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Research halted at Seattle hospital

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 linkurl:Office of Research Oversight;http://www1.va.gov/oro/ determined in a November audit that the linkurl:VA Puget Sound Health Care System;http://www1.va.gov/pugetsound/ should be more careful in documenting that human subjects are competent enough to make reasoned informed consent.

Elie Dolgin
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 linkurl:Office of Research Oversight;http://www1.va.gov/oro/ determined in a November audit that the linkurl:VA Puget Sound Health Care System;http://www1.va.gov/pugetsound/ 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...





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