EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Strengthening Institutional Capacity to Conduct Global Cancer Research in Low- and Middle-Income Countries (D43 Clinical Trial Not Allowed)
D43 International Research Training Grants
New
RFA-CA-20-031
None
93.398
The purpose of this Funding Opportunity Announcement (FOA) is to establish an institutional program for mentored training in global cancer research. This program will support research training led by the United States (U.S.)-based cancer research-intensive institutions working in collaboration with institutions in low and middle-income countries (LMICs). These training programs will be built upon the US institutions pre-existing training infrastructure and research collaborations with LMICs and will leverage these resources to expand the global cancer research workforce both in the US and in LMICs. The overarching goal of this initiative is to build capacity to conduct innovative and collaborative global research projects that will contribute to the advancement of basic, clinical, translational, and population-based cancer research in LMICs.
This FOA does not allow appointed trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.
April 14, 2020
June 24, 2020
30 days prior to application due date
July 24, 2020; June 24, 2021.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
September 2020; August 2021
January 2021, January 2022
March 2021, March 2022
June 25, 2021
Not Applicable
It is critical that applicants follow the Training (T) 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 may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Purpose
The long-term goal of this initiative is to build research capacity of investigators and health professionals who can develop the scientific expertise and leadership skills needed to conduct innovative and collaborative global research projects that will contribute to the advancement of basic, clinical, translational, and population-based cancer research. This initiative will support mentored training of both the U.S. and LMIC scientists and the development of multidisciplinary training curricula to address specific cancer research needs and opportunities in LMICs. These training programs will be built upon the institutions pre-existing training infrastructure and research collaborations with LMICs and will leverage these resources to expand the global cancer research workforce both in the U.S. and in LMICs.
Key Terms for this FOA
Low- and Middle-Income Countries: LMICs are defined by the World Bank classification system, according to Gross National Income per capita as "low-income," "lower-middle-income," and "upper-middle-income". In this program, consistent with NIH and Fogarty programs, "Eligible LMICs" do not include G20 countries in the "upper-middle-income country" category (UMIC) for funding (except for Sub-Saharan Africa). G20 UMIC sites may be involved as additional training sites if no faculty or trainees from that G20 UMIC institution are supported by the proposed D43. For details on the D43 definition of "eligible LMIC" used in this FOA see Notice of Change in Country Eligibility for Fogarty International Training Grants.
Trainee: In the context of this FOA, "trainees" are individuals both from the U.S. applicant institution and the collaborating LMICs. The applicant can propose to train pre-doctoral and postdoctoral candidates. Pre-doctoral trainees must be enrolled in a program leading to a master’s degree, PhD or an equivalent research doctoral degree program. Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Postdoctoral trainees also include clinical fellows and clinicians in residency training.
In the U.S., incidence rates for all cancer sites have decreased on an average 1.1% each year over the last 10 years, but significant disparities persist in cancer incidence and mortality among certain racial and ethnic minorities and immigrant communities. The primary drivers of these disparities such as higher prevalence of risky behaviors, inadequate prevention and early detection, presence of co-morbidities, and poor access to treatment services, also underlie the high cancer-related morbidity and mortality seen in LMICs.
By 2030, 75% of the projected 21 million new cancer cases and 13 million annual cancer deaths worldwide will disproportionately occur in LMICs, where, in addition to the drivers noted above, genetic susceptibilities and cultural practices may also play a significant role in cancer risk. Cancer death rates are higher in these countries than for AIDS, tuberculosis, and malaria combined. These statistics reflect key trends in LMICs, including aging populations, the epidemiologic transition to more non-communicable diseases than infectious diseases, and environmental and lifestyle changes. This global epidemiology suggests that there may be several unique opportunities to study cancer by conducting investigations in LMICs.
Understanding and addressing these global scientific opportunities requires a range of research skills at the individual level as well as the capacity to support cancer research at the institutional level in both the U.S. and LMIC settings. Research training to conduct investigations in global settings is limited in the U.S. and is profoundly lacking in LMICs. Researchers need training in the scientific and methodological aspects of cancer research across the cancer continuum and training to conduct research based on an understanding of the determinants - biological, social, economic of cancer within the partner country.
This initiative proposes to strengthen the global cancer research community through support of training programs built upon preexisting, high-quality cancer research and training infrastructure in the U.S. cancer research-intensive organizations and collaborative LMIC institutions. Programs supported by this FOA are expected to:
Risk factors for cancer are complex and differentially amenable to control. Further, the factors that are responsible for onset, prevention, and management of cancer are so diverse that it is essential that those trained gain a broad appreciation for the need of research across disciplines. As the scientific focus may vary based on LMIC setting and the capacity building needs of the U.S.-LMIC collaboration, a broad range of training activities can be proposed. Research training topics supported by this FOA include, but are not limited to:
Applicants must provide all trainees instruction in research ethics and orientation to regulatory procedures governing research in US and LMIC institution setting, as well as in the broad principles of cross-cultural and cross-national collaboration.
In the context of this FOA, "trainees" are individuals both from the U.S. applicant institution and the collaborating LMIC(s). The applicant can propose to train pre-doctoral, postdoctoral, and pre-professional degree candidates.
