Summary: 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.
