Vaccine Safety Research, Data Access, and Public Trust

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Size: 152 pages, 6 x 9

Publication Year:2005

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Authors:
Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program
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Description:
The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more ...
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Table of Contents
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Front Matter	i-x
Executive Summary	1-12	(skim)
1 Study Background and Contextual Issues	13-24	(skim)
2 Description of the Vaccine Safety Datalink	25-32	(skim)
3 The Vaccine Safety Datalink Data Sharing Program	33-75	(skim)
4 The Vaccine Safety Datalink Research Process and the Release of Preliminary Findings	76-95	(skim)
5 Independent Review of Vaccine Safety Datalink Activities	96-103	(skim)
Concluding Remarks	104-104	(skim)
References	105-110	(skim)
Appendix A Committee Biographies	111-114	(skim)
Appendix B Glossary	115-116	(skim)
Appendix C Acronyms	117-118	(skim)
Appendix D Meeting One Agenda	119-122	(skim)
Appendix E Meeting Two Agenda	123-126	(skim)
Appendix F Summary of Public Submissions	127-131	(skim)
Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center	132-142	(skim)

Description

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database.

In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

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