Applications with due dates on or after January 25, 2018, must use FORMS-E application forms and guidance. We anticipate the new form set will become available on October 25, 2017, with previews posted online by September 25, 2017.
NIH’s main purpose behind implementing the forms change is to consolidate human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms, which will include expanded use of discrete form fields for clinical trial information. The new form set will also incorporate recent Grants.gov changes to R&R Budget and small business information forms.
NIH has begun posting resources to help prepare for the transition. We recommend you review:
- Getting Ready for the Next NIH Forms Update
- April 27, 2017 Guide notice
- High-Level Summary of Form Changes in FORMS-E Application Packages
- Preview of FORMS-E Grant Application Form Changes
January might seem like a long way off, but there are major changes that will affect how you prepare your application and your institution’s workflow in this changeover from FORMS-D.
You will no longer be able to include a Word document or PDF with one long human subjects section from you (the PI) or collaborators. With more structured data elements, it means more keying of information in a form field or choosing a data element from a drop-down pick list. The responses to application answers will prompt the completion of certain information.
Get familiar with the format of the forms now, so you can start planning the time it will take to apply and anticipate adjustments to your institution’s workflow. Allowing sufficient time is especially important when there are collaborators at multiple institutions.
To be fully prepared, you should know how to use submission options other than Grants.gov Downloadable Forms, which will be phased out. See Submission Options for more information.
As with previous rollouts of new application forms, the changeover to FORMS-E will be accompanied by several policy changes. Most significantly:
- Streamlining application and oversight for clinical trial research
- Implementing the single Institutional Review Board policy
- Adding age as an inclusion factor
In case you missed them, check out our previous articles “Update on Efforts to Enhance Clinical Trial Stewardship,” “Use a Single Institutional Review Board for Multisite Protocols” (written before the implementation date changed), and “Provide Feedback on Age Groupings as an Inclusion Criterion” to learn more about those policies, respectively.
We will cover any changes or developments about FORMS-E and the accompanying policies in this newsletter, so be sure to check back regularly.