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Frequently Asked Questions
Form Updates 2016
Last Revised: June 16, 2017


  A. Vertebrate Animals

  1. How has the Vertebrate Animals Section (VAS) of the application changed?
    As announced in NOT-OD-16-006, the VAS is simplified by the following changes: 1) description of veterinary care is no longer required; 2) justification for the number of animals has been eliminated from the VAS; and 3) method of euthanasia is eliminated from the VAS and is addressed in the Cover Page Supplement or PHS Fellowship Supplemental form, as applicable. The justification for the number of animals, sex, ages and other biological variables should be described in the Research Strategy.
  2. When will the simplified VAS be implemented?
    The new instructions and review criteria for the VAS are effective for applications submitted for due dates of January 25, 2016 and beyond.
  3. Why was the VAS changed?
    The changes were made to remove redundancy with Institutional Animal Care and Use Committee (IACUC) review while still meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The changes simplify the VAS criteria and reduce burden on applicants and reviewers.
  4. What are the VAS criteria that must be addressed?

    If live vertebrate animals are involved in the project, applicants must address each of the following criteria in the VAS:

    1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

    2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

    3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

    In addition to the criteria above, applicants should also:

    • Identify all project performance (or collaborating) sites and describe the proposed research activities with vertebrate animals that will be conducted at those sites.
    • Explain when and how animals are expected to be used if plans for the use of animals have not been finalized.
    Note, method of euthanasia is addressed in the Cover Page Supplement or PHS Fellowship Supplemental form, depending on the application.
  5. If an applicant provides responses to the old VAS criteria in their applications submitted for due dates in 2016 and beyond, will it impact the review?
    No, as long as the simplified criteria are addressed, the application will be reviewed. However, the VAS must not be used to circumvent page limits.
  6. Are there any new requirements in the VAS?
    No, the criteria have been reduced and simplified.
  7. Do applicants describe and justify the sex of the animals proposed in the VAS?
    No, how sex is factored into the research design should be described in the Research Strategy. Applicants must state only the sex of the animals in the VAS.
  8. Do applicants justify the number of animals in the VAS?
    No, the justification for the number of animals is an element of rigor in the experimental design and should be described in the Research Strategy.  Applicants must state only the total number of animals proposed in the VAS.
  9. Where can I find more information about the changes in the VAS?

    The Vertebrate Animal Section webpage has more details about the VAS and includes links to the Grant Application VAS Worksheet and the Contract Proposal VAS Worksheet.

  10. Is the method of euthanasia required in the VAS?
    No, the method of euthanasia is eliminated from the VAS and is addressed in a series of questions in the Cover Page Supplement or PHS Fellowship Supplemental form, depending on the application. If the applicant answers “No” to the question “Is method consistent with AVMA Guidelines?”, they must describe the method and provide scientific justification.
  11. Do applicants describe all proposed procedures on animals in the VAS?

    Yes, applicants must include a concise description of all proposed procedures on live animals in the VAS. While additional details of the experimental design may be included in the Research Strategy, a brief description of each procedure must be provided in the VAS and include sufficient detail to allow evaluation by reviewers. Examples of types of procedures include:

    • Behavioral tests
    • Blood collection
    • Surgical procedures
    • Administration of substances
    • Tumor induction
    • Post-irradiation procedures
  12. If an applicant fails to address one of the criteria in the VAS, will the application score be affected?
    Each of the criteria must be addressed in the VAS. Failure to adequately address the criteria may negatively affect the application’s impact score. The VAS must not be used to circumvent page limits. The applicant should only address the required criteria and include descriptions of the proposed use of live animals.
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  B. New Font Guidelines

  1. What are NIH's font requirements for grant application attachments?

    For application due dates before Jan 25, 2017:

    • Font size:  must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%)
      • Some PDF conversion software reduces font size. It is important to confirm that the final PDF document complies with the font requirements.
    • Type density:  must be no more than 15 characters per linear inch (including characters and spaces)
    • Line spacing: must be no more than six lines per vertical inch
    • Text color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable)

    For application due dates on/after Jan 25, 2017:

    Same as above except:

    • Text color: No restriction. Though not required, black or other high-contrast text colors are recommended since they print well and are legible to the largest audience.
  2. Does NIH have recommended fonts?
    Yes. NIH recommends the following fonts at 11 point or larger:
    • Arial
    • Georgia
    • Helvetica
    • Palatino Linotype
  3. How can I tell if my attachments meet the "line spacing must be no more than six lines per vertical inch" requirement?

    In most cases, fonts that meet the “no more than 15 characters per linear inch” requirement will also meet the line spacing requirement when “Line Spacing” is set to “Single”. When in doubt, print off a sample and use a ruler to verify you do not have more than 6 lines within an inch.

