Cook County Health officials for nearly 10 months have halted new clinical trials at one of the nation’s leading HIV/AIDS research centers as they investigate “concerns” about a nonprofit organization that for decades has managed the county’s medical research grants.
The county in April told researchers at CORE Center, a clinic based on Chicago’s Near West Side medical district and run by Cook County Health and Rush Medical Center, that they were to “pause” starting new clinical trials while awaiting results of a county review of the Hektoen Institute for Medical Research, a nonprofit founded in the 1940s by Cook County hospital physicians, according to CORE staff interviewed by the Chicago Sun-Times.
But as the moratorium entered a ninth month this week, staff were told even grant funds for ongoing trials were apparently not forthcoming and more than a dozen CORE researchers could receive pink slips as soon as this week. The layoffs would upend ongoing work and dim the prospects for future funding from state and federal agencies that pump millions of dollars annually into research, said Jim Pickett, an HIV research advocate who has worked with CORE since the 1990s. Tax records show Hektoen received more than $20 million in grants last year.
“This is a disaster,” Pickett said. “This is one of the three or four main sites for this kind of research in the country, and they can’t move forward. To replace that is no small matter.”
Officials at Hektoen did not respond to requests for comment. In a statement Tuesday, CCH spokeswoman Alexandra Normington said the county had “launched an investigation to ensure that all trials are in compliance with applicable regulations.”
“CCH has engaged an impartial firm to review recent trial activity, including compliance with financial and clinical research standards. The investigation is actively underway. In the interim,” the statement reads, “CCH has temporarily paused engaging in new clinical trials.”
The looming layoffs at CORE were necessary, staff were told, because county officials refused to release grant funding— even for ongoing trials— managed by Hektoen. The standoff over the grant money also affected research trials for COVID-19, monkeypox and cancers run through CORE, one researcher said.
County officials said the pause did not affect ongoing research, but one researcher who was informed they were on the list for layoff said there would be no one to continue their work if they and their peers were gone.
“I am concerned about the research, and I’m concerned about my job, but really, I worry for my patients,” said the researcher. “Over the course of a clinical trial that lasts months or years, you really get to know them and their stories, and many of them really need this kind of care that they can’t get, sometimes literally, anywhere else.”
Hektoen has served as a “fiscal agent” to manage finances for grant-funded research, including landmark trials of AIDS medications, that were run through the CORE Center, Pickett said. Hospitals and public health organizations often will partner with a university or outside organization to manage the rigorous record-keeping required by government agencies.
Staff from a law firm hired by the county removed some files from a few grant-funded programs over the summer but have not interviewed any of the staff working on those programs, a researcher said. Had investigators identified issues that threatened the health of research patients, authorities would have been notified within days of the discovery, Pickett said.
