PCORI will consider LOIs and applications as nonresponsive to this PFA, and will administratively withdraw them, if the project proposes to do any of the following:
- Conduct new research, as opposed to disseminating or implementing research findings obtained from completed PCORI-funded studies and evaluating the success of those implementation efforts. Projects proposing to perform CER are not eligible for funding under this PFA and will cause an LOI or application to be considered nonresponsive.
- Disseminate or implement findings that are not associated with a PCORI-funded CER or methods study.
- Translate or adapt a finding without actively disseminating or implementing it.
- Develop or validate a new tool or system for patients or clinicians without the primary purpose of actively implementing evidence from the PCORI-funded study. PCORI will consider modification or adaptation of tools and systems previously found to be effective and proposed as the primary mechanism for actively implementing evidence, as long as modification or adaptation is not the primary activity proposed.
- Use contract funds to incentivize or compensate sites, site personnel, or patients for completing training and/or participating in proposed implementation activities.
- Use contract funds to pay for the cost of the interventions being implemented in the project.
- In general, PCORI does not pay for the cost of the interventions in the projects it funds. Intervention costs include, but are not limited to, activities to identify, recruit, or enroll patients to receive the intervention, salary, and time compensation for personnel who are delivering the intervention, as well as equipment and other material costs associated with delivering the intervention. These are considered patient care costs, and PCORI expects these costs to be covered by the healthcare delivery system or other interested payers. PCORI encourages all applicants to find support from sites, payers, stakeholders, and so on, in the payment or cost-sharing of the interventions. Only under special circumstances will PCORI consider, as an exception, coverage of patient care intervention costs.
- If requesting the use of PCORI funds for any portion of these costs, the applicant must clearly describe these in the LOI. Invited applications must include a detailed justification (in the Budget Justification Template) outlining the importance of the request to the project’s overall success and to the sustainability and implementation once the project is completed (i.e., how these costs will be covered in the future, post-PCORI funding, for implementing the interventions not only at the sites participating in the study but also in other communities and healthcare settings). Such a justification, however, will not guarantee that PCORI will approve the costs.