and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health
(NIH), (http://www.nih.gov).
Components of
Participating Organizations
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
Title: National Cancer Institute (NCI) Cancer Education and Career Development Program
(R25)
Announcement Type
This is a reissue of PAR-03-148,
which was previously released on July 5, 2006.
Update: The following updates relating to this announcement have been issued:
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 SF424 Research and Related (R&R) forms and the SF424 (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 4 weeks prior to the grant submission date. See Section IV.
Program Announcement
(PA) Number: PAR-06-511
Catalog of Federal
Domestic Assistance Number(s)
93.398
Key
Dates
Release/Posted Date: August 4, 2006
Opening Date: September 1, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of
Intent Receipt Date(s): 30 days before submission date
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 Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer
Review Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: January 8, 2010 (per NOT-CA-09-034) - Previously September 8, 2009 (per NOT-OD-07-093) - Originially: July 2, 2009
Due
Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research 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 Electronically to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
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
Section I. Funding Opportunity Description
1.
Research Objectives
Purpose
The purpose of the NCI Cancer Education and Career Development Program (CECDP) is to support the development and implementation of institutional curriculum-dependent research education and career development programs to train predoctoral and postdoctoral individuals in cancer research settings that are highly interdisciplinary and collaborative. Examples of interdisciplinary/collaborative areas of cancer research that are particularly applicable to the intent of the CECDP are cancer prevention and control, behavioral and population sciences, nutrition, imaging, and molecular diagnosis. Institutional training programs in these highly interdisciplinary areas of cancer research require sustained leadership, dedicated faculty time, specialized curriculum development and implementation, interdisciplinary research environments, and more than one mentor per program participant/trainee to achieve their objectives. The goal is to develop a cadre of scientists who are prepared to conduct cancer research in interdisciplinary and highly collaborative team-oriented environments.
The proposed CECDP may be used to enhance ongoing research career development and education efforts at the applicant institution. However, the proposed program must offer participants/trainees experiences that are distinct from those provided by other research career development and education programs currently receiving federal support at the applicant institution. The CECDP cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms
Potential applicants whose research education and career development programs cannot meet the Special Requirements stated in these guidelines may wish to consider the traditional Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Training Grant (T32) as an alternative source of support.
Background
In many developing and emerging fields of cancer research today, scientists must function within interdisciplinary teams. Preparing junior and more experienced basic research scientists and clinicians for this new type of research environment will require education and career development experiences in highly inter-disciplinary and collaborative cancer research settings that are integrated with a specialized curriculum. These experiences will require access to multiple scientific disciplines and methodologies, involve mentors from more than one discipline, and will need to be to be tailored to the individual education and training needs of the investigator. Due to the likely breadth of the science involved, these experiences will frequently require facilitation and coordination across departments, schools, centers, and institutions; concerted management and dedicated time of interdisciplinary faculty. Furthermore, for clinicians lacking any prior research training, these experiences may need to include the completion of requirements for an additional degree, viz. Master of Public Health (M.P.H.), and a number of years of research experience beyond the degree to prepare them for conducting highly interdisciplinary collaborative research as an independent investigator.
Recognizing these special issues and needs, in 1991 the NCI piloted its first "Education Programs in Cancer Prevention and Control", supported by the NIH Education Grant (R25) mechanism and based on the concept of interdisciplinary education and career development. These pilot programs proved to be extremely successful. In 1998, the NCI completed major external reviews of its cancer prevention and cancer control sciences. The scientific experts conducting these reviews noted a national shortage of cancer prevention and control researchers, and a pressing need for researchers educated in the new scientific paradigms that require collaborations with researchers in disparate disciplines (e.g., the quantitative sciences, cancer biology, genetics, molecular biology, nutrition, and the social and behavioral sciences). These groups identified the need for a new approach to the training of prevention and control scientists requiring multi-disciplinary experiences with an interdisciplinary theme and including laboratory experiences. These groups recommended increasing the availability of support mechanisms, such as the R25 mechanism, to the cancer prevention, control, and population sciences to address this need.
