December 4, 2017
January 12, 2018
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
January 8, 2021
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the Career Transition Award (K22) is to help outstanding postdoctoral researchers who are members of an underreprestended group complete needed, mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. The K22 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and that will help advance the mission of theNINDS. The strongest applicants will require, and will propose, a well-conceived plan for 1–3years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs.
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as nationally underrepresented in the biomedical, clinical, behavioral and social sciences. These groups include individuals from underrepresented racial and ethnic groups, individuals with disabilities and individuals from disadvantaged backgrounds (at the undergraduate level and below). For more information, see NOT-OD-15-053.
There is a large loss of talented researchers from underrepresented backgrounds during the transition from postdoctoral training to junior faculty positions. Evidence from several reports demonstrates that an intervention designed to facilitate successful transition at this point would benefit the research community and scientific teaching environment and would provide needed role models for students from underrepresented groups (Expanding Underrepresented Minority Participation: America's Science and Technology Talent at the Crossroads, National Academy of Sciences, 2011; Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, National Research Council, 2005; and Advancing the Nation's Health Needs: NIH Research Training Programs, National Academy of Sciences, 2005). A diverse faculty is critical for providing role models for aspiring scientists from all backgrounds and achieving a balanced research agenda that benefits the nation. Moreover, surveys reveal that a diverse faculty is important for attracting diverse students to research and has a positive impact on retention and career mentoring for diverse students.
Specifically for neuroscience early career researchers, there is a decrease in the proportion of diverse trainees from postdoctoral (9%) to tenure-stream neuroscience faculty (5%); 2011 Survey Report Neuroscience Departments and Programs. The objective of the NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity (K22) is to support talented advanced postdoctoral investigators from backgrounds underrepresented in neuroscience research during their transition to independent research positions. This K22 program is designed to assist transition to secure faculty positions, increase research faculty diversity and enhance the skills needed to progress to independent NIH or other independent research support. As demonstrated in a 2011 NIH Individual Mentored Career Development Awards Program Evaluation, receipt of an individual mentored career development award had a measurable and significant impact on program participants, as seen in their publication records and subsequent applications for and receipt of NIH grants. Collectively, researchers who participated in a NIH K program had a significantly higher R01 success rate than those with no prior career development support. It is envisioned that funding support from the Advanced Postdoctoral Career Transition Award to Promote Diversity will increase the pool of well-trained researchers who are competitively funded to conduct neuroscience research.
The candidate must propose a research project that will be pursued during Phase I and continue into an independent project during Phase II of the award. Consequently, the K22 applicant must have ownership of the project and by explicit agreement of the mentor, must be able to take the project with him/her upon transition to independence. The K22 award will provide up to 5 years of support in two phases. Phase II support will have a maximum duration of 3 years. If an awardee expends the maximum time in Phase I (3 years), Phase II will be limited to two years of support.
The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, Phase II awards will generally only be made to those K22 PDs/PIs who accept independent tenure-track (or equivalent) faculty positions by the end of the Phase I award period. Phase II of the K22 award is not automatic. It will be awarded, following adminstrative review, only if the K22 awardee obtains a full-time tenure-track or equivalent faculty position. This position must include an appropriate startup package that is similar to that currently provided to others hired by the department into a similar position, and which is sufficient to promote success in the applicant's research area, appropriate protected time for research (a minimum of 75%) and access to students and resources normally associated with such a position.
Once the tenure track (or equivalent) position has been secured, NINDS program staff will evaluate the Phase II materials (see below) to ensure that all programmatic requirements are met prior to continuation of the K22 award. Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NINDS. Updated information from the extramural institution on behalf of the candidate will be required for the NINDS to process the second phase of the K22. The sponsoring institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research. It is strongly encouraged that Phase II occur at an institution different from that where the Phase I research occurred. However, as long as the faculty position and start-up package are appropriate, and the candidate has full research independence, Phase II may occur at the Phase I institution. If the applicant remains at the same institution, there must be a clear explanation of how independence from the mentor will be established. The details of the requirements for the activation of the Phase II of the K22 award are described in Section VI of this announcement.
During Phase II, it is expected that K22 recipients will apply for independent research grant support as soon as possible. K22 recipients are strongly encouraged to apply for R01 or equivalent Federal or Foundation awards within the final two years of their K22 award. K22 award recipients that obtain independent support during the K22 award period may hold concurrent research support, and, in the last two years of their K22 award, salary support from their career award and a competing NIH research project grant when recognized as a PD/PI or subproject Director of the research project grant.
