1. An independent review committee with minimal and balanced biases and conflicts of interest to:

  • Review independent external researchers’ proposals to use VSD data through the data sharing program;

  • Review research proposals from internal researchers and provide oversight of changes in or deviations from research protocols for internal VSD studies; and

  • Provide advice on when and how preliminary findings from VSD data should be shared with the public.

The key characteristic of each of the committees is scientific independence. Independent review of the VSD research plan and of various aspects of specific VSD studies is integral to public trust in the use of the VSD to answer questions about vaccine safety.

NVAC SUBCOMMITTEE TO REVIEW AND PROVIDE ADVICE ON THE VACCINE SAFETY DATALINK RESEARCH PLAN

Every year, each VSD managed care organization (MCO) is provided an annual budget allocation. Each MCO conducts or participates in VSD studies given their available resources determined from their yearly budget. For high-priority VSD studies that require additional resources, the NIP sometimes will supplement the budget.1 Decisions about which VSD studies should be pursued with the available resources are reached by consensus among the VSD investigators at the MCOs and the NIP.2

It is somewhat unclear how the priorities for the VSD research plan are set and how much input is sought from stakeholders outside the VSD steering committee. Presentations during the open sessions of the committee’s meetings showed that the public also does not understand how research priorities are set.

The limitations of the VSD data sharing program and the limited ability of independent external researchers to conduct high-quality corroboration studies or studies of new hypotheses create a special need to involve the public in the priority-setting process for the VSD research plan. Only NIP-affiliated or MCO-affiliated researchers have access to VSD data for events before and after January 1, 2001, for corroboration studies and studies of new hypotheses, so independent external researchers may not be able to conduct studies that members of the public consider to have high priority. Novel hypotheses or approaches for studying previously

1  

Personal communication, F. DeStefano, NIP, February 10, 2005.

2  

Personal communication, F. DeStefano, NIP, February 10, 2005.



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