    Compliant example: Arial 11 pt font single-spaced

    Arial 11 pt font single-spaced

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  C. Application Forms Updates and Choosing the Correct Forms

  1. What application form set is used by NIH?

    NIH uses the Standard Form (SF) 424 Research & Related (R&R) family of forms. 

    The SF424 (R&R) is the government-wide data set for research grant applications. NIH application packages are a combination of forms used federal-wide (typically identified as R&R or Research and Related) and agency-specific forms (typically identifed as PHS for Public Health Services).

    The forms presented to an applicant will vary from one Funding Opportunity Announcement (FOA) to another. Applicants must use the application package linked to the FOA to which they want to apply.

  2. What resources are available to help with the form transition?

    We have provided the following resources to help you with our transition from FORMS-C to FORMS-D grant application forms:

  3. Why do the SF424 (R&R) application forms change?

    NIH periodically implements updated versions of grant application forms in order to remain current with the most recent form sets available through Grants.gov and approved by the Office of Management and Budget (OMB).

    NIH grant application forms can change for a variety of reasons:

    • Policy changes require new or different data collection

      A new policy may require that we ask applicants a specific question or ensure a topic is addressed in a new attachment. 
    • Usability

      Forms can be "tweaked" to make the data collection more intuitive.
    • Incorporating changes to forms used federal-wide

      Since NIH leverages forms that are used federal-wide, a change to shared forms also impacts NIH applications. For example, forms may be changed to remove the collection of sensitive data. 
  4. How will I know if grant application forms are changing?

    NIH announces upcoming form changes well before their use to ensure applicants have time to prepare. New application packages and instructions are released at least 60 days prior to the first due date to use them.

    Like all major eSubmission news, applicants can expect that forms changes will be announced in the NIH Guide for Grants & Contracts, on websites, and through various media outlets listed on our News and Events page.

  5. How can I ensure that I am using the correct forms?

    NIH gives each set of updated forms a version name for quick identification and easier communication. For example, our current version is referred to as 'FORMS-D'. Applications for due dates on or after January 25, 2018 will use updated forms versioned FORMS-E. 

    When NIH posts an opportunity and its application package to Grants.gov we provide some basic information (opportunity title and number, key dates, etc.). We also have the ability to provide a 'Competition ID' to further identify an opportunity. NIH uses the Competition ID to convey the form version name.

    The form version name shows up in the Competition ID field found on various screens and within the application package (see  “Do I Have the Right Forms For My Application?” (PDF - 176 KB) document).

    Form changes are announced via a notice in the NIH Guide for Grants and Contracts. The notice will specify when applicants must use the updated forms (e.g., 'Use FORMS-E application packages for due dates on or after January 25, 2018').

  6. During a form update, which form version is used for Resubmission applications?
    Form updates apply to all types of applications (new, resubmission, renewal and revision). If you are submitting your Resubmission application to a due date on or after January 25, 2018 you must use FORMS-E application forms, even if you used FORMS-D forms for your New application on an earlier due date.
  7. When must I stop using the old FORMS-C application forms if I am eligible to submit under the continuous submission policy?

    For non-AIDS continuous submission applications, use Forms-C when you submit your application on or before April 18, 2016.  Non-AIDS continuous submission applications submitted on or before April 18, 2016 will go to the October 2016 advisory council round.  Applications submitted after that time must use Forms-D and will be assigned to the January 2017 advisory council round. 

     

    For AIDS continuous submission applications, use Forms-C when you submit your application on or before May 23, 2016 (note this is an earlier cut-off than standard).  AIDS continuous submission applications submitted on or before May 23, 2016 will go to the October 2016 advisory council round.  Applications submitted after that time must use Forms-D and will be assigned to the January 2017 advisory council round.  

  8. How do form transitions impact late applications?

    Applicants who submit late applications must use the application forms appropriate for the on-time due date. 
    If the intended due date is before January 25, 2018 use FORMS-D; if on or after January 25, 2018 use FORMS-E.

    For example, if you are submitting late to an announcement with a due date of January 19, 2018, then you must use FORMS-D application forms during the two-week late window of consideration (even if submitting between January 25 and February 1).

    Note: Some active FOAs (those posted on/before December 17, 2014) still follow our old late policy and may not have the two-week window of consideration.

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  D. Rigor and Transparency Forms Updates

  1. Does the NIH policy on rigor and transparency apply to all types of NIH grants?

    The rigor and transparency policy applies to any grant that funds research or training in research; grants that support other activities (e.g. shared equipment, construction, etc.) do not need to address rigor and transparency.  The policy applies to most research grants and career development awards as of applications submitted for January 25, 2016 and beyond. It applies to training grants and fellowships as of May 25, 2016 and beyond. Specific exceptions to the rigor and transparency policy are listed in the Research (NOT-OD-16-011) and Career Development (NOT-OD-16-012) Guide notices and will be included in future fellowship and training notices.   