NINDS support for the K22 program relies equally on scientific merit and programmatic considerations. Consequently, we strongly recommend that potential applicants consult Scientific/Research Staff at NINDS before preparing an application.Please also visit the NINDS website for specific resources and webinars to help develop an application. NINDS will not support projects, regardless of the results of merit review, if they do not fulfill current programmatic priorities at NINDS.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. NINDS will only accept applications to this FOA that propose human mechanistic trials/studies that meet NIH's definition of a clinical trial and that fall within the NINDS research priorities. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (PAR-18-469).
Examples of types of applications intended to be supported by NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity in Neuroscience Research (K22-Clinical Trial Required)
include, but are not limited to:
The following types of clinical trials are not intended to be supported by NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity in Neuroscience Research (K22-Clinical Trial Required):
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Required: Only accepting applications that propose an independent clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award budgets are composed of salary and other program-related expenses, as described below.
The total project period may not exceed 5 years.
NINDS will contribute up to $ 100,000 commensurate with salary and effort, as well as fringe benefits during Phase II.
In Phase I, the NIH will contribute salary up to $75,000 plus fringe benefits per year, commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The requested Phase I salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned. The total Phase I salary requested must be based on a full-time, 12-month staff appointment. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits based on the sponsoring institution’s rate and the percent of effort are provided in addition to the salary.
per year. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.
The entire research effort during Phase II need not be associated with this K22 award, and salary for this effort need not come entirely from this K22 award. For Phase II activation, institutions should provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant. Salary support in addition to that provided by the K22 award may be obtained from any non-federal source, as long as 75% effort is protected for research. If the K22 awardee obtains an NIH R01 or federal equivalent as PD/PI, he/she may draw appropriate salary from that federal award in the final 2 years of the K award
The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Research expenses may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.
NINDS will contribute $25,000 in Phase I and $100,000 in Phase III per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.
Reasonable Accommodations: As part of this award, funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under this award include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested must be reasonable.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. NIH Intramural Programs and other Federal laboratories are not eligible to apply for the independent phase. In order for an intramural postdoctoral fellow to activate the Phase II of K22 award, the candidate must transition to atenure-track assistant professor or equivalent position at an extramural institution. Specific information is available for intramural candidates on the Electronic Submission Intranet—link available only to users internal to NIH.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Diversity candidates (as defined in eligiblity catergory below) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) are invited to work with his/her mentor(s) and organization to develop an application for support. Multiple PDs/PIs are not allowed.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status.
Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053).
Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation—requires superior intellect, creativity, and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from underrepresented backgrounds who will help to further NIH's mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in—and benefit from—health research, and enhancing public trust.
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, which includes:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data from the National Center for Science and Engineering Statistics (NCSES), the nation's leading provider of statistical data on the U.S. science and engineering enterprise.). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.
The overarching goal of this FOA is to enhance the pool of independent neuroscience research investigators from underrepresented backgrounds. For the purpose of this announcement, institutions must identify candidates who will increase diversity within the neuroscience workforce on a national basis. The disadvantaged eligibility criterion is not applicable because this announcement focuses on providing support for individuals at the postdoctoral and above academic level.
Candidates for this award must (1) have earned a terminal clinical or research doctorate or a combined clinical and research doctoral degree; (2) have at least 2 years of postdoctoral training in neuroscience research at the time of submission of the initial application; (3) have no more than a total of 5 years postdoctoral experience at the time of application.
Individuals are NOT eligible for the NINDS K22 to Promote Diversity if they:
Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions.. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, an official statement of the institution’s policy (e.g. published position description in an official institutional document) must be included that documents the position as a mentored, postdoctoral training position.
The following is provided as an aid to distinguish independent from non-independent positions. However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Parental leave or other well-justified leave for pressing personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 5-year eligibility limit.
Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K22 program. If an applicant achieves independence (any faculty or non-mentored research position) before a K22 award is made, neither the Phase I nor the Phase II award will be made. An individual who cannot provide a compelling rationale for at least two years of additional mentored research training at the time of award is not a strong candidate for this award.
For individuals from diverse backgrounds who are in the first 3 years of a tenure track (or equivalent) faculty position, NINDS support may be obtained from a K01 funding mechanism. For information on programs supported by other NIH Institutes and Centers (ICs), potential applicants should visit the NIH K Kiosk.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.
