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Significant Changes NIH Proposals

Significant Changes NIH Proposal Guidelines Effective January 2016

NIH has planned changes to policies, forms and instructions for grant applications submitted in 2016.  Phase I and II are summarized below with KUCR’s suggestions for implementation.  For more information, please thoroughly review NOT-OD-16-004

PHASE I
Effective for applications submitted on or after January 25, 2016 up to May 24, 2016

Rigor and Transparency

To enhance reproducibility of research findings through increased scientific Rigor and Transparency, the application updates include:

  • Revisions to application guide instructions for preparing your research strategy attachment
    • Significance
    • Approach
  • Use of a new "Authentication of Key Biological and/or Chemical Resources" attachment
  • Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications

For more information on how this relates to your Research Grant Application, click here.

For more information on how this relates to your Career Development Application, click here.

These updates will not impact institutional training and individual fellowship applications until Phase II.

Vertebrate Animals
  • Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
  • A description of veterinary care is no longer required
  • Justification for the number of animals has been eliminated
  • A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals

For more information on this, click here.  This change does not apply to AHRQ applications.

Definition of a Child

The Definition of a Child applies to individuals under the age of 18.  See NOT-OD-16-010.  This change does not apply to AHRQ applications.


PHASE II
Effective for all applications submitted on or after May 25, 2016

Forms-D

Applicants should default to using FORMS-D application packages, which include new:

  • PHS 398 Research Plan
  • PHS 398 Career Development Supplemental Form
  • PHS Fellowship Supplemental Form
PHS Assignment Request Form

NIH is adding a PHS Assignment Request Form to FORMS-D application packages to provide a consistent way to collect application referral information.  Use of this form will ensure applicant requests are effectively communicated to agency staff and may be used to expedite the processing and assignment of applications.

For more information on this, See NOT-OD-16-008.

Font Guidelines

NIH is changing Font Guidelines for applications.

Text in PDF attachments must follow these minimum requirements:

  • Font size:  must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%)
  • Type density:  must be no more than 15 characters per linear inch (including characters and spaces)
  • Line spacing: must be no more than six lines per vertical inch
  • Text Color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable as long as it is legible)

Certain fonts are recommended, but fonts (both serif and non-serif) that meet the requirements above are allowable.

For more information on this, See NOT-OD-16-009.

Rigor and Transparency
Rigor and Transparency changes will impact institutional training and individual fellowship applications as well.  See NOT-OD-16-011 and NOT-OD-16-012.
Vertebrate Animals
Vertebrate Animals changes carry forward and will impact institutional training and individual fellowship applications as well.  See NOT-OD-16-006.
Definition of a Child
Definition of a Child also carries forward. See NOT-OD-16-010.
Inclusion Enrollment Report
An optional PHS Inclusion Enrollment Report form is being added to FORMS-D application packages. The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORMS-C application packages.
Data Safety Monitoring Plan
A Data Safety Monitoring Plan is being added to the FORMS-D application package and must be included with all applications involving clinical trials.
Research Training Data Table

NIH is changing the Research Training Data Table format for 2016.  Changes include:

  • Reducing the number of tables from 12 to 8
  • Minimizing the reporting of individual-level information
  • Extending the tracking of trainee outcomes from 10 to 15 years

For more information on this, See NOT-OD-16-007.

See the Application and Electronic Submission Information page for specific forms and tables.

KUCR recommends that you utilize NIH’s FAQs related to the Form Updates for 2016, found here.

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