The committee considered the appropriateness of having a subcommittee of the Advisory Committee on Immunization Practices (ACIP) serve this role, but it found that use of an ACIP subcommittee would not achieve the desired level of independence, because the NIP has programmatic responsibility for managing and supporting the ACIP. Use of a subcommittee of the NVAC would achieve an additional level of independence.

Recommendation 5.1: The committee recommends that a subcommittee of the National Vaccine Advisory Committee that includes representatives of a wide variety of stakeholders (such as advocacy groups, vaccine manufacturers, FDA, and CDC) review and provide advice to the NIP on the VSD research plan annually. The subcommittee charged with this role could be the existing Subcommittee on Safety and Communications or a subcommittee created specifically for the purpose.

Recommendation 5.2: The committee recommends that the NIP propose to the National Vaccine Program that additional liaison representatives 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). Many of the specific concerns and the committee’s related recommendations have been described earlier in this report. The concerns have direct implications for the release of preliminary findings.

Independence, transparency, and fairness must characterize VSD research activities if the public is to trust findings and conclusions based on VSD data. If the public questions whether the rules for access to VSD data are applied equitably to all researchers who request use of VSD data, confidence in the legitimacy of the VSD data sharing program and, ultimately, the findings from any VSD studies could be jeopardized.

Because only one group of researchers has accessed VSD data through the data sharing program, the committee could not determine whether the VSD data sharing guidelines have been applied equitably to independent external researchers. However, it has been asked to provide recommendations on any needed modifications of the data sharing program



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