and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
The NCI Transition Career Development Award to Promote Diversity (K22) |
Activity Code |
K22 Career Transition Award |
Announcement Type |
Reissue of PAR-09-069 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-12-062 |
Companion FOA |
Not Applicable |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.398 |
FOA Purpose |
The purpose of the National Cancer Institute (NCI) Career Transition Award (K22) is to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the nation's biomedical, behavioral, and clinical research needs. The Diversity Training Branch (DTB), the Center to Reduce Cancer Health Disparities (CRCHD) (http://crchd.cancer.gov/) invites applications from recipients of the NCI Mentored Career Development Award to Promote Diversity, or from advanced postdoctoral and/or newly independent research scientists representative of groups that are underrepresented in biomedical, behavioral, clinical, and/or social sciences (see Section III, Eligible Individuals). This award will provide "protected time" for recipients to develop and receive support for their initial cancer research program. In addition, this award can provide a two-year mentored experience in NCI intramural programs for interested individuals. |
Posted Date |
December 16, 2011 |
Open Date (Earliest Submission Date) |
January 12, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard dates apply by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
New Date: December 10 ,2014. This PAR has been reissued as PAR-15-063. |
Due Dates for E.O. 12372 |
Not Applicable |
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 Career Transition Award to Promote Diversity (K22) program is to prepare qualified individuals for careers that can have a significant impact on the health-related research needs of the Nation. This K22 mechanism is part of a continuing effort to establish a unique pathway for recruiting and retaining both advanced postdoctoral students and new investigators from groups that are underrepresented in biomedical, behavioral, clinical, and/or social sciences research (see Section III, Eligible Individuals) who can conduct independent competitive cancer programs. These biomedical research investigations are expected, but not required, to address problems that are pertinent to cancer health disparities and the biology, etiology, pathogenesis, prevention, diagnosis, control, and/or treatment of human cancer.
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 that approximately 1.5 million men and women will be diagnosed with cancer, and approximately half of them will succumb to cancer metastases. Past patterns of cancer incidence and mortality predict that the disproportionate increase in U.S. cancer incidence and mortality will be experienced by both minority and underserved populations (http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/index. 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/index). Stomach and liver cancer incidence and death rates are more than twice as high in Asian American/Pacific Islanders as in Caucasians, and cancer mortality rates from prostate, stomach, and cervical cancers among African Americans are more than twice those in Caucasians.
A major obstacle to developing a stronger national diverse cancer research effort has been the lack of significant strategic training programs for students and scientists from underrepresented groups in cancer research. Progress in realizing a significant increase in the number of competitive minority cancer researchers had been disappointing. A greater involvement of minority candidates, who possess the appropriate cultural perspectives, is integral to a successful national minority cancer research effort involving more minority patients and populations.
The Diversity Training Branch (DTB), the Center to Reduce Cancer Health Disparities (CRCHD) (http://crchd.cancer.gov/) invites applications from recipients of the NCI Mentored Career Development Award to Promote Diversity, or from advanced postdoctoral and/or newly independent research scientists representative of groups that are underrepresented in biomedical, behavioral, clinical, and/or social sciences. This award will provide "protected time" for recipients to develop and receive support for their initial cancer research program. In addition, this award can provide a two-year mentored experience in NCI intramural programs for interested individuals.
Funding Instrument |
Grant |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
|
Funds Available and Anticipated Number of Awards |
Because the nature and scope of the proposed K22 award program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt 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 3 years. |
Salary |
NIH will contribute $100,000 per year toward the salary of the career award recipient. The Candidate must commit to a minimum of 9 person months (75% full-time professional effort) on the
K22 award. |
Other Program-Related Expenses |
NIH 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. |
Indirect Costs |
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
For-Profit Organizations
Governments
Other
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.
NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to apply for the mentored phase of the K22 mechanism on behalf of intramural candidates. They are not eligible to apply for the independent phase.
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 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 Directors/Principal Investigators (PD/PI) 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 mentor and organization to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.
Candidates for this award must have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD., or equivalent doctoral degree), or a combined clinical and research doctoral degree. 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).
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.
Eligible individuals include recipients of the NCI Mentored Career Development Awards to Promote Diversity (i.e., K01, K08, K23) and/or individuals from underrepresented groups in biomedical, behavioral, clinical, and/or social sciences research.
The overarching goal of this FOA is to diversify and expand the pool of independent and talented cancer research investigators:
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
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 most recent report on 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: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are 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 HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
Information must be submitted by the applicant Institution in a letter certifying that the applicant belongs to one of the above groups. The letter should be inserted in the application immediately before the Checklist as a PDF file. Application processing may be delayed or the application may be returned if it does not comply with this requirement.
