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Will exemptions and waivers from the Policy be considered?

Yes. The Policy permits Awardees to seek an exemption from the Policy if they are unable to comply due to legal or contractual restrictions that attach to the research project data including circumstances in which appropriate informed consent that permits data sharing for secondary research was not obtained. It is the responsibility of the Awardee to provide a written explanation to PCORI with supporting documentation to demonstrate why it would not be feasible to comply with any or all of the Policy requirements.

PCORI will review such requests on a case-by-case basis.

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