Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
Title: Paul Calabresi Career Development Award for Clinical Oncology (K12)
This Funding Opportunity Announcement is a reissue of PAR-06-449.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-10-155
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: March 26, 2010
Opening Date: May 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): June 10, 2010; June 10, 2011; June 11, 2012
Peer Review Date(s): October/November 2010; October/November 2011; October/November 2012
Council Review Date(s): January 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): April 1, 2011; April 1, 2012; April 1, 2013
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: June 12, 2012
Due Dates for E.O. 12372
Additional Overview Content
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Institutional Research Career Development Program Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
1. Institutional Career Development Program Objectives
This funding opportunity announcement (FOA) issued by the National Cancer Institute (NCI) encourages applications for institutional research career development (K12) programs from applicant organizations that propose to promote the training and career development of translational and clinical trials researchers. The purpose of the Paul Calabresi Career Development Award in Clinical Oncology (PCACO) K12 (NIH Institutional Research Career Development K12 grant mechanism) is to increase the number of clinicians (M.D.s, D.O.s, Pharm.D.s,) and basic research scientists (Ph.D.s, or equivalents) who are trained to design and administer hypothesis-based pilot/Phase I, Phase II, and Phase III cancer therapeutic clinical trials in team research settings. A PCACO can support the research career development of clinicians only or clinicians and Ph.D. basic research scientists. Clinical and basic research scientists will collaborate and interact to expedite the translation of basic science research discoveries into patient-oriented therapeutic cancer research. The PCACO is not intended to train laboratory-based scientists whose research will be primarily focused upon the use of animal or other model systems.
The NCI embarked on a pilot program initiative in 1991 that prepared clinical oncologists to be effective scientific partners with basic research scientists. These well-trained clinical oncology researchers communicated, interacted, and collaborated with basic research, translational, and behavioral scientists in the design and implementation of hypothesis-driven clinical trials. The initial pilot program was highly successful and generated considerable interest in the cancer research community. This pilot program initiative was further implemented through two successive Requests for Applications, and in 1994, the Program was changed from supporting only clinician scientists to one that supports both clinician scientists and basic research scientists. Later, the program was renamed the Paul Calabresi Award in Clinical Oncology (PCACO) in honor of the late Dr. Paul Calabresi, who was a pioneer in the pharmacological treatment of cancer and early translational research.
The advent of an increased emphasis on team science has spurned the dynamic development of the Clinical and Translational Science Awards (CTSAs), beginning in 2006, sponsored by the National Center for Research Resources. Similar to the PCACO, the CTSAs strive to drastically increase clinical and translational research programs in institutions nationwide and provide training and career development experience for the CTSA scholars. Currently, the PCACO is specific to NCI for its emphasis on cancer research.
This funding opportunity announcement (FOA) encourages applications from applicant organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NCI. The NIH K12 grant mechanism (NCI PCACO) is a specialized grant program designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs. The overall goal(s) of the NCI’s Research Career Development programs are to ensure that highly trained scientists will be available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.
The purpose of the Paul Calabresi Career Development Award in Clinical Oncology (PCACO) K12 (NIH Institutional Research Career Development K12 grant mechanism) is to increase the number of clinicians (M.D.s, D.O.s) and basic research scientists (Ph.D.s, Pharm.D.s, or equivalents) who are trained to design and administer hypothesis-based pilot/Phase I, Phase II, and Phase III cancer therapeutic clinical trials in team research settings. A PCACO can support the research career development of senior fellow and/or junior faculty level clinicians only or senior fellow and/or junior faculty level clinicians and postdoctoral Ph.D. basic research scientists. Clinical and basic research scientists will collaborate and interact to expedite the translation of basic science research discoveries into patient-oriented therapeutic cancer research. The PCACO is not intended to train laboratory-based scientists whose research will be primarily focused upon the use of animal or other model systems.
Unique features of PCACO include:1) a requirement for representation of at least 2 oncology specialties among the faculty and the K12 appointees (scholars); 2) mentorship by both a basic science cancer researcher and a clinician (patient-oriented) researcher; 3) a requirement for a laboratory-based research experience for the Scholar and the translation of the results of this experience into clinical trials; 4) a requirement for individualized career development programs for the K12 Scholars; 5) for dual track K12 programs, the joint career development of clinicians with PhD basic scientists; 6) Flexibility to accommodate K12 Scholars with different levels of prior research training/experience; and, 7) relevant coursework.
