February 1, 2019
March 1, 2019
March 1, 2019
April 1, 2019, by 5:00 PM local time of applicant organization. All applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this funding opportunity announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
April 2, 2019
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions will not be reviewed
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The NIH Research Education Cooperative Agreements Program (UE5) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH UE5 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.
The overarching goal of this UE5 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs. This UE5 funding opportunity announcement (FOA) is a part of the National Cancer Institute (NCI) initiative to establish the "NCI Awardee Skills Development Consortium (NASDC)." The major objective is to provide opportunities for current NCI grantees, especially those who are junior faculty (e.g., assistant professors, instructors, research scientists, or equivalent), to enhance their skills in areas that are critical for establishing and maintaining successful independent academic cancer research careers.
To accomplish the stated overarching goal, this FOA will support creative educational activities focused on Short Courses for Skills Development, oriented toward current NCI-funded junior faculty investigators.
This FOA solicits applications for innovative, short Courses for Skills Development oriented at current NCI-funded, junior faculty investigators. The proposed NASDC Short Courses are expected to focus on skills and competencies related to the career development needs of these individuals. The proposed courses may address, but are not limited to, such aspects as:
A companion U24 FOA (RFA-CA-19-011) will support a Coordinating Center to facilitate the activities of NASDC UE5 awardees and coordinate logistics and other aspects of the entire NASDC initiative.
The pool of junior faculty investigators supported by NCI "K" career development mechanisms, R00, R21, and first R01-equivalent awards comprises approximately 1,500 recipients. These NCI grantees are at a critical juncture in their research careers, at which they are expected to continue to compete successfully for NIH funding to support their research groups and also become academic leaders proficient at teaching, mentoring, and managing a research program.
In recent years, it has become increasingly difficult for these investigators to succeed on an academic career trajectory, primarily because of the hypercompetitive funding climate. In recognition of this situation, Congress established the Next Generation Researchers Initiative (NGRI) as part of the 21st Century Cures Act (Title II, Sub-Title C--Supporting Young Emerging Scientists ). The NGRI tasked the NIH "to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to: receive funding; enhance training and mentorship programs for researchers; and enhance workforce diversity."
NASDC will support programs that further develop NCI grantees' essential skills, such as writing competitive grant applications, managing the personnel and finances of a research program, building networks of collaborators, providing mentorship to the next generation of researchers, and staying abreast of relevant technological advances in the field, all to help them navigate through critical career junctures. The development of these skills is especially urgent, given that typical graduate/medical student academic programs and postdoctoral/fellowship training do not provide adequate educational content experiences in these arenas. Although there are existing courses and workshops on some of these topics, none are specifically tailored to meet the needs of junior faculty NCI grantees who are striving to establish successful academic careers.
Targeted (priority) Participants for NASDC Short Courses.
The courses to be supported through the NASDC initiative will primarily focus on meeting the academic career development needs of junior faculty NCI grantees with various "K", R00, R21, and first R01-equivalent awards. It is anticipated that NASDC courses will help participants maintain long-term productivity in their cancer research careers, thereby maximizing the outcomes from NCI's investment in these individuals.
Important Note: The priority participant audience for NASDC Short Courses (as defined above), which is based on current career development needs, should not be confused with the NIH-defined category of Early Stage Investigators (ESI), which is determined by the number of years since the completion of a terminal research degree or end of post-graduate clinical training. Although there is considerable overlap among the individuals in these two groups, the groups are distinct entities.
Specific Attributes and Requirements for Short Courses for Skills Development:
Courses to be proposed should be innovative and include state-of-the-art, evidence-based scientific and/or educational content that is essential to meet the academic career development needs of current NCI-funded junior faculty.
Although each course must be open to all NCI-funded junior faculty, it is to be expected that certain courses may be of greater interest to some NCI awardees than to others based on the topic of the course or where the course is held.
Courses must include in-person educational activities. Additional activities, such as teleconferences or online educational component(s), are optional and may take place before or after the in-person course to supplement the in-person educational activities.
All course instructional activities should be completed within a 6-month period. Course evaluation activities, e.g., follow-up interviews, surveys, etc., may continue beyond 6 months. Applications must propose to offer the course once in Year 1 and twice in each of Years 2 and 3.
Specific examples of topics that are appropriate for this FOA include but are not limited to the following:
Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:
Important Note: Because NASDC UE5 awardees will be required to interact closely with the NASDC Coordinating Center, it is imperative that all applicants responding to this FOA familiarize themselves with the companion U24 FOA for the NASDC Coordinating Center (RFA-CA-19-011).
The NASDC Program will be governed by a Steering Committee. The Steering Committee will include representatives from each NASDC UE5 award (funded through this FOA) and Coordinating Center (funded through RFA-CA-19-011) as well as NCI staff members. For details on the composition and responsibilities of the NASDC Steering Committee, see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. UE5 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trial(s)
NCI intends to commit $1,840,000 (total costs) per year to fund up to five UE5 awards.
Application budgets are limited to $340,000 in direct costs per year.
Applicants may request a project period of up to 3 years.
Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds). A minimal effort of 1.2 person-months is required for all designated PD(s)/PI(s) and cannot be reduced below that level during the project period. The total Direct Costs for all personnel and consultants involved in the project may not exceed $170,000 per year.
Participants are those individuals who are registered in the proposed course. However, reimbursment of any participants costs applies only to those participants, who are NOT federal employees.
UE5 applicants should include up to $1,000 per participant (excluding those who are federal employees) in their budgets to partially pay for and/or to reimburse participants for their travel, housing, and per diem expenses to attend the course. Calculate participant costs assuming one course in Year 1 and two courses in each of Years 2 and 3.
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Note that consultants may include individuals serving in a variety of roles, such as faculty, lecturers, advisors, etc., and that consultant costs are included in the $170,000 limit per year for total Direct Costs for all personnel and consultants involved in the project. See Personnel Costs section above for details.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Note: Institutions applying for the U24 NASDC award under the companion FOA RFA-CA-19-011 are welcome to also apply for the UE5 award under this FOA.
sponsoring institution must assure support for the proposed program.
Appropriate institutional commitment to the program includes the provision of
adequate staff, facilities, and educational resources that can contribute to
the planned program.
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 for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from diverse backgrounds,
including underrepresented racial and ethnic groups, individuals with
disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
Individual(s) designated as PD(s)/PI(s) on applications submitted to this FOA are expected to be senior faculty member(s) with established careers as both educators and researchers, including effective mentoring of junior faculty towards successful academic research careers.
PD(s)/PI(s) are also expected to have demonstrated experience in providing both administrative and scientific leadership to the development and implementation of an education program that extends beyond the applicant institution and attracts participants from a national audience.
An individual may be designated as a PD/PI (or one of multiple PD(s)/PI(s)) on more than one UE5 application submitted in response to this FOA.
An individual designated as a PD/PI (or one of multiple PD(s)/PI(s)) on a UE5 application submitted in response to this FOA must not be also designated as a PD/PI (or one of multiple PDs/PIs) on an application submitted in response to the companion U24 FOA, RFA-CA-19-011.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct (i.e., focused on a different course).
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as Program Faculty, serving as instructors, advisors, preceptors, mentors, etc. Program Faculty should have research and education expertise and experience relevant to the proposed program. Those serving as mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Priority for participation in UE5 programs supported through this FOA will be given to junior faculty who are PDs/PIs of current NCI-funded K01, K07, K08, K22, K23, K25, R00, R21, or first R01-equivalent grants.
Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.
For this FOA, the ”exceptional relevance” may be applied to K99/R00 awardees, who are in the R00 phase conducted at a U.S. institution (which is responsible for determining and documenting that the R00 awardee can remain in the U.S. for the duration of the R00 award).
If open positions remain in the NASDC courses, any current NCI-funded extramural independent PD/PI may also participate. In addition, NCI intramural researchers may participate but cannot receive any financial support from the UE5 award.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, submission of such a letter is strongly encouraged. The information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Jeannette Korczak, Ph.D.
National Cancer Institute (NCI)
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. Note that the UE5 mechanism has the same page limits as the R25 mechanism.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
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. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Follow all instructions provided in the SF424 (R&R) Application Guide. with the following additional modifications:
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Follow all instructions provided in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components listed and then described below:
Research Education Program Plan
Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.
Clearly state the goals and objectives of the proposed course for skills development and describe the in-person course that will implement these goals and objectives. Explain how the course will provide opportunities for junior faculty NCI grantees to enhance their skills in critical areas needed to establish and maintain successful independent academic cancer research careers.
Provide the underlying rationale and evidence supporting the need for the course. Describe innovative aspects and explain the significance of the course at a national level. Describe the educational concepts and principles on which the course is based and the overall strategy, methodology, and analyses to be employed.
Provide support for the feasibility of the proposed activities that involve offering the course once in Year 1 and twice in each of Years 2 and 3. Describe the benchmarks to be used to assess the success of the course. Consider potential problems that may be encountered and describe alternative strategies that could be employed.
Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs; their leadership approach, and governance appropriate for the planned project.
Explain how the complementary teaching, mentoring, and administrative skills of the PDs/PIs or investigator teams will foster successful implementation of the proposed UE5 program.
Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.
Without repeating biosketches, briefly summarize the characteristics of the participating faculty in terms of teaching and mentoring junior faculty, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments.
Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.
Describe any specific scientific backgrounds or research interests that may be needed to participate in the proposed course, if applicable. Describe the recruitment approaches to ensure sufficient numbers of junior faculty NCI awardee participants for the proposed course. Outline also approaches to fill out any remaining available slots (e.g., opening the course to NCI extramural investigators or intramural researchers who are not at a junior faculty level.)
Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
Where appropriate, describe any unique features of the scientific environment or collaborative arrangements that may be leveraged to the advantage of the proposed course. If multiple institutions are participating, describe how this will enhance the quality of the course, as well as how activities will be coordinated and effective communication maintained among the multiple sites.
Recruitment Plan to Enhance Diversity (NOT-OD-18-210): Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints . NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
A. Underrepresented Populations in the U.S. Biomedical,
Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as: Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering).
