IOM Review: VSD Data Sharing Program

1. IOM Review: VSD Data Sharing Program Melinda Wharton, M.D. National Immunization Program, CDC NVAC Vaccine Safety Subcommittee October 5, 2004

2. VSD Data Sharing Program:Background • Heightened public interest for access to VSD data • In direct response to public interest, NIP developed a data sharing program to provide external researchers access to the Vaccine Safety Datalink (VSD) data • Program developed in collaboration with: • Department of Health and Human Services (HHS) • Congressman Dan Burton and staff • Managed Care Organizations (MCOs) participating in the VSD

3. Challenges in Creating VSD Data Sharing Program • Several challenges at the time of creation: • There was no formal CDC data sharing program • Must allow for transparency of VSD data while maintaining privacy of personal medical records at MCOs • Many datasets from previous published VSD studies had not been archived in a standard manner

4. Challenges in Creating VSD Data Sharing Program • Concept of de-identifying data cannot be meaningfully applied to VSD: • Vaccine safety analyses require date of birth, date of vaccination , specific administration of vaccines, date of medical visit and medical diagnosis. • Having all this information could permit identification of individual.

5. Mechanism to Protect Privacy Within the VSD Data Sharing Program • Given the need for protection of the private medical records, the VSD data sharing program was developed within the existing mechanism of the NCHS Research Data Center

6. VSD Data Sharing Program:Background • August 2002, “Guidelines for Data Sharing Program for External Researchers: Access to CDC’s Vaccine Safety Datalink Data” • Types of studies that can be conducted using VSD data: • New studies of vaccine safety from VSD data files that reside at CDC • Re-analyze study-specific datasets from VSD published studies

7. Status of VSD Data Requests • 2 groups of external researchers have requested VSD datasets • Group 1: • Submitted new vaccine safety studies (13 hypotheses) and Re-analyses (11 studies) of CDC published studies • Have accessed data twice at RDC • Time from NIP receipt of first proposal to first RDC visit 9/02 – 10/03 • Group 2: • Submitted re-analysis of 1 CDC published study • Current status: • Step 2 - Submission of proposals to MCO IRBs

8. Challenges Encountered With VSD Data Sharing Program • First data sharing program (outside of NCHS) using the data enclave approach to access data • Learning along the way: • Revision of data sharing guidelines • More explicit • Not all IRBs approved proposals • Some VSD final datasets not available

9. Next Steps for Data Sharing at CDC • VSD Data Sharing Program transferred from NIP to NCHS • Plan to enhance CDC website to list available datasets from published studies • Given need for more transparency, process being developed for creation of public use datasets in the future

10. IOM Review of Data Sharing IOM Task Order initiated in response to Congressional concerns about the program expressed in late 2003/early 2004 IOM Task Order signed April 2004

11. IOM Review Twofold charge to the IOM 1. Review and make recommendations about the Data Sharing Program 2. Review and make recommendations about the handling of preliminary data from the Vaccine Safety Datalink (VSD)

12. Charge to IOM: Data Sharing Review the design and the implementation to date of the program to assess compliance with the current standards of practice for data sharing in the scientific community Make recommendations to CDC for any needed modifications that would facilitate use, ensure appropriate utilization, and protect confidentiality

13. IOM Review of NIP Research Procedures and Data Sharing Program • IOM committee chaired by John Bailar • Meeting on data sharing held on August 23, 2004 • Site visits underway, including to RDC and MCOs • Meeting on release of preliminary data scheduled for October 21, 2004

14. Current Timetable for IOM Reports Must be completed in a timely fashion as the topics under review are the subject of concern in some public and Congressional groups Part A: Report expected November 2004 Part B: Report expected February 2005

16. VSD Data Sharing Program:A 3-Step Process • Step 1: Submission of Proposals to NIP • Step 2: Submission of Proposals to MCO IRBs for approval • Step 3: Use of the NCHS RDC, after signing 308(d) confidentiality protection forms

17. Step 1: Submission of Proposals to NIP • External researcher submits a proposal in format as required in the Guidelines • As stated in Guidelines, NIP’s role is to verify: • Proposals are complete • Variables requested by external researcher to conduct new vaccine safety studies exist • Requested final dataset for re-analysis of VSD published study is available • If proposal is complete and data are available, external researcher is provided IRB contact information for relevant sites

18. Step 2: Submission of Proposals to MCO IRBs for Approval • CDC does not have role in MCO IRB formal review process • External researcher must request IRB application from relevant IRBs • Each MCO IRB has own rules, regulations and fees • Completed IRB application is reviewed by IRBs • Application is either approved or disapproved • Disapproved applications provide opportunity for external researchers to respond to IRB questions • External researcher must provide final IRB dispositions to NIP so that datasets can be created

19. Step 3: Use of NCHS RDC • Upon IRB approval, datasets created and delivered to NCHS RDC • Datasets uploaded on RDC computers • VSD data analyzed only with SAS software • Technical monitor- • Performs disclosure review of all output produced (no line listings, no cells < 5, etc) to assure confidentiality