A CLOSER LOOK AT RECENT NIH APPLICATION CHANGES…. Revised May 5, 2016

NEW SET OF FORMS, VERSION D For all applications with due dates on or after May 25 th, 2016 PHS 398 Cover Page Supplement – New section on Vertebrate Animals: 1.Are animals euthanized? Yes/No 2.If Yes, is method consistent with AVMA guidelines? Yes/No 3.If No to AVMA guidelines, describe method/provide scientific justification New attachments for Data Safety Monitoring Plan and Authentication of Key Biological and/or Chemical Resources PHS Assignment Request Form (optional) - Provides structured information to NIH referral staff regarding: funding component assignment preference, study section preference, individuals who should not review your application due to conflicts, and scientific areas of expertise needed to review your application. PHS Inclusion Enrollment Report – Combines Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms into a single form.

The GUTS of your APPLICATION! PHS 398 Research Strategy SignificanceInnovationApproach

SCIENTIFIC PREMISE

SCIENTIFIC PREMISE, CONT’D

SIGNIFICANCE (SCIENTIFIC PREMISE): 1.Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application. APPROACH (RIGOR & TRANSPARENCY): 1.Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. 2.Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex.

Key Resource Authentication! What is considered a key biological or chemical resource? Generally, these are resources that:  May differ from laboratory to laboratory, over time  Have qualities or qualifications that can influence results  Are integral to the proposed research Examples: cell lines, specialty chemicals, antibodies, other biologics

RESOURCES AND WEBSITES reproducibility reproducibility ntation.html ntation.html guide/forms-d/research-forms-d.pdf guide/forms-d/research-forms-d.pdf support/UpcomingNIHchanges.aspx support/UpcomingNIHchanges.aspx