IOM Review: VSD Data Sharing Program

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IOM Review VSD Data Sharing Program

• Melinda Wharton, M.D.
• National Immunization Program, CDC
• NVAC Vaccine Safety Subcommittee
• October 5, 2004

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VSD Data Sharing ProgramBackground

• 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

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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  had not been archived in a standard manner

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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.

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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

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VSD Data Sharing ProgramBackground

• August 2002, Guidelines for Data Sharing Program
  for External Researchers Access to CDCs
  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

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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

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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

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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

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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

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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)

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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

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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

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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

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VSD Data Sharing ProgramA 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

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Step 1 Submission of Proposals to NIP

• External researcher submits a proposal in format
  as required in the Guidelines
• As stated in Guidelines, NIPs 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

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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

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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 lt 5, etc) to assure
  confidentiality