VA Research:

System for Protecting Human Subjects Needs Improvement

T-HEHS-00-203: Published: Sep 28, 2000. Publicly Released: Sep 28, 2000.

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Stephen P. Backhus
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Pursuant to a congressional request, GAO discussed the Department of Veterans Affairs (VA) system for protecting the rights and welfare of veterans who volunteer to participate in research at VA medical centers.

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.

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