November 20, 2017
January 12, 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.
January 8, 2021
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs, to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
Doctoral-level investigators pursuing careers in all fields of cancer research often require extended periods of mentored research training beyond their original doctoral degrees (e.g., MD, MD/PhD, or PhD). Postdoctoral investigators who have no more than 4 years of postdoctoral research training experience at the time of initial application have access to the NIH Pathway to Independence Award in Cancer Research (K99/R00) for this purpose. However, because of the prolonged training experiences often needed for biomedical researchers, there is a wealth of talented new investigators still in mentored, non-independent positions who have more than 4 years of postdoctoral training in cancer research. These include investigators at domestic extramural institutions/organizations, as well as investigators working in Federal research groups. Many such investigators need additional protected time to develop successful independent research programs.
The objective of the NCI Career Transition Award to Promote Diversity (K22) is to enhance the diversity of the NCI-funded research workforce by supporting eligible individuals from groups that have been shown to be nationally underrepresented in the biomedical, behavioral, clinical, and social sciences. This Funding Opportunity Announcement (FOA) provides opportunities for individuals in mentored, non-independent positions to transition to their first independent tenure-track faculty cancer research positions, or their equivalent, and provides salary and protected time as they further develop their research skills and establish independent cancer research programs. The K22 award is intended to facilitate the establishment of a record of independent research by the candidate and thereby enhance the probability of success in obtaining independent NIH or other research project grant support. The award prepares qualified individuals for careers that can have a significant impact on health-related research needs of the Nation. This one-phase, non-mentored K22 program is part of a continuing effort to establish a unique pathway for recruiting and retaining postdoctoral fellows from groups that are nationally underrepresented in biomedical, behavioral, clinical and social sciences research (see Section III, Eligible Individuals) who can conduct independent competitive cancer research programs. These biomedical research investigations are expected to address problems that are pertinent to cancer health disparities or the biology, etiology, pathogenesis, prevention, diagnosis, control, and/or treatment of human cancers.
To activate the K22 award, the successful candidate must first secure a tenure-track, full-time assistant professor position or equivalent, in an extramural institution within a year of the receipt of the Letter of Intent to Commit Funds. Once the assistant professor position has been secured, the candidate will submit updated information about the K22 application with the support of the sponsoring institution. The sponsoring institution can be the same as the post-doctoral institution, though it is most likely a different institution from the original submission of the K22 application. The updated information of the transition to an assistant professor position at the sponsoring institution will be evaluated and approved by NCI's CRCHD program staff to ensure that all programmatic requirements are met prior to the activation of the K22 award. Details of the requirements for the activation of the K22 award are described in Section VI of this announcement.
The NCI K22 award to promote diversity will provide up to 3 years of support for the most promising and exceptionally talented postdoctoral fellows from populations nationally underrepresented in biomedical, behavioral, clinical, and/or social sciences. This period of support is to allow the investigator to establish an independent research program, and to prepare a competitive application for research project grant support (R01 or equivalent). NIH believes that the creativity and innovation of newly independent investigators in their early career stages play an integral role in addressing the Nation's biomedical, behavioral, and clinical research needs.
NCI K22 award recipients are expected to apply for NIH or other independent research project grant support (R01 or equivalent) prior to the end of the 2nd year of support. Recipients may hold concurrent research support, and, under certain circumstances, salary support from the final 2 years of their K22 award and a competing NIH research project grant when recognized as the PD(s)/PI(s) or Subproject Director of the research project grant. See NOT-OD-08-065 and NOT-OD-17-094.
Substantial national and local efforts are directed toward a reduction in cancer morbidity and mortality in the general population. However, in spite of these efforts, the American Cancer Society estimates approximately 1.7 million new cancer cases will be diagnosed in 2017, and 600,920 cancer deaths will occur. Past patterns of cancer incidence and mortality predict that the disproportionate increase in U.S. cancer incidence and mortality will be experienced by underserved populations (https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html). Specifically, cancer rates for stomach, liver, gall bladder, and cervix are higher in Hispanics than in non-Hispanic whites (http://www.cancer.org/research/cancerfactsfigures/cancerfactsfiguresforhispanicslatinos/). Stomach and liver cancer incidence and death rates are more than twice as high in Asian American/Pacific Islanders as in Caucasians, and mortality rates from prostate, stomach, and cervical cancers among African Americans are more than twice those in Caucasians.
Underrepresentation in the Biomedical Research Workforce
The National Science Foundation reports that African Americans, American Indians and Alaska Natives, Hispanics (or Latinos), Native Hawaiians and other Pacific Islanders are underrepresented at many career stages in health-related sciences on a national basis. (See the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2015). Individuals from these groups are under-represented when compared to their age-cohorts in science-baccalaureate earners, among science-PhD earners, and in the biomedical workforce.
