Is there a safety issue with testing placebo CPAP for 12-18 months?
Clinical research grant applications must address a variety of human subject requirements outlined in the FOA including participant protection and plans for data and safety monitoring. This FOA invites applicants to propose the scientifically strongest research plan, including the design of control comparisons. Study design choices should be appropriate to the goals stated in the FOA and the outcomes addressed by the proposal. If the proposed research plan is associated with potential risks to participant safety, those concerns must be addressed in the application. Reviewers will take into account, in determining overall impact that the project could have on the research field involved, the adequacy of the proposed protection for human subjects. Organizational and logistical costs associated with monitoring participant safety must be factored into the study budget.
