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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 57-58

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From page 57...
... SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS Some elements important to the protection of the rights and interests of those participating in research are not directly addressed in proposed programs for HRPPP accreditation. In most cases, an accreditation process could be used as an indirect means to improvement; however, further actions would be needed in parallel with the establishment of an accreditation process.
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From page 58...
... and the death of Jesse Gelsinger in gene transfer experiments at the University of Pennsylvania in 1999, for example~2 appear to be attributable to the conduct of principal investigators and their collaborators or to institutional decisions unrelated to the IRB, so it is not clear how accreditation of an HRPPP could prevent such cases. An accreditation body should not be expected to be the original source responsible for uncovering violations or the main body responsible for investigating or sanctioning them.
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Key Terms

  • accreditation process
  • pilot testing
  • accreditation body
  • regulatory framework
  • research monitoring

  • gene transfer
  • research institution
  • accreditation organization
  • gene therapy
  • transfer experiments

  • accreditation program
  • hrppp accreditation
  • jesse gelsinger


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