National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
K12 Physician Scientist Award Program (PSA)
Only one K12 application per UM1 applicant institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars in clinical and translational science who have made a commitment to independent research careers (i.e., tenure-track or equivalent faculty positions), and to facilitate their timely transition to more advanced support mechanisms, e.g., K08, K23, R01, R03, etc. Applicants must submit both a UM1 application to PAR-21-293: Clinical and Translational Science Award and a K12 application to this FOA.
This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
|Application Due Dates||Review and Award Cycles|
|New||Renewal / Resubmission / Revision (as allowed)||AIDS||Scientific Merit Review||Advisory Council Review||Earliest Start Date|
|January 26, 2022||January 26, 2022||Not Applicable||June 2022||October 2022||December 2022|
|May 13, 2022||May 13, 2022||Not Applicable||October 2022||January 2023||April 2023|
|September 16, 2022||September 16, 2022||Not Applicable||March 2023||May 2023||July 2023|
|January 13, 2023||January 13, 2023||Not Applicable||June 2023||October 2023||December 2023|
|May 12, 2023||May 12, 2023||Not Applicable||October 2023||January 2024||April 2024|
|September 15, 2023||September 15, 2023||Not Applicable||March 2024||May 2024||July 2024|
|January 12, 2024||January 12, 2024||Not Applicable||June 2024||October 2024||December 2024|
|May 17, 2024||May 17, 2024||Not Applicable||October 2024||January 2025||April 2025|
|September 13, 2024||September 13, 2024||Not Applicable||March 2025||May 2025||July 2025|
It is critical that applicants follow the Training (T) 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.
Purpose and Background Information
The overall goal of the NIH Research Career Development programs 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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.
The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.
The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public. Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare a heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars who demonstrate a commitment to independent research careers, and to facilitate their transition to NIH research grant support, e.g., research career development awards or research grants. This program provides support and protected time to scholars for an intensive, research career development experience under the guidance of an experienced mentorship team with expertise in clinical and translational science. The institutional research career development (K12) programs prepare scholars to transition into research independence in clinical and translational science and to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health. Institutional research career development (K12) programs are expected to be designed with a sustained period of protected time to enhance the scholar’s research-focused career development experiences as clinical and translational science researchers, both in their chosen areas and in research areas that includes: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and/or 4) public health. By understanding the scientific and operational principles underlying each step of the translational process, upon the completion of the institutional research career development program, the scholars will be prepared to launch into research independence. The scholars should be able to turn observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public while simultaneously poised to take on leadership roles in clinical and translational science.
Diversity at all levels—from fields of science to the regions in which it is conducted to the demographic backgrounds of scientists — contributes to excellence in mentored research career development environments and strengthens the research enterprise. This FOA is intended to support outstanding mentored research career development programs that will enhance diversity at all levels (e.g., see the Notice of NIH’s Interest in Diversity).
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics, and medical devices to patients. Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. NCATS studies translation on a system-wide level as a scientific and operational problem. The NCATS approach is not to focus on specific diseases, but on what is common among them and the translational science process. NCATS does this by developing new approaches, technologies, resources and models; demonstrating their usefulness; and disseminating the data, analysis and methodologies to the community.
The objective of the institutional research career development (K12) programs component of the Clinical and Translational Science Awards (CTSA) Program is to prepare and provide protected time to scholars for an intensive mentored research career development experience that leads to full research independence and leadership positions in clinical and translational science. At the end of the research career development experience, the scholars should be well positioned with the knowledge, skills, and ability to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.
Proposed institutional research career development (K12) programs are expected to nurture the scholars’ development of the following characteristics irrespective of their particular area(s) of expertise (Reference: Gilliland CT, et al. The Fundamental Characteristics of a Translational Scientist. ACS Pharmacol Transl Sci. 2019;2(3):213-216. doi:10.1021/acsptsci.9b00022):
Clinical and translational scientists exhibit both deep scientific domain expertise and systems understanding. Their research is designed to produce discoveries that are simultaneously important for their discipline(s) and complementary disciplines, thus advancing the translational process as a whole. These characteristics are required in order for scholars to successfully transition into research independence, and to effectively traverse and contribute to the advancement of the translational science spectrum.
