• Criteria that the committee will use to evaluate VSD research proposals;

  • Process for allowing VSD program staff to provide comments on proposals;

  • Which decisions or deliberations should be made public and when;

  • Whether researchers or the public or both should be allowed to make presentations to the committee; and

  • Types of reports or feedback provided by the committee.

The committee recognizes that the workload may be very small, at least at the beginning, and that a less weighty approach may be needed. Regardless, the three criteria listed above should still be applied.

Adherence to Protocols

When there is proper detailed documentation of research protocols, any deviations from the protocols should be clear, explicit, and adequately justified; otherwise, problems may arise. Some of the public criticisms (Bernard, 2004) of the VSD thimerosal screening study (Verstraeten et al., 2003a) were related to its alleged deviations from the original research protocol.

Good science and public accountability are enhanced when researchers adhere to original, peer-reviewed research protocols and thoroughly document and justify substantive deviations from original protocols. Transparency and public trust in the VSD would be served best by allowing an independent review committee to oversee VSD researchers’ adherence to research protocols and provide advice on the best course of action if protocol deviations are not sufficiently documented and justified.

The committee encourages adherence to research protocols and documentation and justification of deviations from protocols, but it also recognizes the great benefits that may come from unstructured, unplanned research. There can be great value in informal examinations of data for unexpected signals. Such unplanned, unstructured research should not be inhibited but should be viewed as exploratory.

Appeals of Independent Review Committee Decisions

The committee recognizes that some people may dispute decisions made by the independent review committee, and an appeals process may need to be established. The entity considering the appeal should be separate from the independent review committee and should have the authority to overrule a decision of the independent review committee. The committee encourages the NIP and NCHS to establish an appeals process and

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