NIH Proposal Changes
NIH is making changes to their proposals to better capture clinical trial information. As of 01/25/2018, NIH applications must be submitted using ‘FORMS-E’ application packages, and, proposals that involve clinical trials can only be submitted under funding opportunities designated for clinical trials. The NIH definition of a clinical trial is: “A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
Application Form Changes: All types of applications to NIH must use the new FORMS-E application for proposals due on or after 01/25/2018. The majority of changes in the FORMS-E application relate to the consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected on multiple forms. In FORMS-E applications, the human subjects information is entered on one, new form called, PHS Human Subjects and Clinical Trials Information form. FORMS-E also expands the information being collected such as eligibility criteria and the study timeline. Specifics about the new form are available at https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm.
Proposals Involving Clinical Trials: Proposals must be submitted using an NIH Funding Opportunity Announcement (FOA) that explicitly states clinical trials are allowed. The title of the FOA will specify if it accepts clinical trials or not (example FOA Title: “NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)”), as will Section II, Award Information, of the FOA. In addition, Section V, Application Review Information, will include clinical trial-related review criteria if the FOA allows clinical trials.
Cayuse Submission: Cayuse has been updated to accommodate the FORMS-E application. When you find or download the opportunity in Cayuse, click on the “i” icon next to the opportunity number to ensure you have selected a FORMS-E application. The opportunity details will also verify that you should use the application for due dates on or after 01/25/2018. If you begin a Cayuse application prior to 01/25/2018 using FORMS-D (old version) but the due date is on or after 01/25/2018, you will need to “transform” your application in Cayuse. If you have questions or need assistance, contact your Contract & Grant Specialist in the Research Office.
NIH has collected guidance and reference materials about these and other aspects of NIH policy changes related to clinical trials, including the requirement for Good Clinical Practice training, use of a single IRB for multi-site trials, and use of clinical trials.gov to post studies and data at https://grants.nih.gov/policy/clinical-trials.htm.