NIH Upgrading Forms to Forms-F

NIH is updating its forms to FORMS-F and will require the use of application packages with a Competition ID of ‘FORMS-F’ for proposals due dates on or after May 25, 2020. Applications prepared using “FORMS-E” application packages for due dates on or after May 25, 2020 will not be reviewed.

The KC system will be upgraded Friday, May 8, 2020 at 9pm, to incorporate NIH Forms F for System to System (S2S) proposal submissions.  FORMS-F are currently available in Workspace and ASSIST if using these portals to submit your NIH proposals.

Below is a summary of the changes, but please refer to Notice Number: NOT-OD-20-077 for more detailed information. Note: A majority of the changes relate to reporting fetal tissue.

Changes of FORMS-F are summarized below. Additional resources are also found here:

SF 424 (R&R) Form

Clarified instructions regarding Agency Routing Identifier.

4.b. Agency Routing Identifier

Skip the “Agency Routing Identifier” field unless otherwise specified in the FOA or notice in the NIH Guide for Grants & Contracts.

Applications in response to a NIH Notice of Special Interest require the notice number (e.g., NOT-IC-FY-XXX) to be entered into this field in order to assign and track applications and awards for the described initiative.

R&R Senior/Key Person Profile (Expanded) Form

Added instructions for Career Development and Fellowship applications for the “Credential, e.g., agency login” field under the PD/PI Credential Field of the "Profile- Project Director/Principal Investigator" section.

Additional Instructions for Career Development: Enter the eRA Commons username for the PD/PI (Career Development candidate). The eRA Commons Personal Profile associated with the username entered in the Credential field must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons Personal Profile, see the ORCID ID topic in the eRA Commons online help.

Additional Instructions for Fellowship: Enter the eRA Commons username for the PD/PI (Fellowship candidate). The eRA Commons Personal Profile associated with the username entered in the Credential field must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons Personal Profile, see the ORCID ID topic in the eRA Commons online help.

PHS 398 Research Plan Form

Clarified instructions on the content of the "Letters of Support" attachment in the "Other Research Plan Section."

Content:

Letters should stipulate expectations for co-authorship, and whether cell lines, samples, or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only.

For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per budget period anticipated. In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. Letters must focus on the topics listed above and not contain data/figures/tables/graphs, preliminary data, methods, background and significance details that are expected to be found in Research Strategy section of the application. Letters of Support serve to describe terms of a collaboration or consultation and also are not de facto letters of reference from persons not actively participating in the project. Applications with letters containing such excess information may be withdrawn from the review process.

PHS 398 Career Development Award Supplemental Form

  • Added instructions about rigor, experimental design, and quantitative approaches to the “Candidate Information and Goals for Career Development” section.
  • Added new “Description of Candidate’s Contribution to Program Goals” attachment.

PHS Fellowship Supplemental Form

  • Updated OMB Expiration Date to 2/28/2023
  • Added instructions about rigor, experimental design, and quantitative approaches to the “Training Goals and Objectives” section of the “Applicant’s Background and Goals for Fellowship Training” attachment.
  • Added instructions for the “Authentication of Key Biological and/or Chemical Resources” field.
  • Added new “Description of Candidate’s Contribution to Program Goals” attachment.

PHS Human Subjects and Clinical Trials Information

  • Changes were made to the form’s organization in the following sections:
    • Who should use the PHS Human Subjects and Clinical Trials Information form
    • Using the PHS Human Subjects and Clinical Trials Information form
    • Use of Human Specimens and/or Data
  • Clarified and updated instructions throughout. Significant changes were made for the following fields:
    • “Provide the ClinicalTrials.gov Identifier”
    • “Section 2 – Study Population Characteristics” instructions now reflect updated exceptions for required questions.
    • Study Timeline
    • Section 3.2: "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" - reflect updated instructions.
    • “Data and Safety Monitoring Plan” attachment
    • Updated instructions for delayed onset studies regarding use of single IRB.
    • Added new “Inclusion of Individuals Across the Lifespan” attachment.
    • Updated instructions for the “Inclusion of Women and Minorities” attachment to reflect separate “Inclusion of Individuals Across the Lifespan” attachment.
    • Added new “Inclusion Enrollment Report Title” field.
    • Removed the “Brief Summary” field.
    • Changed the “Narrative Study” field to “Detailed Description.”
    • Updated instructions to Section 3.2 "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" and the single IRB plan attachment.
    • Included instructions specific for AHRQ applicants.
    • Included instructions specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring Plan."
    • Added new "Is this an applicable clinical trial under FDAAA?" field.

PHS Assignment Request Form

    • Removed the “Do Not Assign to Awarding Component” and “Do Not Assign to Study Section” fields and instructions.
    • Added new “Rationale for assignment suggestions” field.

Changes Regarding Fetal Tissue

SF 424 (R&R) Form

Added language under section "21. Cover Letter Attachment," sub-section content (Item 9).

9. Include a statement in the cover letter if the proposed studies involve human fetal tissue obtained from elective abortions (HFT), regardless of whether or not Human Subjects are involved and/or there are costs associated with the HFT. For further information on HFT policy refer to the NIH Grants Policy Statement.

R&R Cover Page Supplement

Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):

4. Human Fetal Tissue Section

Does the proposed project involve human fetal tissue from elective abortions?
This field is required.

If the proposed project involves the use of human fetal tissue obtained from elective abortions (HFT), check “Yes” and complete the rest of the “Human Fetal Tissue” section.

If the proposed project does not involve the use of human fetal tissue obtained from elective abortions (HFT), check “No” and skip the rest of the “Human Fetal Tissue” section

PHS 398 Research Plan Form

  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
  • Under the introductory part of section 3, "Research Strategy": Added new section titled Note for Applications Proposing the Use of Human Fetal Tissue.
  • Within section 3 "Research Strategy", subsection 3 "Approach" - added a new bullet point for this information titled 'Special Instructions for Proposed Human Fetal Tissue Research."

PHS 398 Career Development Award Supplemental Form

  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
  • Under the introductory part of Section 4 "Research Strategy:: Added a new section titled Note for Applications Proposing the Use of Human Fetal Tissue.
  • Within Section 4 "Research Strategy" - subsection 3 "Approach" - added a new bullet point for this information titled Special Instructions for Proposed Human Fetal Tissue Research.