NCI Program Review Groups made a number of specific training recommendations that reflect the complexity of the cancer research tracks that will be needed in the future. For example, the NCI Cancer Control Review Group identified a need for Cancer Control researchers to understand the "vocabulary and utility" of cancer biology, quantitative methods, and social and behavioral sciences; and for basic and clinical scientists to obtain training in the basic behavioral sciences, epidemiology, health services, outcomes research, cost-effectiveness research, survivorship, and Quality of Life research, screening, treatment, and adherence. Additionally, behavioral scientists interested in cancer control research should be trained in biomedical fields such as nutrition, pharmacology, genetics, and health services research. The NCI Cancer Prevention Review Group identified a need for cancer prevention researchers to acquire actual laboratory experience and for training in areas such as cancer biology, cancer genetics, molecular biology, carcinogenesis, pharmacological interventions in prevention, biostatistics, epidemiology, health behavior, health policy, and the behavioral sciences. This same group also recommended that behavioral scientists should be trained to function in the new scientific paradigms including genetics, chemoprevention, and diet/nutrition.
Reports from other external NCI advisory groups have made similar recommendations regarding training needs. In the area of imaging sciences, advisors identified a need for postdoctoral training in molecular imaging; for interdisciplinary cross-training of senior investigators in diverse disciplines, such as molecular genetics, molecular and cell biology, chemistry, and clinical oncology. Implementation of all of the above and other similar recommendations will facilitate the connectivity of and communication among disparate disciplines, and facilitate the preparation of investigators for effective participation in team research settings.
In response to the above recommendations, the NCI made a special use of the NIH R25 funding mechanism to develop and implement the NCI Cancer Education and Career Development Program (CECDP). The CECDP was announced in 1999 through PAR-99-095. The original and subsequent announcements were highly successful in developing a large portfolio of programs that subsequently successfully competed for renewal. By fiscal year 2005, the NCI supported 37 CECDP’s at a total cost of $18.2 million. Included among these CECDPs were eight (21%) CECDP’s supporting research career development in imaging sciences, molecular pathology, and in other transdisciplinary sciences, such as molecular pathology and cancer pharmacology, that are currently underrepresented in the NCI T32 grant portfolio. The number of predoctoral and postdoctoral individuals supported by CECDP’s has increased from 87 in FY 2000 to 309 in FY 2005. Significantly, 57% of the current postdoctoral individuals supported in FY2005 by the CECDP’s had M.D. degrees. This FOA provides opportunities for continued support of these successful CECDPs and for the development of new programs.
Individuals completing an appointment to the CECDP have several options in seeking further support:
Program Attributes
The award provides support to institutions for up to 5 years for the PI and an Advisory Committee to manage, coordinate, and evaluate the Program; for faculty to design, develop, implement, and continually refine the program curriculum; for the salaries of predoctoral and post-doctoral CECDP participants (also referred to as participants/trainees); and for other program-related research costs. These programs should provide curriculum-based, multi-disciplinary AND interdisciplinary didactic and cancer-related collaborative education and research career development experiences for predoctoral and/or postdoctoral individuals. The programs should also allow the participants to acquire the research and communication skills to conduct cancer research in an inter-disciplinary and highly collaborative team research setting.
These programs should have the flexibility to provide individualized education and research career development experiences to accommodate the needs of predoctoral or postdoctoral individuals with different backgrounds and different levels of didactic and research experience, and multiple disciplines (see Core Requirements). The expectation of the NCI is that candidates will enter the CECDP with different backgrounds that, initially, may satisfy some of the Core Requirements. Under these circumstances, they would be provided only with those additional didactic and research experiences that fully meet the overall training objectives of the CECDP and that prepare them to conduct research in a highly collaborative research team setting.
Program Environment
The participating institution(s) must have well-established research programs and faculty qualified in curriculum development, implementation, and program evaluation to serve as faculty for the Program. The research environment should be team-oriented and highly collaborative with a strong potential for a dynamic two-way exchange of information and ideas within and across diverse and disparate disciplines, such as the physical, biomedical, behavioral, population, and quantitative (mathematics, computer sciences, etc.) sciences. The research environment should also be capable of supporting the rapid translation of research outcomes into reductions in cancer incidence, morbidity, and mortality. Finally, there must be institutional commitment to provide sustained leadership and dedicated faculty time to the development and implementation of the Program as well as a commitment to the development of junior investigators as productive, independent investigators.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1.
