National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
June 18, 2024 - Notice of Early Termination of NIDCR Dual Degree Dentist Scientist Pathway to Independence Award, PAR-22-042 (K99/R00 Clinical Trial Required) and PAR-22-043 (K99/R00 Basic Experimental Studies Involving Humans Required). See Notice NOT-DE-25-031
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
NOT-DE-22-007 - Notice to Include Additional Application Due Dates for NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00)
PAR-22-042 , K99/ R00 Career Transition Award/Research Transition Award
The purpose of the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) program is to develop and maintain a strong cohort of independently funded dentist scientists dedicated to improving dental, oral and craniofacial health. This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research. An option for five years of independent (R00) support is available to accommodate clinical training in a dental specialty program at no more than 3 person-months effort (25% full-time professional effort) in any year of the R00 phase.
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.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| February 12, 2022 * | March 12, 2022 * | May 07, 2022 * | July 2022 | October 2022 | December 2022 |
| June 12, 2022 * | July 12, 2022 * | September 07, 2022 * | November 2022 | January 2023 | April 2023 |
| October 12, 2022 * | November 12, 2022 * | January 07, 2023 * | March 2023 | May 2023 | July 2023 |
| February 12, 2023 * | March 12, 2023 * | May 07, 2023 * | July 2023 | October 2023 | December 2023 |
| June 12, 2023 * | July 12, 2023 * | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
| October 12, 2023 * | November 12, 2023 * | January 07, 2024 * | March 2024 | May 2024 | July 2024 |
| February 12, 2024 * | March 12, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
| June 12, 2024 * | July 12, 2024 * | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
| October 12, 2024 * | November 12, 2024 * | January 07, 2025 * | March 2025 | May 2025 | July 2025 |
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.
Not Applicable
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
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 NIDCR Dentist Scientist Pathway to Independence Award (K99/R00) is to help outstanding postdoctoral researchers complete mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. A dual degree dentist scientist is defined as an individual with both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent research doctoral) degree. Transition to research independence is particularly difficult for dual degree dentist scientists, whose time for scientific research experiences may be limited by their clinical responsibilities and further clinical specialty training.
Dual degree dentist scientists possess unique knowledge of dental, oral, and craniofacial health that is critical for accomplishing the NIDCR scientific mission. The K99/R00 award is intended to foster the development of creative and independent research investigators who can make long term contributions to dental, oral, and craniofacial research. This program is also designed to meet the specific needs of the dentist scientist career path, including provisions for two years of protected time for mentored postdoctoral training and, under certain circumstances in the independent phase, part-time dental specialty training.
Applicants must have no more than 4 years of postdoctoral research experience since their most recent doctoral degree at the time of the initial or the subsequent resubmission application. The strongest applicants will require, and will propose, a well-conceived plan for 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for additional mentored research training at the time of award is not a strong candidate for this program.
The K99/R00 award will provide up to 7 years of support in two phases. The initial (K99) phase will provide support for 2 years of mentored postdoctoral research training and career development. Early R00 phase transitions require prior approval from NIDCR and are not encouraged for individuals with less than 2 years of postdoctoral research at the submission deadline.
The second (R00) phase will provide either 3 or 5 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position.
Five years of R00 support will be permitted for an awardee who is offered an independent faculty position in a U.S. dental school in conjunction with the opportunity to matriculate into a clinical dental specialty program. In such cases, the specialty program must be structured so that no more than the equivalent of 3 person-months (i.e. 25% full-time professional effort) in any year is devoted to clinical activities; at least the equivalent of 9 person-months (i.e. 75% full-time professional effort) each year must comprise protected research time. NIDCR will not provide tuition for the dental specialty program; the dental school hiring the R00 awardee will be expected to support such training. Only dental specialties recognized by the National Commission on Recognition of Dental Specialties and Certifying Boards of the American Dental Association will be permitted during the R00 phase. These specialties currently include: Dental Anesthesiology, Dental Public Health, Endodontics, Oral and Maxillofacial Pathology, Oral and Maxillofacial Radiology, Oral and Maxillofacial Surgery, Oral Medicine, Orofacial Pain, Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, Periodontics, and Prosthodontics.
