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Highlights

Every year thousands of veterans volunteer to participate in research projects under the auspices of the VA. Research offers the possibility of benefits to individual participants and to society, but it is not without risk to research subjects. VA studies, like other federally funded research programs, are governed by regulations designed to minimize risks and protect the rights and welfare of research participants. VA must ensure that veterans have accurate and understandable information so that they can make informed decisions about volunteering for research. In September 2000, GAO reported on weaknesses it found in VA's systems for protecting human subjects. VA concurred with GAO's recommendations that its human subject protections could be strengthened by taking actions in five domains--guidance, training, monitoring and oversight, handling of adverse event reports, and funding of human subject protection activities. (VA Research: Protections for Human Subjects Need to Be Strengthened, (GAO/HEHS-00-155, Sept. 28, 2000)). GAO was asked to assess whether VA has made sufficient progress in implementing the recommendations and to examine the recent changes in VA's organizational structure for monitoring and overseeing human subject protections.

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