Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PAR-18-940 - Clinical and Translational Science Award (U54 Clinical Trial Optional)

Issued by

National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

The purpose of the NIDCR Administrative Supplement to the National Center for Advancing Translational Sciences (NCATS) supported Clinical and Translational Science Awards (CTSA) program is to develop well trained investigators conducting rigorous clinical and translational research aimed at improving dental, oral, and craniofacial health.

This Notice of Special Interest (NOSI) will support additional scholars to active KL2 grants currently approved under the CTSA Program. The program will provide supplementary funds to support advanced clinical and translational research opportunities for exceptional postdoctoral and junior faculty translational researchers who are early in their dental, oral, and craniofacial (DOC) research careers.

Background

The NCATS CTSA KL2 Institutional Career Development Core supports research career development goals of the CTSA program and is expected to foster high-impact research careers in translational research. Career development across a CTSA hub is expected to be harmonized, and to integrate clinical and translational science across multiple departments, schools, and clinical research institutes. The hubs promote a team science approach to research collaboration that includes a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics, and bioengineering). The objective of the institutional Mentored Career Development KL2 Program award is to facilitate the development of clinician-scientists who will ultimately lead collaborative research efforts in translational science.

The KL2 component of the CTSA has a separate PD/PI to lead, manage and oversee the core, and has program faculty to serve as mentors. The CTSA-funded institution selects KL2 scholars, providing them with a rich career development experience in a multidisciplinary setting. KL2 appointees referred to as Clinical Research KL2 Scholars come from a variety of fields (e.g., medicine, dentistry, nursing, the behavioral sciences, biostatistics and epidemiology) and can receive up to five years of KL2 career development support.

The KL2 program combines formal course work with direct research experience, and an opportunity to pursue additional advanced degrees. All scholars, including those at CTSA partner institutions, have access to CTSA research facilities, which may include courses in clinical research methodology, seminars and workshops; use of specialized core facilities, laboratories, and databases; access to a team of clinical research mentors; administrative and regulatory support for research protocols and funding for pilot research projects.

NIDCR Supplements to NCATS KL2 Program

The goal of this NIDCR KL2 administrative supplement program is to engage the participation of scholars pursuing clinical and translational research training to improve dental, oral, and craniofacial health. For this KL2 supplement program, scholars must be pursuing clinical and translational research in dental, oral, or craniofacial science that aligns with NIDCR extramural grant programs.

NIDCR Programmatic Requirements

Eligible Applicants (Program Director/Principal Investigator)

PD(s)/PI(s) of active NCATS KL2 grants awarded in response to PAR-18-940 are eligible to apply for a supplement if there is at least two years of support remaining in the project period, excluding any extension phase, at the time of the supplement award. Parent KL2 grantees with applications under review are not eligible to apply for a supplement. The PD(s)/PI(s) will recruit and nominate scholars for NIDCR KL2 administrative supplement awards and are encouraged to identify scholars who will enhance diversity on a national basis (see NOT-OD-20-031 Notice of NIH’s Interest in Diversity).

The supplement applications are expected to propose an individualized program of translational science education and career development that leverage the infrastructure support, curriculum, and mentorship expertise of the CTSA program. The scholars' proposed research experience must be integrated with the KL2 career development core.

Mentors

The application must identify a primary mentor who is associated with the parent KL2 grant and a co-mentor who is an NIDCR funded investigator who has expertise in the scholar’s proposed area of research. The PD/PI of the KL2 award is not required to be the primary mentor, but the primary mentor is expected to have a defined role on the KL2 award. Other co-mentors and consultants may be included as needed for the project proposed. The PD/PI of the parent grant must concur with the supplement application. If the primary mentor is a relatively junior faculty member and has modest research and mentoring experience, an experienced and more senior co-mentor should be included.

Eligible Candidates

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

Eligible scholars must have a doctoral dental degree (DDS, DMD or dual degree DDS/DMD and PhD or equivalent degrees).

At the time of award, scholars must have a full-time position at the applicant institution or a partnering institution, must be able to devote a minimum of 75% professional effort to the proposed research experience, and to devote the remaining effort to activities related to the development of a successful career as a clinician scientist.

