Patient Dies in VA Medical Study
Patient Dies in VA Medical Study
Source: Associated Press Health News
At least one patient died recently as a result of a medical error in a study at a Veteran Affairs hospital, prompting a review of the agency’s entire human research effort, according to a memo released Wednesday.
The memo, signed by two deputy undersecretaries for health and dated March 6, called for an intensive 90-day review at all VA medical centers of procedures used to monitor human research. Current projects will continue and patients will still be enrolled in new ones, the memo said.
The memo referred to the death “of one or more patients at one site,” but did not describe the human experiments or offer any details.
VA spokeswoman Karen Fedele said the agency would not comment further, citing an investigation by the VA’s inspector general.
Dr. Jonathan B. Perlin and Laura J. Miller, the deputy undersecretaries who signed the memo, were not available for comment and a receptionist referred all questions to Louise Van Diepen, an associate in their office. She refused to discuss the memo.
The Perlin-Miller memo said recent incidents in VA center human research studies “have had the potential to put research subjects at risk.”
Among the incidents cited:
-Falsification of individual patient data “contributed” to the death of at least one patient.
-Overdosing of a patient in a drug study project at another center.
-An experimental procedure was conducted without the prior approval of the Institutional Review Board or the Research and Development Committee – panels that have the formal responsibility of monitoring human research.
-A drug study was conducted without a researcher who had clinical privileges permitting the prescribing of the study medication.
-Failure of a review board “to meet even the minimal standards required.”
Perlin and Miller ordered the 90-day review “to ensure we are doing all that is possible to ensure the protection of human subjects and the ethical conduct of research.”
The memo directed that directors and other officials at VA centers are to review the operations of review boards and R&D committees to assure they are “functioning at least at the minimum level required.”
The memo required that all researchers and the members of the oversight boards complete training courses on the protection of human research subjects. It also called for new procedures to assure that all researchers have the proper credentials and licenses.
Finally, the memo warned that principle researchers at the VA centers “will be held responsible for ethical breaches in the conduct of their research.”
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