G.120 - Significant Changes

Revision Notes - December 7, 2018

PHS Human Subjects and Clinical Trials Information

• Clarified instructions on who must complete certain attachments in Section 2 - Study Population Characteristics. The affected fields are 2.5 Recruitment and Retention Plan, 2.6 Recruitment Status, 2.7 Study Timeline, and 2.8 Enrollment of First Subject.

Revision Notes - November 26, 2018

How to Use the Application Instructions

• Added "Step 6. Understand what data NIH makes public."

R&R Other Project Information Form

• Proof of registration with the SBA Company Registry is no longer required for SBIR/STTR applicants.
• Instructions for submitting an institutional letter (formerly known as a certification letter) for predoctoral fellowships (F31) to promote diversity have been moved to the funding opportunity announcement.
• Modified text regarding exemption numbers 7 and 8 in question "1.a. If YES to Human Subjects."

SF 424C Budget Information - Construction Programs form

• The G.360 SF 424C Budget Information - Construction Programs form instructions have been added to the General Instructions for NIH and Other PHS Agencies.

PHS 398 Research Plan Form

• Added instructions under the "Research Strategy" section for applications due on or after January 25, 2019:

• Under "Significance," the term "rigor of the prior research" has replaced the term "scientific premise."
• Under "Approach," instructions to describe plans to address weaknesses in the rigor of the prior research have been added.
• See the NIH Guide Notice on NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications for more information.

PHS 398 Career Development Award Supplemental Form

• Added instructions under the "Research Strategy" section for applications due on or after January 25, 2019:

• Under "Significance," the term "rigor of the prior research" has replaced the term "scientific premise."
• Under "Approach," instructions to describe plans to address weaknesses in the rigor of the prior research have been added.
• See the NIH Guide Notice on NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Career Development Award Applications for more information.

• For applicants proposing to gain clinical trial research experience, instructions for the "Plans and Statements of Mentor and Co-Mentor(s)" section have been updated to include guidance on how the mentor should document leadership of the clinical trial and describe the respective roles and responsibilities of the mentor and the applicant.

PHS 398 Research Training Program Plan Form

• Added language in the "Proposed Training" section of the "Program Plan" to provide guidance to applicants who choose to provide a description of opportunities for trainees to be involved in human subjects research.
• Added instructions under the "Letters of Support" section for applications due on or after January 25, 2019 about including a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

• See the NIH Guide Notice on Harassment and Discrimination Protections in NIH Training Applications.

PHS Fellowship Supplemental Form

• Updated and clarified instructions under the "Applicant's Background and Goals for Fellowship Training" section to provide a timeline of the proposed research training, professional development, and other activities planned during the fellowship.
• For applicants proposing to gain clinical trial research experience, instructions for the "Sponsor and Co-Sponsor Statements" section have been updated to include guidance on how the sponsor should document leadership of the clinical trial and describe the respective roles and responsibilities of the sponsor and the applicant.

PHS Human Subjects and Clinical Trials Information

• Clarified and updated instructions throughout these instructions. Significant changes include:

• Clarified instructions for K12 and D43 applicants.
• Added instructions for R25 applicants proposing to provide clinical trial research experience and R36 applicants proposing to gain clinical trial research experience.
• Clarified instructions for Career Development Award and Fellowship applicants who are proposing to gain clinical trial research experience.
• Added instructions about grouping Study Records.
• Clarified instructions for delayed onset studies.
• Removed language that indicated exemption numbers 7 and 8 should not be selected and are not being used.
• Clarified or changed character limits for certain fields.
• Includes the updated inclusion policy that goes into effect for applications due on or after January 25, 2019. See the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects for more information.

Revision Notes - December 29, 2017

• Clarifications made to instructions in G.600 PHS Assignment Request Form.

Release Notes - September 25, 2017

How to Apply - Application Guide and Format Page Changes

• Created a new Rules for Text Fields page that is accessible through the Write Application box.
• Minor clarifications to the instructions for the institutional training grant data tables, including:

• Table 8 - removed language to exclude officially approved leaves of absence from the average time to degree in Part IV. Program Statistics.

SF424 Research and Related (R&R) Form Changes

FORMS-E application packages incorporate the latest versions of the federal-wide forms managed by Grants.gov (OMB Number: 4040-0001, Expiration Date: 10/31/2019).

R&R Budget and associated R&R Subaward Budget Attachment(s) Form

• Added new "Total Costs and Fee" calculation to budget periods and cumulative budget
• Added instructions under the "Other Direct Costs" section about requesting direct costs related to the use of single Institutional Review Board (sIRB) for multi-site human subjects research in item "8-10 Other."

