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 <subject>Internal controls</subject>
 <subject>Medical research</subject>
 <subject>Program evaluation</subject>
 <subject>Veterans</subject>
 <subject>Informed consent (medical law)</subject>
 <subject>Health research programs</subject>
 <subject>Research program management</subject>
 <subject>Safety regulation</subject>
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<titleInfo>
 <title>VA Research: Actions Insufficient to Further Strengthen Human Subject Protections</title>
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<abstract>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&apos;s systems for protecting human subjects. VA concurred with 
GAO&apos;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&apos;s	 
organizational structure for monitoring and overseeing human	 
subject protections.</abstract>
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<note>Testimony</note>
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 <topic>Internal controls</topic>
 <topic>Medical research</topic>
 <topic>Program evaluation</topic>
 <topic>Veterans</topic>
 <topic>Informed consent (medical law)</topic>
 <topic>Health research programs</topic>
 <topic>Research program management</topic>
 <topic>Safety regulation</topic>
 <topic>Safety standards</topic>
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