Nomination: The candidate must be nominated by the institution on the basis of qualifications, interests, accomplishments, and motivation, and based upon the candidate's intent to conduct a research project highly relevant to cancer biology, cancer health disparities, etiology, pathogenesis, prevention, diagnosis, and/or treatment that has the potential for establishing an independent research program. Accordingly, the NCI continues to encourage institutions to diversify their student and faculty populations and to identify candidates who will increase diversity on a national or institutional basis.
Information must be submitted by the applicant Institution in a letter certifying that the applicant belongs to one of the above groups. The letter should be inserted in the application immediately before the Checklist as a PDF file. Application processing may be delayed or the application may be returned if it does not comply with this requirement.
Individuals are NOT eligible if they:
Some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent 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 the position he/she is in complies with the intent of this eligibility requirement.
Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Clinicians (including those with MD, DDS, DVM 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. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K22 award, and should contact a Program staff at the NCI for guidance (See Section VII, Agency Contacts). 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 available for junior faculty development.
Candidates who have U.S. Veterans Administration (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 NIH staff (Section VII) prior to preparing an application to discuss their eligibility, qualifications, rank, and responsibilities in the department concerned.
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.
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions 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.
Recipients of an NCI Transition Career Development Award to Promote Diversity (K22) must submit a competitive research grant application to the NIH/NCI, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support.
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.
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.
The mentor must describe the career development plan for the candidate
(coordinated with the candidate’s research strategy). The description of the
career development plan must include items such as classes, seminars, and
opportunities for interaction with other groups and scientists. Training in
career skills, e.g.,
grant-writing and making effective presentations, is strongly encouraged.The mentor
and any co-mentors are also expected to provide an assessment of the
candidate’s qualifications and potential for a research career. The research
environment and the availability and quality of needed research facilities and
research resources (e.g., equipment, laboratory space, computer time, available
research support, etc.) must also be described..
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)
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.
Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)
Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)
Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)
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 this career award.
Research Strategy (Component of Research Plan)
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.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate, required reference letters will not be reviewed (more details in the Notice). 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 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
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 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.
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 SF 424(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 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.
In order to expedite review, applicants are requested to notify the NCI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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
review system.
Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, 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.
Candidate
Does the candidate
have the potential for becoming a successful independent investigator who will
contribute significantly to a chosen health-related research field? Will the
research experiences in the mentored phase prepare the candidate to implement
successfully the independent phase research project? Do the letters of
reference from at least three well-established scientists address the candidate s
potential for becoming an independent investigator?
Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring
To what extent are the plans for evaluating the awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award? Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the phase of the award?
Research Plan
Is the proposed research project appropriate for the
candidate’s stage of research development and as a vehicle for development of the
research skills described in the career development plan? Are the scientific
and technical merits of the research question, design, and methodology
appropriate in the context of prior training and experience? Is the proposed
research relevant to stated career objectives?
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Are the mentor's research qualifications 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? Is adequate information provided that clearly documents expertise
in the proposed area(s) of consulting/collaboration? Have the proposed
consultant(s) and collaborator(s) provided evidence of commitment to the
candidate and the candidate’s project? Do the proposed
consultant(s)/collaborator(s) provide the required expertise for successful
conduct of the research project?
Environment & Institutional Commitment to the Candidate
Are there adequate and appropriate
research facilities and educational opportunities, including collaborating
faculty? Is there clear commitment of the sponsoring institution to ensure that
the required effort of the candidate will be devoted directly to the research
training, career development, and research activities described in the proposed
career development and research plans? Is there strong institutional commitment
to fostering the career development of the candidate? Are there unique features
of the scientific environment that benefit the proposed research; e.g., useful
collaborative arrangements or subject populations? Is the environment of high
quality and relevance for scientific and professional development of the
candidate?
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.
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/priority score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including level of experience, 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? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? 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 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 submitted in response to this FOA. 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/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,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.
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.
Transition from the mentored phase to the independent phase
is not automatic. Approval of the transition will be based on the success of
the awardee’s research program as determined by annual scientific reviews and
by the evaluation of a research and career development plan to be carried out
at the institution. Additionally, the sponsoring institution must demonstrate a
commitment to the candidate by providing a minimum of nine person-months (75%
full time professional effort) protected research time, space and resources
needed to conduct the proposed research project and appropriate scientific
mentoring. A plan for career development that will lead to research
independence and the ability to successfully compete for research support is
essential. NIH will conduct a formal scientific progress review no later than
two months before the end of the mentored phase.
Candidates must provide a progress report using form PHS 2590,
which should detail progress achieved on the specific aims of the Research Plan
and on the pursuit of identified career and career development goals. Future
goals for the research project and for further career development should also
be indicated. The mentor must provide a separate narrative of the research and
career development of the candidate.
Form PHS 2590 must include the following:
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. 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.
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.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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]
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)
TTY: 301-451-5939
Email: [email protected]
Anil Wali, Ph.D.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-6183
E-mail: [email protected]
Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
Telephone: 240-276-6390
E-mail: [email protected]
Barbara J. Liesenfeld
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6294
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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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