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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 76-76

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From page 76...
... Accreditation of HRPPPs could leave the responsibilities of research sponsors outside the accreditation framework but not necessarily outside the scope of regulation by the FDA or OHRP. FDA regulations, for example, place the mantle of responsibility for the ethical conduct of research on sponsors, and the ICHGCP guidelines have a section devoted to sponsor responsibilities.
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Key Terms

  • accreditation bodies
  • clinical trials
  • research sponsors
  • regulatory authorities
  • ethical conduct

  • adverse events
  • fda regulations
  • draft standards
  • research institution
  • participant protection

  • research sponsor
  • develop standards
  • clinical trial
  • research studies
  • adverse event


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