Author: Jon Merz
Date: 04-21-05 11:02
Source: thenewstribune.com
URL: http://www.thenewstribune.com/health/story/4787763p-4408085c.html
Date published: April 21st 2005
Safety practices at UW criticized
Feds warn the school it could lose hundreds of millions in research funds
M. ALEXANDER OTTO; The News Tribune
Last updated: April 19th, 2005 12:51 PM
The University of Washington has been cited by the federal government for significant problems in how it oversees safety in its human research programs, which involve hundreds of thousands of people in thousands of studies worldwide.
The school must tell the government by April 28 how it will fix the problems or risk losing hundreds of million of dollars the federal government gives the school each year to study medical, social and other problems.
It also must stop some projects the government found were not properly supervised unless doing so would put subjects at risk.
“We are not going to fight these findings,” said Craig Hogan, the UW’s vice provost for research, who oversees human research at the school. “We see this as constructive criticism. We are going to act on it.”
The school has been cited six times in the past four years for safety concerns, and some of the new concerns echo past ones.
But this is the first time regulators found school-wide problems. Previous investigations focused on individual studies.
There is no way to tell if recent oversight lapses harmed people.
Inspectors from the federal Office for Human Research Protections – which polices federally funded human experiments – visited the school in late February on a routine check, randomly pulling records for about 70 experiments.
They found studies not properly reviewed for safety, trials not checked on time to make sure people were doing OK, a breach of privacy in an HIV study, poor record keeping and inadequate written safety policies.
Five of the 15 pages of the April 1 report are blank, having been redacted by the federal government for reasons that are not clear.
Whatever they contain was of such concern that the report was sent directly to UW President Mark A. Emmert, instead of Hogan, which would have been the usual practice, the federal office said.
Hogan would not release the redacted pages to The News Tribune.
Many of the problems the government revealed stem from how UW’s research safety boards – which must sign off on experiments – sometimes approve studies they have concerns about without always following-up to make sure the concerns are addressed.
In a 2003 experiment, for example, a safety board did not make sure premature infants got enough iron in their diets, although there was concern they might not.
“It was inappropriate to grant approval,” the federal report said.
In December, a safety board approved a study on HIV patients without ensuring they would get medications to control the infection.
It doesn’t mean the patients didn’t receive the medications or the babies didn’t get the iron, just that the research protection office determined it wasn’t adequately checked.
At other times, safety boards – known in the research community as institutional review boards, or IRBs – recorded concerns about subject consent and ending a study if drugs proved toxic, but the studies proceeded anyway.
Federal law requires such matters be addressed beforehand.
“UW IRBs often seem reluctant to defer approval of a study,” the federal office noted.
Hogan said contingency approvals would stop.
According to the April 1 report, regulators also found “little evidence” that UW follows federal rules for experiments on prisoners, who, like children, have special research safeguards because they are particularly vulnerable to exploitation.
Hogan said the redacted section, in part, raises concerns about researchers contesting safety board decisions, another practice he said will stop.
Based on information available elsewhere, the redacted pages might also touch on whether people are made fully aware of what they are signing up for in UW studies and on changes made to experiments without safety board approval.
The safety office said the school should create a manual for its researchers on how to comply with basic safety rules.
Past citations involved experiments on Alzheimer’s disease patients and people near death due to lung failure, among others. In those cases, too, the school was cited for not doing enough to keep people safe and for not letting them or their caretakers know what they were in for.
In each case, the school addressed the problems.
Hogan said the UW would make the necessary changes this time, too, and soon. “What we’re are looking at is a bunch of procedural stuff we can fix. We want to get it right.”
The school was already planning to change “a lot of polices and procedures,” he said.
The UW will soon be inspected by an independent group for research safety accreditation, a growing but still not universal trend among research institutions.
The research protection office is hopeful the UW will improve, too. Despite the criticism, the April 1 report commends the school on its “enthusiastic and sincere concern for, and commitment to, the protect of human subjects.”
Study safety has in recent years become a major concern in the medical community following several highly publicized deaths, including that of 18-year-old Jesse Gelsinger, whose 1999 death in a poorly supervised University of Pennsylvania gene therapy experiment focused national attention on problems in human research.
Considering signing up for a study?
Get all the information you can before agreeing to participate in a research study.
Ask if will you at least get the standard treatment if you participate, if not the experimental one? What will you be required to do? Is the doctor making money by signing you up?
The Bureau of National Affairs, a news company in Washington D.C., has pulled together what you need to know, along with tips on how to find trials and other important information, at www.bna.com/medicalresearch/#2
M. Alexander Otto: 253-597-8616
alex.otto@thenewstribune.com
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