Slots: Only one K12 application per UM1 applicant institution is allowed.
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.
Deadlines
Internal Deadline: Monday, March 18th, 2024, 5pm PT Contact RII.
LOI: N/A
External Deadline: May 17, 2024
Recurring Deadlines: September 13, 2024
Award Information
Award Type: Grant
Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Anticipated Award Amount: 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.
Who May Serve as PI: 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.
Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-336.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
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):
- Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between.
- Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.
- Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team.
- Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.
- Skilled Communicator: Communicates clearly with all stakeholders in the translational process across diverse social, cultural, economic, and scientific backgrounds, including patients and community members.
- Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.
- Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility.
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.
Considerations
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.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.