In 2013, only 6 percent of science and engineering doctorate holders employed as full-time, full professors at all institutions were from underrepresented racial and ethnic groups, and at Research Intensive institutions, this proportion falls to only four percent. Moreover, among science and engineering doctorate holders with full-time faculty employment at any four-year institution, those from underrepresented racial and ethnic groups were less likely to receive federal grants or contracts than their white counterparts.
The lack of diversity of the biomedical and behavioral research workforce, which may be due to a failure of support infrastructure at various levels, is a source of concern to the NIH. Thus, evidence-based interventions that broaden participation in science careers and those that promote successful transitions at the various career stages have been proposed: (From the NIH: A Systems Approach to Increasing the Diversity of the Biomedical Research Workforce.) and (P01: Scientific Workforce Diversity -Opportunity for Enhancing Research Excellence).
The Americans with Disabilities Act (ADA) defines an individual with a disability as a person with a physical or mental impairment that substantially limits one or more major life activities. In 2010, the Bureau of the Census reported that nearly 20 percent of the United States population had a disability. The National Center for Education Statistics (NCES) reported that in 2012, 11 percent of college students had a disability, and 34 percent of undergraduates with disabilities are from underrepresented racial and ethnic groups. According to the Council of Graduate Schools and statistics from NCES, in 2008 about seven percent of all doctoral students and about six percent of doctoral students in health or life science programs had a disability.
NCI's Interest in Diversity
NCI is committed to making sure that all Americans share equally in the medical advances that result from cancer research, and that current disparities in the burden of several diseases, including cancers, are reduced or eliminated. As part of that mission, NCI is helping to build a diverse workforce for the biomedical sciences—a critical step in reducing the burden of cancer for an increasingly diverse America. This includes providing a smoother path towards careers in science and medicine as an important means to attract and engage the nation's most talented students, especially those from backgrounds nationally underrepresented in cancer research and care.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as nationally underrepresented in the biomedical, clinical, behavioral and social sciences. See, NOT-OD-15-053.
Promoting diversity in the extramural scientific workforce is critical to the success of NIH/NCI mission, and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity supports the NIH/NCI mission, expanding the pool of investigators from nationally underrepresented backgrounds in the biomedical research workforce remains an elusive goal.
Two problems previously cited by potential applicants for not applying for K-awards were the allowable salary cap and the lack of protected time for research activities. A common opinion that emerged from the NCI CRCHD Annual Professional Development Workshops for K awardees was that the salary cap and protected time needed to be modified by the NCI. As a result, the salary cap was increased from $75,000 to $100,000 per year.
Providing salary support and protected time for an intensive period of research training, such as through the K-award represents a specific opportunity to develop and sustain a diverse biomedical research workforce. In an evaluation of the NCI career development awards program, K-awardees proportionately received more subsequent NIH grants and authored more publications. Furthermore, of those not pursuing research, K-awardees were more likely to participate in activities that indicated continued scientific engagement. Thus, receiving the K award impacted participants' career progression positively, and also led to outcomes that are significant to the scientific enterprise: (Outcome Evaluation of the NCI Career Development Awards Program).
Specific Research Objectives
A major obstacle to developing a stronger and diverse national cancer research effort has been the lack of significant strategic training programs for students and scientists from underrepresented groups in cancer research. Thus, progress in realizing a significant increase in the number of competitive underrepresented cancer researchers has been slow. A greater involvement of underrepresented candidates, who bring unique cultural perspectives to the research, is integral to a successful national cancer research effort towards underserved populations.
The Diversity Training Branch (DTB) of NCI's Center to Reduce Cancer Health Disparities (CRCHD) (http://crchd.cancer.gov/) seeks to promote diversity in biomedical, behavioral, translational, clinical, and/or social sciences. DTB invites applications from eligible scientists from backgrounds nationally underrepresented in these cancer research areas. This award will provide "protected time" for recipients to develop and receive support for their initial cancer research program. Efforts to diversify the workforce in these areas are expected to lead to the recruitment of the most talented cancer researchers from all groups. Accordingly, this award forms an important part of NCI's initiative to attract talented individuals from underrepresented backgrounds to the challenges of cancer research.
The program will provide successful candidates with professional development workshop opportunities and mock review experiences to enhance their knowledge and understanding of the NIH peer review system and to develop the skills required to prepare competitive grant applications to NIH and other funding agencies. To this end, the NCI CRCHD will:
Monitor the implementation of the NCI Transition Career Development Award to Promote Diversity (K22) program to determine its impact on individual awardees;
Track and maintain an updated census of the status of funded K22 grantees; and
Encourage development and testing of metrics that can be used to assess the impact of the program on scientific and workforce diversity.
Special Note: Prospective applicants are strongly encouraged to consult the NCI Scientific/Research contact listed under Section VII.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA (PAR-18-367). Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.
