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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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 (e.g, SSN) across all federal forms.
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. Application packages for reissued FOAs are released at least 30 days prior to the first due date to use them.
NIH gives each set of updated forms a version name for quick identification and easier communication. For example, applications for due dates on or after May 25, 2020 must use updated forms versioned FORMS-F.
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.
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-F application packages for due dates on or after May 25, 2020').
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.
Applicants who submit late applications must use the application forms appropriate for the on-time due date. If the intended due date is before May 25, 2020 use FORMS-E; if on or after May 25, 2020 use FORMS-F.
For example, if you are submitting late to an announcement with a due date of May 21, 2020, then you must use FORMS-E application forms during the two-week late window of consideration (even if submitting between May 25 and June 4).
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.
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.
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)
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)
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.
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.
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.”
Once a user creates Table 8 in xTRACT, the next steps depend on the award type. For training grant activities that are required to create Table 8 using the xTRACT system (i.e., T15, T32, T90/R90, and TL1), once a “Research Training Dataset” for an RPPR is created and finalized in xTRACT and includes all the new and updated data needed for Table 8, nothing further needs to be done. Upon submission of the RPPR, the xTRACT system will automatically create and append Table 8A, 8B, and/or 8C; there is no longer any need to upload these tables in the RPPR module.
However, for training grant activities for which the use of xTRACT to create Table 8 is optional (e.g., T34, T35, T37, TL4, RL9, K12/KL2), users must continue to upload a PDF of the relevant version(s) of Table 8 in the RPPR module, whether generated by xTRACT or by the user.
Because Part II of Table 8 is a relatively 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.
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.
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.
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.
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.
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.
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.
Existing training grant recipients are required to use the xTRACT system to prepare the required data tables for Research Performance Progress Reports (RPPRs), beginning with progress reports due on or after October 1, 2019 (FY 2020). As described in NOT-OD-19-108, this requirement applies to NIH and AHRQ T15, T32, T90/R90, and TL1 RPPRs. System validations in the RPPR module will check to ensure that the data tables were created via xTRACT, and users will not be able to submit RPPRs that are not in compliance.
The use of xTRACT to prepare the data tables for new and renewal training grant applications is not mandatory at this time but may be required in future years. Applicants for new or renewal training grant awards are encouraged to take steps now to gain experience with the system prior to its required use.