Mechanism of Support
This FOA will make a special NCI-specific use of the NIH
Research Education Grant (R25) award mechanism. Specifically,
this use integrates the education component of a standard NCI Cancer Education
Grant (http://grants.nih.gov/grants/guide/pa-files/PAR-05-065.html)
and a long-term research career development element
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.
Support under this FOA is renewable. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a competing renewal (formerly competing continuation ) application.
Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
Because the nature and scope of the proposed research education program will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the NCI
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the 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 research proposed, it is expected that the direct costs per annum for most applications will stay below $500,000.
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.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
Foreign institutions are not eligible to submit an application in response to this FOA.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply provided that the proposed research education and career development experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism cannot be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.
Applicants must provide a statement clearly explaining why this NCI-specific use of the R25 grant mechanism, rather than the more traditional training mechanisms, is essential for accomplishing the proposed goals of their Program. (See SectionIV.6. Other Submission Requirements.)
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3. Reporting. )
The PI must have a doctoral degree, be an established investigator in the field proposed for the Program, and be able to provide both administrative and scientific leadership to the Program.
Faculty must have independent research support, experience in conducting collaborative, team-oriented research; and for mentors, experience in training individuals in highly collaborative and team-oriented research environments
Candidates for participation in the program may be at the predoctoral or post-doctoral stages of their career. Candidates usually must be (see exception below) citizens or non-citizen nationals of the U.S., or must have been lawfully admitted to the U.S. for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the U.S. (i.e., American Samoa and Swains Island). Individuals on temporary visas normally are not eligible.
Under exceptional circumstances, the CECDP may be used to support foreign nationals who do not have the above-defined residency certifications. These exceptions require NCI approval and depend upon the special international, collaborative nature of the research areas that the education and research career development program emphasizes.
Candidates who were former or who are current PIs on NIH Small Grants (R03s) or Exploratory/ Developmental Grants (R21s) are ELIGIBLE.
Former or current PIs on NIH research project grants (R01s), FIRST Awards (R29s), sub-projects on Program Project Grants (P01s) or on center grants (P50s) and the equivalent are NOT ELIGIBLE candidates unless specifically approved in writing by NCI. Candidates who have been supported on NIH or non-NIH career development awards are NOT ELIGIBLE.
2.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
The CECDP should not be used to achieve research education and career
development objectives that can be achieved using more traditional training
mechanisms, such as the Ruth L. Kirchstein NRSA Institutional Training Grant
(T32) mechanism
The CECDP cannot significantly overlap, in total or in part, with any other institutional training or research career development programs (e.g., T32, R25, K12) available at the institution(s) and receiving Federal support. .
The CECDP needs to include the development of a specialized curriculum not otherwise available at the participating institution(s) that is linked in an essential manner to the research education and career development goals of the CECDP.
The administrative organization of the CECDP needs to include a permanent multidisciplinary Advisory Committee (AC) representing all of the disciplines, departments, schools, etc. involved in the CECDP.
The CECDP needs to include didactic and laboratory research core components that a candidate is expected to complete before leaving the CECDP.
The CECDP must have a clear cancer focus. This should be reflected in the overall objective of the proposed program, the research support of the PI and faculty, and in the didactic and laboratory components of the core curriculum.
The proposed CECDP must require more than one mentor for each predoctoral or postdoctoral participant during the course of their multidisciplinary research education and career development program.
The CECDP needs to require that each predoctoral or postdoctoral participant engage in multi-year long-term (at least 2 years) research experiences. The CECDP is not a grant that is to be used to support the types of short term experiences in research provided by the NCI Cancer Education Program.
As part of the research education and career development experience, the CECDP needs to require that each post-doctoral CECDP participant who is near the end of his/her tenure prepare a mock application to the NIH, following the instructions provided in the PHS Form 398/SF424 (R&R). The faculty must provide (i.e., conduct) a simulated peer review of that mock application.
