Probe Targets Experiments at Hospitals
The Los Angeles County Board of Supervisors ordered health officials Tuesday to review how the county’s six public hospitals oversee experiments on human subjects in the wake of Martin Luther King Jr./Drew Medical Center’s decision last month to halt all such research after federal regulators found dozens of problems with the facility’s procedures.
The motion by Supervisor Yvonne Brathwaite Burke, whose district includes King/Drew, also calls for the county’s director of health services to brief supervisors privately on what, if any, discipline will be meted out for King/Drew’s violations of federal policies meant to protect people who consent to participate in medical research.
Those violations were found by federal investigators last month--at the conclusion of a two-year inquiry--and a day later, King/Drew halted about 250 experiments until the hospital draws up new safeguards, which would be submitted to the Office of Protection from Research Risks in Washington, D.C.
The supervisors’ move came as county health officials conduct their own audit of research and warned that all facilities could have weaknesses in their procedures that may be targeted by newly aggressive federal regulators.
And the president of Drew University--the medical school with which King/Drew is affiliated--said Tuesday he expects the school to form a panel to investigate what led to the current voluntary suspension and added that some problems there were not corrected earlier because of general unfamiliarity with federal requirements.
Drew’s president, Dr. Charles Francis, said that his school has made numerous changes to its policies and hopes to submit its corrective action plan to the national agency by the end of this week.
He said his institution, founded in the wake of the Watts riots, is sensitive to its obligations in the blue-collar, largely uninsured communities it serves. “We want people to be sure and understand that any research done here” is safe, he said. No research subjects were harmed, King/Drew officials have said.
But Francis, who joined Drew 18 months ago, said he himself does not know what specifically prompted the U.S. investigation. The federal agency has confirmed it had an existing investigation but otherwise declined to comment because the case remains open.
More than a dozen doctors and other medical staff members late last month signed a petition demanding a full accounting of the suspension’s causes and of what impact it will have on the $32-million in federal research grants the institutions receive, about $5 million of which, federal officials say, funds research on humans.
“We believe the current . . . crisis was preventable,” the petition states. “We believe that appropriate recommendations and warnings were transmitted to top university administration officials over the past 12 months or more.” Francis said the board of directors for Drew University will probably create a panel independent of the administration to examine the issue.
He acknowledged that the institution did not move decisively enough to correct the procedural problems, which he blamed on the lack of familiarity on the part of officials, including himself, with the technical requirements of once-obscure federal regulations. “Certainly, we could have been much more thorough in trying to get an understanding of what difficulties were going on,” he said.
Prompted by the voluntary suspension at King/Drew, the county’s health department has launched its own audit of human subject research protections at all county hospitals, said Dr. Donald Thomas, associate director of health services.
“Most of our facilities are pretty good, but all of them have something they’re worried about,” Thomas said. “I think that every research facility in the country has vulnerabilities.”
Thomas said that does not necessarily mean bad research is occurring. Instead, he attributed the vulnerabilities to the Office of Protection from Research Risks’ increasingly aggressive enforcement of long-standing policies designed to ensure that patients and other subjects are fully informed of the risks of experiments and are protected from undue harm.
In the past two years, the office has shut down research at seven facilities, including Duke University and the University of Illinois. It canceled the federal research contract at the Veterans Hospital in West Los Angeles last year, throwing that facility into turmoil.
A scathing 1998 report from the federal department of Health and Human Services found that the legally mandated committees that are supposed to review research on humans--known as institutional review boards--were overwhelmed and dramatically losing effectiveness.
King-Drew’s weaknesses, according to internal documents, included its review board’s being insufficiently staffed, having inadequate facilities and not reviewing all experiments.
“We now appreciate that it’s going to take more resources than are available to the IRB,” Francis said. In response, the board now reports directly to him and is moving to new offices.
Drew has revamped its consent forms--which were not always in the native language of the research subjects--and implemented numerous other changes, Francis said.
Supervisor Burke said Tuesday that she proposed the county review “because I’ve had a real concern with medical research involving humans in the county of Los Angeles.”
She proposed that the county’s Research Oversight Committee--composed of county doctors, medical experts and others--monitor King-Drew’s corrective actions and develop uniform standards for review boards of all county hospitals.
The Research Oversight Committee was formed in 1998 at Burke’s urging after questions were raised about a county doctor’s use of human subjects in AIDS research. The researcher was placed on one month’s administrative leave, but his attorney said he had been made a scapegoat.
Burke Tuesday said the King-Drew situation demonstrated that the county must track research on humans carefully. “We should have some controls on the type of experiments we have going on within the county,” she said.
