issues related to the VSD. The NIP asked IOM to convene a panel of experts to address the following charge:1

(1a) review the design and the implementation to date of the new Vaccine Safety Datalink Data Sharing Program to assess compliance with the current standards of practice for data sharing in the scientific community and, (1b) make recommendations to the National Immunization Program and the National Center for Health Statistics for any needed modifications that would facilitate use, ensure appropriate utilization, and protect confidentiality and (2a) review the iterative approaches to conducting analysis that are characteristics of studies using the complex, automated Vaccine Safety Datalink system. Examples of recent studies to be examined are a completed screening study on thimerosal and vaccines (Verstraeten et al.) and cohort studies on asthma; (2b) review whether, when, and how preliminary findings about potential vaccine-related risks obtained from the Vaccine Safety Datalink system should be shared with other scientists, communicated to the public, and used to make policy or recommendations to CDC; and (2c) make recommendations to the National Immunization Program on the release of such preliminary findings in the future.

The charge was expanded to include the National Center for Health Statistics (NCHS) in part 1 of the charge because organizational responsibility for the VSD data sharing program was transferred from the NIP to NCHS in March 2004. The recommendations related to the VSD data sharing program apply to both the NIP and NCHS; the recommendations related to the release of preliminary findings apply to only the NIP.

In response to the NIP request, the IOM assembled a committee of experts in epidemiology, biostatistics, research design, research ethics, vaccine research, risk communication, and public input into the scientific process. (See Appendix A for committee biographies.) This report is the committee’s response to the charge.

Readers familiar with vaccine safety issues may be aware of the work of earlier IOM committees focused on vaccine safety. The Committee on the Review of the National Immunization Program’s Research Procedures and Data Sharing Program is separate and distinct from other IOM committees. It was convened solely to address the charge stated above, and it has examined issues of process related to the VSD, not issues of scientific validity pertaining to specific VSD studies.


After the transfer of some administrative responsibilities for the VSD from the NIP to the National Center for Health Statistics, the charge was modified on August 31, 2004, to include “and the National Center for Health Statistics” in section 1b of the charge. The charge was modified on November 17, 2004 to substitute “preliminary findings” for “preliminary data” in sections 2b and 2c.

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