In the initial K99/R00 application, applicants who propose clinical dental specialty training during the independent (R00) phase must identify which specialty he/she plans to pursue and how certification in that specialty relates to and will enhance the path towards an independent research career. Institutional commitment for dental clinical specialty training is not provided in the initial K99/R00 application. Upon activation of the R00 phase, each awardee will be required to provide institutional assurance that the dental specialty program will be customized such that clinical activities will occupy no more than the equivalent of 3 person-months (i.e. 25% full-time professional effort) each year and will be supported in-kind by the sponsoring institution.
Dual degree dentist scientists who do not intend to pursue dental clinical specialty training during the independent R00 phase are also eligible and encouraged to apply for this award. In this case, a 3 year R00 project period should be requested. Additionally, K99/R00 awardees who had proposed dental clinical specialty training in the peer reviewed application may elect not to engage in the proposed specialty training during the R00 phase. These individuals will receive a 3 year R00 award, if they meet all other requirements for R00 transition.
The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.
In addition to this initiative, NIDCR supports mentored career development programs designed to foster the transition of new investigators to research independence, which may be more suitable for some candidates. For information on other NIDCR-sponsored career development programs please refer to http://www.nidcr.nih.gov/CareersAndTraining.
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 a 'Clinical Trials Required' FOA (PAR-22-042), but not under this FOA.
Observational studies involving humans should submit under the Clinical Trials Not Allowed FOA (PAR-22-041).
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See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission
Revision
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?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The total project period may not exceed 7 years.
Mentored Phase (K99): Support for 2 years mentored postdoctoral research training and career development.
Independent Phase (R00):Independent research support for either 3 or 5 years, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position.
R00 support beyond three years will be permitted for an awardee who is offered an independent faculty position in a U.S. dental school in conjunction with the opportunity to matriculate into a clinical dental specialty program
Other Award Budget Information
Mentored Phase (K99)
Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory. Salary will be consistent with that offered scientists in similar, intramural NIH positions.
Extramural: NIDCR will contribute up to $100,000 a year for salary support for mentored candidates at an extramural sponsoring institution/organization.
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 may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Independent Phase (R00)
The total cost for the independent phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.
Mentored Phase (K99)
Intramural: Research-related expenses for the intramural phase are provided by the candidate's NIH intramural laboratory or branch.
Extramural: NIDCR will contribute $25,000 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.
Research expenses during the K99 phase may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
1. Eligible Applicants
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
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- 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
- Regional Organizations
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.
The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applicant Organizations
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.
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,individuals with disabilities and women are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.
Candidates must have both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent research doctoral) degree and have no more than 4 years of postdoctoral research experience (i.e. employment in a research position since completing the requirements for the doctorate) at the time of application (resubmissions must also comply with this requirement). It is not required that the degrees were earned together as part of dual degree (DSTP) training program. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. Candidates in a clinical faculty position that denotes independence in clinical responsibilities, but not in research, may also be eligible for the K99/R00 award.
Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), NIH will approve an extension of one year for childbirth within the 4 year K99 eligibility window. Applicants who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the FOA at least 12 weeks before submitting an application.
Potential candidates are encouraged to discuss their individual situation with the NIDCR Scientific Program Contact before applying. In addition, parental, medical, military, or other well-justified leave for personal or family situations of generally less than 12 months duration is typically not included in the 4-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Only time dedicated to research activities counts toward the 4-year limit. Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit.
Additional clarifications are provided under Frequently Asked Questions.
There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, 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), or be a non-U.S. citizen.
For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate’s visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.S institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.
Candidates in clinical faculty positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award and should contact the NIDCR Program Director for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.
Candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the NIDCR before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, the request for an exception must be accompanied by an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.
Individuals are NOT eligible if they:
- Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
- Have more than 4 years of related postdoctoral research training at the time of initial application or resubmission; or
- Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25) unless the previous career development award was used to earn a PhD or equivalent research doctoral degree, or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.
