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Smaller textReports: VA researchers drew patients' blood without their consent
Researchers at the Veterans Administration Medical Center in Philadelphia drew blood samples from veterans for a research project without their knowledge or consent, resulting in "serious noncompliance" with federal law and regulations, according to reports from several internal reviews.
Records released yesterday by the VA under the federal Freedom of Information Act show the unauthorized drawing of blood from veterans came to light more than a year ago after a veteran questioned why an extra vial of blood was drawn during a routine examination.
The complaint triggered an internal investigation and a series of reports that were not publicly disclosed.
VA officials did not respond to questions about the report. The Philadelphia center is under increased scrutiny because of botched treatment of prostate cancer patients.
The records released to the Tribune-Review show a review panel recommended the lead researcher in the blood tests — whose name was removed from reports — be barred from projects at the facility for at least two years. Though it focuses on 11 veterans, the report indicates some 400 blood samples were processed for possible use in the study and at least 150 of those lacked any clinical justification.
"The Philadelphia VAMC must not use the blood samples collected from patients without informed consent for any research purposes," the final report from a VA review panel states.
Dr. Rajeev Sachdeval, the only doctor whose name appears in the report, said she was not the investigator in the studies. She said she could not comment further.
The 11 patients whose blood was drawn inappropriately were notified eventually, the records show. Two of them were homeless.
The blood was used for a study of genetic factors that may affect the usefulness and needed dosages for anticoagulant medications.
The records show the anticoagulation study and another study on prostate cancer involving the same unnamed investigator were discontinued as a result of the inquiry. The prostate study was conducted with a researcher from the University of Pennsylvania.
The panel report cites 16 deficiencies in the blood study, including failure to get written consent from patients and drawing blood samples without a treating physician's order.
Other problems include utilizing blood samples for research without the approval of a federally mandated institutional review board, retaining patient information for samples and improperly allowing volunteer staff access to patient-specific information.
The panel found improper use of VA personnel in a research project, lack of proper training and "problematic interpersonal relationships" and staff intimidation.
In addition to shutting down the two studies, the remedial action included adopting revised procedures for review and approval of similar research.
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