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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 64-66

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From page 64...
... The three sets of standards were reminders of the vastness of the research enterprise and the distinctive nature of certain types of research and research settings. For example, the PRIM&R standards appear to focus on research conducted in traditional academic health care settings, the NCQA standards encompass research conducted by the VA in its own self-contained health care system, and the ICH-GCP guidelines are specific to investigators and sponsors conducting clinical trials, a specialized type of research with human participants.
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From page 65...
... In the United States, the principles embodied in The Belmont Report have served as the foundation for the ethical requirements in human research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979~. The three basic ethical principles in The Belmont Report are (1)
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From page 66...
... They should be based on sound and widely accepted ethical principles.2 ., ~ The committee does not mean that any member who could have a conflict with any conceivable protocol coming to an IRB for review should be excluded from service on an IRB but, rather, that the individual should recuse himself or herself from reviewing such protocols. 2 The principles laid out in The Belmont Report are one foundation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979~.
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Key Terms

  • human research
  • ncqa standards
  • informed consent
  • accreditation standards
  • research participants

  • human subjects
  • clinical trials
  • human participants
  • research sponsors
  • ethical principles

  • research involving
  • human subject
  • academic health
  • dhhs oig
  • research environments

  • involving human
  • research protection
  • accreditation body
  • fda regulations
  • conducting clinical

  • research monitoring
  • research institution
  • national commission
  • belmont report
  • research participant

  • proposed research
  • research sponsor
  • accepted ethical
  • traditional academic
  • parallel fda


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