See Section VIII. Other Informationfor award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
Note: Applicants may propose to gain experience in a clinical trial led by another investigator as part of their research career development.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award budgets are composed of salary and other program-related expenses, as described below.
The total project period may not exceed 3 years.
During the independent phase, NCI will contribute up to $ 100,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.
During the independent phase, NCI will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.
Salary for advisors, consultants, collaborators, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grant 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
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
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.
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 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 who meets the eligibility criteria below (see Enhancing Diversity), and who has 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 organization to develop an application for 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
The overarching goal of NIH diversity programs is to enhance the pool of independent cancer research investigators from backgrounds nationally underrepresented in the biomedical, clinical, behavioral, and social sciences (NOT-OD-15-053), which includes:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27, and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf .
C. Individuals from disadvantaged backgrounds, defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.
2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.
For the purposes of this funding opportunity announcement, only individuals from categories A and B are eligible to apply for support under this program.
Additional Eligibility Criteria
Postdoctoral Investigators: At the time of the initial application submission, candidates for this award must: (1) have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or equivalent doctoral degree) or a combined research doctorate/clinical degree; (2) have at least 2 years of postdoctoral training in cancer research at the time of submission of the initial application (e.g., postdoctoral fellow, postdoctoral associate, clinical fellow, clinical associate or equivalent); and (3) have no more than a total of 8 years of mentored research training experience after the terminal clinical or research doctorate at the time of initial application.
Clinicians: Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral 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. Time spent in clinical training is not counted for the 8-year postdoctoral research experience limit; a clinical faculty member who does not hold an independent research faculty position may be eligible for this K22 award, and should contact the NCI Program Director listed in Section VII 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.
Other Candidates: Some institutions appoint postdoctoral fellows in positions with other titles (e.g., research associate, instructor, or equivalent) but they are still in mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that he/she is in a position that is equivalent to that of a post-doctoral scientist.
Investigators trained in Mathematics, Physical Sciences and/or Engineering may want to consider re-orienting to cancer-focused research careers. Such investigators should have some prior training in cancer research to be competitive for this non-mentored K22 grant.
NIH Intramural Candidates: Mentored, non-independent investigators in NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to apply for the NCI K22 award.
Individuals affiliated with an NIH Intramural Laboratory may apply (specific information is available for intramural candidates on the Electronic Submission Intranet – link available only to users internal to NIH).
Individuals not affiliated with an organization may apply (specific information is available for unaffiliated candidates).
Individuals are NOT eligible for the NCI K22 to Promote Diversity if they:
Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or their equivalents.
The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
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, 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:
At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development and research activities during this non-mentored K22 award. 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.
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
Include a description of your current research and the research you propose to continue in the independent phase.
A letter certifying candidate's eligibility as described in Section III.1A and B (Enhancing Diversity), must be submitted by the applicant institution. Name the PDF-formatted letter 'EligibilityCertification.pdf'.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed
All instructions in the SF424 (R&R) Application Guide must be followed
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Career Goals and Objectives
Candidate's Plan for Career Development/Training Activities During Award Period
Research Plan Section
Training in the Responsible Conduct of Research
Consultant, Collaborators Section
Plans and Statements of Mentor and Co-mentor(s)
If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoringinvestigator(s) responsible for the clinical trail in which the applicant will gain reseearch experience, team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
Description of Institutional Environment
Institutional Commitment to the Candidate's Research Career Development
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
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 a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.
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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
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.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
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.
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.
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.
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.
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.
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).
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).
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:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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.
There will not be a formal Notice of Award (NoA) for applications until an awardee institution has been identified by the candidate and approved by the NCI. The NCI will initially notify candidates who have successfully competed for funding with a Letter of Intent to Commit Funds. Selected candidates will then have up to 12 months from the date of the letter to accept an appointment in a domestic academic institution that has offered a position at the tenure-track faculty level, or its equivalent (e.g., Assistant Professor, Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish his/her own independent research program, prepare applications for regular (non-career development) research project funding, and act as a PI(s)/PD(s) on such independent research projects. No funds will be issued for use while the candidate occupies a mentored, non-independent position at the submitting institution or awardee institution.
In the Request to Activate the K22 Award, the awardee institution needs to:
The awardee institution will also need to provide a description of the institutional commitment to the candidate's career development for the following:
In addition, the candidate and the new awardee institution will also need to provide a revised budget according to the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions. This information should be provided through the Change of Grantee Organization (Type 7 Parent) Program Announcement if the candidate changes institutions or through "just-in-time" procedures if the candidate obtains a tenure-track faculty position at the postdoctoral institution.
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.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed.
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.
Within ten years of making awards under this program, NIH will assess the program's overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Abigail Soyombo, Ph.D., M.B.A
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Email: email@example.com .
National Cancer Institute (NCI)
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 Part 75.
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