    Funding opportunity announcements for which rigor and transparency should be addressed will include specific review language for rigor and transparency. For announcements published in October 2015, the Funding Opportunity Announcements for which rigor apply will be updated with the applicable review criteria at the end of November 2015.


  2. How will the updated policy on rigor and transparency be applied to training grants?
    Training grant applications will be expected to include a formal plan for training in rigor and transparency beginning with applications submitted for the May 25, 2016 due date and beyond.  The new section will be reviewed under a new additional review criterion that will contribute to the overall impact score.  An NIH Guide Notice with further details will be published in the fall of 2015.
  3. Where in grant applications should applicants include information addressing the focus areas of the NIH policy on rigor and transparency?

    Three elements of the policy (scientific premise, scientific rigor, and relevant biological variables such as sex) should be addressed within the Research Strategy section, as these elements are integral to the research plan. Since scientific premise will be reviewed and scored as part of the Significance review criterion, it is suggested that applicants address premise as part of their corresponding Significance section in the research strategy. Scientific rigor and relevant biological variables will be reviewed and scored as part of the Approach review criterion.

    Authentication of key resources will be addressed in a separate attachment, not to exceed one page in length.

    Details on the updated application instructions, progress reporting, and review language can be found in the following guide notices:

    • changes to policies, instructions, and forms for 2016 grant applications (NOT-OD-16-004)
    • rigor and transparency in research grant applications (NOT-OD-16-011)
    • rigor and transparency in career development awards (NOT-OD-16-012)

     

  4. How will reviewers be instructed to assess applications to address the NIH policy on rigor and transparency?

    Reviewers are directed to consider all of the strengths and weaknesses associated with each of the review criteria and weigh them appropriately for the specific application assigned to them. Thus, the NIH policy on rigor and transparency will contribute to the criterion scores and overall impact score of each application, with the exception of Authentication of Key Biological and/or Chemical Resources.

    Reviewers will be instructed to evaluate scientific premise, scientific rigor, and consideration of relevant biological variables such as sex as part of the significance (scientific premise) and approach (rigor & biological variables) criteria, as well as in their assessment of overall impact.

    Reviewers will comment on the proposed Key Biological and/or Chemical Resource Authentication Plan as an additional review consideration, but should not consider it in the overall impact score.

    Details on the updated application instructions, progress reporting, and review language can be found in the following guide notices:

    • Rigor and transparency in research grant applications (NOT-OD-16-011)
    • Rigor and transparency in career development awards (NOT-OD-16-012)

     

  5. Will an application go to review if it does not follow the new instructions for applicants pertaining to rigor and transparency?

    Yes. Applications that do not address the new instructions for rigor and transparency will be reviewed.

  6. How is consideration of sex as a relevant biological variable different from NIH’s inclusion requirements?

    The NIH is mandated by law (Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2) and NIH policy to ensure the inclusion of women, minorities, and children in clinical research. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study.

    The new instructions for applicants and review language introduced in October 2015 expand upon the NIH inclusion policy in crucial ways. NIH expects sex as a biological variable to be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Appropriate analysis and transparent reporting of data by sex may enhance the scientific rigor, transparency, and applicability of preclinical biomedical research. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex. Please refer to NOT-OD-15-102 for further consideration of NIH expectations about sex as a biological variable.

    Similarly, investigators should consider other biological variables, as appropriate, in the design and analyses of their proposed studies. Research plans and findings should clearly indicate which biological variables are tested or controlled. Clear justification should be provided for exclusion of variables that may be relevant but are not considered in the research plan. For example, for studies involving young adult animals the study population should be clearly described and not generalize findings to juvenile or aged animals.

     

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  E. Research Training Data Tables

  1. Does the term "trainee" refer to a person appointed to the T32 training grant, or does it refer to all students/postdoctorates in the program?
    When used in the data table instructions, the term “trainee” generally refers to individuals appointed to the training grant.
  2. How many years of trainee data should be included on Part I of Table 8, Outcomes, when submitted with an RPPR? What should we do if we don’t have all the historical data?

    When Table 8, Outcomes, is submitted with an RPPR, the expectation is that PD/PIs will include 15 years of data in Part I, updating the data to reflect new appointments to the training grant, and other changes over the reporting period.  Where complete historical data are not available, PD/PIs should provide as much as reasonably possible, and begin collecting the relevant information, so that it will be available in the future. 

