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Vaccine Safety Research, Data Access, and Public Trust (2005) / Chapter Skim
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5 Independent Review of Vaccine Safety Datalink Activities
Pages 96-103

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From page 96...
... A perception of bias in the VSD proposal-review process and in the priorities established for the VSD research plan could jeopardize public confidence in VSD activities. There are legitimate reasons for public concern about the independence and fairness of the review of VSD data sharing proposals and of determinations about when and how to release preliminary findings of VSD analyses.
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From page 97...
... The key characteristic of each of the committees is scientific independence. Independent review of the VSD research plan and of various aspects of specific VSD studies is integral to public trust in the use of the VSD to answer questions about vaccine safety.
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From page 98...
... By utilizing a subcommittee of the NVAC to review the VSD research plan annually, regular voting members of the NVAC, nonvoting ex officio members (such as CDC, FDA, and other federal agencies) , and nonvoting liaison representatives (such as a representative of America's Health Insurance Plans)
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From page 99...
... Recommendation 5.2: The committee recommends that the NIP pro pose to the National Vaccine Program that additional liaison repre sentatives be appointed to ensure that all perspectives are heard by adequately representing advocacy groups and other members of the public at subcommittee meetings addressing the VSD research plan. INDEPENDENT COMMITTEE TO REVIEW VACCINE SAFETY DATALINK RESEARCH PROPOSALS AND PROVIDE ADVICE ON THE RELEASE OF PRELIMINARY FINDINGS The committee heard about public concerns regarding the review of VSD research proposals and the procedures that independent external researchers must follow to use VSD data (Geier and Geier, 2004)
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From page 100...
... The public should feel confident that the risks and benefits related to releasing such findings will always be evaluated and that an independent committee will offer advice on the most appropriate course of action. For all those reasons, the committee believes that establishment of an independent review committee (advisory to the director of CDC)
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From page 101...
... Whether a new committee is created or an established committee is found or reconfigured, the following criteria should guide its creation and operation: · The committee's organization, operation, and deliberations are characterized by independence; · Members' biases and conflicts of interest are minimal and balanced; and · Members are chosen on the basis of scientific and technical expertise. As long as an independent review committee meets those criteria, the committee believes that the NIP and NCHS should have flexibility in determining the structure and operating procedures of the committee.
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From page 102...
... Transparency and public trust in the VSD would be served best by allowing an independent review committee to oversee VSD researchers' adherence to research protocols and provide advice on the best course of action if protocol deviations are not sufficiently documented and justified. The committee encourages adherence to research protocols and documentation and justification of deviations from protocols, but it also recognizes the great benefits that may come from unstructured, unplanned research.
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From page 103...
... INDEPENDENT REVIEW OF VSD ACTIVITIES 103 specify who will be responsible for appeals decisions; the deputy director for science and public health at CDC may be an appropriate entity for this role. Although an appeals process is needed, it is hoped that researchers and the public will trust the decisions made by the independent review committee.
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Key Terms

  • vsd data
  • research plan
  • provide advice
  • vaccine safety
  • research proposals

  • data sharing
  • vsd studies
  • sharing program
  • independent external
  • public trust

  • external researchers
  • preliminary findings
  • research protocols
  • safety datalink
  • national vaccine

  • vsd activities
  • limited ability
  • internal vsd
  • review research
  • plan annually

  • appeals process
  • provide input
  • datalink research
  • includes representatives
  • applied equitably

  • corroboration studies
  • findings based
  • public concerns
  • vsd program
  • vaccine program


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