NIH Reminder: Changes to Submission Forms Effective January 2018

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NIH released a reminder that applicants must use FORMS-E application packages for due dates on or after January 25, 2018, and must use FORMS-D application packages for due dates on or before January 24, 2018. For a transition period, both FORMS-D and FORMS-E application packages and instructions will be active. Applicants must choose the appropriate application package and associated instructions for their due date when presented with both FORMS-D and FORMS-E application packages on the same FOA.

Applications submitted using the incorrect application package for their due date may be withdrawn and removed from funding consideration.

FORMS-E makes a few significant changes to the application forms in regards to the sIRB mandate that will be effective with the Final Common Rule changes, which goes into effect January 2018.

There are significant changes, including:

  • Updates to the sIRB/STTR form
  • R&R Senior/Key Person Profile (Expanded) Form: Updated biosketch instructions so that scholastic performance requires only scientific/professional graduate courses to be listed.
  • PHS 398 Research Plan Form/PHS 398 Career Development Award Supplemental Form: Removed Human Subjects Section; clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form.
  • PHS Human Subjects and Clinical Trials Information: Introduced new form for consolidated human subjects, inclusion enrollment report, and clinical trial information; includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
  • Supplemental Instructions: Discontinued use of Supplemental Instructions for all competing applications and progress reports; all information has been folded into the Application Form Instructions and/or is contained in the appropriate policy website.

The changes to the forms can be viewed in full on the NIH website here. Please review the changes for any NIH submission after January 25, 2018. The updated application guide describes these changes

NIH also released a notice regarding changes to the Parent R01 and Parent R21 Funding Opportunity Announcements. Previously parent announcements covered submissions for both clinical trial and non-clinical trials studies. NIH has implemented a change over the past year, in which a solicitation must explicitly state if it allows for the submission of a clinical trial proposal. This new split parent announcement covers this change. Note, the notice below does go into the NIH definition of a clinical trial and the types of studies covered under this change. View the notice here.

If you have any questions regarding these changes, please contact Tina Stanger, in MHRI’s Office of Contracts and Grants Management at [email protected].