Recommendation 4.2: To support greater use of the VSD and to promote opportunities for collaborative work outside the existing community of VSD researchers, the committee recommends that the annual VSD research plan include provisions for allocating some existing funds, on a competitive basis, to external researchers interested in conducting collaborative work with VSD data.

Recommendation 4.3: The committee recommends that detailed research protocols for each study conducted by an internal VSD researcher be developed, peer-reviewed, and archived. Each protocol should include well-specified definitions of the study population, exposures, and cases; detailed analytic plans; sample size requirements; and study timelines. Data collection forms, procedures, data and analysis files, programming code, and database versions should be documented, cataloged, and archived for a period of at least 7 years after completion of a study.

Recommendation 4.4: To promote collaboration and information-sharing, the committee recommends that the NIP update and improve its list of publications and presentations by establishing a VSD research clearinghouse that provides on a timely basis status reports, study findings, and conclusions for current and completed VSD studies.

Recommendation 4.5: The committee recommends that the NIP and NCHS release publicly the procedures that will be used for record-keeping of VSD data sharing program documents and update the status of the program regularly.

Recommendation 4.6: The committee recommends that in nearly all situations preliminary findings from the VSD be subject to independent external peer review before being communicated to the public or used as the basis of a policy decision. When CDC determines that purely internal peer review is necessary before release, external peer review should be undertaken as soon as possible.

Recommendation 4.7: The committee recommends that preliminary findings from VSD data be shared with the public whenever the findings are presented to anyone other than collaborators in the research, federal employees responsible for research activities, MCO-affiliated VSD researchers, scientific journals, peer reviewers for scientific journals, and people responsible for oversight of the research.

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.



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