This program announcement will build upon the success of the last PCACO. Several significant changes are proposed for the new FOA. First, an initial year for curriculum planning and development, with K12 scholars beginning work in the second year of the grant will be required for type 1 applications.The objective of this initial year is to maximize the productivity of the curriculum planning committee and advisory committee by allowing finalization of preparation for scholar training in the second year of the grant. Second, limited funds (no greater than $5,000 per year) will be allocated for external advisory committee meeting travel. These funds will facilitate meetings of the external advisory committee. Finally, scholar salaries will be listed as up to $100,000 in the new FOA, in accordance with new K salary guidelines.
The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.
The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving federal support.
1. Mechanism of Support
This FOA will use the NIH Institutional Research Career Development (K12) award mechanism. The PDs/PIs (if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed institutional career development program.
This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit detailed categorical budget requests using the SF24 Research and Related (R&R) Budget Component found in the application package for this FOA.
Institutional career development grant support is renewable. Institutional career development grant support is for new and renewal (formerly “competing continuation”) applications. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal (formerly “competing continuation”) application. Only one resubmission (formerly “revision/amendments”) of a previously reviewed grant application may be submitted. See NOT-OD-09-003, NOT-OD-09-016.
2. Funds Available
Because the nature and scope of the proposed institutional career development 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 National Cancer Institute provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the institutional research career development program proposed, it is expected that applications will stay within the following annual budgetary guidelines: $750,000 for single-track programs and up to $1,050,000 for dual-track programs.
Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004. .
All awards are subject to the availability of funds.
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented, and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, “Selecting the Appropriate Budget Component”.
Personnel: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.
Program Administration Costs: If applicable and justified, the costs of a Research Administrator and/or program assistant with responsibilities directly associated with the institutional career development program can be requested, and salaries must be commensurate with institutional policy for similar positions, and specifically identified and justified. When applicable, this expense must be itemized in Section A or B, as appropriate.
Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Sections C, D, and F, as appropriate. Programs may request up to $5,000 annually for External Advisory Committee travel.
Scholar Costs: Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in Section B (scholar salaries) and F (other program-related expenses) as appropriate.
The NCI will provide support for each scholar position up to $100,000 salary and associated fringe benefits per year based on a full-time professional 12 person-month effort commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank.
The total salary requested must be based on a full-time, 12-month staff appointment and requires scholar to devote a minimum of 9 person-months of full-time professional effort to conducting career development and health-related research with the remaining effort devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-022.html.
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 staff person in the relevant Institute prior to preparing an application to discuss their eligibility.
The proposed salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salaries may be required prior to the issuance of an award.
The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. Additional PHS funds may not be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K12 award. However, under expanded authorities, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.
Mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a PI or subproject director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html.
Research and Development Support: Up to $30,000 per individual scholar may be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. These costs must be specifically documented for each individual scholar and must be both specifically and directly related to the scholar's research activities. They cannot be pooled and used for advertising, recruiting, or other programs unrelated or indirectly related to the research activities of individual scholars. It is expected that the K12 scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to include the scholar.
Items that may NOT be supported with K12 funds include: Salaries for support of ancillary personnel, i.e. mentors, secretarial, and administrative assistance, etc.
Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (excluding tuition, fees, and equipment).
NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Foreign institutions are not eligible to apply in response to this FOA.
In many cases, it is anticipated that the proposed institutional research career development program will complement other ongoing research training and career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals.
Institutions with existing K12 or other training programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed career development program as the PD/PI is invited to work with his/her institution 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.
The PD/PI should be an established, independently funded, cancer investigator in the scientific area in which the application is targeted who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed institutional research career development program.
The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. (See Section VI.3. “Reporting.”)
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.
A single PD/PI application may not be converted to a multiple PI application within a 5-year budget period. Likewise, a multiple PD/PI application may not be converted to a single PD/PI application within a 5-year budget period.
Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other - Special Eligibility Criteria
Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program (see Section IV.6, item 14).
Scholars: Appointees to the Program must be designated “Paul Calabresi Scholars”.
