What if I am not able to deposit the Full Data Package due to applicable legal or contractual restrictions?

Applicable legal or contractual restrictions may include but are not limited to: the informed consent obtained from research project participants is not sufficiently broad, my research project data includes health system or other types of proprietary data.

PCORI recognizes that there may be applicable restrictions that preclude the deposition of certain research project data due to contractual and legal obligations that may attach to them. In such cases where deposition of the Full Data Package is not feasible, PCORI will determine if a complete or partial exemption from the requirements of this Policy should apply.

For further guidance on the exemption request process, refer to the below FAQ “Will exemptions and waivers from the Policy be considered?”