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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 131-132

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From page 131...
... 3.3 Investigators must meet organizational requirements for conducting research with human subjects and comply with all applicable federal, state, and local regulations and guidelines dealing with the protection of individuals studied in research. COMMENTARY on Standard 3.3: Investigators are responsible for the overall design, development, conduct, and analysis of the investigation,
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From page 132...
... must assure that all research involving human subjects is reviewed and approved by an IRB before study initiation and that it remains approved for the duration of the study. COMMENTARY on Standard 3.4: The IRB should be consulted when questions arise regarding whether a given research activity constitutes human research.
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Key Terms

  • human research
  • individuals studied
  • research participants
  • expedited review
  • human subjects

  • continuing review
  • ethical principles
  • research involving
  • human subject
  • adverse events

  • involving human
  • irb review
  • adequate resources
  • applicable federal
  • belmont report

  • research participant
  • proposed research
  • research studies
  • research process
  • adverse event

  • research protocol
  • respective research


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