Individuals are eligible for a K22 award if they have been,
or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal
award that duplicates the specific aims or research goals of an R03 or R21
grant. Individuals are NOT eligible to apply if they have pending an
application for any other PHS career development award, an NIH
institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals
are not eligible to apply if they have been or are currently a PD/PI on an NIH
research grant (such as R01, R29, P01) or a subproject leader on a Program
Project (P01) or Center Grant (P50), or a non-NIH equivalent to these
At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (or advisory committee), if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage.
The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial. The primary mentor should be in the candidate's home institution or, in rare circumstances, be available locally. Also, if the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should also be included.
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Include a description of your current research and the research you propose to continue in the independent phase.
Certification Letter: Applicants are required to attach a letter from the institution certifying eligibility of the candidate for support under this program. The statement must include a clear description of how the appointment of the candidate will expand the pool of underrepresented individuals within science nationally. Populations that are nationally underrepresented for the purposes of NIH diversity programs are identified in the Notice of Interest in Diversity. NIH relies on data compiled and analyzed by the National Science Foundation (NSF), using an evidence-based method that reviews the representation of populations across the STEM pipeline. The institutional certification letter must state the basis for the individual’s eligibility for this program by reference to, and inclusion of, the relevant national data from NSF. In addition to the NSF data, the certification letter may also address how the individual would further diversity in the neuroscience workforce. Since certification happens at the Institution and not NIH, the information contained in the certification letter adds a level of transparency and alignment with program goals for the reviewers. For specific information regarding the racial and ethnic categories, please refer to Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes, NOT-OD-15-089.
The Certification Letter from the institution certifying eligibility of the applicant for the program must be on institutional letterhead and scanned so that an institutional official signature is visible. Name the PDF-formatted letter "Diversity_Eligibility_Ltr.pdf". This letter is limited to 1 page.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed
All instructions in the SF424 (R&R) Application Guide must be followed
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Career Goals and Objectives
Candidate’s Plan for Career Development/Training Activities During Award Period
Research Plan Section
Training in the Responsible Conduct of Research
Mentor, Co-Mentor, Consultant, Collaborators Section
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.
Specific to applications proposing clinical trials, ancillary or feasibility studies
Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.
For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials, or a new ancillary study to an ongoing clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition from the mentored phase to the independent phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, space and resources needed to conduct the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. NIH will conduct a formal scientific progress review no later than two months before the end of the mentored phase.
The materials for the Phase II of the award must be submitted no later than 2 months prior to the proposed activation date of the award by the Phase II grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact their NINDS program official as soon as plans to assume an independent position develop, and not later than 6 months prior to the termination of Phase I of the award, to discuss plans for transition to, and the information to be submitted for Phase II.
Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the candidate.
Form PHS 2590 must include the following:
These materials should be sent directly by your Phase II Business Official to NINDSDiversityTraining@ninds.nih.gov (preferably in PDF format), assigned Program Official and grants management specialist. The Phase II materials will be evaluated by a committee of extramural program staff of the awarding component for completeness and responsiveness to the program.
The start-up package and other institutional support must be
described and should be comparable to that given to other faculty recently
hired into tenure-track or equivalent positions. Institutions must provide a
startup and salary package equivalent to that provided to a newly hired faculty
member who does not have a grant; Phase II funds may not be used to offset the
typical startup package or to offset the usual institutional commitment to
provide salary for tenure-track (or equivalent) assistant professors who are
hired without grant support. The Phase II sponsoring institution should
describe the candidate’s academic appointment, bearing in mind that it must be
tenure-track assistant professor (or equivalent), and confirm that the
appointment is not contingent on the transfer of the award to the institution.
The Phase II institution must describe how the awardee’s ability to apply for
and secure independent research grant (R01) support will be fostered and
supported during Phase II of the award.
Teaching, clinical duties and other non-research activities should be minimal during the award period. NINDS staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent faculty phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NINDS institute program official prior to submission of the Phase II application. NINDS will not activate the independent faculty phase if the institutional commitment is deemed inadequate.
Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This letter typically will be sent within 60 days of receipt of the Phase II application.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Michelle Jones-London, Ph.D.
tional Institute of Neurological Disorders and Stroke (NINDS)
Ernest Lyons, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Tijuanna E. DeCoster, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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