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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 36-37

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From page 36...
... The empirical literature about the informed-consent process, cultural variations in how to interpret the ethical conduct of research, and diverse methods for obtaining and documenting informed consent will be reviewed in the committee's subsequent report. Even before that report appears, however, the committee notes that retrieval and documentation of informed consent are essential and are required by federal regulations, but accreditation bodies should strive to permit and even encourage experimentation with alternative methods to ensure informed consent within the parameters of current regulations.
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From page 37...
... Dept. of Education, Bureau of the Census, etc.~; pharmaceutical, device, and biotechnology firms; private foundations; marketing firms T C p A N T S RESEARCH ORGANIZATIONS Examples: academic health centers, survey research organizations, contract research organizations, cooperative groups, research management unit of sponsor's organization INVESTIGATORS 1 PERFORMANCE ASSESSMENT Monitoring Education and Feedback Including in Including data vestigators, IRB safely and members and monitoring staff, and boards, data community centers, adverse members event reporting, ombudsman programs Quality Improvement Including selfassessment of program function, outcomes, and support ~ ~ 1 - 1 l RESEARCH INVOLVING HUMAN PARTICIPANTS FIGURE 1-1 Human research participant protection programs.
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Key Terms

  • consent forms
  • human research
  • accreditation process
  • informed consent
  • accreditation standards

  • accreditation bodies
  • consent form
  • human participants
  • research involving
  • human subject

  • quality improvement
  • consent process
  • ethical conduct
  • health centers
  • academic health

  • subsequent report
  • involving human
  • subject protection
  • research participant
  • participant protection

  • genuine informed
  • protection programs
  • common rule
  • minimal risk


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