NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications

Notice Number: NOT-OD-16-004

Key Dates
Release Date:   October 13, 2015

Related Announcements
NOT-OD-16-120
PA-16-172
NOT-HD-16-010 - Updated Application Forms (FORMS-D) Available for PAR-16-106 "Rapid Assessment of Zika Virus (ZIKV) Complications (R21)" on May 25, 2016
NOT-HG-16-018 - Updated Application Forms (FORMS-D) Available for PAR-14-207 "Center for Inherited Disease Research (CIDR) High Throughput Sequencing and Genotyping Resource Access (X01)" on May 25, 2016
NOT-OD-16-084 - Restructured and Streamlined Application Guides and Supplemental Instructions Available for Applications Due Dates On or After May 25, 2016
NOT-OD-16-080 - Clarifications and Consolidated Biosketch Instructions and Format Pages Available for Applications with Due Dates On or After May 25, 2016
NOT-OD-16-081 - Reminder: NIH & AHRQ Grant Application Changes for Due Dates On or After May 25, 2016
NOT-OD-16-068 - Plan to Move to Updated Forms (FORMS-D) for Administrative Supplement, Successor-In-Interest and Change of Institution Opportunities
NOT-OD-16-064 - Impact of Grant Application Form Update (FORMS-D) on Late and Continuous Submission Applications
NOT-OD-16-058 - Reminder: NIH & AHRQ Grant Application Changes for Due Dates On or After January 25, 2016
NOT-OD-16-034 - Advanced Notice of Coming Requirements for Formal Instruction in Rigorous Experimental Design and Transparency to Enhance Reproducibility: NIH and AHRQ Institutional Training Grants, Institutional Career Development Awards, and Individual Fellowships
NOT-OD-16-031 - Updates to NIH & AHRQ Research Performance Progress Reports (RPPR) to Address Rigor and Transparency
NOT-OD-16-029 - Revised SF424 (R&R) Application Guides and Supplemental Instructions Available for Application Due Dates On and Between January 25, 2016 and May 24, 2016
NOT-OD-16-012 - Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications
NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications
NOT-OD-16-010 - Inclusion of Children in Clinical Research: Change in NIH Definition
NOT-OD-16-009 - NIH & AHRQ Change Font Guidelines for Applications to Due Dates On or After May 25, 2016
NOT-OD-16-008 - NIH & AHRQ Announce New Form for PHS Awarding Component and Peer Review Requests
NOT-OD-16-007 - NIH & AHRQ Announce Transition to New Research Training Table Formats for 2016 and Upcoming Release of the xTRACT System
NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals
NOT-OD-16-005 - NIH & AHRQ Announce Upcoming Changes to Post-Award Forms and Instructions
NOT-OD-15-146 - OMB Approval for Form Changes Underway - Continue to Use Current Forms Until Further Notice
NOT-OD-15-112 - Advance Notice: NIH Anticipates Transition to New Research Training Data Table Formats in FY 2016

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:

  • Rigor and transparency in research
  • Vertebrate animals
  • Inclusion reporting
  • Data safety monitoring
  • Research training
  • Appendices
  • Font requirements
  • Biosketch clarifications

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.

  • Phase 1: Implements a subset of the policy changes using existing (FORMS-C) forms and updated instructions and will impact due dates on or after January 25, 2016.
  • Phase 2: Completes the implementation with the introduction of new (FORMS-D) forms and instructions and will impact due dates on or after May 25, 2016.

Implementation

Policy & Guidance Changes - Phase 1

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:

  • Updates to application guide instructions for preparing your research strategy attachment
  • Use of a new "Authentication of Key Biological and/or Chemical Resources" attachment (uploaded in Other Attachments section of R&R Other Project Information form)
  • Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications 

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:

  • 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

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:

  • "Recruitment and Retention Plan to Enhance Diversity" - applicants will be asked to focus on recruitment
  • "Human Subjects" - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
  • "Vertebrate Animals" - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
  • "Progress Report" - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process

*Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.

Policy & Guidance Changes - Phase 2

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:

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

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:

  • PHS 398 Research Plan
  • PHS Fellowship Supplemental Form

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:

  • PHS 398 Research Plan
  • PHS 398 Career Development Supplemental Form
  • PHS Fellowship Supplemental Form
  • PHS 398 Research Training Program Plan

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:

  • 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

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:

  • Awarding component (NIH institute) assignment preference
  • Study Section preference
  • List of potential reviewers in conflict, and why
  • List of scientific expertise needed to review the application
  •  

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:

  • Indicating that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography
  • Allowing publications (peer-reviewed and non-peer-reviewed) and research products to be cited in both the personal statement and the contributions to science sections
  • Explicitly stating that graphics, figures and tables are not allowed

* Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.

Resources:

Inquiries

Please direct all inquiries to:

NIH Grants Information

Email: grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-435-0714

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