New NIH FOAs and Application Changes for 2019
NIH implemented new policies and funding opportunity announcements (FOAs) for 2019.
January 25th, 2019 or later: Application changes take effect involving the Rigor and Reproducibility Policy, inclusion reporting, and new exemption criteria.
February 5th, 2019 due date or later: Must prepare proposal using the new or re-issued Parent FOAs.
See One-Page Summary of Changes to use for discussions. See below for details and guidance.
February 5th deadline or later:
Most existing Parent Research-series grants (R01s, the R03, R21s), and Career Development Awards (K-awards) have been re-issued. See https://grants.nih.gov/grants/guide/parent_announcements.htm
The NEW, re-issued Parent Announcements must be used on the February 5, 2019 standard due date or later.
If you have already started an application for the February 5th deadline or later, please check to make sure you are using the re-issued FOA.
AIDS-Related Applications Only:
FEBRUARY 7th, 2019 is the last standard due date the OLD Parent Announcements will be accepted for applicants eligible for continuous submission
NIH issued new Parent FOAs for basic science experimental studies involving humans, referred to as “prospective basic science studies involving human participants.” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.
Participation in Funding Opportunities will vary by NIH Institutes and Centers (ICs). Check the FOA carefully for a listing of participating ICs.
CONTACT a Scientific Program Official to discuss the appropriate FOA to be used for your particular project. Get it in writing.
- Guidance for Basic Experimental Studies with Humans (BESH) Funding Opportunities
- Use this Chart to compare FOAs by clinical trial allowability: Comparison of Funding Opportunity Announcement Types by Clinical Trial Allowability
The term "rigor of the prior research" will replace "scientific premise" under the Significance section for most research grant and career development award applications.
Per the Mike Lauer blog dated December 13th, 2018:
"NIH defined this term originally to mean the rigor of the prior research used to support the proposal, not solely the hypothesis or rationale for the study. So as noted on the updated webpage, for applications due on January 25, 2019 and beyond, the term “rigor of the prior research” will replace “scientific premise” under the Significance section for most research grant and career development award applications (see NOT-OD-18-228 and NOT-OD-18-229). Applicants will be asked, on and after that submission date, to also describe plans to address weaknesses in the rigor of the prior research in the Approach section."
See NIH’s new Rigor & Reproducibility website.
See Columbia's Research and Data Integrity (ReaDI) program
New policy requirements for inclusion reporting. See NOT-OD-18-116 and Inclusion Across the Lifespan - Policy Implementation.
Individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to include them.
Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in Section 2.4 - Inclusion of Women, Minorities, and Children (see "For applications submitted for due dates on or after January 25, 2019" in these instructions) of the PHS Human Subjects and Clinical Trial Information Form of the proposed research project.
Applications must include:
- A description of plans for including individuals across the lifespan, including a rationale for selecting the specific age range.
- An acceptable justification for the exclusion, if individuals will be excluded from the research based on age.
- Reminder of Policy in Extramural Nexus
Revised Common Rule see: NOT-OD-19-050
Several provisions in the Revised Common Rule resulted in changes to NIH policies and procedures. From an application submission perspective, the most notable changes are:
- Changes to categories of research qualifying for exemptions (FAQs)
- Use of new exemptions 7 and 8, when applicable
The exemption language within the review criteria for the Protections for Human Subjects will be updated in preparation for the implementation of the Revised Common Rule.