VA mandates review of research programs
The U.S. Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.
The department ordered a 90-day review in its 115 medical centers following a series of accidents, including the death of one patient at an undisclosed location. The review, outlined in a March 6 memo to VA research personnel, requires individuals who run and oversee medical research to update their training on patient protection.
VA studies have not been suspended during the review process. Stopping testing could do more harm to patients who need the procedures being offered without increasing the chance to prevent rare adverse incidents, said Nelda Wray, MD, the VA’s chief research and development officer, in her memo.
Wray called the review a "stand down," a military term that means halting procedures to identify a problem. "The purpose of this stand down is to focus attention on proactively reviewing the human study program to ensure we are doing all that is possible to ensure the protection of human subjects and the ethical conduct of research," she wrote. The review will last until June 6.
The VA is responsible for more than 15,000 research studies involving around 150,000 patients each year, according to the agency. As a result of the review process, each hospital involved in research must confirm to VA headquarters that it ensures its ethics procedures and system for catching errors meet widely accepted human research standards.
Incidents cited, while not specific because of the ongoing investigation, include:
- falsified individual patient data that contributed to the death of one patient;
- a patient overdose in a drug study project at another center;
- an experimental procedure being conducted without the approval of the institutional review board (IRB);
- a drug study being conducted by a researcher who lacked the clinical privileges required to prescribe the study medication;
- failure of a review board to meet even minimally required standards.
The incidents are "exceptions in a VA program that is otherwise outstanding," Wray wrote. She did note that since taking her position eight weeks ago, she had learned of practices that "will not be tolerated," she said.
The medical director, chief of staff, or chief of staff for research will have to attest that the IRB and research and development committees are appropriately constituted and meet on a regular basis to provide timely review and oversight of new and continuing protocols and a review of adverse events and serious adverse events, according to the memo.
Investigators involved in human studies research will be notified that if they conduct research without IRB approval, it will affect their standing in the VA, warned Wray.
Partial-birth abortion ban approved by Senate
A ban on a late-term abortion procedure known as "partial-birth" abortion overwhelmingly passed the U.S. Senate in March.
The 65-32 vote sent the legislation to the House of Representatives, where passage is expected this spring. The majority Republican Senate defeated several challenges to the bill banning the procedure on March 12, clearing the way for passage.
Congress has twice before passed legislation to impose a ban, but President Clinton vetoed both measures. A third attempt was sidetracked in 2000 when the Supreme Court invalidated a Nebraska state law that closely resembled the measure moving through the House and Senate. And a fourth attempt failed last year when Democrats, then in control of the Senate, refused to schedule a vote.
The current bill prohibits doctors from committing an "overt act" designed to kill a partially delivered fetus. "Partial birth" is described as a case in which the entire fetal head is outside the body of the mother, or, in the event of a breech delivery, if "any part of the fetal trunk past the navel is outside the body of the mother." The legislation includes an exemption in cases in which the procedure is necessary to save the life of the mother.
If the bill becomes law, physicians performing procedures that fall under the ban would face either fines or a maximum jail term of two years.
The American College of Obstetricians and Gynecologists (ACOG) officially opposes all state and federal efforts to enact "partial birth abortion bans." As indicated by a policy statement passed by its executive board in 1997, "ACOG continues to find it disturbing that legislators would take any action that would supersede the medical judgment of a trained physician, in consultation with a patient, as to what is the safest and most appropriate medical procedure for that particular patient."
And, although a panel convened by the college could cite no circumstances under which intact D&X would be the only option to protect the life or health of a woman, "intact D&X may be the best or most appropriate procedure in a particular circumstance to save the life or preserve the health of a woman, and only the doctor, in consultation with the patient, based upon the woman’s particular circumstances, can make this decision," the statement concludes.
The House of Representatives is scheduled to consider its version of a "partial-birth" abortion ban in April.
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