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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 118-123

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From page 118...
... Committees or boards that review research to ensure the protection of human subjects. The term includes, but is not limited to Institutional Review Boards (per the Common Rule, 45 CFR 46)
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From page 119...
... 1.2 The organization must uphold ethical principles underlying the protection of individuals studied in research. COMMENTARY on Standard 1.2: The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (19 79J provides the philosophical basis for federal regulatory requirements.
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From page 120...
... Organizational policies need to define conflicts of interest, provide mechanisms for disclosure of conflicts, establish a process for evaluating whether a conflict of interest may interfere with protection of the individuals studied in research, and institute actions to manage conflicts of interest determined to have the potential to interfere with that protection. Organizations need to disseminate these policies to individuals responsible for the conduct of research involving humans and they need to determine what role the IRB should play in monitoring the application of these policies.
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From page 121...
... New research personnel must also be provided with this information and all staff must be kept apprised of any changes. 1_10 The organization must assure that all personnel conducting or supporting human research or involved in the HRPP demonstrate and maintain sufficient knowledge of the protection of individuals studied in research appropriate to their role.
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From page 122...
... COMMENTARY on Standard 1.13: The organization must both recruit and maintain a quality IRB by having high-caliber chairs, members, and staff. The organization's policies must foster the retention of individuals knowledgeable of and sensitive to the principles of the organization's human research protection program sufficient to assure continuity of high levels of performance.
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From page 123...
... Persistent problems in human research protection and the changing nature of clinical research, public expectation, and organizational best practices have thus necessitated that the organization, IRBs, and investigators regularly evaluate their performance and assess outcomes. An organization seeking accreditation must propose its own methods/procedures for evaluating the performance of all aspects of the HRPP.
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Key Terms

  • human research
  • individuals studied
  • human subjects
  • proposed standards
  • ethical principles

  • research involving
  • human subject
  • institutional official
  • test article
  • involving human

  • research protection
  • irb review
  • adequate resources
  • fda regulations
  • applicable federal

  • seeking accreditation
  • belmont report
  • research participant
  • appropriate institutional
  • responsible institutional

  • written policies
  • perceived conflicts
  • institutional review
  • local laws
  • common rule

  • federal regulatory
  • protecting human
  • review boards
  • institutional officials
  • research studies


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