NIDCD Research Career Enhancement Award (K18)

NIDCD Research Career Enhancement Award (K18) is sponsored by NIH NIDCD. Provides support for career development in speech and language pathology research.

Expired PAR-21-096: NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) K18 Career Enhancement Award Reissue of PAR-19-143 - NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) Notices of Special Interest associated with this funding opportunity February 8, 2024 - This PAR has been reissued as PAR-24-142 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-094 - NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Required) PAR-21-095 - NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Clinical Trial Not Allowed) See Section III. 3. Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences.

This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants. ” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

Studies conducted with specific applications toward processes or products in mind should submit under PAR-21-094 " NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Required)" ’ Applicants not planning an independent clinical trial or basic experimental study with humans, or proposing to gain research experience in a clinical trial or basic experimental study with humans led by another investigator, must apply to companion FOA PAR-21-095 "NIDCD Research Career Enhancement Award for Established Investigators (K18Independent Clinical Trial Not Allowed)" .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) February 8, 2021; June 8, 2021; October 8, 2021; February 8, 2022; June 7, 2022; October 7, 2022; February 8 2023; June 8, 2023; October 10, 2023 apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date . AIDS Application Due Date(s) Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

The first AIDS date for this application is May 7, 2021. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. July 2021; November 2021; March 2022; July 2022; November 2022; March 2023; July 2023; November 2023; March 2024 apply.

October 2021; January 2022; May 2022; October 2022; January 2023; May 2023; October 2023; January 2024; May 2024 apply.

December 2021; April 2022; July 2022; December 2022; April 2023; July 2023; December 2023; April 2024; July 2024 apply Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Funding Opportunity Description The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.

NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.

More information about Career programs may be found at the NIH Extramural Training Mechanisms website. The objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge.

The purpose of this FOA is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in research areas supported by the sponsoring NIH Institute(s)/Center(s).

Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions.

It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

The objective of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to provide support for experienced scientists to remain current in state-of-the-art techniques, evolving technologies, and the fundamental, translational, and clinical research frontiers related to the hearing, balance, smell, taste, voice, speech, and language sciences.

Established investigators often express an urgent need for compensated protected time and mentored training to augment their research capabilities and to keep their research programs in-step with emerging technologies and evolving scientific frontiers and, thereby, competitive for continued NIH funding.

This initiative provides candidates with protected time and mentored guidance to augment or redirect their research career trajectories within the NIDCD research mission. It focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent research support (past and/or present).

The purpose of this FOA is to provide such investigators with support for short-term, intensive periods of mentored research experience over a period of six- to twenty-four months to acquire new research capabilities in the study of hearing, balance, smell, taste, voice, speech, or language sciences.

Such experiences, typically undertaken during an academic sabbatical year, will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; 2) redirect their research programs in new trajectories within the NIDCD scientific mission; and/or 3) catalyze research collaborations in new research directions.

It is expected that this initiative will lead to new and augmented research programs competitive for NIH funding.

In addition to serving as a short-term career development vehicle for investigators within the NIDCD Extramural research community, this program is also intended for investigators working outside of the hearing, balance, smell, taste, voice, speech, and language sciences who wish to add research direction within the NIDCD scientific mission to their overall research programs.

The research career enhancement experience shall take place in a host laboratory, whether in the applicant institution (i.e., in which the candidate holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career development experience. In both cases, the tutelage of a well-qualified host/mentor (or team of mentors/hosts) is required.

In most cases, the applicant and proposed mentor(s) and host laboratory will not have had previous research collaborations. The research career development experience proposed must have the potential to substantially augment the research capabilities of the candidate at the applicant institution, and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s).

The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate, and will generally incorporate two components: 1) didactic (e.g., directed study/tutorials, semester-long courses, short courses, seminar series, journal clubs) and/or laboratory-based instruction in the new discipline, techniques or technologies; and, 2) a small-scale research project at the host site.

The research enhancement experience may comprise translational or clinical/patient-oriented research (including epidemiologic, outcomes and health services research).

All applications submitted to this Funding Opportunity Announcement must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. ” ( 32 CFR 272. 3 ).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." ( NOT-OD-15-015 ).

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this FOA, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena should submit under this FOA.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate FOA for the type of study Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the PAR-18-562 ‘Independent Clinical Trial Required’ FOA , but not under this FOA.

Observational studies involving humans should submit under PAR-18-564 'Independent Clinical Trial Not Allowed’ FOA. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Required - Basic Experimental Studies with Humans: Only accepting applications that propose independent clinical trial(s) that also meet the definition of basic research. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIDCD anticipates funding 3 to 5 awards, corresponding to a projected total of $600,000 per year. Award budgets are composed of salary and other program-related expenses, as described below. Generally, the research experience shall span a contiguous period of six months to two years.

Other Award Budget Information NIDCD will contribute up to the legislatively mandated salary cap in effect at the time of award per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094.

The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants. nih.

gov/grants/policy/salcap_summary. htm . Other Program-Related Expenses NIH will contribute $ 40,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed. Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants. gov registration. 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.

All PD(s)/PI(s) must be registered with ORCiD . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator) Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Candidates for the K18 award must have a research or health-professional doctoral degree.

This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). At the time of award, the candidate must have a "full-time" appointment at the academic institution that is the applicant organization.

The candidate is required to devote at least 6 calendar months (50% of full-time professional effort) to the K18 program, but may devote their full-time (12 calendar months) effort to it. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056 .

The allowance for a part-time commitment of professional effort will enable candidates to hold their ongoing research grants (if applicable) and/or meet their academic responsibilities in a limited capacity, and in accordance with NIH policy, as they pursue the career enhancement program. However, the total effort cannot exceed 100%, and all other activities must be consistent with the goals of the K18 award.

Generally, the research experience shall span a contiguous period of six months to two years. However, a six-month research experience may be apportioned over two successive summer semesters (of three months each), provided the experience is pursued on a full-time (100%) basis during these periods.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research.

The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research.

The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research. Section IV. Application and Submission Information 1.

Requesting an Application Package Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications . All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. 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.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Include a description of your current research and the research you propose to continue in the independent phase.

SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed. IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an ORCID ID.

For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Information and Goals for Career Development Describe the candidate's commitment to a career as a health related research scientist.

Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support. Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress through this career enhancement plan.

Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines. If applicable, describe the candidate's prior clinical trials research efforts, research interests and experience.

Career Goals and Objectives​ Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed research career development enhancement program. Justify the need for further career enhancement in order to achieve the candidate's future research goals.

Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team. Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program.

Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities.

Explain how the career development plan will enhance the candidate’s independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.

Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided.

The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research. The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.

Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.

Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.

If proposing an ancillary study to an ongoing clinical trial, provide a brief description of its relationship to the larger clinical trial. If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of