Notice Number: NOT-OD-16-004
Key Dates
Release Date: October 13, 2015
Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Purpose
This notice informs the biomedical and health services research communities of planned changes to policies, forms and instructions for grant applications submitted in 2016.
The planned changes focus on the following areas:
Some of the new policies require additional data collection and updates to our application forms. We have received approval from the Office of Management and Budget to make the needed form updates and we expect to have system support and guidance for these updates in place by March 25, 2016 (NOT-OD-15-146).
In order to move forward with the subset of policies which must remain consistent for all research applications in a funding year, we will implement the policy and guidance changes in two phases.
Timing
Effective for applications submitted for due dates on or after January 25, 2016
Application Forms
FORMS-C (current forms; already available)
Instructions
By November 25, 2015, we will update the general and small business (SBIR/STTR) application guides used with FORMS-C application forms. Instructions for individual fellowship applications will be incorporated into the general application guide and no longer maintained as a separate document. These application guides must be used for due dates on or after January 25, 2016, and before May 25, 2016.
Changes
Topic |
Change |
Rigor and Transparency* |
We are changing application requirements and review language to enhance reproducibility of research findings through increased scientific rigor and transparency. These changes will take effect for most research grant applications (including small business and complex research grant applications), but will not impact institutional training and individual fellowship applications until Phase II. Changes include:
See NOT-OD-16-011 and NOT-OD-16-012. |
Vertebrate Animals* |
We are removing redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Changes include:
See NOT-OD-16-006. Note: This change does not apply to AHRQ applications. |
Definition of Child* |
We are redefining the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old. See NOT-OD-16-010. Note: This change does not apply to AHRQ applications. |
Research Training |
We are updating requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form to reflect recent policy guidance and reduce applicant burden. Changes include:
|
*Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.
Timing
Effective for applications submitted for due dates on or after May 25, 2016
Application Forms
Our updated forms, identified by a Competition ID of "FORMS-D", must be used for all applications submitted for due dates on or after May 25, 2016.
All active Funding Opportunity Announcements (FOA) will be reissued or updated to include "FORMS-D" forms at least 60 days prior to the first due date on or after May 25, 2016.
We will reissue parent announcements, administrative supplements, research training, career development, individual fellowship and multi-project FOAs that include "Indiv Career Dev", "Inst Career Dev" or "NRSA Training" component types.
We will add FORMS-D application packages to all other active research FOAs (i.e., update existing FOAs; no reissue). FORMS-C application packages will be set to expire after the May 7, 2016 AIDS due date. During a short transition period, you will need to select the appropriate application package based on due date.
Instructions
By March 25, 2016, we will provide new application guides to be used with FORMS-D application forms for due dates on or after May 25, 2016.
Changes
Topic |
Change |
Rigor and Transparency* |
We are extending Phase 1 changes to include institutional training and individual fellowship applications. We are adding a new "Authentication of Key Biological and/or Chemical Resources" attachment to the following forms in FORMS-D application packages:
New Plan for the Instruction in Methods for Enhancing Reproducibility attachment will be added to the PHS 398 Research Training Program Plan form in FORMS-D application packages. Update 2/29/2016: Rigor and transparency changes for training and individual fellowship application delayed until 2017 per NOT-OD-16-034 issued on 12/17/2015. |
Vertebrate Animals* |
We are extending Phase 1 changes to include institutional training and individual fellowship applications. See NOT-OD-16-006. We are adding new questions regarding euthanasia to the following forms in FORMS-D application packages to replace the euthanasia criteria in the vertebrate animals section:
Note: These changes do not apply to AHRQ applications. |
Inclusion Forms* |
We are adding an optional PHS Inclusion Enrollment Report form 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. We will provide more details about these changes prior to release of the updated forms. |
Data Safety Monitoring Plans |
We are adding a new Data Safety Monitoring Plan to the following forms in FORMS-D application packages:
This new attachment must be included with all applications involving clinical trials. Although the requirement of a data and safety monitoring plan for clinical trials is not new, the use of a separate attachment to collect this information will emphasize its importance and facilitate systematic enforcement of its presence. |
Research Training |
We are changing the research training data table format. Changes include:
NIH’s xTRACT system to help applicants prepare the new tables will be available October 16, 2015. See NOT-OD-16-007. |
Appendix Policy |
We are reevaluating the current appendix policy. A notice describing specific appendix policy changes will be issued by spring 2016. Update 2/29/2016: Appendix policy changes on hold until further notice and will not be part of the initial roll-out of FORMS-D forms. |
New PHS Assignment Request Form |
We are adding an optional PHS Assignment Request Form to FORMS-D application packages to provide a consistent way to collect application referral information, including:
See NOT-OD-16-008. |
New Font Guidelines |
We are providing additional flexibility regarding the fonts allowed in PDF attachments included in grant applications. Although we will continue to recommend specific fonts, we will also allow other fonts (both serif and non-serif) as long as they comply with specific type density and line spacing guidelines. See NOT-OD-16-009. |
Biosketch Clarifications |
We are clarifying biosketch instructions. Clarifications include:
|
* Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.
Inquiries
Please direct all inquiries to:
NIH Grants Information
Email: grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573