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), individual career development awards (e.g., K01, K08, K22, K23, K25, K99/R00), or Project Leads of program project (P01) or center grant (P50) sub-projects, or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Planning Grant (R34/U34), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

At the time of award, the scholar may not have pending an application for any other PHS mentored career development award (e.g., K08, K23) that duplicates any of the provisions of the KL2 administrative supplement. In keeping with the type of mentoring and career development being provided by the CTSA, a KL2 scholar who is already in the process of applying for an independent mentored career development award, an R01 or equivalent grant is likely too senior for the KL2 award.

Scholars are encouraged to apply for individual mentored K awards (e.g., K08, K23) and independent awards (R03, R21, R01) during their period of KL2 support. If the candidate successfully competes for a mentored K award, the KL2 appointment would be terminated, and funding would be received from the new individual K. KL2 scholars and mentored K awardees may have a concurrent independent R03, R21, R01 or equivalent awards from NIH or another federal agency (see NOT-OD-08-065, and the NIH Grants Policy Statement (12.3.6.2 Concurrent Support).

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

Each applicant organization (Hub) may submit up to two applications in response to this NOSI. Each application must include only one named candidate (scholar) in the administrative supplement application.

Award Budget

Budget forms: Using the R&R budget form, only include funds requested for the additional supplement activities.

Application budgets must reflect the actual needs of the proposed project. Requests may be for a minimum of 2 years of consecutive funding for each scholar, consisting of 12-month appointments. The requested number of years of support is expected to align with the typical length of appointments at the parent KL2 program.

NIDCR will contribute up to $100,000 per year toward the salary of the KL2 scholar supplement award recipient. The award requires the scholar to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting dental, oral, or craniofacial translational research. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the KL2 research career development program.

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to salary.

Other Direct Costs: The KL2 supplement budget will include funds to support the scholar's research project and career development activities. Applicants may request up to $25,000 per year to cover the following expenses: (a) tuition and fees related to career development; (b) research expenses such as supplies, equipment, and technical personnel; (c) travel to scientific meetings and research training workshops; and (d) statistical services.

In addition, mentor support may include up to $10,000 per year associated laboratory or other research-related expenses. Salary support for mentors is not an allowable budget item.

R&R Other Project Information form, Facilities and Other Resources attachment: Describe how the scientific environment in which the career development activities will be done contributes to the probability of the scholar’s success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Program hub training resources, describe the training resources that are available to the scholar.

Biographical sketch Senior/Key Personnel: Include a biographical sketch of the KL2 PD(s)/PI(s) and of each of the individuals who will comprise the scholar's mentoring team and advisory team (if applicable). The personal statements of the individuals who will serve as mentors or are on the scholar's mentoring team should include a description of their specific role in mentoring the scholar.

Biographical sketch Scholar: The personal statement of the candidate’s biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NIDCR KL2 supplement award. Relevant factors include previous training and research accomplishments in dental, oral, and craniofacial research and any source(s) of current research funding. The description should include a description of how the supplement will further the candidate’s career goals.

Program Faculty: Provide information about the program faculty who will be involved in the supplement activities, including their complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

Proposed Research Career Development Plan: (5 page limit)

The proposed research career development plan must align with the NIDCR’s research mission and the KL2 program. Scholars must pursue clinical and translational research in dental, oral, or craniofacial science. The research experience should challenge the scholar's scientific curiosity while introducing a creative, novel, and clinically significant approach to dental, oral, or craniofacial research. The research supported under this FOA is intended to enhance the scholar's transition to an independent research career as a PI or as an investigator providing expertise in a collaborative team science approach. The research plan should augment the scholar's research development and be individualized to their scientific discipline and expertise. Describe key activities during the supplement, including mentored team science activities, didactic coursework, and technical training to enhance skills and proficiency in conducting translational research. Describe how these experiences will build the candidate’s expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, if applicable. Address the candidate's priorclinical training in dental, oral, or craniofacial disease and describe how it will be incorporated into the research career development plan. Describe the candidate’s contribution to the proposed research. Provide a detailed timeline of activities and benchmarks of success or goals to be achieved over the duration of support.

