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Vaccine Safety Research, Data Access, and Public Trust
mation can be affected by their trust in the scientific findings that were the basis for those decisions. The committee believes that if preliminary findings have a direct impact on a policy decision or vaccine administration guidance, the data and the findings that were the basis of that decision or guidance should be made available to the public.
Recommendation 4.8: The committee recommends that preliminary findings from VSD data be shared with the public whenever these findings contribute to the basis of a policy decision or are used to change guidelines on vaccine administration.
Although “preliminary analyses” are not considered to be research data under the provisions of the Shelby Amendment, research findings may be subject to the law if they support “an agency action that has the force and effect of law” (Pub. L. No. 105-277 ). The committee encourages the NIP to determine the applicability of the Shelby Amendment in situations where preliminary findings contribute to the basis of a policy decision or a change in guidelines.
Release of Preliminary Findings Superseded by Later Findings
Different considerations affect the release of preliminary findings that have already been superseded by later findings and the release of preliminary findings that represent the most recent analysis of data. In the normal scientific process, preliminary results often differ from the final results obtained through the rigorous, comprehensive analysis of a full dataset. The peer-review process is meant to ensure that final results represent the most rigorous analysis and account for confounding factors and data anomalies that were present in the preliminary results. When the peer-review process works appropriately, final results should always be considered as representing the most accurate and valid analysis of the data. However, there may be reasons to review earlier stages in the research process; for example, to determine whether and how something may have gone wrong, to allocate proper credit for scientific advances, or to simply understand scientific processes.
Because the peer-review process is designed to ensure the validity and scientific quality of the final results, preliminary findings should not be relied on as the most valid interpretations of the data. For VSD studies, the committee believes that preliminary findings superseded by later findings should not normally be released.
Recommendation 4.9: The committee recommends that when final results from VSD analyses or studies are released through publication or through presentation at a meeting, preliminary findings be