The CECDP must include a detailed diversity recruitment and retention plan. Competing renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period.
The CECDP must include a plan for evaluation, with specific parameters and criteria for determining the performance and outcomes of the Program.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/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 Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: 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 GrantsInfo: Telephone:
301-710-0267, Email: [email protected].
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 and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Research Education and Career Development Program
While the proposed cancer research education and career development program may complement other, ongoing research training, research career development and education occurring at the applicant institution, the proposed experiences must be distinct from those research training, career development and research education programs currently receiving federal support.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
Although
CECDP grants are not typical research instruments, they do involve
experiments in research education and/or dissemination of research knowledge
that require an evaluation plan in order to determine the degree of success or
failure. A plan must be provided for program evaluation. Benchmarks should be
specified, and specific plans and procedures must be described to capture,
analyze and report outcome measures that would determine the success of the CECDP
awardee institution in achieving program
objectives.
Allowable Costs
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.
Personnel: Individuals participating in the design and implementation of the CECDP may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. 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 students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited 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. The CECDP does not allow salary for ancillary personnel support such as mentors, secretarial and administrative assistants. Partial salary for a dedicated administrator is allowable.
The PI will be provided salary support for leadership, management, coordination and evaluation of the Program, in accordance with the percent effort commitment to the Program. Faculty critical to the design, development, implementation and refinement of the specialized curriculum essential to the training and didactic needs of the Program will be provided salary support in accordance with the percent effort commitment to the Program. Salary support may not be provided to Program faculty for their service on the Advisory Committee (see SPECIAL REQUIREMENTS). The PI and Program faculty may derive additional compensation from other Federal sources or awards provided the additional compensation does not exceed the maximum annual salary level for Federal employees and their total percent effort on all awards does not exceed 100 percent. In addition, there is an upper limit salary and other costs for predoctoral and post-doctoral participants (See Participant Costs below)
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 research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.
Up to $20,000 for a predoctoral participant per year and up to $30,000 for a post-doctoral participant per year in direct costs (prorated for the actual percent effort) can be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to career development; (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 candidate and must be specifically and directly related to the candidate’s education and research career development activities.
A small proportion of the budget can be used for advertising and recruitment in order to attract the best possible candidates to the Program. It is assumed that to affect this kind of multi-disciplinary, multi-departmental, multi-institutional approach, a centralized fund for advertising and recruiting, but NOT for any entertaining, will be needed. Consult with the appropriate persons listed as contacts under INQUIRIES if there are questions about the use of funds for this purpose.
This specialized R25 (CECDP) grant, as administered by the NCI, is not subject to the Streamlined Non-competing Application Process (SNAP). In general, this means that all reporting of budgetary information and Program progress is provided in greater detail. While the CECDP is subject to expanded authorities, the one exception is that carryover of funds from one fiscal year to the next must be approved by the NCI Grants Administration staff (see INQUIRIES).
Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant Support Costs) of the Research & Related Budget.
Pre-doctoral CECDP participants can be provided salaries of up to $22,000 per year for full-time effort plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience and rank (see also: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html).
Post-doctoral CECDP participants can be provided salaries of up to $75,000 per year for full-time effort plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience and rank.
The institution may supplement the NIH contribution to an appointee's salary to a level that is consistent with the institution's salary scale. Institutional supplementation of a salary must not require extra duties or responsibilities that would interfere with the purpose of the award.
Non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/NCI mission, CECDP’s should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.
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.
3. Submission Dates and Times
See Section IV.3.A. for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: September 1, 2006 (Earliest date an application may
be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): 30 days before the submission date
Application Submission Date(s): Standard dates apply,
please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a
letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows NCI
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Dorkina Myrick, M.D., Ph.D.
Cancer Training Branch
Office of
Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite
7019, MSC 8346
Bethesda, MD 20892-8346 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for
express/courier delivery; non-USPS service)
Telephone: (301) 496-8580
Fax: (301) 402-4472
E-mail: [email protected]
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.
