New NIH “FORMS-F” Grant Application Forms and Guidelines Coming for Due Dates on/after May 25, 2020
NIH/AHRQ applicants, there’s a new form application coming soon. Applicants submitting applications with due dates on or before May 24, 2020 must use the current FORMS-E application package. Beginning May 25, 2020 those submitting applications are required to use FORMS-F application packages.
For a transition period, both FORMS-E and FORMS-F application packages will be active. Applicants must choose the appropriate application package for their due date when presented with both FORMS-E and FORMS-F application packages on the same FOA. Applications submitted using the wrong forms for their intended due date will not be reviewed. Therefore, it is extremely important to take care in selecting the correct version of the forms package when responding to a proposal deadline near the May 25th cutoff.
The transition to the FORMS-F package will also impact investigators who have Continuous Submission privileges, along with application submitted under the NIH Late Policy. Therefore, additional care should be taken to ensure the correct application package is selected. The following information from the NIH Notice should be helpful in ensuring the correct package is selected.
You must use FORMS-E application package if your intended due date is:
On or before May 24, 2020, including:
- Applications submitted for due dates on or before May 24, 2020
- Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before May 24, 2020
- Applications submitted by June 7, 2020 under NIH Continuous Submission Policy for the May 7, 2020 AIDS intended due date
You must use FORMS-F application package if your intended due date is:
On or after May 25, 2020, including:
- Applications submitted for due dates on or after May 25, 2020
- All application types (New, Resubmission, Renewal, Revision)
In addition to the new forms package for New and Renewal applications, Administrative Supplement, Successor-in-Interest (Type 6) and Change of Institution (Type 7) Parent Announcements will be reissued with new FOA numbers, FORMS-F application packages, and FORMS-F instructions on May 25, 2020. Applications started on or after May 25, 2020 must use the new FORMS-F Parent FOAs. The FORMS-E FOAs will expire on June 25, 2020 giving applicants one month to complete their initiated FORMS-E applications.
NIH Notice Number: NOT-OD-20-026
What’s the difference in the FORM-F Applications?
Some highlights of the changes include:
PHS 398 Cover Page – includes a new Human Fetal Tissue Section, including the question “Does the proposal project involve human fetal tissue obtained from elective abortions?” If the answer is yes, two new attachments are required – a HFT Compliance Assurance and an HFT Sample IRB Consent Form.
PHS Career Development Award Supplemental Form – includes a new attachment titled, “Description of Candidate’s Contribution to Program Goals” to the Environment and Institutional Commitment to Candidate section.
PHS Fellowship Supplemental Form – includes a new attachment titled, “Description of Candidate’s Contribution to Program Goals” to the Institutional Environment and Commitment to Training section.
PHS Human Subjects and Clinical Trial Information form – includes several updates, including:
- Requirement to answer the question, “Does any of the proposed research in the application involve human specimens and/or data?” for all applications
- Changes to Study Record sections, such as:
- Defaulted Clinical Trial Questionnaire question “1.4.a Does the study involve human participants?” to Yes, since study records are only available when the answer to the “Are Human Subjects Involved?” question on the R&R Other Project Information form is Yes
- Separated “Inclusion of Women, Minorities, and Children” attachment into two attachments – “Inclusion of Individuals Across the Lifespan” and “Inclusion of Women and Minorities”
- Renamed “Enrollment of First Subject” field to “Enrollment of First Participant”
- Added “Inclusion Enrollment Report Title” field to the Inclusion Enrollment Report
- Removed “Brief Summary” attachment
- Renamed “Narrative Study Description” attachment to “Detailed Description”
- Added new question and checkbox – “Is this an applicable clinical trial under FDAAA?”
PHS Assignment Request form – clarified instructions and updated fields and field labels.
In addition, the following changes should be noted.
Institutional Training and Institutional Career Development Grants (T32 and K12s)
Program Plan section of the application will be expected to include a description of how the program and faculty will provide training in rigorous research design and relevant data science and quantitative approaches.
Requirement to include a Plan for Instruction in Methods for Enhancing Reproducibility attachment will be expanded to all applicants.
The Progress Report attachment for renewal applications will be limited to five pages for a program overview and one page for each appointee to the grant; applications that exceed the specified page limits will be withdrawn.
The My Bibliography report of publications arising from work conducted by appointees while supported by the grant will be no longer be requested Just-in-time but will be collected in the Interim Final Research Performance Progress Report.
Minor modifications to the data elements collected in the research training data tables.
Fellowships
Program Plan attachment is different – training goals and objectives are expected to address any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation.
Research Strategy section of the Program Plan attachment, fellowship candidates will be expected to describe (a) the strengths and weaknesses in the rigor of the prior research that serves as the key support for the proposed project, (b) plans to address any weaknesses in the rigor of the prior research, (c) how the experimental objectives proposed will achieve robust and unbiased results, and (d) how relevant biological variables are factored into research designs and analyses.
if applicable, fellowship candidates will be required to include the Authentication of Key Biological and/or Chemical Resources attachment.
Applicants for diversity-related fellowship programs will be expected to attach a Description of Candidate’s Contribution to Program Goals, explaining how the candidate’s participation would further the goals of the program to promote diversity in health-related research.
Individual Career Development (K-series)
In describing their career development plans in the Program Plan attachment, candidates for career development awards will be expected to address, as applicable, any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation.
Applicants for diversity-related career development programs will be expected to attach a Description of Candidate’s Contribution to Program Goals, explaining how the candidate’s participation would further the goals of the program to promote diversity in health-related research.
