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Vaccine Safety Research, Data Access, and Public Trust (2005) / Chapter Skim
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1 Study Background and Contextual Issues
Pages 13-24

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From page 13...
... and thus the low risk of long-term damage or death from these diseases in the United States and other industrialized countries have led to detailed studies of the riskbenefit balance of vaccines. In 1971, for example, concerns about the welldocumented frequency of adverse reactions to the smallpox vaccine, the elimination of endemic smallpox in the Western Hemisphere, and the excellent progress made in the World Health Organization smallpox eradication program by that time led the U.S.
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From page 14...
... CHARGE TO THE COMMITTEE The Institute of Medicine (IOM) Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program was convened at the request of the NIP to offer advice on two
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From page 15...
... review the design and the implementation to date of the new Vac cine Safety Datalink Data Sharing Program to assess compliance with the current standards of practice for data sharing in the scientific community and, (1b) make recommendations to the National Immunization Program and the National Center for Health Statistics for any needed modifica tions that would facilitate use, ensure appropriate utilization, and pro tect confidentiality and (2a)
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From page 16...
... The first, on August 23-24, 2004, focused on the first part of its charge, the VSD data sharing program; its full agenda is in Appendix D The second meeting, on October 21-22, 2004, focused on the second part of the committee's charge, the release of preliminary findings from the VSD; its full agenda is in Appendix E
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From page 17...
... The confluence of the concerns affects how the public, advocacy groups, researchers, the federal government, and MCOs approach vaccine safety and data sharing issues. Over the last two decades, community engagement in the health enterprise generally and in vaccine safety activities in particular has come under increasing public scrutiny.
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From page 18...
... . CIPSEA was enacted to establish uniform confidentiality protections and promote statistical efficiency by authorizing limited data sharing (Title V Pub.
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From page 19...
... It is in that environment that the committee conducted its review and the committee's report has been developed. Some people have criticized the NIP for how the VSD data sharing program was developed and implemented, for the processes used to conduct a thimerosal screening study (Verstraeten et al., 2003a)
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From page 20...
... Trust in the VSD -- as a program designed, implemented, and maintained in the public interest -- suffers when members of the public do not have confidence that systems for access are fair and transparent. Confidence in the NIP and its public health decisions that touch the lives of millions of Americans is tied directly to the perceived independence, transparency, and fairness of the VSD data sharing program.
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From page 21...
... . The committee was not charged with reviewing the procedures used for that study, but it was asked to examine the preliminary findings issue by using it and other studies as illustrative examples of the iterative analysis approaches used for VSD studies.
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From page 22...
... . For the VSD, when researchers do not trust that other researchers conducted a study appropriately or reported the results accurately, they may ask to conduct an audit or reanalysis of a published study through the data sharing program.
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From page 23...
... OVERARCHING PRINCIPLES In the course of its deliberations, the committee found that four overarching principles emerged. The principles can be described as common themes inherent in the committee's recommendations and thus principles that should be considered in any modifications to the VSD data sharing program or any determinations about whether, when, and how to release VSD preliminary findings.
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From page 24...
... Concerns that arise about the independence and transparency, in particular, of the general VSD research process spill over into people's perceptions of the independence and transparency of the VSD data sharing program and of the determinations about whether, when, and how to release VSD preliminary findings. The committee believed that it had to consider how the VSD research plan, the setting of priorities among VSD studies, and the VSD peer-review process affect the VSD data sharing program and the release of preliminary findings if it wanted to provide the most appropriate and useful recommendations requested in its charge.
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Key Terms

  • data sharing
  • vsd data
  • preliminary findings
  • sharing program
  • public trust

  • safety datalink
  • national immunization
  • vsd research
  • vsd studies
  • trust relationships

  • safety activities
  • scientific process
  • iom committees
  • safety issues
  • overarching principles

  • research process
  • infectious diseases
  • immunization program
  • increasing public
  • release vsd

  • evaluate vaccine
  • results accurately
  • research procedures
  • public comment
  • findings accurately

  • vsd preliminary
  • screening study
  • health information
  • statistical efficiency
  • thimerosal screening


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