Does the application need to include a target/planned enrollment form?
• No. Because the application does not contain a fully specified research plan, a target/planned enrollment form is not needed. Based on the RFA instructions for Section 7 (Human Subjects Research) should the application include a Human Subjects section that was used for an ongoing (or previous) clinical trial? Is that correct? • The instructions intend that this section provide an exemplar for what the proposed research team would do for human subjects protection. It can replace or be a part of the typical Human Subjects section that might appear in a typical application for a Research Project Grant. In that case, should the application include a Human Subjects section for one of the proposed studies? This is difficult, since the specifics of these proposed studies are, per RFA request, pretty vague. Please clarify. • No. The proposed research questions in the requested Research Agenda are not to be fully developed proposals. The application can select one of them and BRIEFLY describe
