University's Human Experiment Violations

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The News Tribune

Tacoma, WA

April 22, 2005

 

UW oversees research safety at 100 locations

M. ALEXANDER OTTO

 

The University of Washington oversees safety of human experiments not only

on its own campus, but at approximately 100 institutions and companies

throughout the world, greatly expanding the pool of people who may have been

put at risk by safety lapses recently uncovered by federal investigators.

 

The list the UW helps supervise includes familiar, local institutions such

as the Fred Hutchinson Cancer Research Center, Swedish Medical Center,

Seattle Children's Hospital and the Washington Department of Health, along

with other state agencies.

But the UW also helps oversee research for less obvious candidates,

including Fred Meyer stores in Portland; Walgreen's Pharmacy; Seattle's

African-American Community Health Network; the Boise Veterans Affairs

Hospital; the Pierce County AIDS Foundation; the Papa Ola Lokahi health

center in Honolulu; and the Centers for Disease Control and Prevention in

Atlanta.

 

UW research boards also have helped oversee studies for high schools in New

Mexico and Moscow, Russia, plus biotechnology firms in Rockville, Md., and

Heidelberg, Germany. Scores of additional places include public schools,

senior living centers, drug treatment facilities, and clinics for migrant

workers, both in the Puget Sound region and beyond.

 

According to an April 1 report, investigators from the federal Office for

Human Research Protections found significant problems in how UW oversees

research, including allowing studies with safety questions to proceed.

 

It also is concerned the school might have bypassed laws meant to protect

subjects, including children, and has demanded further documents for review.

 

UW officials say they recognize the seriousness of the problems and are

committed to fixing them. The school is under federal order to say by April

28 how it will do that.

" We need to make improvements, for sure. We are taking seriously what they

have found in these documents, " said David Thorud, UW's acting provost.

 

In 2004, UW oversaw about 6,500 human experiments at any one time. Six

safety boards, each with about six members, meet every two weeks for three

hours to approve and monitor experiments, said Helen McGough, director of

the UW Human Subjects Division.

 

UW administrators could not say how many of those were outside projects, as

opposed to ones run primarily at the UW. Projects involve everything from

relatively harmless interviews to potentially dangerous drug and surgical

studies.

 

Approximately 250 of the 6,500 human experiments were paid for by

pharmaceutical companies or other for-profit business. The school charges

about $1,000 to review and monitor studies for industry, McGough said.

 

Patient-safety advocates, remembering several research deaths at major

universities, said they are concerned because the April 1 report is the

seventh time in four years that UW has been cited by the federal government

for safety problems.

 

The report did not say anyone had been hurt because of the lapses.

Advocates also noted that the federal report said that the school's safety

boards " often seem reluctant to defer approval of a study, " perhaps, they

said, because the federal government and industry pay the school hundreds of

millions of dollars annually to conduct such research.

 

Advocate Vera Sharav, president of the Alliance for Human Research

Protection, said that because of universities' financial ties to companies

paying for research and other conflicts of interest, they " are no longer

capable of meeting their responsibly to safeguard human subjects and comply

with ethical requirements. "

 

Research institutions like the UW often " cut corners on safety to speed up

the process and get as much research business as possible, " she said. " It's

a business ethic totally inappropriate to a realm where human beings' lives

are at stake. "

" These scandals keep coming up. In this culture, it does not surprise me, "

said Dr. John Pesando, who blew the whistle several years ago on what he

said were safety problems in Fred Hutchinson Cancer Research Center

experiments.

 

UW has an agreement with the Hutchinson Center, Swedish Medical Center, and

a handful of other local institutions to share research safety oversight.

It's not an unusual arrangement. Research centers often ban together to

share study oversight, especially if one board is particularly expert in an

area or if it has the time to take on another study.

 

But the majority of places that rely on the UW for safety oversight do not

have such arrangements and turn to the school because they lack their own

review board or for some other reason, said Karen Moe, the assistant

director of UW's Human Subjects Division.