The intent of the Study Advisory Committee (SAC) described in the PFA is to ensure that a broad spectrum of stakeholders and patients advise and assist the research team with further refinement of the study questions, outcomes, and protocols. These stakeholders and patients must include national or regional organizations that represent, at minimum, patients and/or families with lived experience, relevant clinicians, payers, and health plans. Other representation may be recommended in collaboration with PCORI including individual patients with lived experience and other relevant stakeholders, including scientific and methodological experts. However, PCORI understands that engagement structures and approaches vary widely.
Other engagement approaches such as forming stakeholder groups, panels, task forces, working groups, and other bodies, and/or involving individual patient and stakeholder partners in various ways are also permissible to employ, either in addition to or instead of the formation of the SAC. The SAC provision is not meant to require that a separate governance and/or advisory entity must be established beyond the study governance and advisory structure the awardee has planned, if an applicant already has an approach for including the relevant, required stakeholders and patient partners. For clarification in your application materials and for purposes of merit review, please indicate which body or structure is filling the requirements of the SAC, including the requirements for in-person meetings at least two times per year, and appropriate budgeting.