Officials have halted enrollment in more than 600 human research studies taking place in Seattle this week after a federal audit found shoddy paperwork in some consent forms.

The Department of Veterans Affair's Office of Research Oversight determined in a November audit that the VA Puget Sound Health Care System should be more careful in documenting that human subjects are competent enough to make reasoned informed consent. Local oversight committees were also censured for not formally judging risk levels on a study by study basis.

"This is a procedural issue," Norm Arkan, a University of Washington spokesperson, told The Scientist. "There were no issues here of any subject being in jeopardy with regard to safety issues."

"There were administrative oversight issues, and we've begun the process of making changes," added Jeri Rowe, the VA Puget Sound Health Systems' director of public affairs.

Researchers can continue collecting data from patients already enrolled in ongoing studies but cannot add new subjects or publish any results until the hospital cleans up its documentation methods, according to the Seattle Post-Intelligencer.

The decision applies to about 600 studies being conducted at the hospital and at the University of Washington, and 15 studies at the Fred Hutchinson Cancer Research Center that were actively recruiting bone-marrow transplant and oncology patients at the hospital.

Arkan expects that the studies will now be delayed by "several weeks." In the meantime, researchers may have to turn to data analysis and other minor research-related tasks until the wrinkles are ironed out. "The biggest impediment," he said, will be that "our researchers have a lot of paperwork to fill out," but the research will resume eventually.


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