NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22 Basic Experimental Studies Involving Humans Required)

NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22 Basic Experimental Studies Involving Humans Required) is sponsored by National Institute of Dental and Craniofacial Research (NIDCR). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-22-046: NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22 Basic Experimental Studies Involving 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 of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22 Basic Experimental Studies Involving Humans Required) K22 Career Transition Award July 18, 2024 - Notice of Early Termination of NIDCR Dentist Scientist Career Transition Award for Intramural Investigators PAR-22-045 (K22 Clinical Trial Required) and PAR-22-046 (K22 Basic Experimental Studies Involving Humans Required).

See Notice NOT-DE-25-030 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 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentists from NIH Intramural postdoctoral research positions to extramural academic tenure-track or equivalent faculty positions at eligible institutions.

The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution. 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 be submitted 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.

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 the 'Independent Clinical Trial Not Allowed' companion FOA.

The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) 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 .

New Date July 18, 2024 (Original Date: January 08, 2025) per issuance of NOT-DE-25-030 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 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 goal of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) is to provide support to outstanding newly trained dentist scientists to develop their research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a subsequent period of support at an extramural institution.

The award is intended to facilitate the establishment of a successful, independent dental, oral, and craniofacial research career. To achieve this goal, the program is structured to provide two years of mentored research training in an NIH intramural laboratory (Phase 1) followed by three years support (Phase 2) as an independent scientist.

During the intramural training phase of the K22 (Phase 1), support will be provided by the candidate's NIH intramural laboratory or branch. Funds from the K22 award may be used to support Phase 2 at an extramural sponsoring institution/organization to which the individual has accepted a tenure-track full-time assistant professor position (or equivalent).

This allows the individual to continue to work toward establishing his/her own independent research program and prepare an application for research grant support, such as an R01, or equivalent award. Candidates should select a mentor from the NIH Intramural Research Program with whom the candidate can consult in preparing and submitting the application for the NIH intramural mentored phase of the award.

Candidates may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career. Candidates are encouraged to include co-mentors or collaborators from extramural institutions to assist with the transition from the NIH Intramural Research Program to an extramural research institution.

The K22 application should describe the research planned during both the mentored and independent phases of the program. This research should align with NIDCR extramural research areas. The application will be peer reviewed and receive an overall impact score.

Applications approved for funding will receive an approval letter from the NIDCR to initiate the intramural NIH research training (Phase 1) that will be supported through NIH intramural funds. The approval letter will include the terms and conditions to activate the funds from the K22 award at an extramural institution/organization (Phase 2).

A transition application from the extramural institution/organization on behalf of the K22 recipient will be required to begin the activation process. Activation of the extramural phase of the award is not automatic.

Approval to activate the extramural phase will be based on an administrative review of the transition application by the NIDCR, and will consider the recipient’s research performance progress during the intramural phase and the achievement an independent tenure-track (or equivalent) position at a United States extramural institution.

Note: 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 may 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 'Clinical Trials Required' FOA ( PAR-22-045 ), but not under this FOA.

Observational studies involving humans should submit under the Clinical Trials Not Allowed FOA ( PAR-22-044 ). 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.

Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 5 years. Other Award Budget Information Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch.

Support for the intramural phase may not exceed two years in duration. The salary support will be consistent with that provided by the NIH intramural program for other investigators in the same position and with similar levels of postdoctoral experience. Support for the extramural phase will be provided to the extramural institution.

Support for the extramural phase may not exceed three years in duration. The total cost for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below). The total NIH contribution to salary may not exceed the legislatively mandated salary cap.

See: http://grants. nih. gov/grants/policy/salcap_summary.

htm . Other Program-Related Expenses Research-related expenses for the intramural phase are provided by the candidate's NIH intramural laboratory or branch. Total expenses for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below).

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) Eligible Agencies of the Federal Government 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 The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs.

Only NIH Intramural Programs are eligible to apply for the mentored phase of the K22 mechanism on behalf of intramural candidates. Federal laboratories, including the NIH Intramural Programs, are not eligible to apply for the independent phase. 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.

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 K22 award must have earned a clinical dental doctoral degree (DDS, DMD or equivalent) or a combined dental (DDS, DMD, or equivalent) and research doctoral degree (PhD or equivalent). At the time of application, the candidate must be in an NIH intramural postdoctoral fellowship position and have demonstrated potential for a productive basic or clinical research career.

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 ). Candidates may submit research project grant (RPG) applications concurrently with the K application.

However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065 .

Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aims or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00).

Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on an NIH multicomponent grant or cooperative agreement (e.g., P01, U19, P20, P30, P50, U54, UM2), or an equivalent NIH or non-NIH award. At the time of K22 application, candidate's must have a "full-time" appointment to the NIH Intramural Program.

At the time of the extramural K22 phase 2 award , the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development.

Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution.

Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

Before submitting the application, the candidate must identify a mentor in the NIH Intramural Research Program 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 resources 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.

If the candidate's primary mentor is not based in the NIDCR Intramural Research Program, the candidate should include a co-mentor with expertise in dental, oral, and craniofacial research. This mentoring team may include investigators at NIH Intramural Research Laboratories and investigators at extramural institutions. 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. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: K22 Phase 1: An itemized budget is not required for the K22 intramural phase (Phase 1); a total requested amount for each budget period is acceptable.

Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch; therefore the Direct and Indirect Costs should specify $0. The applicant should indicate 12 person-months effort for him/herself for each project period during Phase 1.

K22 Phase 2: An itemized budget is not required in the initial application for the K22 independent phase (Phase 2); a total requested amount for each budget period is acceptable. The applicant should indicate a minimum of 9 person-months effort for him/herself for each project period.

The exact amount of direct and indirect costs does not need to be specified; however, a line item in section F: Other Direct Costs titled Independent Phase requesting $249,000 should be added for each period during Phase 2. At the time of transition to the independent K22 phase (Phase 2), the applicant extramural institution will submit a detailed budget for the K22 Phase 2 project period.

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 Candidate’s Background Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIDCR. Describe current training and research efforts of the candidate.

Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate. Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and reference letters.

If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial. If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research. Career Goals and Objectives?

Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.

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. A timeline, including publications, is strongly encouraged.

The mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study or to monitor the candidate's progress through the career development program. The career development plan must be tailored to the needs of the individual candidate, incorporating the candidate's goals, current activities, prior experience, and the ultimate goal of achieving independence as a researcher.

Include a plan to obtain the necessary research experience to launch an independent research career. Suggested activities include, but are not limited to, those designed to improve skills and understanding in grant writing, clinical trials methodology, research design and management, statistical analysis, and bioethics.

Candidates must justify the need for both the mentored phase and the independent phase, and provide a convincing case that the proposed period of support (1-2 years as a mentored scientist followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem.

The candidate and intramural mentor must describe a plan, including a timeline with milestones, for evaluation of the candidate's progress during the intramural mentored phase and plans for the transition to the independent extramural phase. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The research plan must span both phases of the award.

The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).

The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. The application must include a description of how the mentored phase research will lead to the independent phase research.

Describe the proposed timelines for the proposed clinical trial, feasibility or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).

Training in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Plans and Statements of Mentor and Co-mentor(s)