NIH is making quite a few changes to the NIH grant instructions and forms. The changes will be implemented in two phases with the first phase effecting grants due on or after January 25, 2016 and the second phase effecting grants due on or after May 25, 2016. Here are the areas that will be impacted and guide notices explaining the changes so you can familiarize yourself with them.
Phase I Changes – Effective on or after January 25, 2016
Rigor and Transparency in Research – NIH is 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
NIH Guide Notice Vertebrate Animals – NIH is 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
NIH Guide Notice Definition of Child – NIH is 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.
NIH Guide Notice
Research Training – NIH is 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
Phase II changes – effective on or after May 25, 2016New grant forms will be released. In addition the following changes will also take effect:
Rigor and Transparency – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They 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.
NIH Guide Notice Vertebrate Animals – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They 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
Inclusion Reporting – NIH is 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. They will provide more details about these changes prior to release of the updated forms.
Data Safety Monitoring – NIH is 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 – NIH is 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.
NIH Guide Notice Appendices – NIH is reevaluating the current appendix policy. A notice describing specific appendix policy changes will be issued by spring 2016.
New PHS Assignment Request Form (Formerly a Cover Letter) - NIH is 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
NIH Guide Notice Font Requirements - NIH is providing additional flexibility regarding the fonts allowed in PDF attachments included in grant applications. Although they will continue to recommend specific fonts, they will also allow other fonts (both serif and non-serif) as long as they comply with specific type density and line spacing guidelines.
NIH Guide Notice Biosketch Clarifications – NIH is 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
