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Vaccine Safety Research, Data Access, and Public Trust
committee’s recommendations can be understood best in the context of the four overarching principles.
Some principles are inherent in the scientific process (such as scientific integrity, protection of human subjects, and ethical conduct of research); such principles also are inherent to the VSD research process. The four overarching principles identified by the committee build on the principles that are inherent in the general scientific process. They represent important concerns for VSD research; their relative importance for other kinds of research will vary.
The four overarching principles that emerged from the committee’s recommendations are:
Independence. Ensure that potential biases and potential conflicts of interest are minimized, balanced, or otherwise managed in the design and implementation of all processes, practices, and policies related to the VSD.
Transparency. Ensure that all processes, practices, and policies related to the VSD are developed in the spirit of openness, clearly articulated, and easily available to interested persons or entities, and that any deviations from them are documented and justified.
Fairness. Ensure that all processes, practices, and policies related to the VSD are designed and implemented in a fair manner.
Protection of confidentiality. Ensure that the design and implementation of the VSD protect the confidentiality of individually identifiable information.
The committee determined that it could not adequately address issues of independence, transparency, fairness, and protection of confidentiality without examining how the VSD research process supports or hinders the application of those principles. Concerns that arise about the independence and transparency, in particular, of the general VSD research process spill over into people’s perceptions of the independence and transparency of the VSD data sharing program and of the determinations about whether, when, and how to release VSD preliminary findings. The committee believed that it had to consider how the VSD research plan, the setting of priorities among VSD studies, and the VSD peer-review process affect the VSD data sharing program and the release of preliminary findings if it wanted to provide the most appropriate and useful recommendations requested in its charge.