This program is intended to provide a foundation for subsequent grant applications and support for continued research career development, or for independent research funding from NIDCR/NIH or other sources. Scholars must include plans to apply for individual mentored K awards (e.g., K08, K23) or independent research grants (R03, R21, R01) or other sources of independent support before their KL2 supplement period ends. Include a timeline for activities and potential publications and grant applications for independent research support.

Describe the mentoring and supervision from the primary and co-mentor(s) that will occur during the award period and a plan for monitoring the candidate's progress. Clearly state how the candidate’s project is, or will lead to, a research project independent of the parent grant and the PI’s research area.

Candidate’s Personal Statement (up to 2 pages):

Describe prior research experiences and accomplishments, short- and long-term research objectives and career goals, including plans for submission of an independent K, R, or other type of NIDCR independent award to support dental, oral, and craniofacial research and how the supplement research experience will contribute to these goals.

Institutional Environment and Commitment: Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned KL2 supplement program. The letter should provide assurance that the scholar will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to their KL2 research career development program. The remaining effort should be devoted to activities related to the development of the scholar’s career as an independent investigator or clinician-scientist, e.g., clinic responsibilities, teaching and administration, and/or additional research activities.

Letters of Support:

Appropriate letters of support should be provided from all individuals confirming their roles in the proposed supplement program. Primary and co-mentor(s) should include a statement of commitment to provide appropriate guidance and supervision of the candidate's research experience that supports an independent research career trajectory.

PHS Human Subjects and Clinical Trials Information form: Complete this form if the scholar will design and conduct their own independent human subject research. Approval by the reviewing Institutional Review Board is required prior to award. Adherence to all the NIH policies for human subject research must be ensured if additional human subjects' involvement is planned for the supplement component.

Awardee-selected projects that involve human subjects research and/or animal research require prior approval by NIH prior to initiation. The awardee institution will provide NIH/NCATS with a written study package submitted through the Human Subjects System (HSS) for human subjects research and via email for animal studies. The guidance and contents of the study package may be found posted under the NCATS Prior Approval checklist (https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/prior-approval-of-planned-research-involving-human-subjects/).

KL2 PD(s)/PI(s) and potential scholars are strongly encouraged to contact NIDCR to discuss their proposed research experience prior to application submission.

Award Date(s) January-July 2023

Requested award start dates should align with the parent award CTSA KL2 start date.

Application Review Criteria

Budget and Period of Support

NIDCR staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research and research career development activities.

Overall Impact

NIDCR staff will consider the following questions to determine the likelihood that the proposed supplement activities will contribute to a well-trained dental, oral, and craniofacial early career research workforce with competencies in clinical and translational research and skilled in team science approaches and will provide a foundation for the scholars to apply for subsequent NIDCR career development or research awards:

• Do the qualifications of the candidate including career goals, prior research training, and any relevant experience support the candidate’s research potential and strong dental, oral, or craniofacial clinical and translational research trajectory?
• Will the proposed Research Career Development Plan and timeline increase the likelihood for the scholar to develop a strong clinical and translational research program, or to develop collaborative expertise and contribute as a strong member in team science approaches?
• Is there evidence that the proposed research and career development experiences will expand and foster the research capabilities, knowledge, and/or skills of the candidate and provide a foundation for subsequent grant support?
• Is there evidence that the candidate will receive appropriate guidance, mentoring and supervision to achieve the proposed activities and goals?
• Do the proposed mentors have the appropriate mentoring experience and research qualifications, expertise, and research accomplishment in the areas of the proposed research?
• Do mentor(s) demonstrate commitment to the candidate and have research funding available to support the scholar's proposed research project?
• Is there clear commitment from the sponsoring institution to ensure that the required minimum of the scholar’s effort will be devoted directly to the research training and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities, if applicable?

Although NIDCR is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to:

Anissa J. Brown, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4805
Email: [email protected]

Carol Merchant, MD, MPH
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0605
Email: [email protected]