National Institutes of Health (NIH)
National Cancer Institute (NCI)
Funding Opportunity Title
NCI Established Investigator Award in Cancer Prevention and Control (K05)
K05 Research Scientist Award
Reissue of PAR-09-088
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.393, 93.398, 93.399
The purpose of the NCI Established Investigator Award in Cancer Prevention and Control (K05) is to provide protected time to senior investigators with exceptional mentoring records and sustained, high levels of research productivity in cancer prevention, cancer control, or the behavioral or population sciences to devote to research and mentoring.
December 21, 2011
Open Date (Earliest Submission Date)
January 12, 2012
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Standard dates apply
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
January 8, 2015
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially 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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the NCI Established Investigator Award in Cancer Prevention and Control (K05) is to provide salary support for a sustained period of protected time (3-5 years) to senior scientists to focus on their research and on mentoring junior investigators. Candidates for the K05 should be recognized leaders in their respective research fields who have demonstrated a sustained, high level of productivity and a distinguished record of original contributions in their field, and whose expertise and contributions to these research fields will continue to be critical to the mission of the NIH.
Candidates should typically be in a senior career stage at the Professor level or performing at that rank in an academic setting or equivalent non-academic setting. This award is intended for individuals who have an extensive record of supervising and mentoring junior investigators.
Candidates should have active, cancer-focused research programs in cancer prevention, cancer control, or the behavioral or population sciences. For the purpose of the K05 award, cancer control research is defined as "basic and applied research in the behavioral sciences that independently or in combination with biomedical approaches reduces cancer risk, incidence, morbidity, and mortality across the lifespan and over the entire process of carcinogenesis from primary behavioral prevention in youth, to screening, treatment, and survivorship" (Report of the NCI Cancer Control Progress Review Group, 1998).
Renewal. Award may be renewed one time for an additional 3-5 years of support if the award recipient continues to have peer-reviewed, independent R01 or R01-like research support at the time of submission of the renewal application and at the time of award. Candidates should clearly demonstrate their continuing need for protected time.
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period
The total project period may not exceed 5 years.
NCI will contribute up to 3 person months (25% full-time professional effort) per year toward the salary of the
career award recipient. The total salary requested must be based on a full-time
staff appointment. The salary must be consistent with the established salary
structure at the sponsoring institution; 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; with the
career award recipient's institutional salary; and with the level of effort
requested, up to the maximum legislated salary rate in effect at the time of
award (see: http://grants.nih.gov/grants/policy/salcap_summary.htm).
The career award recipient must devote this effort to the research and
mentoring activities of the K05.
Other Program-Related Expenses
NCI will contribute up to $25,000 direct costs per year ($5,000 direct costs per mentee, for up to 5 mentees) to support expenses directly resulting from mentored activities. Expenses for the mentored investigators may include tuition and course fees; travel to research meetings or to obtain training; and research costs, including technical services and personnel, statistical services and personnel, and computer time. Funds provided for mentoring expenses may not be rebudgeted for any other purpose.
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are
not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
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 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 PD(s)/PI(s) are not allowed.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Candidates for this award must have a research or health-professional doctoral degree or its equivalent and must have peer-reviewed, independent R01 or R01-like research support at the time of submitting a new or a renewal K05 application, as well as at the time of award.
K05 awardees are expected to continue to maintain peer-reviewed, independent R01 or R01-like research support for the duration of this award. Awardees losing this support during the award period must document in their annual Continuation Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K05 award; continuation of the award requires approval by NCI Program staff.
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. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
K05 awardees may apply for a one-time renewal for an additional 3-5 years of support if the K05 recipient continues to maintain peer-reviewed, independent R01 or R01-like research support at the time of submission. Candidates should clearly demonstrate their continuing need for protected time for research and to serve as mentors to junior investigators.
At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. 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.
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.
The forms package associated with this FOA includes all applicable components, mandatory 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 SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate’s Background (Component of Candidate Information)
Career Goals and Objectives (Component of Candidate Information)
Career Development/Training Activities During Award Period (Component of Candidate Information)
Training in the Responsible Conduct of Research (Component of Candidate Information)
Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.
Mentoring Plan (Component of Candidate Information)
Statements by Consultants, Contributors (Component of Statements of Support)
Research Strategy (Component of Research Plan)
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via 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 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
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 SF 424 (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.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) 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 Central Contractor Registration (CCR). 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-10-115.
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
Reviewers should provide their assessment of the likely impact of the research plan and proposed mentoring activities, taking into consideration the criteria below in determining the overall impact/priority 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.
Is the candidate an outstanding scientist who is making significant contributions to cancer prevention, cancer control, or the behavioral or population sciences as related to cancer prevention and control? Is there evidence of ongoing, high-quality research productivity as evidenced by contributions to the scientific literature and success in obtaining independent funding? Does the candidate have stable research support? Is there evidence of the candidate's capabilities and commitment to serve as a mentor? Is the candidate's level of training, experience, and competence commensurate with the purposes of the award?
Career Goals & Objectives/ Plan to Provide Mentoring
Is there evidence that the award will enable the candidate to devote time to research and mentoring by release from teaching, administration, clinical work, and/or other responsibilities? What is the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate's mentees? Are the plans to provide mentoring to junior investigators adequate? Have past and current mentoring activities been adequately described? Is an appropriate level of effort proposed for the mentoring component?
Candidates must have peer-reviewed, independent R01 or R01-like research support at the time of application and when the career award is made. Reviewers should not re-evaluate the research plan. Rather, the reviewers should evaluate how the research and mentoring plans coordinate to further mentees' research careers and fulfill the candidate's career goals. Is the research plan of high quality, and does it have potential for advancing the field of study? Is the scientific and technical merit of the proposed research plan of significance? Is the research plan an appropriate vehicle for developing the prospective mentees' skills and capabilities in research? Is the research plan explicitly coordinated with the mentoring plan? Is the proposed research relevant to the candidate's career objectives?
Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality? Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
Environment & Institutional Commitment to the Candidate
Is the level of the applicant institution s commitment to the scientific development of the candidate appropriate? Are the research facilities and resources available to the candidate appropriate and adequate? Are the size and quality of the pool of investigators to be mentored by the candidate adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate? Is the commitment from the sponsoring institution to provide protected time for the candidate to conduct the research program adequate?
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/priority 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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
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.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period. The applicant must have peer-reviewed, independent R01 or R01-like research support at the time of submitting a renewal application, as well as at the time of award.
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/priority score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups that the candidate will participate in? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety? Do the plans adequately describe the candidate’s role in the participation in instruction in RCR? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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.
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), convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD(s)/PI(s) 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
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, CCR 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) 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.
In addition, the awardee must provide a summary or table of mentees that lists their degrees and career stage and describes their research achievements, publications, and presentations during the past year. The report should also summarize the role that the awardee played in these achievements and in the progress of each mentee towards his or her career goals. If the awardee has lost peer-reviewed, independent R01 or R01-like research support during the award period, he or she must document efforts to replace this support and demonstrate that he or she continues to meet all other requirements of the K05 award.
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.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Susan N. Perkins, Ph.D.
Cancer Training Branch, Center for Cancer Training
National Cancer Institute (NCI)
National Institutes of Health
Branch Telephone: (240) 276-5630
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Grants Management Specialist
Office of Grants Administration
National Cancer Institute (NCI)
National Institutes of Health
Telephone: (240) 276-6294
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.
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