VA Research

The Department of Veterans Affairs (VA) has adopted a system of protections for human research subjects but has had substantial problems with its implementation. For example, medical centers did not comply with all regulations to protect the rights and welfare of research participants. Specifically, VA headquarters has not provided medical center research staff with adequate guidance on protections for human subjects. Insufficient monitoring and oversight of local human subject protections have permitted noncompliance with regulations to go undetected and uncorrected. VA has not ensured that funds needed to for human subject protections are allocated for that purpose at the medical centers. To VA's credit, substantial corrective actions have been implemented at three medical centers in response to sanctions by regulatory agencies taken against their human research programs, but VA's systemwide efforts at improved protections have been slow to develop. Despite some difficulties, these three medical centers have made progress and each has resumed human research activities. Also, VA has established an Office of Research Compliance and Assurance to monitor human subject protections. This testimony summarizes the September report, GAO/HEHS-00-155.

GAO noted that: (1) VA needs to take action to strengthen the protection of human research subjects; (2) although the extent of the problems was uneven, GAO documented a disturbing pattern of noncompliance across the centers GAO visited; (3) the cumulative weight of the evidence indicated failures to consistently safeguard the rights and welfare of research subjects; (4) GAO also identified three specific weaknesses that have compromised VA's ability to protect human subjects--lack of adequate guidance to medical centers about human subject protections, insufficient monitoring of local protections, and inadequate attention to ensuring that funds needed for human subject protection activities are allocated and available for those purposes; (5) to VA's credit, at three other medical centers GAO visited, substantial corrective actions have been implemented in response to sanctions by regulatory agencies taken against their human research programs; and (6) in contrast, VA's systemwide efforts at improving protections have been slow to develop.