Vaccine Safety Research, Data Access, and Public Trust (2005) / Chapter Skim
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3 The Vaccine Safety Datalink Data Sharing Program
3 The Vaccine Safety Datalink Data Sharing Program
Pages 33-75
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From page 33... ...
The team of VSD researchers set research priorities, determined which studies to undertake, and planned how studies would be monitored.1 External researchers could in principle pursue a collaborative research project with any of the VSD researchers at the NIP or the MCOs, but no process had been established to allow use of VSD data outside such a collaborative relationship, and there appear to have been no proposals for broader participation. Development of the VSD data sharing program began in August 2000, and the program was formally established on August 30, 2002 (CDC, 2004d)
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Summary of VSD Data Sharing Program Guidelines Four successive versions of the VSD data sharing program guidelines for independent external researchers have been released publicly. Each version of the guidelines was intended to provide greater clarification about program requirements and expectations than the version before it.
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. THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM'S ABILITY TO SHARE DATA 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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A true VSD data sharing program would need to include the following three elements: access to the core VSD data for exploratory analyses; access to studies that involve chart review, and so on, to consider alternative explanations; and new collaborative studies with the NIP and the MCOs to pursue new hypotheses. If the intention is to allow true data sharing, researchers should be allowed use of all available years of data for new studies and not be limited to final datasets for reanalyses.
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Despite the limitations of the sharing function of the VSD data sharing program, the term is now well established. CURRENT STANDARDS OF PRACTICE OF SIMILAR DATA SHARING PROGRAMS Benefits and Costs of Sharing Data Sharing of VSD data or any other type of data has both benefits and costs.
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From page 38... ...
The constraints that limit access to VSD data and can be considered costs of the VSD data sharing program include protection of proprietary information, protection of detailed medical information, and protection of intellectual property rights of researchers. The benefits of, costs of, and risks posed by data sharing are important in examining the VSD data sharing program so that any proposed changes in the program can be understood properly.
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From page 39... ...
Researchers conduct their analyses at the data enclave, and all output must be reviewed for the risk of disclosure before it can leave the data enclave. Review of Similar Data Sharing Programs To assess how the VSD data sharing program compares with current standards of practice for data sharing in the scientific community, the committee reviewed extensive information about different data sharing policies, different types of data sharing activities, and legal and regulatory provisions governing confidentiality of data.
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Description of Data Sharing Provisions for Different Data Enclaves Table 1 (page 42) summarizes the specific provisions that govern access to restricted data at the data enclaves the committee reviewed in depth.
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. Health and Retirement Study The HRS at the University of Michigan includes information that is made available to external researchers only under strict conditions (HRS, 2004a)
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GENERAL INFORMATION ON THE DATA SHARING PROGRAMS Type of Data MEPS is the third (and Census data include most recent) in a series of microdata and data that national probability cannot be released publicly, surveys conducted by because they contain detailed AHRQ on the financing information on geographic and use of medical care in location and other the United States.
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a unique and potentially Restricted-release files powerful resource for the contain sensitive Restricted-use files at CHIS continuing evaluation of information that can be available at the DAC vaccine safety. made available only under contain detailed geographic specified conditions.
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Confidentiality Protection The proposed study must Researchers must obtain Measures in Study Design be done without Special Sworn Status. compromising confidentiality of Researchers can use respondents.
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confidential data only for Disclosure and Use of the purpose for which the Data from the Michigan Researchers must sign a data are supplied. Center on the Demography Nondisclosure Affidavit of Aging Data Enclave and Data Access must be read and signed Confidentiality by the researchers.
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From page 46... ...
The need for IRB approval is based on the source of the confidential data, and the researchers must follow the rules and regulations of that agency. OTHER GUIDELINES Costs and Fees At the data center: $3,125/month for full-time use.
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MiCDA. Researchers must be Copy of approval or Researchers must obtain affiliated with an exemption by home IRB approval from each institution with an institution's IRB MCO whose data they NIH-certified Human is necessary.
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Who Reviews The manager at the Both the RDC and the Researchers' Application CFACT-DC coordinates Census Bureau must and Proposal? the review of each approve the proposal.
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Process not specified for for review by the DCC VSD data. for review and final approval.
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Assistance from Currently, there are Researchers work closely Program Staff limited staff resources to with the RDC help at the CFACT-DC, so administrator to develop extensive programming a preliminary proposal. support must be contracted ahead of time for a fee.
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is installed on request. SAS is the standard program for use of VSD data, but other languages can be made available with sufficient lead time.
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be submitted to Census Bureau personnel for disclosure review.
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Researchers can also gain access to restricted files after proposal approval by e-mailing computer programs to DAC staff, who will run them and send results to the researchers. Users are allowed to DAC manager or senior All output and materials remove results of programmer conducts a removed from the RDC statistical analysis from disclosure review for all are subject to disclosure the data enclave only output before it is limitation review.
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Census Bureau. Resumes or CVs for all persons who will access Preliminary and final the data center.
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(Information not available.) Researchers must also: External researchers are required to submit a copy Acknowledge CHIS in of the data-sharing their manuscript for guidelines and a copy of publication.
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. To view CHIS data, researchers must request specific variables from the Data Access Center (DAC)
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All materials are inspected before they can be taken out of the CHIS data center. Current Standards of Practice for Data Enclaves Independent external researchers are allowed access to VSD data only through the RDC at NCHS.