The following is provided as an aid to distinguish independent from non-independent positions:
However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
- The candidate’s research is entirely funded by another investigator’s grants.
- The candidate’s research is conducted entirely in another investigator’s assigned space.
- According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
- According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
- The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.
Conversely, evidence for independence, and therefore lack of eligibility, includes:
- The candidate has a full-time faculty position or has formally accepted a faculty position.
- The candidate received a start-up package for support of his/her independent research.
- The candidate has research space dedicated to his/her own research.
- The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
- The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.
2. Cost Sharing
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. 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.
R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.
Mentor(s)
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, individuals from underrepresented racial and ethnic groups, individuals with disabilities and women 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.
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.
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.
SF424(R&R) Cover
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.
Project Summary/Abstract
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.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Itemized budget information is not required for the R00 phase; a total requested amount for each budget period is acceptable. However, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period of the R00 phase:
- Select the appropriate Budget Type
- Provide the Budget Period Start Date and End Date
- In Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, $0 for Requested Salary and $0 for Fringe Benefits
- In Section F: Other Direct Costs add a line item titled R00 Independent Phase and provide the total request for that period (up to $249,000).
At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.
Requesting a 7 year budget period: The candidate should provide total R00 phase costs for budget periods 3-7. In the budget justification the applicant must specify the dental specialty program planned for the R00 phase and justify how certification in that specialty relates to and will enhance the path towards an independent research career.
Please note that for this program, the NIDCR Scientific/Research Contact's preapproval of the additional budget periods is not required.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Career Development Award Supplemental Form
Other Plan(s):
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:
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidate Section
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, behavioral, or clinical research field relevant to the mission of the NIDCR.
- Describe the candidate’s potential to develop into a successful, independent investigator.
- 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 the candidate’s current and long-term research and career objectives.
- Present a scientific history that: (1) shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences proposed for the mentored phase of the award (K99) and subsequently to the independent phase of the award (R00); and (2) justifies the need for further mentored career development to become an independent research investigator.
- If currently supported by an institutional training grant or individual fellowship award (such as provided through the Ruth L. Kirschstein NRSA program), describe the candidate’s current research training or fellowship program.
- Describe how the candidate plans to separate scientifically from his/her mentor and advance to research independence.
- 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, including in the inclusion of women and minorities and individuals across the lifespan.
Candidate’s Plan for Career Development/Training Activities During Award Period
- A systematic plan should be presented for obtaining the biomedical, behavioral, or clinical science background, research experience, and career development activities necessary to launch the stated independent research career. Describe current activities and how they relate to the candidate’s career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as related skills such as grant-writing, communication, leadership, and laboratory management. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher.
- Describe how the skills and knowledge obtained during the mentored phase will enhance research productivity and facilitate the development of new approaches and directions for investigation. Describe how the career development plan will promote the candidate’s success and transition to scientific independence. Candidates must justify the need for the award, particularly the mentored (K99) phase, and must provide a convincing case that the proposed period of support (2 years as a mentored candidate followed by 3-5 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. Candidates should make clear why additional mentored research training and career development are critical before transitioning to research independence and pursuit of the proposed independent phase research.
- The candidate must describe a plan, including a timeline with milestones, for evaluation of his/her progress during the mentored phase and for the transition to the independent phase.
- Candidates who plan to pursue clinical dental specialty training during the R00 phase must describe how the proposed training will benefit an independent academic research career.
Research Plan Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
- The research plan must span both phases of the K99/R00 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 research plan should state the significance, innovation and approach of the proposed research during the K99 and R00 phases of the award. The research plan should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application.
- Describe the relationship between the mentor’s research and the candidate’s proposed research. Describe how the candidate will gain independence from his/her mentors and separate his/her scientific research program from that of the mentor(s).
- 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).
- Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a 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)
- The application must include a statement from the primary mentor that provides: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan describing the nature of the supervision and mentoring that will occur during the proposed K99 award period, including how the candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research training and career development, including any formal course-work; 4) a plan for transitioning the candidate from the mentored phase to the independent phase of the award and a description of how the mentor will help the candidate achieve scientific independence from his/her mentor(s); 5) a statement identifying the components of the proposed research that the K99 applicant can take when he/she transitions to research independence and that can be part of his/her independent (R00) phase award; and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the applicant to the independent phase of the award.
- The mentor should have sufficient independent research support to cover the costs of the proposed K99 research project in excess of the allowable costs of this award, and should state that needed costs will be covered. If funds are needed beyond what will be provided by the mentor, the source of additional funds should be identified and documented in a letter signed by the responsible individual.
- Similar information must be provided by all co-mentors. If more than one mentor is proposed, the respective areas of expertise, the responsibility of each, and the nature of the involvement with the candidate should be explicitly described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate to provide an integrated mentoring effort.
- The primary mentor must agree to write and provide annual evaluations of the candidate’s progress for the initial mentored phase as required in the annual progress report.
- The mentor must agree to assist the candidate in transitioning to an independent research position by guiding the candidate during the job search and negotiation process and by commenting on the R00 phase application.
- The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.
Letters of Support from Collaborators, Contributors and Consultants
- Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
- Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
- The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
- Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
- Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.
Institutional Commitment to the Candidate’s Research Career Development
- The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator, i.e. conducting the proposed mentored research and career development during the K99 phase and competing for, and transitioning to, a tenure-track assistant professor position at an academic institution. While the K99 phase sponsoring institution is not responsible for sponsoring the applicant during the R00 phase, it should be supportive of the candidate prior to initiation of the R00 phase.
- Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of his/her research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
- Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs during the K99 award period.
- Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K99 award period.
- For individuals in postdoctoral positions with other titles although still in non-independent, mentored training positions, provide evidence of eligibility for the K99/R00 program.
- If the candidate is not a U.S. Citizen or permanent resident, the sponsoring institution must include information about the candidate’s visa status, an assurance that the candidate’s visa provides sufficient time to complete the K99 phase of the award at a U.S. institution, and assurance that there are no known obstacles (e.g. home country requirement) to the candidate obtaining a visa at the time of the R00 transition.
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Section 1 - Basic Information
1.4 Clinical Trial Questionnaire
Applications to this FOA must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.
Candidate
- Based on the candidate’s prior research and training experience, track record, referee’s evaluations, and the quality and originality of prior research and the current application, what is the candidate’s potential to become a highly successful, independent investigator who will contribute significantly to his/her chosen field of biomedical, behavioral, or clinical related research?
- Considering the years of postdoctoral research experience to date, what is the candidate’s record of research productivity, including the quality of peer-reviewed scientific publications?
- What is the quality of the candidate's pre- and postdoctoral research training, with respect to development of appropriate scientific and technical expertise?
- Given the candidate’s prior training, proposed career development plan, and the referees evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent faculty position within the time period requested for the K99 phase of this award?
- Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
- Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?
Career Development Plan/Career Goals and Objectives
- Are the content and duration of the proposed components of the career development plan appropriate and well-justified for the candidate’s current stage of scientific and professional development and proposed research career goals?
- To what extent does the proposed career development plan enhance or augment the applicant’s research training and skills acquisition to date?
- Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate his/her successful transition to independence?
- To what extent are the plans for evaluating the K99 recipient’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?
- Is the timeline planned for transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development, anticipated productivity, and the career development proposed for the K99 phase of the award?
- If clinical dental specialty training is proposed during the R00 phase of the award, will it enhance the academic research career of the candidate?
Research Plan
- Is the prior research that serves as the key support for the proposed project rigorous?
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Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
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Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
- Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
- Is the proposed K99 phase research significant and scientifically sound?
- Are the scientific and technical merits of the K99 research appropriate for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program?
- Is the proposed R00 phase research significant, scientifically sound, and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan?
- Does the R00 phase project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
- To what extent is the proposed R00 phase research likely to foster the career of the candidate as a successful, independent investigator in biomedical, behavioral, or clinical research?
- Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
- If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
- Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
- Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
- Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
- Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
- For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
- To what extent does the mentor(s) have a strong track record in training future independent researchers?
- To what extent are the mentor’s research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant’s career development needs?
- Is the supervision proposed for the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant’s career development appropriate and sufficient?
- Does the mentor provide an appropriate plan that addresses the candidate’s training needs, and that is likely to foster the candidate’s continued development and transition to independence?
- Does the mentor describe an acceptable plan for clear separation of the candidate’s research and research career from the mentor’s research, including identifying the components of the research plan that the K99 candidate may take to an independent research position?
- If applicable are the consultants /collaborators research qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment?
- If applicable, are the Advisory Committee members qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment?
- Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?
Environment & Institutional Commitment to the Candidate
- To what extent does the institution provide a high quality environment appropriate for the candidate’s development during the K99 phase of the award?
- To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate’s research and career development goals during the K99 phase of the award? Is adequate evidence provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and preparation for transition to independence?
- Is there adequate assurance that the required minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research training, career development, and research activities proposed for the K99 phase of the award?
- Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
- Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
- If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
Study Timeline for Clinical Trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the R00 phase of the award.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to theFederal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition to the Independent Phase
Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, NIDCR will not extend the K99 phase beyond the 2-year limit. NIDCR may, at its discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.
An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. Applicants are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards.Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIDCR Program staff well in advance of accepting such an offer.
To avoid potential problems in activating the independent phase, applicants are strongly encouraged to contact their NIDCR program official as soon as plans to apply for and, assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award.
At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIDCR program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase recipientorganization.
The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:
- A new face page signed by the R00 phase institutional representative;
- A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);
- Detailed budget pages for a non-modular budget;
- Biographical sketches for the PD/PI and any other Key Personnel;
- A new Resources page;
- A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase;
- An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages);
- Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals across the Lifespan (as appropriate);
- Authentication of Key Biological and/or Chemical Resources (as appropriate);
- Updated Vertebrate Animals (as appropriate);
- Updated Biohazards (as appropriate); and
- A new checklist.
These materials should be sent directly to the NIDCR. The R00 transition application (preferably in PDF format) is to be e-mailed to the NIDCR Financial or Grants Management contact person listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.
Two additional documents are included with the R00 application. A letter from the R00 Department or Division Chairman must be submitted that describes the R00 institution’s commitment to the candidate and plans for his/her career development (see below). If not already provided, the final evaluation statement by the K99 phase mentor, must be provided.
In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months or 75% of the candidate’s full-time professional effort) at least for the duration of the R00 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must describe how the awardee’s ability to apply for and secure independent research grant (R01) support will be fostered and supported during the R00 phase of the award.
In order to receive a 5 year R00 award to accommodate dental specialty training, the candidate must have requested this project period in the original peer reviewed application. In the transition application, the sponsoring institution must provide a description of the dental specialty program and institutional assurance that during the R00 phase, clinical specialty training will occupy no more than 3 person-months (25% full-time professional effort) per year. The sponsoring institution must verify that tuition costs will be provided in-kind. Dental specialty training must begin no later than year 3 of the R00 award and may conclude following the completion of the R00 award. If dental specialty training is not initiated by year 3 of the R00 phase, the final 2 years of the R00 phase will not be awarded.
Candidates originally designated for a 5 year R00 award who elect not to engage in clinical specialty training but meet all other requirements for R00 transition will also receive a 3 year R00 award.
The R00 award requires that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the NIDCR Program Official prior to finalizing the offer. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).
The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of the NIDCR.
Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.
Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Termination of the K99 award phase
If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition at an extramural institution occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
3. Reporting
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
R00 recipients who receive a 5 year R00 project period to accomodate part time dental clinical specialty training are expected to provide a brief update on progress in the dental specialty training program in the annual RPPR.
4. Evaluation
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
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eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Anissa J. Brown, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
Telephone: (301) 594-4805
Email: [email protected]
Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]
Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.
and Human Services (HHS)