3.C. Application
Processing
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.
Once an application package has been successfully submitted through Grants.gov, any 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 2 business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
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.
The NCI has developed a policy that will require Clinical Terms of Awards
for clinical studies and trials when they are a component of the proposed
research and education experiences. The policy requires that studies be
monitored commensurate with the degree of potential risk to study subjects and
the complexity of the study. The components of the policy relevant to a CECDP
(R25T) can be found at: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines/page4. All funded applicants will be expected to adhere to the new policy.
6. Other Submission Requirements
A CECDP application must include:
1. A "Statement of applicability" clearly explaining why this NCI-specific use of the NIH R25 grant mechanism rather than the more traditional training mechanisms, such as the Ruth L. Kirschstein NRSA Institutional Training Grant (T32) grant mechanism, is essential for accomplishing the proposed educational and research career development needs of the Program. Applicants should refer to the following website address for information on T32 grants: http://grants1.nih.gov/grants/guide/pa-files/PA-06-468.html.
2. A specialized curriculum, developed by the PI together with Program faculty, not otherwise available at participating institution(s), which is linked in an essential manner to the training goals and objectives of the CECDP.
3. A description of the composition and function(s) of
a permanent multidisciplinary Advisory Committee (AC), These functions may
include the recruitment and selection of candidates for the Program; the
establishment and review of effectiveness of specialized curriculum; the
approval of the education and training plans (e.g., curriculum, research
experiences, mentors) for each candidate; interim monitoring and evaluation of each
candidate's progress with recommendations for changes in the plan, if
necessary, or termination of a candidate who is not making adequate progress;
and monitoring and evaluation of the overall effectiveness of the Program. The
AC must also provide a summary report with each annual progress report (See
Reporting below)
4.A description of the core requirements that each candidate is expected to complete before meeting the Program's training objectives. These requirements should include the following:
5. A description of the procedure to be used to conduct a simulated peer review of a mock research grant application prepared by the CECDP postdoctoral participants.
6. A recruitment plan detailing the pool of candidates as well as the effort made to recruit, in the case of post-doctoral candidates, outside the limits of participating institution(s). Ideally, these multidisciplinary training programs should be unique enough to attract post-doctoral candidates from the entire country; and (b) a separate strategic diversity recruitment plan for recruiting individuals from underserved and underrepresented groups, as defined by the institution, must be included together with an explanation on how this plan will be implemented.
7. A statement from the sponsoring institution committing to provide the sustained leadership and faculty time necessary to develop and implement the CECDP and to the development of junior investigators as productive, independent investigators.
8. A progress report (for competitive renewal applications) describing:
Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).
Applications must contain an evaluation plan. Applications submitted without this section may be delayed in the review process or not reviewed.
Evaluation from NCI: In carrying out its stewardship of human resource related programs, the NCI may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of the educational program, including, but not limited to, achievement obtained through the program, participant accomplishments, publications, dissemination, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program.
Specific Instructions for Applications Requesting $500,000 (direct
costs) or More per Year.
Applicants requesting $500,000 or more in
direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6
weeks before submitting the application, i.e., as you are developing plans for
the study;
2) Obtain agreement from the IC staff that the IC
will accept your application for consideration for award; and,
3) Include a cover letter with the application
that identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
The NIH requires the PD/PI 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for CECDP applications:
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.
Supplementary CECDP Application Instructions
Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.
1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.
If multiple sites are involved in the research education 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.
2. SF 424 Research &
Related Other Project Information, Item 9 (Facilities & Other Resources): Describe
the educational environment, including the facilities, laboratories,
participating departments, computer services, and any other resources to be
used in the development and implementation of the proposed program.
Provide the information described
below as an attachment to Item 9 and, where appropriate, in a tabular format . Suggested
tabular formats for this information can be found under "Summary
Information on Program" as a Word document (http://www.cancer.gov/images/Documents/beb3f7a5-8f60-4c10-b196-0ab3d2379ab6/r25ttable.doc) or as a pdf file (http://www.cancer.gov/images/Documents/beb3f7a5-8f60-4c10-b196-0ab3d2379ab6/r25ttable.pdf )
3. SF 424 Research & Related Senior/Key Person Profile Expanded: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.
Provide biosketches for Senior/Key Persons in the following sequence: Program Faculty, Advisory Committee Members, Mentors, other participating faculty, and predoctoral and postdoctoral participants (when available).