The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.
In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf
C. Individuals from disadvantaged backgrounds, defined as:
1.Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.
2.Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
The disadvantaged background category (C1 and C2) refers to the financial and educational background of individuals, particularly before graduating from high school, while residing in the United States
Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).
New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.
Additional information on the required Recruitment
Plan to Enhance Diversity is available at Frequently Asked Questions:
Recruitment Plan to Enhance Diversity (Diversity
Applications lacking a diversity recruitment plan will not be reviewed.
Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). For the UE5 NASDC Short Courses program, follow the guidence provided in NOT-OD-10-019 for short-term training and research education programs:
NIH recognizes that the duration of an institutional training or research
education program should be considered in the design, implementation, and
review of plans for instruction in responsible conduct of research. The
duration of such instruction within short-term institutional programs should be
appropriate for the total duration of the program and should be justified in
the application. This is an instance where on-line instruction could be
appropriate. Such programs may also use innovative strategies to
incorporate instruction in responsible conduct of research and to relate
instruction in responsible conduct of research to the scientific focus of the
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
Evaluation Plan. Applications must include a plan for evaluating the course that is appropriate for an education program, not a research project, and may include, for example, surveys completed by participants and/or publicly available information about participants. In particular, the application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the success of the course in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. A timeline for conducting the evaluation must be described.
Letters of Support
A letter of institutional commitment must be attached as part of Letters of Support (see section above:”Institutional Environment and Commitment.”
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
When relevant, 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:
Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this FOA, note the following: The priority of this UE5 FOA is on educational activities (in the form of short courses) that will help NCI-supported junior faculty investigators to develop skills they need to establish and maintain successful independent cancer research careers. It is essential that the proposed courses are specifically tuned to the distinct needs of these junior faculty cancer researchers.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this UE5 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
Specific to this FOA: How likely is the proposed course to provide important opportunities for junior faculty NCI grantees to enhance their skills in critical areas needed to establish and maintain successful independent academic cancer research careers? Is convincing evidence presented of a national-level need for the course?
Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: How appropriate is the prior experience of the proposed course faculty, e.g., in terms of teaching and mentoring junior faculty?
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
Specific to this FOA: Are the educational concepts and principles on which the course is based innovative?
Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
Specific to this FOA: How adequate are the plans to recruit junior faculty, NCI awardee participants? Are these plans sufficiently flexible to allow filling any remaining spots in the course by recruiting other NCI extramural investigators or intramural researchers who are not junior faculty? How well is the content of the course matched to the scientific profiles of the intended junior faculty participants? Are the overall strategy, methodology, and analyses to be employed adequately described and feasible? Is the plan to evaluate the UE5 program appropriate for an education program rather than a research project? Is there sufficient consideration of potential problems that may be encountered and an appropriate description of alternative strategies that could be employed?
Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
Specific to this FOA: How conducive is the scientific environment and/or collaborative arrangements in terms of ensuring the quality and/or allowing for unique features of the proposed course? If multiple institutions are participating, how strong are the plans for coordination of activities and effective communication across these sites?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does
not involve one of the categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the format of instruction (a plan with only on-line instruction is acceptable for this FOA); 2) Subject Matter - the breadth of subject matter, as appropriate for a given short course, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the given Short Course; and 5) Frequency of Instruction –instruction must oprovided for each offering of the Short Course. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research education program.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute (NCI), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH
grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
One or more designated NCI Program staff members will have substantial involvement as Project Scientist(s) for the NASDC initiative.
Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The role of the Project Scientist(s) will be to facilitate, but not to direct, the NASDC project activities.
The specific roles of the substantially involved NCI staff members include the following activities:
While NASDC awardees will retain custody of the data and resources developed under these awards, the NCI will have access to all recruitment data, course materials, evaluation data etc., and may periodically review these data.
The NCI reserves the right to reduce the budget or withhold an award in the event of substantial awardee underperformance or other substantial failure to comply with the terms of award.
Areas of Joint Responsibility include:
A Steering Committee will be convened to serve as the NASDC main governing board. The Steering Committee will be composed of the following voting members:
The Chair and co-Chair of the Steering Committee will be selected from the representatives of all NASDC awardees.
Additional NCI staff members may participate in Steering Committee meetings as non-voting members.
The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientist(s) may serve on such sub-committees as they deem appropriate.
The Steering Committee will meet monthly by teleconference and annually in-person. The annual Steering Committee meetings will take place in the Washington, DC area and will be logistically arranged by the U24 NASDC Coordinating Center. In addition to Steering Committee members, the annual meeting is expected to include additional investigators from each NASDC awardee team, as determined by the respective PDs/PIs.
Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.
In carrying out its stewardship of human resource-related programs, the NCI will periodically evaluate its UE5 research education program, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.
Upon the completion of a program evaluation, NIH and its ICs will determine whether to: (a) continue a program as currently configured; (b) continue a program with modifications; or (c) discontinue a program.
In evaluating this research education program the NCI expects to use the following evaluation measures:
For Courses for Skills Development:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Jeannette F. Korczak, Ph.D.
National Cancer Institute (NCI)
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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