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

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