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What has PCORI done to address data privacy concerns and human subject protections in this Policy?

In developing this Policy, PCORI has been attentive to data privacy and human subject protections concerns. More specifically, the data subject to the requirements of the Policy must be de-identified in accordance with HIPAA regulations. Additionally, for research projects in which informed consent was obtained, only data from participants whose informed consent allows data to be used for secondary research by researchers not affiliated with the Awardee’s institution are subject to the requirements of the Policy.

The Policy also requires that third-party data requestors enter into a data use agreement with clear prohibitions against using the data to re-identify individuals and redistributing the data to people who haven’t been approved to use the data.

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