questing Institutional Review Board (IRB) approval from each of the MCOs whose data would be examined.

In October 2003, CDC released the second version of the guidelines, Guidelines for Data Sharing Program for External Researchers: Access to CDC’s Vaccine Safety Datalink Data (CDC, 2003a). The second version provided additional details about the process that independent external researchers were to use to request access to VSD data, clarified the difference in access between two categories of VSD data (new vaccine safety studies and reanalyses of published VSD studies), described the provisions governing use of the RDC at NCHS to access VSD data, and laid out requirements for the publication of research based on VSD data.

The third version of the VSD data sharing program guidelines was provided by NCHS after the programmatic responsibility for the data sharing program was transferred from the NIP to NCHS in March 2004 (CDC, 2004d). NCHS decided not to create separate guidelines for access to VSD data but rather used its general Procedures for Use of the RDC (CDC, 2004b) document and the accompanying RDC General Description document (CDC, 2004c) to serve as the interim guidelines for the VSD data sharing program until those documents could be updated.

On November 18, 2004, NCHS published a Federal Register notice and request for comments on Procedures and Costs for Use of the Research Data Center (CDC, 2004a). Although this document outlines procedures that apply to all datasets available through the RDC, it also constitutes the fourth version of the VSD data sharing program guidelines because it includes project-specific requirements for VSD data in an appendix to the main document (CDC, 2004a). The Federal Register notice includes the information that was contained in the two documents that constituted the third version of the VSD data sharing program guidelines and additional information on the RDC and VSD-specific requirements. NCHS requested public comment on this document. The original deadline for public comment was December 9, 2004 (CDC, 2004a); this deadline was extended to March 1, 2005 (CDC, 2004g). (The Federal Register notices can be found in Appendix G.) The new RDC procedures provide additional explanation of the expectations for guest researchers at the RDC and costs for use of the RDC (CDC, 2004a). The new VSD-specific guidelines have additional requirements for information that is to be included in proposals, compared with earlier versions of the guidelines for the VSD data sharing program (CDC, 2004a).


The VSD data sharing program does not meet the traditional definition of data sharing, because of the limitations of the data available

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