Will exemptions and waivers from the Policy be considered?

Yes. PCORI will consider amending or waiving some or all of the requirements of the Policy if an Awardee’s research project data is subject to legal, contractual, or institutional policy requirements that preclude data sharing.

If an award is made, 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 part or all of the Policy. 

Refer to the Policy webpage for access to the Data Sharing Exemption Request Form. Please keep the following in mind when considering an exemption from PCORI’s Policy:

• Per the terms of the Policy, only de-identified data will be deposited in the data repository.
• Information about the Policy is included in the PFA as well as executed PCORI contracts – claiming lack of knowledge or failing to include specific language about data sharing into study consent forms is not an adequate justification.
• Claiming business or operational competitive risks are not an adequate justification.

Any questions regarding PCORI’s Policy on Data Management and Data Sharing should be sent to fundedpfa@pcori.org.