Individuals to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award. This effort may be reduced to 6 person-months (50% of full-time professional effort) for surgeons. Clinician Candidates (required): All clinician candidates must currently be physicians holding the M.D. or D.O. degrees, Pharm.D.s, or be nurses with a clinical Ph.D. degree; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research.
Basic Science Candidates (encouraged but optional): All basic science candidates must have doctoral-level degrees (e.g., Ph.D., or the equivalent), a minimum of 2 years of postdoctoral research training, and a total basic science research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research.
The program must involve clinical and basic science scholars representing at least two clinical oncology disciplines such as medical oncology, surgical oncology, radiation oncology, pediatric oncology, gynecologic oncology, and oncology nursing. Clinical scholars from non-oncology medical subspecialties (e.g., thoracic surgery, pulmonology) may also be represented in the Programs. However, the research career objectives of these scholars must clearly be the application of their medical training and research experience to research in clinical oncology; and the individualized career development plans developed for these scholars must be focused on clinical oncology research.
Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Individuals who may have been or currently are a PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions of an R03 or R21 grant remain eligible for an NCI K12 appointment.
Individuals are NOT eligible for an appointment if they:
Due to the emphasis of the K12 on patient-focused research, clinician scholars appointed to a K12 grant are encouraged to subsequently apply for a K23 and not a K08 if they need additional mentored career development; a K99/R00 if they need additional mentored career development (K99) and will then transition to the independent stage of their research career (R00); or for a patient-oriented NCI K22 if they need protected time to develop their independent patient-oriented research or patient-focused translational research program in their first independent research position.
Recipients of a K12 appointment may hold concurrent research support (and under certain circumstances (see Allowable Costs below) salary support) from their appointment and a competing NIH research project grant (RPG) when recognized as a PI or subproject director of the RPG (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html) if they have first completed at least 2 years of training supported by the K12 grant.
Applicants are strongly encouraged to consult with the scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and program requirements.
Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually persons born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.
Mentors: Mentors will interact closely with the scholar, and should have research expertise and experience relevant to the proposed career development program. Mentors must be committed to continue their involvement throughout the total period of the scholar’s career development under this award. The program must involve clinical and basic science mentors representing at least two clinical oncology disciplines such as medical oncology, surgical oncology, radiation oncology, pediatric oncology, gynecologic oncology, and oncology nursing. At least 50% of the mentors on this K12 should have independent research support in cancer.
Advisory Committee: The PI must use an Advisory Committee (AC) to provide an oversight function and annual evaluation of the Program as a whole. The committee's responsibilities should include but are not limited to: selecting clinician, nurse, and basic science scholars (Note: basic science scholars are encouraged as part of these Programs but they are optional), assigning preceptors, approving each scholar's career development plan, evaluating each scholar's progress, authorizing the termination of a scholar who is not performing adequately, monitoring the overall effectiveness of the program and recommending mid-course changes when needed. A detailed description of the committee's composition, function, and frequency of meetings should be provided. Plans for an annual evaluation of the program by the AC should be described, and annual written reports from the AC are required that describe the progress (e.g., success of scholars in achieving core didactic and research requirements) of the Program, evaluate its effectiveness (e.g., recruitment methods, effectiveness of mentors, effectiveness and appropriateness of curriculum), and provide recommendations for improvements. This annual report must also address the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds in the Program.
Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals: Renewal applications are allowed for this institutional research career development (K12) program.
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact Grants Info -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications”.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
SF 424 Research & Related Budget (R&R)
PHS398 Cover Letter
Research and Related Subaward Budget Attachment(s) Form
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 14 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI”. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Training Program plan entitled “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.
If budget allocation is planned, the distribution of resources to specific components of the program or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Application Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.
The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression, including publications, and post-training positions. Evaluation results should be included in future renewal applications and as part of the Final Progress Report.
3. Submission Dates and Times
IV.3.A for details.
3.A. Application Due,
Review and Anticipated Start Dates
Opening Date: May 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not applicable
Application Due Date(s): June 10, 2010; June 10, 2011; June 11, 2012
Peer Review Date(s): October/November 2010; October/November 2011; October/November 2012
Council Review Date(s): January 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): April 1, 2011; April 1, 2012; April 1, 2013
3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.
3.B. Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
3.C.1. Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.
All applications must meet the following criteria to be considered “on-time”:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3. Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, application will be evaluated for completeness by the CSR Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
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. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or renewal award if such costs: are
necessary to conduct the project, and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications”.
