investigated hypotheses essentially cannot be pursued independently by researchers who do not wish to collaborate with other researchers or cannot find willing collaborators. In view of the limited ability of independent researchers to conduct high-quality VSD studies of new hypotheses and the limited ability of the public to provide input on which VSD studies should be pursued with federal tax dollars, there needs to be greater opportunity for input into the setting of priorities in the VSD research plan and greater transparency of the priority-setting process.

To give the full array of stakeholders an opportunity to provide input into the VSD research priority-setting process and to ensure that the process is as transparent as possible, an independent group should be used to review and provide advice on the plan. It is important that such a group represent all relevant stakeholders so that the priorities of each can be heard. Such a group should represent a broad cross-section of stakeholders and be charged with thinking strategically about VSD research priorities. The group should meet publicly and allow interested persons to observe the process and provide input through established mechanisms.

It is expected that such a group would have conflicts of interest, inasmuch as the goal would be to hear from knowledgeable persons, most of whom will be stakeholders. But the group’s deliberations are also expected to occur through an open, public process. Conflicts of interest should not be avoided in a research priority-setting process meant to include all stakeholders, but the process should be transparent so that anyone can observe the deliberations that are influencing it.

The committee believes that a subcommittee of the NVAC would be the most appropriate group to review and provide advice on the VSD research plan because: (1) one of its functions is to recommend research priorities and other measures to enhance the safety and efficacy of vaccines (HHS, 2003b); (2) it includes federal officials as nonvoting ex officio members, and this allows input into the VSD research plan from other federal partners; and (3) it reports to the director of the National Vaccine Program (NVP) and is managed and supported by the NVP, which is organizationally in the Office of the Secretary of the Department of Health and Human Services. The NVAC is governed by the provisions of the Federal Advisory Committee Act (FACA). Because the NVAC is a FACA committee, the membership of the NVAC is subject to the NVAC Charter, and provisions are in place to ensure that there is public notice of meetings and that meetings are open to the public. 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) (HHS, 2003b) can provide input on priorities for VSD research.



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