TABLE 2 VSD Research Options for Independent External Researchers

 

Pre – 1/01/01 Data

Post – 1/01/01 Data

Audit

Possible; no collaboration required

Possible; no collaboration required

Broader reanalysis

Possible; no collaboration required

Possible; no collaboration required

Corroboration study

Possible; collaboration recommended to improve quality

Not possible without collaboration

Investigation of a new hypothesis

Possible; collaboration recommended to improve quality

Not possible without collaboration

types of studies that can be done with VSD data to conceptualize the full range of studies that independent external researchers may wish to conduct with the data: an audit, a broader reanalysis, a corroboration study, and an investigation of a new hypothesis.

It also will be necessary for independent external researchers to be explicit in their proposals about the purpose of their proposed analysis: if an audit or application of an alternative statistical method is intended, a final dataset may suffice; for a broader reanalysis, access to an intermediate or extended dataset, rather than the final dataset, will almost surely be necessary; and if a corroboration study or investigation of a new hypothesis is proposed, independent external researchers will need access to source data, which may require the assistance of a VSD collaborator. When collaboration is sought, the external researchers should contact a facilitator for collaboration at each MCO (see Recommendation 3.3) to pursue a collaborative research relationship with a researcher at the MCO or contact the lead staff person for the VSD data sharing program to pursue a collaborative research relationship with a NIP-affiliated researcher. 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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