R&R Other Project Information Form

• Added exemption numbers 7 and 8 to question 1.a; however, these exemptions will not be used at this time.

SBIR/STTR Information Form

• Added "Agency to which you are applying" question with options for DOE, HHS, USDA and Other
• Added "SBC Control ID" field for the 9-digit code obtained from the Small Business Administration
• Added "Direct Phase II," "Phase IIA," "Phase IIB," and "Commercialization Readiness Program" as Application Type Options
• Added "Phase I Letter of Intent Number" field
• Added "Agency Topic/Subtopic" field
• Added two additional questions regarding eligibility:

• "1c. Is your small business majority owned by venture capital operating companies, hedge funds, or private equity firms?"
• "1d. Is your small business a Faculty or Student-Owned entity?"

• Added "DUNS Number of non-profit research partner for STTR" field
• Minor text changes

Forms-E Changes

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

• Updated biosketch instructions so that scholastic performance requires only scientific/professional graduate courses to be listed

PHS 398 Career Development Award Supplemental Form

• Updated OMB Expiration Date to 03/31/2020
• Removed Human Subjects Section, including the following attachments:

• Protection of Human Subjects
• Data Safety Monitoring Plan
• Inclusion of Women and Minorities
• Inclusion of Children

• Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form
• Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups
• Renumbered form fields
• Made minor text edits
• Includes the updated appendix policy that goes into effect for applications due on or after January 25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Cover Page Supplement Form

• Updated OMB Expiration Date to 03/31/2020
• Removed Human Subjects Section, including:

• "Clinical Trial" question
• "Agency Defined Phase III Clinical Trial" question

• Renumbered form fields
• Made minor text edits

PHS 398 Modular Budget Form

• Updated OMB Expiration Date to 03/31/2020

PHS 398 Research Plan Form

• Updated OMB Expiration Date to 03/31/2020
• Removed Human Subjects Section, including the following attachments:

• Protection of Human Subjects
• Data Safety Monitoring Plan
• Inclusion of Women and Minorities
• Inclusion of Children

• Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form
• Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups
• Renumbered form fields
• Made minor text edits
• Includes the updated appendix policy that goes into effect for applications due on or after January 25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Research Training Program Plan Form

• Updated OMB Expiration Date to 03/31/2020
• Removed the following attachments from the Other Training Program Section:

• Human Subjects
• Data Safety Monitoring Plan

• Renumbered form fields
• Made minor text edits
• Includes the updated appendix policy that goes into effect for applications due on or after January 25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS 398 Training Budget Form

• Updated OMB Expiration Date to 03/31/2020

PHS 398 Training Subaward Budget Attachment(s) Form

• Updated OMB Expiration Date to 03/31/2020

PHS Assignment Request Form

• Updated OMB Expiration Date to 03/31/2020
• Clarifications made to instructions

PHS Fellowship Supplemental Form

• Updated OMB Expiration Date to 03/31/2020
• Removed Human Subjects sub-section from Other Research Training Plan Section, including:

• "Human Subjects Involvement Indefinite" question
• "Clinical Trial" question
• "Agency Defined Phase III Clinical Trial" question
• Protection of Human Subjects attachment
• Data Safety Monitoring Plan attachment
• Inclusion of Women and Minorities attachment
• Inclusion of Children attachment

• Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form
• Included instruction to describe research methods for trials that randomize groups or deliver interventions to groups
• Removed "Vertebrate Animals Use Indefinite" question from the Vertebrate Animals sub-section of the Other Research Training Plan Section
• Renumbered form fields
• Made minor text edits
• Includes the updated appendix policy that goes into effect for applications due on or after January 25, 2018. This policy eliminates clinical trial-related materials. See the NIH Guide Notice on Allowable Appendix Materials for more information.

PHS Human Subjects and Clinical Trials Information

• Introduced new form for consolidated human subjects, inclusion enrollment report, and clinical trial information
• Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See the NIH Guide Notice on Notice of Extension of Effective Date for more information.
• Added exemption numbers 7 and 8 to question 1.3; however, these exemptions will not be used at this time

PHS Inclusion Enrollment Report

• Discontinued use (data collection moved to new PHS Human Subjects and Clinical Trials Information form)

Supplemental Instructions

• Discontinued use of Supplemental Instructions for all competing applications and progress reports
• All information has been folded into the Application Form Instructions and/or is contained in the appropriate policy website (e.g., NIH Grants Policy Statement)