Are patients from other countries allowed to participate in the study?

Yes; however, PCORI requires that the study’s results be directly applicable to a general U.S. population and healthcare system. For studies that propose to include patients from an international population, the application must provide an explicit justification for the decision to include that population and should clearly demonstrate the applicability and benefits of this approach to the U.S. population, U.S. healthcare system, and U.S. patient-centered outcomes research (PCOR).