PHS 398 Research Training Program Plan Component Sections
Page limitations of the Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for K12 applications:
An initial year for curriculum planning and development, with K12 scholars beginning work in the second year of the grant is required for initial (type 1) applications. No scholars will be appointed during the first year of the grant on these initial awards. The objective of this initial year is to maximize the productivity of the curriculum planning committee and advisory committee by allowing finalization of preparation for scholar training in the second year of the grant.
These requirements should include the following:
A DIDACTIC CORE REQUIREMENT (e.g., formal courses in clinical trial design, biostatistics, informed consent, Institutional Review Boards, data safety and monitoring, lecture series, seminars, and journal clubs) based on the experience and needs of each candidate. The requirements for this core component should be the same for all scholars whether or not they have clinician or basic science research backgrounds.
A CLINICAL RESEARCH CORE REQUIREMENT that provides "hands-on" experience (e.g., protocol development; preparation of IRB applications; administration of clinical trials including patient accrual, analysis of outcomes) in all aspects of Phase I, Phase II, and where possible Phase III clinical trials. Except for the administration of treatment to patients, this component should be the same for all scholars whether or not they have clinical backgrounds or basic science research backgrounds. Basic science scholars are expected to be full partners with clinicians and become equally proficient in the design and the evaluation of results from translational, therapeutic clinical trials.
A BASIC SCIENCE RESEARCH CORE REQUIREMENT that provides a hands-on research experience for CLINICIAN scholars for up to 2 years that results in peer-reviewed first author publication(s) and that clearly serves as a tool for ensuring that these scholars are fully prepared to communicate, coordinate and collaborate with basic research scientists in the conduct of hypothesis-driven cancer therapeutic research. Ideally, this experience should be linked to the core clinical research component.
The expectation of the NCI is that clinician and basic research science scholars will enter the Program with different levels of experience that already satisfy many of the Didactic, Clinical Research, and Basic Science Research Core Requirements. Thus, individual scholars will need to complete only those additional didactic and research experiences that help them meet all of the core requirements of the Program and are likely to be supported by the Program for different periods of time.
Scholars are required to submit, but not necessarily obtain an investigator-initiated research project grant.
All scholars who successfully complete the program are expected to receive some formal recognition from the parent institution (e.g., Masters in Clinical Research degree or special certification in clinical research).
If basic science scholars are included in the Program, special efforts must be made to treat the clinician and basic science scholars as a COHORT with regard to sharing, presenting, and discussing their research career development and training experiences.
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 http://www.nsf.gov/sbe/srs/women/start.htm). 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 http://aspe.hhs.gov/poverty/index.shtml. 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.
Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.
Applications lacking a Diversity Recruitment and Retention Plan will be considered incomplete and will not be reviewed.
Applications lacking a plan for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.
Project/Performance Site Locations Component
Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.
If multiple sites are involved in the institutional career development program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.Research and Related (R&R) Other Project Information Component
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
Data Sharing Plan: Not Applicable.
Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”Senior/Key Person Profile(s) Component
The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.
Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons, involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to and have key roles in the proposed institutional research career development program.
See Section 4.5 of the Grants.gov Application Guide SF424 (R&R)
Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R).
Multiple-Program Directors may be proposed only if the FOA to which you are responding indicated the multiple PD/PIs will be accepted. If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration. If your application involves Multiple PD/PIs, follow the directions in Section 4.5 to designate the Contact PI and to assign the PD/PI role to other Senior/Key Persons. Additionally, the application must include a Multi-PD/PI Leadership Plan.
Complete the Profiles for Other Senior/Key Persons according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R)
The PD/PI, applicable faculty and any other individuals whose contributions are critical to the development, management and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the multiple PDs/PIs, if applicable, and other program staff. Since these efforts are not project related research endeavors, they should not be identified in Other Support information.
Other Personnel: See “R&R Budget Component Research & Related Budget,” Item “B” below.
Institutional Research Career Development Program applications will use the non-modular budget format (Research & Related Budget component) and "Just-in-Time" concepts. See Sections II and Section IV for budgetary guidance. Instructions for completing the R&R Budget Component are provided below. Information regarding allowable costs is provided in the specific FOA. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K. Applicants must complete a separate detailed budget for each year of support requested.