4. Research & Related Budget: Complete for each budget period requested.
A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI must be included here.
B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.
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 CECDP.
E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other Direct Costs. State the number of participants/trainees to be supported by the proposed CECDP. See Section IV.2.
F. Other Direct Costs: itemize as appropriate and allowed for the R25 program.
G. Budget Justification: Provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.
Under PERSONNEL, for each individual in the following categories, provide percent effort, salary, and fringe benefits: Principal Investigator; Program Faculty paid from the grant; Pre-doctoral Candidates identified by name or by position (if the name is unknown); and Post-doctoral Candidates identified by name or by position (if the name is unknown). Note that, for 100% effort, there is an upper limit of $22,000 in salary and of $20,000 in other costs for predoctoral participants and an upper limit of $75,000 in salary and of $30,000 in other costs for post-doctoral participants. There is no minimum percent effort required for predoctoral and postdoctoral participants in this Program, but salary must be prorated accordingly and other expenses justified by the PI in relation to the effort and activities of the individual participant.
Separate costs for predoctoral and post-doctoral participants, and specifically identify the requested costs under each budget category (e.g., supplies, travel, tuition, etc.) for each participant by name or position (if the position is not filled).
If costs are requested for Advertising and Recruitment, make sure that these costs are identified under each budget category
5. PHS 398 Research Plan Attachments:
Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal applications.
For the Progress Report, briefly describe the accomplishments of the CECDP. State the period covered:
Part 5 of this section (Research Design and Methods) should be retitled "Research Education and Career Development Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.
Program Director(s): Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NCI, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.
Describe the qualifications and role of the PI to provide leadership and coordination of the Program.
Describe how the Advisory Committee will function in providing oversight of the development, implementation and evaluation of recruitment strategies; recruitment and selection of candidates for the CECDP; establishment, implementation and evaluation of the core/specialized curriculum; approval of individual education and research career development plans (e.g., curriculum, research/methodology experiences, mentors); interim monitoring and evaluation of the progress of each predoctoral/postdoctoral participant, including a determination of when they have successfully completed the Program, with recommendations for changes in the plan and, if necessary, termination of the CECDP appointment for a participant not making adequate progress; review of mock grant applications; and monitoring of the overall effectiveness of the Program.
Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty. Provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NCI. For each mentor participating in the CECDP, Include a description of their track record in training cancer scientists.
Proposed Research Education and Career Development Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).
Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.
If such training is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.
For New Competing applications, provide recruitment statistics indicating the number of minority individuals meeting the CECDP eligibility requirements who applied to the participating departments/units in each of the past 5 years. Give the number of minority candidates offered admission and the number who entered the participating departments/ units.
For competing Renewal applications, provide recruitment statistics indicating the number of minority individuals meeting the CECDP eligibility requirements who applied to the CECDP Program and/or participating departments/units in each of the past 5 years:
Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the CECDP. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the CECDP as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:
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 of the US Department of Health and Human Services (DHHS) for use in all health professions programs. The DHHS 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 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.
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. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. NCI staff members, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will be returned.
Statement of Applicability: Provide a clear, substantive statement indicating why the use of this specialized form of the R25 grant mechanism, in contrast to the other education/training support mechanisms (viz., Ruth L. Kirschstein NRSA Institutional (T32) Training Grants), uniquely allows for the success of the proposed education and training program. Applications lacking this statement may be delayed in the review process or not reviewed.
Plan for Sharing Research
Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal Web site, through a
data archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness
of the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Applications submitted in response to this FOA must include a plan to share
unique research resources/materials generated with the support of this program
and disseminate curricula and educational tools developed for the program, if
such activities are planned. In addition, applications are expected to include
a software dissemination plan if support for development, maintenance, or enhancement
of software is requested in the application. There is no prescribed single
license for software produced. However, the software dissemination plan should
address, as appropriate, the following goals:
The initial review group will comment on the appropriateness of the proposed dissemination plan. Program staff will also consider the adequacy of the resource sharing/dissemination plan as one of the criteria for award.
