA where doctors removed excessive liver samples from sick veterans without their consent.
The whistleblower points to those instances as “a testament to the judgment of our senior leadership” and partially blames the human research protections program’s director, Kip Kantelo, as well as Eric Mah, the assistant dean for clinical and translational medicine.
Also listed in the complaint is Karen Allen, regulatory affairs director for the clinical and translational institute.
inewsource reached out to Kantelo, Mah and Allen but did not receive a reply.
“We work hard,” the whistleblower’s letter says. “We are a great asset to the institution and UC as a whole. In our small capacity we have tried to be the check and balance to our leadership’s tendencies to ill-advised policy actions.”
However, the whistleblower says, “Our moral compass is consistently challenged.”
The letter also faults the U.S. Food and Drug Administration, which inspects and monitors bioresearch, drug trials and medical device development.
During a recent visit to UCSD, the letter says, “The FDA inspector that showed up was eager to leave the moment she arrived; was given sanitized minutes to inspect; and didn’t dig nearly as deep as she could have.”
The federal investigator found no problems, and the whistleblower contends, “If the FDA had inspected us with a road map, there would have been a very different outcome.”
An FDA spokesman told inewsource the agency is working on a response to questions sent Tuesday about the UCSD visit.
Money and safety
Conflicts involving funding and ethics arise at many universities, said Robert Klitzman, an ethics expert, author and director of Columbia University’s bioethics program.
“They are inherent in the process and they need to be managed,” Klitzman said.
Researchers at UCSD helped bring in more than a billion dollars in sponsored research support last year. Its scientists have broken ground identifying early signs of autism, made gains in diabetic and genetic research, and advanced the treatment of Alzheimer’s disease.
Those advances were made using people’s bodies, and the human research protections program helps those people maintain their legal and ethical rights.
Employees of those programs must feel comfortable making decisions based on federal guidelines, Klitzman said, and not feel institutional pressure to approve dangerous research.
A complication at UCSD is that the human research protections program operates out of the Altman Clinical and Translational Research Institute, a federally funded institute within the university that “expedites the translation of discoveries into therapies” and “facilitates the training and education of the next generation of researchers.”
“We carry out our activities in collaboration with institutional and corporate partners,” the institute’s website says.
Those partners, in addition to federal and state funding, contributed to the more than $686 million raked in by UCSD’s health sciences departments in 2018.
“We understand that UCSD has to compete for research dollars,” the whistleblower writes, but added no matter how much more the protection program is made to be flexible so it can approve more research projects, “it alone is not going to help fill the deficit gap.”
The whistleblower alleges Allen, the regulatory affairs director for the institute, supervises two departments: staff for the researchers looking to gain university approval for their trials, and staff for the university board that grants those approvals and is charged under federal mandate to look out for the well-being of participants.
“Essentially the fox is guarding the henhouse,” the whistleblower says, urging everyone within the UC system – from President Janet Napolitano on down – to remove the human research protections office from the Altman Clinical and Translational Research Institute and put it under a separate, independent office.
Carome, the former associate director at the federal human research protections office, agreed.
“You need to try to separate out the leaders of the institution, who primarily are responsible for doing the research and bringing in the research dollars, from the leaders who are responsible for overseeing and ensuring compliance with the regulations to protect human subjects,” he said.
Carome added, “There's clearly a need to reorganize the structure here.”
Lafee, the UCSD spokesman, said the clinical and translational research institute “falls within the purview” of Dr. Gary Firestein. Firestein’s responsibilities also include overseeing the human research protections program in a “strictly administrative” manner. Lafee said that precludes Firestein from “any participation” in that program’s decisions and deliberations.
Lafee did not comment on questions about Allen’s alleged role supervising both staffs.
Unlike UCSD, inewsource found that at least seven of the other nine UC schools have human research review programs that are independent from the administrators responsible for conducting research, avoiding potential conflicts of interest. Those schools include UC Berkeley, UC Davis, UC Irvine, UC Merced, UC San Francisco, UC Santa Barbara and UC Santa Cruz.
The remaining two UC schools — UCLA and UC Riverside — haven’t confirmed to inewsource how their IRBs are overseen.
