vaccine safety research within the constraints of law, protection of confidentiality, and VSD contract provisions;

  • Bureaucratic and technical barriers to accessing the VSD should be minimized, although some types of studies may require collaboration with or facilitation by data custodians;

  • Guidelines for proposals from independent external researchers should be developed and publicized to facilitate access;

  • Responses to proposals should be timely;

  • Criteria for the independent review of proposals should be publicly accessible;

  • Costs to researchers should approximate the incremental costs of access;

  • Descriptions of the objectives and methods of current and published studies should be made publicly available;

  • All VSD users should provide a timely and detailed public report of their results to the NIP; and

  • All completed VSD studies should be subjected to scientific peer review before any public release.

LIMITATIONS OF DATA AVAILABLE THROUGH THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM

The VSD data sharing program allows external researchers to submit a proposal to conduct new vaccine safety studies with the pre-2001 VSD data files that reside at CDC or reanalyze study-specific final datasets from some VSD published studies (CDC, 2004a).

Limitations of the Data Available to External Researchers for New Studies

The November 2004 version of the guidelines states that external researchers can conduct new vaccine safety studies “from the VSD data files that reside at CDC” (CDC, 2004a). Later in the guidelines, it is explained that “VSD data files contain data through December 31, 2000” (CDC, 2004a). Data that were included in the VSD only before the contract renegotiation in 2002 (data for events through the year 2000) are considered “VSD data files that reside at CDC.” Therefore, only VSD data for events before January 1, 2001, are available for new vaccine safety studies through the VSD data sharing program. The committee finds that that important provision limiting the data available to independent external researchers for new vaccine studies is not sufficiently clear and explicit in the current version of the VSD data sharing guidelines.



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