The RDC uses a variety of procedures to ensure that the confidentiality of data is protected. The committee has reviewed the general policies of the NCHS RDC and finds them to be reasonably reflective of generally recognized professional statistical standards, given the confidentiality concerns of the data because of the different types of linkable data that are available on individuals in the VSD database.
Even though the NIP, NCHS, and the MCOs have decided to use the data enclave model of the NCHS RDC to allow access to VSD data, other data sharing models could be considered. Offering data through a restricted data use agreement or licensing model could be feasible as an alternative model for sharing VSD data. The committee finds that this alternative model could protect confidentiality of individually identifiable data although the mechanism for ensuring confidentiality in this model (the threat of prosecution for breaches of confidentiality) is less stringent than the mechanism used in the data-enclave model (disclosure review to ensure that no identifiable data leave the data enclave). A restricted data use agreement model would reduce the burden on interested external researchers, although it potentially creates a greater risk of disclosure of confidential information. 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.
Reflecting on all the information gathered throughout its study, the committee finds that the VSD data sharing program has three short-term goals:
To facilitate access to and use of the VSD;
To protect the confidentiality of individually identifiable data in the VSD; and
To enhance public trust in the VSD as a tool to address specific concerns about vaccine safety.
On the basis of those three goals, the committee developed its recommendations in the following framework:
The NIP should support the broadest feasible use of the VSD for