University of Washington "Oversees" Research Safety at 100 Locations

University of Washington “Oversees” Research Safety at 100 Locations

Sat, 23 Apr 2005

The third report in the News Tribune reveals that in 2004, the University of Washington – which for the seventh time in four years has been found in gross violation of federal research protection regulations–“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.”

The fact that major research institutions, such as the University of Washington, has been caught seven times violating the very federal regulations under which these institutions have a federal license, demonstrates that the current system for reviewing and monitoring research is a sham.

How many times can a research institution expect to get off scot free after being caught violating safety regulations whose purpose is to protect human subjects?

If such violations occurred in research conducted on laboratory animals, the researchers and the institutions would face stiff penalties under the National Animal Welfare Act of 1966.

AHRP urges the Secretary of Health and Human Services to convene a summit of experts and watchdog organization representatives to address the crisis posed by systemic failure of local institutional review boards (IRBs). A body of evidence demonstrates that IRBS continue to fail in their performance to protect the safety, dignity and welfare of human research subjects. Academic research centers have been transformed into commercial factory production lines.

AHRP believes that the Secretary’s advisory panels (e.g., SACHRP) that have been charged with reducing the “regulatory burden” for the research community is the wrong way to address the problem of unethical and unlawful human experiments conducted under the seal of a government license.

Contact: Vera Hassner Sharav
212-595-8974

The News Tribune
Tacoma, WA -Friday, 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.

More information
The Alliance for Human Research Protection in Manhattan has for years worked to make human research safer. See what’s on their mind by visiting their Web site at http://www.ahrp.org.

Locations
The UW monitors the safety of human experiments at about 100 places, including;

  • Oregon Health and Science University in Portland
  • Group Health Cooperative
  • Universidade de Lisboa, Portugal
  • Senior Services of Seattle and King County
  • Puget Sound Neighborhood Health Centers
  • Bartell Drugs
  • NW Hand and Orthopedic Surgery, Tacoma
  • Jacksonville Hearing and Balance Instituted, Jacksonville, Fla.
  • Southeast Kansas Education Service Center, Girard Kansas
  • Skagit Pediatrics, Mt. Vernon
  • Yakima Valley Farm Workers Clinic
  • Washington Hand Surgery, Kirkland, Pa.
  • Seattle Public Schools
  • Residence XII, a Kirkland drug treatment center
  • King County Public Hospital, District 1
  • Planned Parenthood
  • Seattle Plastic Surgeons, Inc.
  • Evergreen Orthopedic Surgery, Kirkland
  • Seattle Reproductive Medicine
  • Olympic Medical Centers, Port Angeles
  • Management Services Organization, a Tacoma medical management company
  • Northwest Research Associates, Bellevue
  • Quantigraphics, Inc., Mercer Island

Source: U.S. government records

M. Alexander Otto: 253-597-8616

Originally published: April 22nd, 2005 12:01 AM (PDT)

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