VA Research Subjects Still at Risk, Audit Says

Despite promises to do better, Veterans Affairs hospitals still do not adequately protect veterans who take part in studies, according to a nationwide audit of eight facilities prompted by the research crisis last year at the VA medical center in West Los Angeles.

The audit by the General Accounting Office, scheduled for release today, is the most extensive independent probe of research ethics in the VA medical system, the nation’s largest health care organization. It credited the VA with improvements but also documented what the GAO calls a “disturbing pattern” of VA hospital failures to follow regulations that safeguard research subjects.

Besides auditing eight facilities, investigators scrutinized three recently sanctioned VA medical centers, including the one in West L.A., which was cited as an example of poor research management.

According to a summary of the GAO audit obtained by The Times, it was “premature” of VA officials to authorize the West Los Angeles hospital to resume reviewing proposed studies in April 1999, less than a month after VA and other federal officials suspended research activities because of deficiencies in human subject protections.

The hospital still lacked written research guidelines, depended on untrained personnel to review studies and had not taught researchers regulations for vital procedures, such as obtaining informed consent, the accounting office said.

Dr. Dean Norman, the medical center’s chief of staff, disputed that timeline, saying research remained in limbo for much longer than a month while hospital managers engaged in a “thoughtful and deliberative” effort to reinstate studies. The hospital now spends more than $2 million annually administering human research and the safety net is now in good shape, he said.

Lawmakers requested the audit at a House of Representatives hearing last year. The request came soon after U.S. officials suspended research at the West Los Angeles facility and The Times reported that a cardiologist there conducted research on four heart patients in 1995 without their legally required consent.

The question lawmakers asked the accounting office to explore was whether similar problems occurred elsewhere in the VA system. Its answer: Yes.

The eight VA facilities audited did one or more studies that did not comply with regulations for obtaining valid informed consent from prospective volunteers. One undisclosed medical center did human research with no consent.

At most of the facilities audited, the ethics committee responsible for reviewing proposed studies was not doing its job, according to the report. Review boards approved studies without adequate information and kept poor records of meetings where members decided to enter patients in sometimes risky studies.

Boards at two facilities had members who might personally or financially benefit if the board authorized a study, auditors found. Regulations prohibit such potential conflicts of interest.

The auditors’ reasons for the shortcomings included lax guidance of research staff. Five facilities reported having “insufficient funds to ensure adequate operation of their human subject protection systems.”

A VA spokeswoman said of the GAO findings: “We believe the [VA] initiatives currently under way will significantly strengthen processes for the protection of human research participants.”

Some medical centers and the VA system have improved research monitoring, the audit found, again largely in response to the West L.A. crisis. For instance, the VA has contracted with a private firm to accredit research centers and created regional offices to scrutinize research activities.

The VA health system includes 172 medical centers, 70% of which conduct human research. The audited facilities are in Atlanta, Baltimore, Cleveland, Dallas, Louisville, Ky., Providence, R.I., Seattle and Washington, D.C. Other sanctioned facilities are in Chicago and Denver.