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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 136-140

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From page 136...
... The principal sources were: VA regulations at 38 CFR 16-17; . DHHS regulations at 45 CFR 46; FDA regulations at 21 CFR 50, 56, 312, and 812; VA policy as documented in Chapter 9 of the M-3 manual; FDA Information Sheets; International Conference on Harmonisation Good Clinical Practice Guideline; and .
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From page 137...
... Depending on their performance, Human Research Protection Programs can achieve Full Accreditation, Conditional Accreditation, Probational Accreditation, or No Accreditation. Each accreditation outcome brings with it a set of actions by NCQA as well as VA offices.
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From page 140...
... 140 c he - F ~ in, i, ~ >I< me, c ~ u - ~ _ ~ ~ o ~ ~ _ ~ — 3 _ S v =- z ~ ~ .e -, .
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Key Terms

  • human research
  • informed consent
  • accreditation standards
  • research involving
  • research protection

  • fda regulations
  • protection programs
  • practice guideline
  • irb protocol
  • clinical practice

  • data source
  • protocol files


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