Applicants are expected to identify research career development needs and objectives (i.e., specific and measurable outcomes the program intends to achieve).
Funded programs are expected to implement the following:
Core Knowledge Expectations in Clinical and Translational Science Research: The institutional research career development (K12) program should be designed to ensure that by the end of the research career development training period, scholars are able to launch into independent research careers in clinical and translational science research areas, which include 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and/or 4) public health. Scholars are expected to apply their cumulative experiential research training and knowledge in broad areas of research including, but not limited to: clinical and clinical trial research, regulatory science, biostatistics, epidemiology, health disparities, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement and cultural diversity, translational team science, entrepreneurship, scientific communication, project management, patents, Investigational New Drug (IND) filling process, FDA regulatory process, teaching pedagogy, leadership, and responsible conduct of research and rigorous research design.
The award may be used to support scholars with different levels of prior research training and at different stages in their mentored career development. For example, a scholar with limited experience in clinical and translational science may receive support in the career development experience that includes a designated period of didactic training followed by a period of closely mentored research experience. A scholar with previous research experience and training may not require extensive additional didactic preparation and may receive support in the form of career development experience that focuses on an intensive, mentored research experience in clinical and translational science.
Clinical and Translational Science Research is a Team-Based Endeavor:
The institutional research career development (K12) programs are encouraged to be personalized so that scholars can further refine their domain-specific knowledge, skills and abilities (KSAs) and effectively transition to full research independence in clinical and translational science. Scholars are expected to carry out independent research in their disciplinary mastered competencies, while also gaining complementary knowledge of other disciplines and operational principles underlying at least two sectors of the translational science ecosystem to improve their capacity to effectively lead, communicate, collaborate, and break down barriers across multidisciplinary teams and the translational process. Clinical and translational science research is a team-based endeavor that requires input from many different disciplines, sectors, and points of view to be successful. Programs should support partnerships that give scholars scientific practice outside of their area(s) of expertise, both within the research academic domain and with stakeholders and with sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.
Building on Institutional Strengths in Clinical and Translational Science Research: Each institutional research career development (K12) program is to be innovative in their research career development program efforts. The goal is for the scholars to improve their core competencies so that they can conduct high quality independent clinical and translational science research. To achieve this, research-focused career development programs are encouraged to build on the local strengths and demonstrated translational innovations of their companion CTSA Program hub (e.g., health disparities, telehealth and telemedicine, community engagement, bioinformatics, dissemination and implementation, entrepreneurship, etc.) to effectively curate and foster research independence of clinical and translational science scholars. In this spirit, programs should identify research-focused career development strengths, needs and objectives (e.g., specific and measurable outcomes the program intends to achieve) that will lead the scholar’s transition to fully independent research careers while creating a community of clinical and translational science research scholars that extends beyond the career development program. Building on institutional strengths can include approaches on how to expose scholars to a larger cadre of mentors with diverse clinical expertise, experiences, resources, and backgrounds relevant to clinical and translational science and who can help the scholars launch into independent research careers, thusly, be competitive for research project grant (e.g., R01) funding.
Diversity Contributes to Excellence: Within the framework of the institutional research career development (K12) program’s commitment to excellence and projected need for investigators in particular areas of research, attention must be given to diversity at all levels—from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it. Diversity contributes to excellence in research training environments, is needed to address complex translational problems, and strengthens the clinical and translational science research enterprise. Programs are expected to demonstrate a commitment to promoting inclusive, safe and supportive scientific and training environments. Programs are expected to collectively expand the pool of clinical and translational science-trained professionals and ensure the translational science workforce is broadly representative across racial, ethnic, sex, gender, age, socioeconomic, geographic and disability status. This FOA is intended to support outstanding institutional research career development programs that will enhance diversity at all levels (e.g., see the Notice of NIH’s Interest in Diversity).