  3. In Table 8, where should subsequent fellowship awards be reported?

    In Table 8A, if a predoctoral trainee receives a fellowship during graduate school, it should be reported in the “Summary of Support During Training.”  If a predoctoral trainee goes on to receive a fellowship after completing graduate school, it should be reported under “Subsequent Grant(s)/Role/Year Awarded.” 

    In Table 8C, fellowships supporting postdoctoral training should be reported in the “Summary of Support During Training.”  Fellowships received after postdoctoral training is complete (e.g., F33) should be reported under “Subsequent Grant(s)/Role/Year Awarded.”

  4. How many years of data should be included on Part II of Table 8, Outcomes?

    Because Part II of Table 8 is a completely new reporting requirement, users should initially report only current “clearly associated” students.  Then, in each subsequent year, they should continue to add new entrants and provide updated information about current and past clearly associated students until 15 years of data have been completed.

  5. How should one define students and postdoctorates "clearly associated" with the program for Part II of Table 8?

    Those “clearly associated” with the program are those with a training experience identical to those appointed to this grant, but who are supported by other NIH or HHS awards (e.g., fellowships or research grants).

    Because of the nature of postdoctoral training, Part II of the table may not be applicable for some postdoctoral programs. 
  6. For Table 8, are there criteria to define “research-related careers”?
    Research-related positions generally require a doctoral degree, and may include activities such as teaching, administering research or higher education programs, science policy, or technology transfer.  Other positions that may be classified as research-related are those focusing on the review of research, providing scientific direction or guidance to research, and supporting research through analytic or other technical activities.  Such work may take place in academic, government, non-profit, or commercial settings, including biotechnology or pharmaceutical companies.
  7. Should students and postdoctorates who are non-citizens on temporary visas be included in the counts for Table 2?
    Yes, all students and postdoctorates in full-time research training under the supervision of participating faculty should be reported.
  8. Is Table 4 limited to active support? What about awards that have received no-cost extensions?
    Only active support should be reported on Table 4.  If an award is in a no-cost extension, report the direct costs remaining in the grant award.
  9. If a faculty member is a co-investigator on a grant, should that be listed on Table 4?
    No.  The only awards that should be reported on Table 4 are those for which the faculty member serves as a PD/PI (either singly or on a multi-PD/PI award) or, in the case of a multi-project grant such as a PO1, as a project PI.  In the latter case, provide information only for that component of the grant for which the faculty member is the Project PI.
  10. In completing Table 5A or 5B, Publications, how should we report on the publications of past trainees whose faculty mentors have retired or are no longer involved in the training grant?

    The intent of Table 5 is to provide reviewers with information about current training grant faculty and their ability to foster trainee productivity.  As such, former faculty and their trainees should not be included on Table 5. 

  11. Are PMCID numbers required for publications listed in Table 5?
    No.  NIH has modified its process for reporting on publications that arose from work conducted by the trainee while supported by the training grant.  As indicated in the Training Grant Application Guide’s instructions for progress reports, information on publications that arose from work conducted by the trainee while supported by the training grant will be collected Just-in-Time for renewal applications.
  12. We’re preparing a training grant application for the May 25, 2016 due date, but don’t have all the historical data requested in the new data tables, such as the length of prior, full-time research experience for trainees entering the program five years ago. What should we do?

    Because reviewers are asked to assess a training program and its record based, in part, on data presented in the tables, applicants should provide as much data as reasonably possible. Where complete historical data are not available, applicants should indicate that in their applications and begin collecting the relevant information, so that it will be available in the future. 

  13. In completing Table 6A or 6B, Applicants, Entrants, and their Characteristics, how should we treat the shaded cells in Part II?

    The shaded portions of the tables indicate areas that should not be completed.  Leave the shaded cells blank.

  14. For Table 6B, if postdoctorates are hired on an ad hoc basis by individual faculty members or by Human Resources, how do we determine the total applicant pool?
    In situations such as this, the applicant pool would be the number of postdoctorates applying for the relevant positions. 
  15. What tables should applicants for undergraduate programs use (e.g., T34s)?

    Applicants for programs targeted to undergraduates (e.g., T34 awards) should use the new, fillable tables designed for undergraduate programs for applications for the May 25, 2016 due date and after. For applications to be submitted prior to the May 25, 2016 due date, applicants should follow the instructions regarding training data tables provided in the Funding Opportunity Announcement.

  16. Are applicants or grantees required to use the new xTRACT system in the eRA Commons to create the training data tables?

    No. The xTRACT system is available on a pilot basis to create training tables for RPPRs and applications. Applicants and grantees may continue to create training data tables by using fillable tables in MS Word available on the NIH website.

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