R&R Budget Component Research & Related Budget: Complete for each budget period requested.
A. Senior/Key Person: complete for all senior/key persons associated with the institutional career development program. The PD/PI (or multiple PDs/PIs) must be included here.
B. Other Personnel: complete for all other personnel (including clerical and program administrative staff) associated with the institutional career development program. Include here the salary costs proposed for the planned scholars, identifying as the Project Role “Scholar”.
C. Equipment: self-explanatory.
D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the program.
E. Participant/Trainee Support Costs: Do not complete this budget category (does not apply to K12 programs).
F. Other Direct Costs: Include the funds requested for research development costs allowed for the scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.
G. Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.
K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research and development costs in the Budget Justification.
Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.
Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.
When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the “View Attachment” button to determine if the correct version has been attached.
Supplementary Instructions - NCI PCACO K12 Tables
Provide in a tabular format the information described below. Suggested tabular formats for this information can be found under "Summary Information on Program" as a Word document (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.doc or as an Acrobat file (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.pdf)
Only the review criteria described below will be considered in the review process.
2. Review and
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH-supported research training, education, and career development programs areto help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high impact/priority score. These criteria are not listed in any order of priority.
The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs.
Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).
Scored Review Criteria: Reviewers will consider each of the five 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. For example, a project that by its nature is not innovative may be essential to advance a field.
Career Development Program Plan and Environment:
Program Director(s)/Principal Investigator(s) (PD/PIs):
Additional Review Criteria
As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific merit, 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.
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.
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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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 program.
Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:
Has the program been innovative in the past and does it continue to demonstrate innovation?
Additional Review Considerations
As applicable for the program proposed, reviewers will address 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.
Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Select Agents 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:
When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
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 institutional career development program and the number of proposed scholars.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and
1. Award Notices
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 NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
A formal notification in the
form of a Notice of Award (NoA) will be provided to the applicant organization.
The NoA signed by the grants management officer is the authorizing document.
Once all administrative and programmatic issues have been resolved, the NoA
will be generated via email notification from the National Cancer Institute to the grantee business
2. Administrative and National Policy Requirements
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
Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.
Change of Institution: The institutional career development program may not be transferred from one institution to another.
Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.
Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
Changes in Research or Career Development Program: Awards are made to a specific institution for a specific program under the guidance of a particular PD/PI or PDs/PIs. Changes in any of these parameters require prior approval by the NCI. A scientific rationale must be provided for any proposed changes in the aims of the original peer reviewed program. The new program will be evaluated by NCI staff to ensure that the program remains within the scope of the original peer reviewed research program. If the new program does not satisfy this requirement, support could be withheld or the award could be suspended or terminated.
The following related administrative policies apply generally to NIH Research Career Award (“K”) programs:
A. Other Income
Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.
All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:
Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NCI.
B. Leave Policies
Leave of a K12 scholar to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding institute or center NCI is required. Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130).
To obtain prior approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.
Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.
Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.
C. Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent (equivalent to 9 person months). Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort (equivalent to 6 person months). The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. See: NOT-OD-09-036.
K12 awards are NOT subject to the streamlined non-competing application process (SNAP). Complete applications with detailed budgets and progress reports are required annually.
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program (if applicable), and a list of any publications and/or other materials arising from the program.
This report should provide information about changes in the Program, a summary of any ongoing evaluation results , a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development
Special Reporting Requirements
Please adapt the application for continuation to contain the following information:
A final progress report, invention statement, and Financial Status Report are required upon either completion of an award or relinquishment of an award.
3.A. Additional Reporting Requirements
Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted.
Evaluation: 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. Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.
Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”
Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.
Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
1. Scientific/Research Contact
Ming Lei, Ph.D.
Deputy Director, Center for Cancer Training
Acting Chief, Cancer Training Branch, Center for Cancer Training
National Cancer Institute
National Institutes of Health
6116 Executive Boulevard, Suite 700
Rockville, MD 20852
Jeannette F. Korczak, Ph.D.
Scientific Review Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8115, MSC 8328
Bethesda, MD 20892-8326 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 594-1182
3. Financial or Grants Management Contact
Kimery B. Griffin
Office of Grants Administration
National Cancer Institute
6120 Executive Blvd., EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3196
FAX: (301) 496-8601
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
Sharing of Model
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data
through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And
Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as
Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the
Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116 .html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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