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Wednesday, April 20, 2005 - Page updated at 10:57 a.m.

UW told to tighten research oversight

Seattle Times staff reporter

The federal government has warned the University of Washington that it needs to tighten its oversight of research conducted on human subjects.

In a letter sent to UW President Mark Emmert earlier this month, the Office of Human Research Protection wrote that the committees that oversee human research at the UW "often seem reluctant to defer approval of a study" despite "substantive questions" about the risks and benefits to subjects.

Among the other findings, the Office of Human Research Protection criticized the oversight committees for granting contingent approval for research involving human subjects pending major changes instead of deferring approval until the committees confirmed the changes. As a result, in several instances the committees did not "fully determine" whether the subjects' safety was protected.

While Emmert did not dispute the findings, he said "our early assessment was nobody was put in danger because of these issues."

Said Emmert: "The critique and criticism is accurate and suggests that we have a number of policies that are out of compliance. ... We had some sloppy record-keeping and procedures going on and we're going to address that aggressively and fix what needs to be fixed."

The Office of Human Research Protection ensures research supported by funds from the U.S. Department of Health and Human Services is conducted according to ethical standards. The University of Washington receives the most federal research money out of all the public universities in the country. In 2003-04, the UW received $954 million in research funding.

Findings


The findings of the federal Office of Human Research Protection include:

• The University of Washington's oversight committees frequently approved studies contingent on major changes, but the full committee didn't follow up on whether the changes were ever made. The committee should have deferred approval, instead of giving contingent approval, investigators said. In a study on HIV-positive subjects, for instance, the committee failed to "fully determine" whether investigators were protecting subjects when collecting data. In the same study, investigators also found that the oversight committee did not "fully determine" that risks to subjects were reasonable in relation to anticipated benefits.

• The minutes of committee meetings did not go into enough detail about discussions.

• Annual reviews of research projects were conducted on incorrect dates.

• When a subject's confidential information was inappropriately used during an HIV study, the committee did not promptly report the problem to the federal office.

• The oversight committee did not ensure that studies involving prisoners conformed to federal policy.

In general, documentation about application review and approval was insufficient.

The UW must submit a plan to the Office of Human Research Protection by April 28 that explains how the university plans to correct all of the problems detailed in the letter.

All research involving human research subjects at the UW has to be approved by independent review boards, committees made up of volunteers from the university and the public. Six committees review about 5,000 applications a year. The UW conducts research involving human subjects in medicine, psychology and other disciplines. In February, investigators from the Office of Human Research Protection reviewed 38 studies that UW committees had approved, 30 exempt studies and the minutes of meetings between 1998 and this year.

On April 1, the office's compliance officer sent Emmert a letter detailing several noncompliance issues. Among the findings, the office noted that in a specific instance when a patient's confidential information was inappropriately used, the UW's oversight committee did not promptly report the problem to the federal office. Annual review dates were set incorrectly for many research projects. The report also flagged several documentation issues — not detailing the discussions that took place at meetings and not providing enough detail about the review and approval of research projects.

Overall, though, investigators said the committees demonstrated "a sincere concern for, and commitment to, the protection of human subjects."

Normally the letter would have been sent to Craig Hogan, vice provost of research, but because the investigators flagged Hogan's actions on a specific application, the letter went to Emmert.

The investigators wrote that Hogan had "inappropriately interfered" with a committee's authority by referring an application it was reviewing to another committee. Hogan said he had followed an outdated policy.

The University of Washington had already started revamping its oversight committees, Hogan said. This year, he said he had already added six more employees to supplement the 12-person support staff, and volunteered to undergo an accreditation process.

He called the federal findings "a very useful external set of feedbacks."

"We have policies and procedures that need fixing and we're going to fix them," Hogan said. "We're very grateful that there were no human subjects put at risk."

Sharon Pian Chan: 206-464-2958 or schan@seattletimes.com

Copyright © 2005 The Seattle Times Company


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