The following NIH announcement was released yesterday. Please review in its entirety:
The announcement provides you with a summary of the major changes in the upcoming FORMS-E application packages, most notably the new PHS Human Subjects & Clinical Trials Information Form. A video is available to walk you through this form. You can also look at the Annotated Forms-E Set to preview the full set of forms. Subsequent communications will be sent to you regarding the new NIH policies related to clinical trials in order to prepare you for application submissions due on or after January 25th, 2018.
NIH is getting ready to release its new FORMS-E application packages. Yesterday, the instructions for FORMS-E were released online. However, the application packages themselves are not yet available. NIH will be reissuing all their parent announcements with new Funding Opportunity Announcements (FOA) numbers, beginning October 25th, 2017. The process of reissuing FOAs to include FORMS-E packages will happen incrementally throughout October 25th – November 25th. All new application packages will be published at least 60 days ahead of the first due dates.
Applicants must use FORMS-E for due dates on or after January 25th, 2018. Therefore, there will be a period of transition where you must make sure you are using the correct application package based on the due date of the funding opportunity. Below is a chart from NIH which describes when you need to use FORMS-D vs FORMS-E.