Optimizing Mentor Training: Effective mentoring is expected to increase self-efficacy, educational and career satisfaction, career advancement, and research productivity for individuals pursuing clinical and translational science research-focused careers. Institutional research career development (K12) programs are to describe how the participating faculty and preceptors are trained to use evidence-informed mentoring practices that launch scholars from all backgrounds e.g., scholars from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity) into independent research-focused careers. The evidence-informed mentor training assessments are expected to move beyond the faculty’s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness. The application is to include a plan to assess and monitor how well the faculty mentor/preceptor promotes a safe, inclusive, and supportive research training environment and to make adjustments if needed. Scholars are to corroborate the self-report of changes in mentoring behaviors of each mentor in the mentoring team. Institutions are encouraged to develop strategies to recognize and reward outstanding mentors, including mentor awards, and to create opportunities where effective mentoring practices pervade the education and clinical and translational science research landscape of the institution.
Leadership and Management: In addition to the above referenced Fundamental Characteristics of a Translational Scientist, leadership is another essential characteristic of clinical and translational science scientists. Leadership and management training should be infused into the research-focused career development program activities of the institutional research career development (K12) program in Clinical and Translational Science Awards (CTSA) Program so that scholars can develop professional and leadership skills (e.g., emotional intelligence, implicit bias, imposter phenomenon, conflict resolution, job offers negotiation, laboratory management, balancing competing priorities) to be effective leaders in clinical and translational science.
Career Visibility and Enhancement: The career outcomes of scholars supported by the institutional research career development (K12) program in Clinical and Translational Science Awards (CTSA) Program include, but are not limited to, independent research-intensive careers in academia and industry. Research-focused career development programs must make available structured, career development advising and coaching (e.g., academic job search strategies, Individual Development Plans, Diversity, Equity and Inclusion workshops, microaggression, grant-writing, publishing,) aimed at increasing the competitiveness of the scholars to successfully transition, in a timely manner, to the next stage of their independent research career and become fully independent researchers. The career development activities should enhance the scholars’ scientific and professional network beyond the local institution.
NCATS seeks the submission of one set of companion applications. With this FOA for the K12 application, a separate, companion FOA seeks applications for a required UM1 (PAR-21-293: Clinical and Translational Science Award). Resubmission of a K12 application without the required UM1 application is only allowed if the companion UM1 application is awarded.
Note: This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
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. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are to reflect no more than $700,000 Direct Costs for Hub Tier G; $900,000 Direct Costs for Hub Tier T; $1,000,000 Direct Costs for Hub Tier C; and $1,500,000 Direct Costs for Hub Tier A per budget period. Hub tiers must be ascertained in order to determine the maximum budget that can be requested for the UM1 companion application. Please see PAR-21-293: Clinical and Translational Science Award.
Funds may be used only for those expenses that are directly related to and necessary for the career development of K12 Scholars and must be expended in conformance with OMB Cost Principles and the NIH Grants Policy Statement.
The award budget includes salary support for the PD(s)/PI(s) and Scholars, research and development support, and administrative support costs.
The project period duration is up to 5 years.
Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.
Salary support for individuals involved in program administration and management must be substantially justified. Salary support for ancillary personnel (e.g. administrative assistance or secretarial support) on CDAs is not allowable.
Up to 1.2 person months total effort per annum may be allocated for all PDs/PIs of the K12 program to partially offset their salaries and associated fringe benefit costs, depending on commitment of effort (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-045.html). These salary and fringe benefit expenses must be included in Section A of the R&R Budget.
Up to 6.0 person months total effort per annum may be allocated for all other program administrative and management personnel (e.g., program administrator/program coordinator and/or program assistant) to partially offset their salaries and associated fringe benefit costs. These salary and fringe benefit expenses must be substantially justified and included in Section A of the R&R Budget.
Salary requests for the Program Faculty, mentors, or ancillary personnel are not allowed.
Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.
NCATS will contribute up to $120,000 per year toward the salary of each K12 scholar. Note that the salary allowance will be commensurate with the actual number of person months committed to program-related activities. The $120,000 amount is exclusive of fringe benefits. In general, 9 person-months (75 percent of the K12 full-time effort) must be devoted to the K12 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below. The total amount budgeted per scholar must not exceed $180,000 in direct costs per year.
Scholar Research and Development Support: The K budget must include funds to support K scholar research projects and career development activities. No less than $10,000 and up to $30,000 per individual Scholar must be provided for the following types of research-related expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training that the institution determines to be necessary for the individual’s career development experience; and (d) statistical services including personnel and computer time. No more than $5,000 of the scholar research and development support funds per scholar may be pooled for program-wide activities only if such activities support the career development of all scholars. It is expected that the K12 Scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to the scholar. These expenses must be itemized in Section F of the R&R Budget.
