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AUDIT LEADS TO HALT IN HUMAN RESEARCH
ENROLLMENT
AT PUGET SOUND VA -- The VA Puget Sound Health
Care
System has stopped enrolling new patients for all
its
medical research after a federal audit found
deficiencies
in the documentation of safeguards for patient
safety.
For more about VA research, use the VA Watchdog
search engine... click here...
http://www.yourvabenefits.org/sessear
ch.php?q=va+research&op=ph
Story here...
http://seattletimes.nwsource.c
om/html/localnews/2008488704_veter
ansresearch10m0.html
Story below:
Your comments accepted at bottom of
page.
-------------------------
Audit leads to enrollment halt in research at
veterans hospital
The VA Puget Sound Health Care System has stopped enrolling new patients
for all its medical research after a federal audit found deficiencies in
the documentation of safeguards for patient safety.
By Kyung M. Song
Seattle Times health reporter
The veterans hospital in Seattle has halted all new enrollments in
research involving human subjects after a federal audit found that patient
safeguards weren't properly documented.
The decision — which applies to about 600 studies being conducted at the
veterans hospital and the University of Washington — could delay the work
of some researchers by weeks or longer, in some cases forcing them to turn
to minor but still research-related tasks to avoid running afoul of the
conditions of their research grants.
Researchers also will be barred from analyzing or publishing their data at
the veterans hospital without a special waiver.
 Also
affected are about 15 bone-marrow transplant and oncology studies at the
Fred Hutchinson Cancer Research Center that were actively recruiting
patients at the hospital.
Nationally, the federal Department of Veterans Affairs has been a fertile
proving ground for medical breakthroughs, including advances in artificial
limbs, the CT scanner and drug trials for tuberculosis and hypertension.
Locally, thousands of veterans and their dependents are enrolled in human
studies. The research spans a range of conditions and treatments,
including testing the effects of testosterone in men with mild cognitive
impairments to studying the genetic propensity for certain diseases.
Subjects often receive modest payment, ranging from $20 or $30 for a visit
to $200 for a lumbar puncture.
The restrictions in Seattle announced this week stem from a review
completed last month by the federal department's Office of Research
Oversight, which is responsible for ensuring patient safeguards.
The oversight office found, among other things, that patient-consent forms
did not conform to department regulations and that local committees in
charge of approving each clinical study failed to make a formal judgment
about risk levels.
 Dr.
Steven Kahn, director of research and development at the VA Puget Sound
Health Care System, which includes the hospital, stressed that the federal
audit largely found record-keeping problems and raised no concerns with
specific studies.
Kahn said that while this is the first time the hospital here has
suspended enrollment in human studies, "there has been no violation of
federal regulation and no harm to patients."
Kahn, who also is a professor of medicine at UW, said several other VA
health systems — including Boise, San Diego and Palo Alto, Calif. — also
have received similar findings from the federal oversight office.
Kahn said researchers can continue collecting data, blood and other
samples from people already enrolled in their studies. However, they can't
add new subjects or analyze or publish the results of their research until
their study protocols have been re-reviewed and cleared.
Researchers can seek special waivers, Kahn said, if the delays would
compromise patient safety or otherwise jeopardize their research.
Vera Sharav, president of Alliance for Human Research Protection, a New
York nonprofit group that promotes ethical medical research, said
particular care is needed to safeguard veterans enrolled in studies.
They "are vulnerable to being coerced into becoming guinea pigs in order
to get treatment," she said.
Kahn said the action was unrelated to recent national headlines about
patient-safety issues at VA research centers elsewhere around the country.
In August, a report by the department's inspector general's office
concluded that VA researchers in central Arkansas broke rules on human
experimentation multiple times since the 1980s.
Researchers allowed people with no medical experience to collect muscle
tissue, destroyed consent forms and failed to report the deaths of 105
patients who had been involved in studies at VA facilities throughout
Arkansas.
Later that month, Veterans Affairs Secretary James Peake apologized
publicly to the widow of a veteran who died of a human form of mad-cow
disease after being turned away from a veterans hospital in the Bronx
borough in New York.
The man's family contended he was steered into hospice care after
declining to enroll in an Alzheimer's study.
Kyung Song: 206-464-2423 or
ksong@seattletimes.com
-------------------------
posted by Larry Scott
Founder and Editor
VA Watchdog dot Org
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