Review of the National Immunization Program's Research Procedures and Data Sharing Program
The "Vaccine Safety Research, Data Access, and Public Trust" report from the Institute of Medicine Committee on Review of the National Immunization Program's Research Procedures and Data Sharing Program was released on Thursday, February 17, 2005 at
4:00 pm EST.
Statement of Task
The committee will:
(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. The committee will use that review to
(2b) consider 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 statement of task was modified on 8/31/04 to include "and the National Center for Health Statistics" in section 1b above. The statement of task was modified on 11/17/04 to substitute "preliminary findings" for "preliminary data" in sections 2b and 2c above***
In the course of its deliberations, the Committee on Review of NIP's Research Procedures and Data Sharing Program found overlapping issues between the two parts of its statement of task. The committee concluded that it could provide its best advice to NIP and NCHS if it integrated its findings, conclusions, and recommendations into one comprehensive report. At the committee's request, NIP has agreed to allow the committee to provide one comprehensive report rather than two separate reports.
The First meeting of the committee was held on August 23, 2004.
The Second meeting of the committee was held on Thursday, October 21, 2004.
The Third Meeting of the committee was held on December 13-14, 2004 in Irvine, CA. This meeting was closed in its entirety.
Page last updated on February 17, 2005
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