Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
Mentored Quantitative Research Development Award (Parent K25) |
Activity Code |
K25 Mentored Quantitative Research Career Development Award |
Announcement Type |
Reissue of PA-11-196 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-14-048 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847; 93.856; 93.855; 93.846; 93.113; 93.398; 93.839; 93.838; 93.837; 93.233; 93.279; 93.859; 93.273; 93.121; 93.286; 93.866; 93.173; 93.865 |
Funding Opportunity Purpose |
The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and protected time for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. Prospective candidates are encouraged to contact the relevant NIH staff for IC-specific programmatic and budgetary information: Table of IC-Specific Information, Requirements and Staff Contacts. |
Posted Date |
December 19, 2013 |
Open Date (Earliest Submission Date) |
January 12, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, with the first due date on February 12, 2014 Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Standard AIDS dates apply, with the first AIDS due date on May 7, 2014 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. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
New Date: May 10, 2016 (previously January 8, 2017) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series) , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. Information about all NIH Career Development programs may be found at the NIH Extramural Training Mechanisms website.
A particular area of research is often invigorated by novel perspectives that may be provided by individuals trained outside that research arena. In an effort to advance research relevant to the mission of the National Institutes of Health (NIH), which includes basic biomedical, clinical biomedical, bioengineering, bioimaging, and behavioral research, the participating Institutes and Centers (ICs) encourage applications for the NIH Mentored Quantitative Research Career Development Award (K25). The K25 mechanism is meant to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. Examples of quantitative scientific and technical backgrounds considered appropriate for this award include, but are not limited to: mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry, and engineering.
The NIH is especially interested in increasing the number of scientists trained to conduct high-quality research that combines insights derived from, and cuts across, different scientific, technical, and biomedical areas. Accordingly, the K25 award forms an important part of an initiative to attract talented individuals with highly-developed quantitative skills to the challenges of research relevant to the mission of NIH. The K25 award is intended to increase the availability of high-quality, multidisciplinary, didactic training and research project guidance, in the context of a mentored research career transition experience. Candidates interested in cross-disciplinary research will become well grounded in behavioral, biomedical, bioimaging, or bioengineering research. At the completion of the award, candidates should have both the knowledge and the skills necessary to compete for independent research support from NIH, or to participate as leading members of multi-disciplinary research teams.
The specific objectives of the K25 award are to:
- Encourage research-oriented quantitative scientists and engineers with little or no experience in biomedicine, bioengineering, bioimaging, or behavioral research to gain fundamental knowledge in these areas and develop relevant research skills, and to gain experience in current concepts, advanced methods, and experimental approaches that will allow them to conduct basic or clinical biomedical, behavioral, bioimaging, or bioengineering research, and to become independent investigators or play leading roles in multi-disciplinary research teams.
- Increase the pool of quantitative researchers who can conduct biomedical, behavioral, or bioengineering studies, capitalizing on the quantitative backgrounds of these investigators to inform new directions in biomedical, behavior and bioengineering research.
- Provide a unique opportunity for candidates holding degrees in quantitative science or engineering to embark on three to five years of special study, including course work, seminars, meetings, and mentored research, to achieve the career enhancement goals outlined above.
Because of the focus on a progression toward independence as a quantitative biomedical, behavioral, bioimaging, or bioengineering researcher, the prospective candidate for the Mentored Quantitative Research Career Development Award will require enhanced skills in the experimental, theoretical and conceptual approaches used in biomedicine, behavioral science, bioimaging or bioengineering. To satisfy this requirement, the candidate should propose a period of study and career development that is complementary to his or her previous research and experience. For example, a candidate with no or very limited experience in a given field of biomedical research may find a phased developmental program lasting for five years that includes a designated period of didactic training together with a closely supervised research experience the most efficient means of attaining independence. A candidate with, for example, more research experience in biomedicine may benefit from a program with greater emphasis on appropriate laboratory research with lower levels of supervision and direction. All programs should be carefully tailored to meet the individual needs of the candidate and must include (an) active mentor(s) who is (are) competent and willing to provide the appropriate research guidance. Candidates should strongly consider incorporating into their training plan formal courses in relevant areas of biomedicine, behavioral science, bioimaging, or bioengineering; this program offers a unique opportunity to devote protected time to this activity.
Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Award budgets are composed of salary and other program-related expenses, as described below. |
Award Project Period |
The total project period may not exceed 5 years. |
Salary |
The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). The total salary requested must be based on a full-time 12 months staff appointment. Mentored career awards require the candidate to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting health-related research. The remaining effort may be devoted to other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. The total salary requested must be based on a full-time staff appointment. The
salary must be consistent both with the established salary structure at the
institution and with salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must
be appropriately related to the existing salary structure. Confirmation of
salary may be required prior to the issuance of an award. Fringe benefits,
based on the sponsoring institution’s rate and the percent of effort, are
provided in addition to the salary. |
Other Program-Related Expenses |
The participating NIH Institutes and Centers will provide research development support for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as 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 assistance, etc., is not allowed. |
Indirect Costs |
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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)
- U.S. Territory or Possession
Other
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
Non-domestic (non-U.S.)
Entities (Foreign Institutions) are not eligible to apply. Non-domestic
(non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.
Former PDs/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K awards), or the equivalent are not eligible. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.
Candidates must have an advanced degree in a quantitative area of science or engineering (M.S.E.E., Ph.D., D.Sc., etc.) and have demonstrated research interests in their primary quantitative discipline. The candidate should have demonstrated professional accomplishments consonant with his or her career status, and should have demonstrated experience or interest in pursuing research (including research outside of biomedicine, behavior, bioimaging, or bioengineering).
The award is intended for research-oriented investigators at any level of experience, from the postdoctoral level to senior faculty level, who have shown clear evidence of productivity and research excellence in the field of their training, and who would like to expand their research capability, with the goal of making significant contributions to behavioral, biomedical (basic or clinical), bioimaging or bioengineering research that is relevant to the NIH mission.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the specific aims and other provisions (e.g., salary) of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.
At the time of award, the candidate must have a full-time appointment at the applicant 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 career development and research training during the mentored phase. 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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
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. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. 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 principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.
Institutional Environment
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the 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 (R&R) Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Candidate Information
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate’s Background
- Describe prior training and research experience and how these relate to the objectives and long-term career plans of the candidate. Explain how the award will contribute to their attainment.
- Describe the candidate’s research efforts and professional accomplishments consonant with career status, including any publications that demonstrate the candidate’s experience and interest in pursuing research (including research outside of biomedicine, behavior, bioimaging, or bioengineering).
- Provide a description of the candidate's commitment to a career in quantitative biomedical, bioimaging, behavioral, or bioengineering research that is relevant to the NIH mission.
- Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.
- Include a statement that the candidate will commit at least 9 person-months (75% full-time professional effort) to this career development program. The mentor or department chair must agree that this amount of the candidate's time will be protected
Career Goals and Objectives
- Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.
Candidate's Plan for Career Development/Training Activities During Award Period
- Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Propose a plan to obtain the necessary theoretical and conceptual background and research experience to launch an independent research career in quantitative biomedicine, bioengineering, bioimaging or behavioral research must be proposed.
- Include a list of the specific course of study in which the candidate will engage, including specific coursework which is essential to gaining the required theoretical and conceptual understanding of biomedicine, behavioral science, bioimaging, or bioengineering, important to the candidate's short- and long-term research interests and the manner of integration of these studies into the career development plan.
- The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher in quantitative biomedicine, behavioral science, bioimaging, or bioengineering. Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely didactic in nature that is followed by a period of intense, supervised research. Candidates with more experience at the time of application may need a shorter developmental period and may already have an adequate theoretical background.