The application must clearly indicate the number of scholar appointments proposed for each year. Candidates must have a full-time appointment at the applicant institution or a partnering institution. Scholar support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments, provided their progress towards an independent academic career is on track and satisfactory. Applications must be able to show their ability to recruit scholars who can complete the entire two to five-year proposed program. Programs may not split funds for an awarded slot across two or more individuals.
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
K12 funds cannot be used to recruit scholars (e.g., travel for interviews, recruitment events, recruitment brochures, advertisement costs, etc.). All costs associated with recruitment will be deemed unallowable.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
With this solicitation for the K12 application, a separate, companion FOA solicits applications for a required UM1 (PAR-21-293). A UM1 hub application without the required companion K12 application will not be reviewed. The required K12 application will only be awarded if the UM1 application is awarded. Initial and resubmission of K12 will be accepted concurrently or if the UM1 application is awarded.
The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. The applicant institution must be the UM1 applicant. The UM1 institution must have a strong and high-quality research program in the area(s) proposed under this K12 FOA and must have the requisite faculty, staff, potential scholars and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goal.
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 must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. In order to ensure that the PD/PI has adequate time to devote to the training program, a UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the K12 application or award.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed."
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Only one K12 application will be awarded if the UM1 application is awarded. If the UM1 is awarded and the initial K12 is not, the K12 application may be resubmitted. If the UM1 (A0) application is not awarded, then the K12 (A0) will not be awarded.
NCATS solicits the submission of one set of companion applications. With this FOA for the K12 application, a separate, companion FOA seeks applications for a required UM1 (PAR-21-293: Clinical and Translational Science Award). The UM1 and initial K12 applications must be submitted concurrently; a K12 application without the required companion UM1 application will not be reviewed. The required K12 application will only be awarded if the UM1 application is awarded. Resubmission of a K12 will be allowed only if the UM1 application is awarded.
Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Program faculty should have experience in working in multidisciplinary teams. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (see Notice of NIH's Interest in Diversity) and at different career stages (i.e., early-career as well as established faculty).
Each scholar should have at least two mentors and at least one mentor should have a clinical background. The mentors should hold faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in the area of clinical and translational science. Mentors must have an excellent track record for supporting and advancing the careers of young clinical and translational scientists. Established, funded investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by scholars for research projects that will enhance their knowledge and skills. Mentors must have track records in mentoring and training. Mentors are expected to interact directly and consistently with the scholar in order to develop an individualized career development plan. No less than two mentors must be appointed to the scholar’s research-focused career interest and provide guidance for the development of each scholar. Mentors must be committed to continue their engagement throughout the scholar's total period of development under the award.
Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.
Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.
Scholars must have a research or health-professional doctoral degree or its equivalent.
Candidates should be later stage postdoctoral fellows or junior faculty who can take full advantage of and benefit from the described state-of-the-art research-focused career development program in clinical and translational science. Consistent with the type of mentoring and career development being provided by the CTSA Program, a K12 scholar candidate who is already in the process of applying for an independent mentored career development grant, Program Project Grants/Center Grants or equivalent grant is likely too senior for the K12 award.
Non-surgical specialties scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award. Surgical specialties can have less than 9 person-months (75% of full-time professional effort), but no less than 6 person-months (50%), protected time for this program, if sufficiently justified and programmatically approved.
Candidates must have a full-time appointment at the applicant institution or a partnering institution.
Individuals from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity) are always encouraged to be appointed to the K12.
At the time of appointment, scholars must not have a pending application for any other PHS mentored career development award (e.g., K07, K08, K22, K23, F99/K00) that duplicates any of the provisions of the K component. Former or current PDs/PIs on any NIH research project grant [this does not include NIH small grants (R03), Exploratory/Developmental (R21) or SBIR, STTR (R43, R44 grants)] or equivalent non-PHS peer reviewed grants that are over $100,000 direct costs per year, or project leaders on sub-projects of Program project (P01) or center grants (P50) are NOT eligible to participate as scholars.
Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (e.g., R01, R03, R15, R21, R34, or equivalent application from another Federal agency); if successful, scholars may be required to reduce effort on the mentored career award to a minimum of six-person months and hold concurrent support from their mentored career award and a competing PHS research grant on which they are the PD/PI or component lead or terminate the K12 appointment depending on Program requirements (See NOT-OD-08-065).
Scholars must be selected with the anticipated ability to complete the entire two to five-year proposed program. The selection committee must consider whether individuals who have pending NIH research grant applications with fundable scores that would require early K12 termination are appropriate for this award.
Repeated selection of individuals who subsequently require early termination may affect outyear funding.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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 Training (T) 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (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.
Descriptive Title of Applicants Project: Use the format “CTSA K12 Program at Name of Institution.”
Cover Letter Attachment: The Cover Letter is one pdf file only. Applications that are part of a collaborative set must include the following information: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/3”), and 3) the Applicant Institution. Each site should submit an identical listing.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:
An External Advisory Committee (3-page maximum). A plan must be provided for the appointment of an External Advisory Committee. The External Advisory Committee will be a group of scientists from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to clinical and translational science. The two major functions of the committee are to evaluate: 1) applications from potential scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the scholars' research experience), and makes recommendations regarding their continuation. The committee may use institutional or outside consultants, if needed.
In the plan provided, describe the composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information. Describe how the External Advisory Committee will evaluate the overall effectiveness of the program. Proposed External Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with External Advisory Committees should include the names of all committee members during the past project period. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file “External_Advisory_Committee.pdf”.
Scholar Selection and Appointment Process (3 page maximum). Define and justify the selection and appointment criteria for scholars. The applicant must provide information about the process that will be taken by the participating departments/interdepartmental programs to recruit grant eligible individuals. Where applicable in the application the applicant must explain how it will identify and recruit a diverse pool of potential candidates from a wide variety of institution types and backgrounds (e.g., individuals from underrepresented groups in the biomedical sciences, NIH's Interest in Diversity). Applicant must explain how it will ensure that the selection process will recruit scholars who can complete the entire two to five-year proposed program. Please name the file “Trainee_Selection_Process.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.
Mentor/Scholar Assessment Plan (5-page maximum): The assessment plan is to describe how the program will monitor mentoring relationships. The plan must describe the approaches and tools that will be used to support the mentors’ self-rated quality of mentoring with those perceived by their mentees. The plan must include a description of how the Program leadership monitor, address and intervene in instances of major discrepancies. A plan for removing faculty displaying unacceptable mentorship qualities from the training program must be described. The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor the mentoring relationship progress and (b) determine whether the training and research environment is effective, inclusive, safe, and supportive. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file “Mentoring_Assessment.pdf”.
Sustainability Plan (1-page maximum). The application must provide a plan for supporting scholars whose appointments will be on-going at the end of the project period. Additionally, to plan for situations in which a Renewal application of the K12 and the UM1 are deemed to be non-competitive during peer review, renewal applications must include contingency plans for supporting current scholars so that they may complete their career development activities beyond the funding period. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file “Sustainability_Plan.pdf”.
Outcomes Data Collection and Storage Plan (2-page maximum). Funded programs are expected to track scholars for a minimum of 15 years beyond the scholar’s participation in the program. The applicant must provide a plan to track the outcomes for all supported scholars. Programs are encouraged to make the aggregate outcome data available on the grantee institution's website. If the applicant intends to make the data available, describe how the aggregate data will be de-identified before public posting. The applicant must include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name the file “Data_Collection_Storage_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.
Dissemination Plan (1-page maximum). The application must provide a specific plan to disseminate nationally any findings or materials developed under the auspices of the program. Examples of dissemination may include data or materials from successful training or mentoring interventions via web postings, presentations at scientific meetings, and/or workshops. Please name the file “Dissemination_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.
Coordination and Interaction Plan (3-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 and any optional components. The application must describe the overarching goals of each component and the coordination, integration, synergy, and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Please name the file “Coordination_Interaction_Plan.pdf”. If this attachment is not included, the application will be considered incomplete and will not be reviewed.
Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.
Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral, faculty ), and intended scholar outcomes
The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application.
