# Presentation: 631302

## IOM Review:  VSD Data Sharing Program

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

## 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**

## 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**Many datasets from previous published VSD studies had not been archived in a standard manner**

## 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.**

## 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**

## 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**

## 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 **

## 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**

## 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**

## 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 **

## 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)**

## 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**

## 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**

## 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**

## 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**

## 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**

## 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**

## 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**