For Broad PFAs, patient partners will ideally be involved in drafting the proposal as well as in the study design. We encourage patients and patient advocacy groups to carefully evaluate potential participation in a study carefully. For example, potential partners should have concerns if a research team first approaches them just before a proposal submission is due and asks for “sign-off” on the plan but not for input.
For Targeted PFAs and Pragmatic Clinical Studies (PCS), applicants are not required to demonstrate that patents and other stakeholders are already engaged as research team members at the time an application is submitted. However, applicants should outline how patients and other stakeholders will participate as partners in various phases of the proposed research, once awarded. Applicants should describe their plan to form a Study Advisory Committee (SAC) or other appropriate engagement body, to ensure that a broad spectrum of patients and other stakeholders advise and assist the research team with refining the study questions, outcomes, and protocols.