Are engagement plans included in the LOI?

Investigators are required to consult patients and stakeholders on the decisional dilemma being addressed in the proposed study but are not required to include a formal engagement plan in the LOI. The LOI should include a brief description of the strategy for meaningful engagement patients and other stakeholders in the planning and conduct of the proposed study. The LOI should also describe the types of planned partnerships, names of organizations that have committed to the study, and the stage of contact for the proposed organizations.