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How much stakeholder involvement is acceptable for PCORI requirements under the COVID-19 PFA?

The application must demonstrate consultation with patients and other stakeholders or their representative groups to determine if the study is answering a relevant question—one that, if adequately answered, would substantially inform clinical and public health responses, decision making, and planning – and is including outcomes important to patients. Recognizing that the pandemic presents challenges to conventional partnerships, many different forms of patient and stakeholder engagement may be acceptable. For the purposes of this PFA, it would be acceptable to use a combination of approaches to facilitate the inclusion of stakeholder perspectives. For example, patients and other stakeholders could participate through engaging in one-time events or a series of activities such as virtual community forums or through techniques like crowdsourcing, or by having sustained involvement through serving in ongoing advisory roles. Creative and flexible methods are encouraged. At the time of application, applicants are required only to submit their initial ideas about who will be consulted, how will they be engaged, and which activities will they contribute to (e.g., refining the research design, developing strategies for implementation and recruitment, interpreting and disseminating study results). Funded projects will be required to submit a more detailed engagement plan within two months after contract execution.

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