Vaccine Safety Research, Data Access, and Public Trust

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. Table of Contents Front Matter Executive Summary 1 Study Background and Contextual Issues 2 Description of the Vaccine Safety Datalink 3 The Vaccine Safety Datalink Data Sharing Program 4 The Vaccine Safety Datalink Research Process and the Release of Preliminary Findings 5 Independent Review of Vaccine Safety Datalink Activities Concluding Remarks References Appendix A Committee Biographies Appendix B Glossary Appendix C Acronyms Appendix D Meeting One-Agenda Appendix E Meeting Two-Agenda Appendix F Summary of Public Submissions Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center