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 any related data sharing plans 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.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process:
2. Review and Selection
Process
Applications that are complete will be evaluated for
scientific and technical merit by an appropriate review group convened by the
NCI in
accordance with the review criteria stated below.
As part of the initial merit review, all
applications will:
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:
The goals of NIH-supported research training, education, and career development programs are to 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, weighting them 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 priority score.
For example, an investigator may propose to carry out important work that by
its nature is not innovative but is essential to move a field forward.
SIGNIFICANCE
APPROACH
INVESTIGATORS
ENVIRONMENT
RENEWAL APPLICATIONS: In addition to the review criteria above, adequacy of addressing any concerns expressed in the Summary Statement for the prior 5-year award and success in achieving the overall objectives of the CECDP during the prior funding period.
2.A. Additional Review
Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of Human Subjects from
Research Risk: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. See item 6 of the
Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and
Children in Research: The adequacy
of plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, the
adequacy of the proposed protection will be assessed.
2.B. Additional Review
Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to the
proposed research education program will be assessed by the reviewers. Is the
effort listed for the PD/PI appropriate for the work proposed? Is each budget
category realistic and justified in terms of the aims, methods, educational
opportunities, and participant activities?
Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.
Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
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. The review panel s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. NCI staff members, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans 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.
3.
Anticipated Announcement and Award Dates
Not applicable
Section
VI. Award Administration Information
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 NCI to the grantee business official.
If the application is under consideration for funding, NCI will request at the
appropriate time additional information from the applicant. This information
will include the NCI Special Institutional Statement Regarding Human Subjects
Research Under K12 or R25T support and may also include updated OTHER SUPPORT
and IRB approvals. For details, applicants may refer to the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
(http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm.)
2.
Administrative and National Policy Requirements
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: CECDP awards 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 Specific Aims of the original peer-reviewed CECDP application 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.
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.
Special Leave: Leave to another institution of an appointee, including a foreign laboratory, may be permitted if 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 NCI is required. To obtain prior approval, a written request must be submitted to NCI by the PI on behalf of the participant/trainee. 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 award will continue during such leave. NCI Program staff should be contacted prior to submitting the request for leave.
Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the NCI and the grantee institution.
3.
Reporting
Awards
made in response to this FOA, as administered by the NCI, are not subject to
the Streamlined Non-competing Application Process
(SNAP). Awards made in response to this FOA remain under "Expanded
Authorities," except that carryover of funds from one fiscal year to the
next requires approval by the NCI.
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 CECDP (including education in the responsible conduct of research), modifications to the CECDP as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. The Progress Report should also contain a Summary Report of the Advisory Committee activities including a description of the committee's actions, and that discusses the progress of the Program including evaluation of areas of strengths and weaknesses.
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 during and after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, 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.
Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.
We 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 management issues:
1. Scientific/Research
Contacts:
Dorkina Myrick, M.D., Ph.D.
Cancer Training Branch
Office of Centers, Training, and
Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7019, MSC 8346
Bethesda, MD 20892-8346 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for
express/courier delivery; non-USPS service)
Telephone: (301) 496-8580
Fax: (301) 402-4472
E-mail: [email protected]
2. Peer Review Contacts:
Sonya V. Roberson, Ph.D.
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8037, MSC 8326
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
Fax: 301-594-4074
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Catherine Blount
Office of Grants
Administration
National Cancer
Institute
6120 Executive
Boulevard, 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)
Phone: (301) 496-3179
Fax: (301) 496-8601
E-mail: [email protected]
Section VIII. Other Information
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); and 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).
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.
Sharing of Model Organisms:
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.
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 (hESC):
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-02-005.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. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from: 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
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 DHHS 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
URLs 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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy People 2010:
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 PA 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 , is authorized under Federal Regulation 42USC Section 285a-2,and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. 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 2 years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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