- Describe the professional responsibilities/activities (including other research projects) beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the K25 award. Explain how these responsibilities/activities relate to the career development objectives of this award and will help ensure career progression to achieve independence as an investigator.
- The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
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).
- The plan must address the five, required instructional components outlined in the NIH policy: 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 instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
- Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.
Statements and Letters of Support
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
- The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
- The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
- The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
- Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
- The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence. The mentor or department chair must agree and provide a statement in the application documenting that the required amount of the candidate’s time will be protected.
- Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
- The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
Letters of Support from Collaborators and Consultants
- Consultant(s) and/or Collaborator(s): Signed statements must be provided by each consultant and/or collaborator confirming their participation in the project and describing their specific roles. 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. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
- 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. These individuals generally do not need to provide their biographical sketches.
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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.
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 and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K25 award.
- Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.
- Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
- Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.
Research Plan
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Research Strategy
- A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
- Provide a sound quantitative biomedical, behavioral, or bioengineering research plan that is consistent with the candidate’s level of research development and objectives of his/her career development plan.
- The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan and the benefits of that relationship including how the candidate’s project will lead to an independent line of research. For disciplines such as large epidemiological studies requiring team-based approaches, explain how the research will enhance the candidate’s expertise to have a major role in designing and leading future projects.
- If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in NOT-OD-11-079). 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.
Part I. Overview Information contains information about Key Dates. 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.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). 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.
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.
This initiative is not subject to intergovernmental review.
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.
Add additional information about funding restrictions. If any of these
restrictions become part of the terms of award that must be stated in Section
VI.1.
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.
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.
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 (SAM). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Important Update: See
NOT-OD-16-012 and
NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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.
Reviewers should provide their assessment of the likelihood for 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.
Candidate
- Does the candidate have the potential to develop as an independent and productive quantitative biomedical, behavioral, bioimaging or bioengineering researcher or to play a significant role in multi-disciplinary research teams?
- Is the candidate’s academic, clinical (if relevant), and research record of high quality?
- Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?
- Do the letters of reference address the candidate’s potential for becoming an independent investigator?
Career Development Plan/Career Goals and Objectives
- What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
- Are the candidate's prior training and research experience appropriate for this award?
- Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
- Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
Research Plan
- Are the proposed research question, design, and methodology of significant scientific and technical merit?
- Is the research plan relevant to the candidate’s research career objectives?
- Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?
- Will the proposed research lead to an independent line of research for the candidate? If the proposed research discipline requires team-based approaches, will the candidate develop skills to play a major leadership role in the chosen research field?
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
- Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
- Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
- Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
- Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
- Is there evidence of the mentor s, consultant s, collaborator s previous experience in fostering the development of independent investigators?
- Is there evidence of previous research productivity and peer-reviewed support?
- Is active/pending support for the proposed research project appropriate and adequate?
- Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
Environment & Institutional Commitment to the Candidate
- Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research and career development activities described in the application, with the remaining effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
- Is the institutional commitment to the career development of the candidate appropriately strong?
- Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
- Is the environment for scientific and professional development of the candidate of high quality?
- Is there assurance that the institution intends the candidate to be an integral part of its research program?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human
subjects but does not involve one of the six 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 six 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 Children
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 children 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 five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.
Renewals
Not Applicable
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.
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.
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 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.
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.
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) Genome Wide Association Studies (GWAS).
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.
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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- 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.
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.
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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award Conditions
and Information for NIH Grants website.
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, Grantees, 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
A final progress report, 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 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.
Because of the difference in individual Institute and Center
(IC) program requirements for this FOA, prospective applicants are strongly
encouraged to consult the Table
of IC-Specific Information, Requirements and Staff Contacts, to
make sure that their application is responsive to the requirements of one of
the participating NIH ICs. Prior consultation with NIH staff is strongly
encouraged.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems
that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Phone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
See Table of IC-Specific Information, Requirements and Staff Contacts
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
See Table of IC-Specific Information, Requirements and Staff Contacts
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.
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 Parts 74 and 92.
