REGULATORY DEVELOPMENTS

This report follows up on an earlier one the agency issued in September 2000, when it reported on weaknesses in the VA's systems for protecting human research subjects. At that time, the VA concurred with the GAO's recommendations that it strengthen the protections accorded to research subjects in projects sponsored or funded by the agency ( in the areas of guidance, training, monitoring, handling of adverse event reports, and funding of human subject protection activities). See VA Research: Protections for Human Subjects Need to Be Strengthened (GAO-HEHS-00-155, Sept. 28, 2000).

In the June 2003 report, Ms. Bascetta noted that while the VA has taken some steps toward improving protection of human subjects in research, it has not taken sufficient actions to strengthen its human subject protection systems, which poses risks to patients participating in these studies. In fact, as Ms. Bascetta observed in her introductory remarks to the Subcommittee,

'Concerns about VA's protections of its human research subjects came to national attention in March 1999[,] [when] ' all human research was suspended at the West Los Angeles VA Medical Center after officials there failed to correct long-standing problems with its system for protecting human subjects. Recently, serious concerns were raised about the safety of research programs at several VA medical centers ' where the possibility of patient deaths related to research is under investigation.' VA Research: Actions Insufficient to Further Strengthen Human Subject Protections, at 1.

The proposed arrangement between a non-profit hospital and a for-profit emergency medical services transport services provider that serves a 17-county area in a prominently rural area of an anonymous state is the subject of a new OIG ruling. On July 3, 2003, the OIG posted Advisory Opinion No. 03-14, which involved a request concerning emergency helicopter transports of trauma patients. The unidentified state's Department of Transportation had concluded there was a real need for such emergency transport services because of higher mortality rates involved in transporting patients in this part of the state to appropriately equipped emergency rooms. Under the arrangement, the ambulance provider would buy, operate, staff, and maintain a helicopter that is equipped with a mobile intensive care unit to transport trauma victims, while the hospital would provide a landing pad next to the facility, and modest crew quarters and services for the helicopter ' which would be available to any ambulance company that brings or receives a patient to or from the facility. Moreover, emergency calls to 911 in the area are routed, based on pre-determined criteria, to a predetermined hospital, based on the patient's needs.

The OIG observed that while the arrangement could potentially result in improper remuneration that may violate the federal Antikickback Statute, there were enough factors involved that militated against the risks to Medicare and other federal programs, and that the arrangement would be for the general public good.

On June 18, 2003, Cynthia A. Bascetta, Director, Health Care-Veterans' Health and Benefit Issues for the U.S. General Accounting Office (GAO) provided written testimony to the House of Representatives Committee on Veterans' Affairs, Subcommittee on Oversight and Investigations concerning VA research safeguards. Her testimony is assembled in a GAO report entitled VA Research: Actions Insufficient to Further Strengthen Human Subject Protections (GAO-03-917T) (available from the agency's Web site: ).

This report follows up on an earlier one the agency issued in September 2000, when it reported on weaknesses in the VA's systems for protecting human research subjects. At that time, the VA concurred with the GAO's recommendations that it strengthen the protections accorded to research subjects in projects sponsored or funded by the agency ( in the areas of guidance, training, monitoring, handling of adverse event reports, and funding of human subject protection activities). See VA Research: Protections for Human Subjects Need to Be Strengthened (GAO-HEHS-00-155, Sept. 28, 2000).

In the June 2003 report, Ms. Bascetta noted that while the VA has taken some steps toward improving protection of human subjects in research, it has not taken sufficient actions to strengthen its human subject protection systems, which poses risks to patients participating in these studies. In fact, as Ms. Bascetta observed in her introductory remarks to the Subcommittee,

'Concerns about VA's protections of its human research subjects came to national attention in March 1999[,] [when] ' all human research was suspended at the West Los Angeles VA Medical Center after officials there failed to correct long-standing problems with its system for protecting human subjects. Recently, serious concerns were raised about the safety of research programs at several VA medical centers ' where the possibility of patient deaths related to research is under investigation.' VA Research: Actions Insufficient to Further Strengthen Human Subject Protections, at 1.