The purpose of the NIDCR Dentist Scientist Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented independent dual degree dentist scientists.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. The option for five years of independent (R00) support is available to accommodate clinical training in an advanced specialty education program at no more than 3 person-months effort (25% 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 submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate ‘Clinical Trials Required’ FOA (PAR-18-432). Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA ( PAR-19-144 ).
December 28, 2018
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.
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.
The objective of the NIDCR Dentist Scientist Pathway to Independence Award (K99/R00) is to help outstanding postdoctoral researchers complete needed, 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 a unique knowledge of dental, oral, and craniofacial biology that is critical for accomplishing the NIDCR scientific mission. The K99/R00 award is intended to foster the development of a creative, independent research program in the mission of the NIDCR that will be competitive for subsequent independent funding. 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 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 award.The K99/R00 award will provide up to 7 years of support in two phases. The initial (K99) phase will provide support for up to 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 two 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.
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 dental advanced specialty education program. In such cases, the specialty education program must be structured so that no more than the equivalent of 3 person-months (i.e. 25% effort) in any year is devoted to clinical activities; at least the equivalent of 9 person-months (i.e. 75% effort) each year must comprise protected research time. NIDCR will not provide tuition for the advanced specialty education 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 Public Health, Endodontics, Oral and Maxillofacial Pathology, Oral and Maxillofacial Radiology, Oral and Maxillofacial Surgery, Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, Periodontics, and Prosthodontics.
In the initial K99/R00 application, applicants who propose an advanced specialty education program during the 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 advanced specialty education is not necessary in the K99/R00 application. Upon activation of the R00 phase, each awardee will be required to provide institutional assurance that the advanced specialty education program will be customized such that clinical activities will occupy no more than the equivalent of 3 person-months (i.e. 25% effort) each year and will be supported in-kind by the sponsoring institution.
Dual degree dentist scientists who do not intend to pursue advanced specialty education during the independent R00 phase are also eligible and encouraged to apply for this award. In this case, a three year R00 project period should be requested. Additionally, K99/R00 awardees who had proposed advanced specialty education in the initial peer reviewed application may elect not to engage in the proposed specialty training during the R00 phase. These individuals will also receive a three year R00 phase, 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 a number of other 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 or 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, “without specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to improve the health status 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 conditions and receive an intervention or experimental manipulation where the effect will be assessed or for the purpose of understanding fundamental aspects of phenomena should submit under this FOA.
Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate FOA for the type of study
Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the companion ‘Clinical Trials Required’ FOA (PAR-18-432), but not under this FOA.
Observational studies involving humans should submit under the companion ‘Clinical Trials Not Allowed’ FOA (PAR-19-NNN).
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.
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 dental advanced specialty education program.
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.
The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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 as well as individuals with disabilities 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.
If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Parental, medical, or other well-justified leave for personal or family situations of generally less than 12 months duration is not included in the 4-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). 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. Only time dedicated to research activities would count toward the 4-year limit.
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 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.
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.
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 fellowship and career development awards are encouraged to apply for an extramural LRP award.
However, it is not sufficient merely to cite one or more of the following items to document 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:
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.
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.
If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should also be included.
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 application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspaceare available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Include a description of your current research and the research you propose to continue in the independent phase.
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:
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 advanced specialty education 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.
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
• Describe the candidate’s commitment to a career 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.
Career Goals and Objectives?
Candidate’s Plan for Career Development/Training Activities During Award Period
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Training in the Responsible Conduct of Research
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)
Letters of Support from Collaborators, Contributors and Consultants
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
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
Section 1 - Basic Information
1.4 Clinical Trial QuestionnaireApplications 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
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
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.
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
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.
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.
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII.
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.
Only the review criteria described below will be considered in the review process. Applications submitted in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.
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 K awards may be sufficient to support only small studies.
Career Development Plan/Career Goals and Objectives
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
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)?
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.
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.
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.
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.
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.
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.
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).
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 applicant, including any prior instruction or participation in RCR as appropriate for the applicant’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.
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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:
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.
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 grantee’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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the NIDCR-specific terms and conditions identified in the NoA.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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 or basic experimental studies with humans) 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).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general 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/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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 the Federal 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 from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the 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. Such outcomes are consistent with the goals of the K99/R00 award initiative. 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 NIH 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 grantee organization.
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:
These materials should be sent directly to NIDCR. The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center 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.
An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424(R&R) Application Guide.
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. If the candidate will engage in advanced specialty education during the R00 phase, the sponsoring institution must provide a description of the advanced specialty education program and institutional assurance that specialty education will occupy no more than 3 person-months (25% professional effort) per year. The sponsoring institution must verify that tuition costs will be provided in-kind.
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. NIDCR 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. NIDCR 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 an NIH awarding component.
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.
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.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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Leslie A. Frieden, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Diana Rutberg, MBA
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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