Upcoming NIH Proposal Preparation
Changes
NOT-OD-16-004 (Summary of All Changes)
Revised SF 424 RR Application Guide
PHASE I:
Changes Effective for Proposals
with a Due Date on or after
January 25, 2016
Rigors and Transparency
NOT-OD-16-011 and NOT-OD-16-012
• Purpose: Enhance reproducibility of research
findings through increased scientific rigor and
transparency.
• See notices for which grant mechanisms this
applies to.
• Changes include:
– Use of a new “Authentication of Key Biological
and/or Chemical Resources” attachment.
– Changes to instructions for Research Strategy
including Significance and Approach sections.
Rigors and Transparency
NOT-OD-16-011 and NOT-OD-16-012
• Authentication of Key Biological and/or Chemical
Resources
– Briefly describe methods to ensure the identity and
validity of key biological and/or chemical resources used in
the proposed studies.
– These include, but are not limited to, cell lines, specialty
chemicals, antibodies, and other biologics.
– Standard laboratory reagents that are not expected to vary
do not need to be included in the plan.
• Provide this section to your fund manager as a
separate PDF upload.
– Jan. 25 – May 24 – Uploaded under Other Attachments
section.
– On or after May 25 – New attachment section under
Research Plan with release of FORMS-D.
Rigors and Transparency
NOT-OD-16-011 and NOT-OD-16-012
• Resources:
– Rigors & Transparency NIH Page
– FAQ
– Training Module
Vertebrate Animals
NOT-16-16-006
• Purpose: To remove redundancy with IACUC review
while meeting the requirements of PHS policy.
• Effective for all proposals except Ts and Fs as of Jan.
25th. Ts and Fs will be effective May 25th.
• Changes include:
– Updated guidance on criteria to be addressed
– Description of veterinary care is no longer required
– Justification for the number of animals has been
eliminated
– Description and justification of method of euthanasia is
required only if the method is not consistent with AVMA
Guidelines
Definition of Child
NOT-OD-16-010
• Purpose: To align the NIH definition for the
age of a child with the typical age of consent
and the common perception of the age of
adulthood.
• Change:
– For the purposes of inclusion policy, the age of a
child will be defined as individuals under 18 year
old instead of under 21 years old.
PHASE II:
Changes Effective for Proposals
with a Due Date on or after
May 25, 2016
Summary of Upcoming Changes
• NIH will be releasing a new set of proposal
preparation forms (FORMS-D), along with an
updated set of instructions (NIH SF424 RR
Application Guide).
– Expected Release Date: March 2016
• Changes include:
– New PHS Inclusion Enrollment Report Form will
replace the Planned Enrollment Report and
Cumulative Inclusion Enrollment Report Forms found
in FORMS-C.
– New Data Safety Monitoring Plan as a new separate
attachment from the Resource Sharing Plan.
– Appendix Policy is currently being reevaluated.
Summary of Upcoming Changes
• Changes Continued:
– New PHS Assignment Request Form will be added.
• NOT-OD-16-008
• Applicants will no longer include the following requests in
the Cover Letter.
– Institute Requests, Study Section Request, List of Potential
Reviewer Conflicts, List of Scientific Expertise Needed to Review
– New Font Guidelines
• NOT-OD-16-009
– BioSketch Clarifications
• URL for a publication list is optional, and if provided, must be
to a government website like My Bibliography.
• Explicitly stating that graphics, figures and tables are not
allowed