2016 NIH Policy & Guidance Changes - Phase II
Phase II (due dates on or after 5/25/2016)
For Frequently Asked Questions related to NIH form updates
Phase II changes apply to all NIH applications submitted on or after May 25, 2016.
Be sure to follow the General Instructions (Forms Version D) for due dates during Phase II.
Overview of Phase II Changes
Rigor & Transparency
Phase I has been extended to include institutional training and individual fellowship applications. There is a new attachment field for the “Authentication of Key Biological and/or Chemical Resources” file on certain forms in the FORMS-D application packages.
There is also a new “Plan for the Instruction in Methods for Enhancing Reproducibility” attachment on the PHS 398 Research Training Program Plan in FORMS-D packages.
Vertebrate Animals
Institutional training and individual fellowship applications are now included in NIH changes. There are new questions regarding euthanasia on the PHS 398 Research Plan and PHS Fellowship Supplemental Form that replace the euthanasia criteria in the vertebrate animals section.
Resource Link: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html
Inclusion Forms
There is now an optional PHS Inclusion Enrollment Report form that will replace the Planned Enrollment Report and Cumulative Inclusion Enrollment Report Forms that were used in FORMS-C packages.
Data Safety Monitoring Plans
A new “Data Safety Monitoring Plan” has been added to FORMS-D packages and applies to all applications involving clinical trials. The inclusion of this information is not a new requirement, but it now must be submitted as a separate attachment in the assigned form field.
Research Training
The research training data table format has been changed, and NIH’s xTRACT system helps applicants prepare the new tables.
Resource Link:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-007.html
New PHS Assignment Request Form
There is a new optional PHS Assignment Request form to collect application referral information. This form complements the Cover Letter, which should no longer be used to make requests related to the assignment and review of applications.
Resource Link:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-008.html
New Font Guidelines
NIH has granted applicants more flexibility around fonts used in PDF attachments in grant applications.
Resource Link:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-009.html
Biosketch Clarifications
NIH has clarified instructions on biosketches, including advising that a URL for a publication list is optional and, if given, must be to a government website; allowing publications and other research products to be cited in the Personal Statement and the Contributions to Science sections; and stating that graphics, figures and tables are not permitted.
Resource Link:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-080.html
Important Reminders
If you’re applying under the NIH late or continuous submission policies, use the set of forms for the intended due date, not the actual date of submission.
Resource Link:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-064.html
The Competition ID will tell you if you’re using FORMS-C or FORMS-D. This ID is visible in several parts of your proposal, whether submitted through grants.gov or ASSIST. NIH also has clear and helpful system warnings in place to ensure that the correct forms are used.
Resource Link:http://grants.nih.gov/grants/ElectronicReceipt/files/right_forms.pdf
Other NIH Changes In Effect
NIH has transformed its existing website to help users more easily find the information they need. The new and improved Grants & Funding website is a work in progress, and NIH will continue to make enhancements.
FORMS-D application packages are now available for some FOAs. You can view FORMS-D currently in development and start familiarizing yourself with changes.
The NIH Application SF424 R&R Guide has been significantly restructured. The new “Research Instructions for NIH and Other PHS Agencies – Forms Version D Series” features reordered forms that match the order of appearance in the application, consolidated instructions, new page numbering, form screenshots, and other enhancements.