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The committee believes that an evaluation of the appropriateness and user-friendliness of alternative data sharing models for the VSD is reasonable and that alternative data sharing models should not be rejected without further consideration of their benefits, risks, and costs. FRAMEWORK OF RECOMMENDATIONS ON ACCESS TO VACCINE SAFETY DATALINK DATA Reflecting on all the information gathered throughout its study, the committee finds that the VSD data sharing program has three short-term goals: 1.
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From page 59... ...
are considered "VSD data files that reside at CDC." Therefore, only VSD data for events before January 1, 2001, are available for new vaccine safety studies through the VSD data sharing program. The committee finds that that important provision limiting the data available to independent external researchers for new vaccine studies is not sufficiently clear and explicit in the current version of the VSD data sharing guidelines.
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From page 60... ...
If they cannot obtain such data and want to conduct studies of new hypotheses through the data sharing program, they must rely solely on the automated data from the MCOs' administrative databases, which are now available only for events that occurred in or before 2000. Recommendation 3.2: The committee recommends that the distinc tion between the annual automated VSD data (whose quality can not always be guaranteed)
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From page 61... ...
However, NIP-affiliated or MCO-affiliated researchers that collaborate with external researchers should not attempt to censor or discourage the testing of any particular hypotheses; all types of vaccine safety hypotheses should be considered. Because independent external researchers can use the VSD data sharing program for new studies only with data for events before 2001, the only way that such researchers can conduct new studies with all years of VSD data (in particular, data from 2001 and later)
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From page 62... ...
The committee notes, however, that ensuring a workable system for collaboration may have implications for renegotiation of the VSD contract. Recommendation 3.3: Because of the limitations in the data avail able to independent external researchers through the VSD data sharing program, the committee recommends that the NIP require the designation of a facilitator for collaboration at each MCO as a condition of the VSD contract.
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. When independent external researchers have access only to final datasets from particular VSD studies, they can do little more than try different computational methods or audit the originally reported statistical calculations.
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What Can Be Accomplished Through the VSD Data Sharing Program, Given the Limitations? The current VSD data sharing program guidelines allow external researchers to submit proposals to conduct two types of studies: new vaccine studies and reanalyses of final datasets from published VSD studies (CDC, 2004a)
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From page 65... ...
That will aid access to the data, reduce the likelihood of concerns about confidentiality, and help to facilitate direct, knowledgeable reanalyses of VSD data. SPECIFIC COMPONENTS OF THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM GUIDELINES The committee considered modifications of the VSD data sharing program guidelines needed to facilitate use of VSD data by external research
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Review of Proposals Required Proposal Elements All four versions of the VSD data sharing program guidelines contain information about the elements that are required or suggested in proposals for accessing VSD data (CDC, 2002, 2003a, 2004a,b)
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Determining whether a study can be carried out successfully with the VSD data that are available to external researchers is important for ensuring that the resources of the NIP, NCHS, the MCOs, and the researchers are not spent on studies that have no possibility of answering a proposed question. The committee emphasizes, however, that technical feasibility should be determined on the basis of stated objective criteria.
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Recommendation 3.8: To assist independent external researchers who want to use VSD data through the data sharing program, the committee recommends that the NIP and NCHS add to the VSD data sharing program guidelines a list of recommended competen cies for VSD data analysis. Technical Assistance Not all external researchers may want to pursue a collaborative research project with a NIP-affiliated or MCO-affiliated researcher who previously has analyzed VSD data.
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From page 69... ...
Protecting the confidentiality of the information requires that procedures for use of the VSD be clearly stated and explained in the VSD data sharing guidelines. Institutional Review Board Application Process for VSD Proposals The VSD data sharing program guidelines require that independent external researchers receive approval from the IRB at each MCO whose data will be accessed.
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From page 70... ...
The institution that delegated its IRB review is responsible for ensuring compliance with the IRB's determinations, even though it is relying on the IRB of the other institution. For research proposals submitted through the VSD data sharing program, use of IRB authorization agreements could streamline the IRB approval process for independent external researchers by reducing the number of MCO IRB applications that must be submitted.
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From page 71... ...
Use of the NCHS Research Data Center Confidentiality Protections at the RDC When independent external researchers access MCO data, NCHS takes extensive measures to ensure the confidentiality of individually identifiable information. When MCO-affiliated or NIP-affiliated researchers use VSD data, their employers have provisions (for example, the possibility of termination of employment)
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From page 72... ...
. It is understandable that some additional restrictions on data access need to be in place for researchers not affiliated with one of the parties to the VSD contract, but equitable application of the confidentiality restrictions on all researchers will help to ensure public trust in the VSD data sharing program.
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From page 73... ...
It is reasonable to expect independent external researchers who want to use VSD data to acquire or provide funding to support their research. Recommendation 3.12: The committee concludes that it is reason able to expect researchers who request access to VSD data to have their own funding and it therefore recommends that RDC costs not be waived for independent external researchers.
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From page 74... ...
Requiring standardized, specific information from users of the data sharing program and standardized research protocols from internal VSD researchers will leave all VSD researchers subject to similar informationsharing requirements. Recommendation 3.13: The committee recommends that, as a condi tion of accessing VSD data, all independent external researchers that use the VSD data sharing program be required to submit a report to the NIP (with a copy to NCHS)
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From page 75... ...
Failure to comply with either of those reporting requirements could be grounds for NCHS to deny future access to VSD data through the data sharing program. Creation of a Basic Analytic File The VSD is a complex database, and generally only sophisticated users will be able to master use of its data files.
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