Author: Jon Merz
Date: 04-21-05 11:04
Source: thenewstribune.com
URL: http://www.thenewstribune.com/news/local/story/4790788p-4410194c.html
Date published: April 21st 2005
Feds find more cause for concern with UW
M. ALEXANDER OTTO; The News Tribune
Last updated: April 20th, 2005 12:01 AM
The federal government is concerned there could be additional serious safety problems at the University of Washington’s human research program beyond those already confirmed in an April 1 inspection report.
Documents released Tuesday raise the possibility that the school might in some cases have completely bypassed laws and regulations meant to keep people in studies safe, including children.
The federal Office for Human Research Protections – which polices federally funded human research – has demanded that the school turn over additional files for review.
Based on a random review of about 70 experiments, the office has concluded the university approved studies that should not have been approved.
The concerns about additional problems are contained in the five pages originally redacted from the 15-page report, but released Tuesday by the university in response to a request from The News Tribune made under state public disclosure laws.
The federal office is concerned some members of the boards charged with keeping research at the school safe “appear to lack a detailed understating of the specific requirements of (federal) regulations for the protection of human subjects,” the office said.
The April 1 report is the seventh time in four years the federal government has found safety problems with human research at the University of Washington.
Safety oversight at the school “will never be perfect,” said Craig Hogan, the UW’s vice provost for research, who oversees human experiments there. The program is just too big and complex, he said, and the potential for human error too great.
“But we are committed to making it the best we can,” Hogan said, adding that the report “is useful feedback” and that improvements are being made.
The university, one of the world’s leading research institutions, conducts thousands of studies on hundreds of thousands of people worldwide.
Experiments run the gamut from virtually harmless interviews to potentially dangerous research on new surgical techniques.
The federal government and industry give the school hundreds of millions of dollars annually to run the studies, and UW scientists recruit for subjects on the radio, in newspapers and elsewhere.
The federal research office is concerned safety board members might not always have been told of some studies and that scientists might not have followed federal rules when running an experiment without participants’ full knowledge and consent.
It is also worried that consent documents combine explanations of purpose and possible benefits in such a way that could mislead people to think they will benefit from an experiment and thus entice them to sign up, when in most cases people do not benefit from their participation in research.
In addition, the research protection office said “documents reveal little evidence” that the school follows the law when running experiments on children, for whom there are extra safeguards.
“Please respond,” federal inspectors said repeatedly in the April 1 report.
As they have previously, university officials maintain the school has largely been doing the right things to keep people safe, but actions have not been sufficiently documented.
But one area that does need change, Hogan conceded, are policies that undermine the power of school research safety boards – dubbed “institutional review boards,” or IRBs – to control what studies go forward and how.
Until now, UW policy allowed researchers to appeal IRB decisions. Also, Hogan himself switched a neurology experiment from one review board to another in March after the scientist complained about the first board.
“OHRP is concerned Dr. Hogan undermined the independence of the IRBs,” the office said.
Hogan said review board appeals and “IRB shopping,” as it’s called in the research community, will end.
Laws to keep people in studies safe have evolved in the United States in response to research atrocities, including Nazi war crimes, syphilis experiments on poor black men and the infamous Willowbrook experiment, in which retarded children at a state school in New York were infected with hepatitis in the 1950s and 1960s to see how it progressed.
More recently, several deaths at major research universities have heightened scrutiny, including that of 24-year-old Ellen Roche, killed at Johns Hopkins University in Baltimore in 2001 when she was accidently given a lung poison to inhale in an asthma study.
The federal research protection office temporarily shut down human research at Johns Hopkins after a subsequent investigation revealed widespread, basic safety problems.
M. Alexander Otto: 253-597-8616
alex.otto@thenewstribune.com
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