Applicants may designate a Training Director (TD) who will have responsibility for the day-to-day administration of the program. The Training Director may be one of the PD(s)/PI(s). The Training Director should be an established scientist with the expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary career development program of this scope. The Training Director will be expected to monitor, assess, and submit all documents and reports as required.
Follow all instructions provided in the SF424 (R&R) Application.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Research and Related (R&R) Budget
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
The PHS 398 Research Training Program Plan Form is comprised of the following sections:
Follow all instructions provided in the SF424 (R&R) Application Guide.
Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.
For this FOA, applicants should use the following Data Tables only (Data for scholars should be entered into the Postdoctoral sections of the Data Tables):
Describe the strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD(s)/PI(s) and Training Director. Relate these strengths to the proposed management of the career development program. Describe the respective roles of those in leadership positions and the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PD(s)/PI(s), then the plan for Program Administration is expected to synergize with the “Multiple PD(s)/PI(s) Leadership Plan” section of the application. The program leadership is to demonstrate a commitment to developing the next generation clinical and translational science workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. The PD(s)/PI(s) should have received evidence-informed training on how to effectively mentor individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity).
When an administrative coordinator position is planned, a description of the administrative capabilities essential to coordinate a program for developing investigators must be included in the application.
Institutions with existing K12 programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.
The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful career development guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation. The program faculty are to employ the highest standards of scientific rigor and impact those standards to the scholars. The program faculty are to receive evidence-informed training on how to effectively mentor individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity).
The application should describe plans for scheduling scholar appointments. Candidates must have a full-time appointment at the applicant institution or a partnering institution. Support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of 12-month appointments. If the event that a clinical trial may be proposed, discuss the potential of prospective Scholarsto organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.
Support of scholars is renewable at the discretion of the PD/PI, contingent upon presentation of evidence of satisfactory progress as determined by the External Advisory Committee. The pool of potential scholars and criteria for selecting scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified and diverse scholars.
Proposed Career Development
Describe how the research-focused career development program activities will ensure that scholar’s transition into research independence in clinical and translational science. In addition, describe proposed training in leadership and management (e.g., emotional intelligence, conflict resolution, negotiation, communication, self-advocacy, stress management and wellness, balancing competing priorities, etc.).
Programs should also describe the anticipated timeline by which scholars will develop a research project that will begin during the K12 support period that will be suitable for continuation beyond the K12 support period via an individual funding mechanism or independent NIH research funding (e.g., R01, R21, P50) or equivalent grants. Programs should also describe an administrative structure that facilitates successful adherence to this anticipated timeline, including potential corrective measures if milestones are not met.
Provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for any clinical trial, including any feasibility or ancillary study, proposed by scholar(s).
If any mentors will supervise a Scholar proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.
If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.
Institutional Environment and Commitment to the Program
The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program. Programs are encouraged to rigorously enforce this protected time. Surgeon-scientists must devote a minimum of 50% full time professional effort to research and career development activities.
The application must include a signed letter, on institutional letterhead, that describes the applicant institution's commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
This commitment may include features such as PD/PI salary, or tuition support for individuals involved in the proposed career development program, or other commitments essential to a successful career development program.
Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.
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 theSF424 (R&R) Application Guide instructions.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:
Study Record: PHS Human Subjects and Clinical Trials Information
DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.
If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.
All instructions in the SF424 (R&R) Application Guide must be followed.
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). 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. Each application of a collaborative set must be on-time. Considerations for late applications that are based on the institution or PD/PI apply only to his/her individual application.
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.
Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?
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.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific aspect of the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.
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 specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
Select Agent Research
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).
Budget and Period of Support
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), convened by NCATS 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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Will receive a written critique.
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 appropriate national Advisory Council or Board.
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 recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.6. 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.
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. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
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.
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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
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.
The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year,
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. Evaluation results should be included as part of the final RPPR.
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.
NCATS intends to assess the overall evaluation of the program and it 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, application errors and warnings, documenting system problems that threaten on-time submission, and 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)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Mercedes Rubio, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Carol Lambert, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
National Center for Advancing Translational Sciences (NCATS)
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 and 2 CFR Part 200.
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.
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.