• Investigator Initiated Research (IIR) support is only provided to institutions/ organizations (not individuals).
• IIR grant requestors and their institutions/ organizations, must be in good standing with Shire as it pertains to any current contractual obligations (e.g., ongoing IIR studies) and in compliance with all applicable laws and regulations.
• Shire reviews all IIR requests for scientific soundness, safety, legal, and ethical considerations. IIR requests are also reviewed according to local applicable laws and regulations.
• Shire does not fund any portion of a study that may have taken place prior to a fully executed agreement.
• Shire does not provide operational support (e.g., authorship of a protocol, statistical analysis, study report, publication, site monitoring) for an IIR.  Operational support for IIR research is the responsibility of the sponsor-investigator.
• A written agreement between the requesting organization and Shire must be fully executed before payment or materials are provided as part of an IIR grant.

Shire is not the sponsor of an IIR. The investigator and institution/organization assume all legal and regulatory responsibilities as a sponsor-investigator.