Vaccine safety research, data access, and public trust / Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program, Board on Health Promotion and Disease Prevention.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program.

Language:

English

Subjects (All):

Vaccination--United States--Safety measures--Databases.

Vaccination.

Vaccines--United States--Safety measures--Databases.

Vaccines.

Physical Description:

1 online resource (152 p.)

Edition:

1st ed.

Place of Publication:

Washington, DC : National Academies Press, c2005.

Language Note:

English

Summary:

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.

Contents:

FrontMatter

Reviewers

Contents

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

Appendixes

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.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references (p. 105-110).

ISBN:

9786610179282

9780309165242

0309165245

9781280179280

1280179287

9780309548748

0309548748

OCLC:

70774150