While innovative cancer research training models are encouraged, typically research training programs may involve the following:
The application should incorporate an appropriate mix of these types of training to address the cancer research training needs identified for the LMIC.
Training may take place in the U.S. or LMIC, with the expectation for most of the training to occur within the LMIC by the end of the initial grant award period.
Training for senior personnel to serve as mentors is strongly encouraged.
Additional institutional capacity-building efforts are encouraged. These may include, but are not limited to, in-country training workshops in advanced techniques; distance learning; and interaction with other national and regional efforts to strengthen the ability of institutions to identify and undertake successful cancer research and research training.
This FOA encourages mentored research projects in LMIC settings.
All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, have written evidence of documentation of education in the protection of human subjects for the trainee, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted.
It is expected that trainees will disseminate the results of their research at scientific conferences and in peer-reviewed publications.
Where appropriate, the design of training-related research projects should account for potential gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.
This research training program strongly encourages Program Directors/Principal Investigators (PDs/PIs) to include women, and individuals from groups underrepresented in biomedical and behavioral research in the country (including individuals from racial, ethnic and socially disadvantaged backgrounds and those living with disabilities), as faculty and research trainees at all sites.
The awardee institution will be expected to participate in an annual investigators' meeting that may be hosted at NCI and/or on a rotating basis at the participating institutions. The meetings will provide a forum for presenting scientific findings from each of the funded studies and will facilitate interactions among the community of funded scientists. Applicants should budget for the PD(s)/PI(s) and one additional project personnel to attend the planned annual grantee meeting. Attendees to PI meeting should also include PD/PI/key personnel from the LMIC partner institution. Investigators will be expected to participate in conference calls for planning purposes biannually or at other appropriate intervals; they may also be asked to participate in committees that meet periodically by conference call.
This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
Need help determining whether you are doing a clinical trial?
NCI intends to commit $1.08 million in FY2021 to fund up to 4 awards and $810,000 in FY2022 to fund up to 3 awards.
Application budgets are limited to $250,000 per year (total direct costs).
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Awards may provide stipends as a subsistence allowance to help defray living expenses during the research training experience. Awards may also contribute to the combined cost of tuition and fees at U.S. or foreign institutions.
Stipend: Trainees may be paid a stipend comparable to their professional experience.
Stipend for U.S. citizens and U.S. permanent residents: Stipends for trainees who are U.S. citizens or permanent residents is the same as for Ruth L. Kirschstein National Research Service Award (NRSA) fellowships. See: https://researchtraining.nih.gov/resources/policy-notices.
Stipend for LMIC citizens: Stipends for LMIC trainees may be paid at a level comparable to their professional experience and commiserate with the institution at which they are training.
Tuition and Fees: Tuition and fees are allowable trainee costs only if such charges are applied consistently to all individuals in a similar training status at the organization, without regard to their source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program and requires NCI prior approval.
Tuition and Fees for training at U.S. institutions: NCI will contribute to the combined cost of tuition and fees at the rate in place at the time of award, at the same level set for NRSA fellowships; see https://researchtraining.nih.gov/resources/policy-notices.
Tuition and Fees for training at LMIC institutions: For predoctoral and Postdoctoral Trainees who train at LMIC institutions, a reasonable proportion of the tuition and fees may be requested not to exceed allowances for U.S. trainees.
However, programs may seek cost sharing arrangements with the grantee institutions to provide reduced tuition for trainees.
Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees.
Award will provide funds to help defray other research training expenses, such as health insurance, training equipment (up to $5000), trainee research supplies, computers and internet access, relevant journal subscriptions and publication costs and costs for short courses or workshops.
For trainees who are U.S. citizens or U.S. permanent residents, research training expenses can not exceed allowances provided in NRSA fellowships. See: https://researchtraining.nih.gov/resources/policy-notices.
Applicants may include costs to support mentored research projects for medium- and long-term trainees as part of their training. Direct costs should be limited to up to $15,000 per project per long-term trainee. Similar costs for medium-term trainees should be commensurate with the amount of time spent on the research projects or the particular need for the project. These funds should not be used to support travel. Trainees will not be paid directly. All costs for mentored research projects will be awarded to the applicant institution. It is expected that the U.S. institution will make necessary arrangements with the collaborating LMIC institution(s) to support mentored research projects. Only one project is allowed per trainee.
Faculty: Salary for the PD(s)/PI(s), other key personnel, training faculty, and administrative staff may be requested at levels commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at https://grants.nih.gov/grants/policy/salcap_summary.htm. As this is a training award, it is expected that PD(s)/PI(s) will devote between 0.6 and 1.2 person months per year.
Collaborators at partner institutions may receive appropriate compensation for significant contributions to activities in the program, such as trainee recruitment and selection activities, as well as leading courses, supervising research projects, or other program-related roles.
Funds may be requested to support faculty/staff travel directly related to the research training program, and to attend necessary training program associated meetings.
Support for senior/key personnel, faculty and collaborators to attend other scientific meetings and conferences is not allowed.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, 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
Governments
Other
The 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.
U.S. institutions engaged in cancer research and that meet the following criteria are eligible to apply:
As previously mentioned, LMICs are defined by the World Bank classification system, according to Gross National Income per capita as "low-income," "lower-middle-income," and "upper-middle-income". In this program, consistent with NIH and Fogarty programs, "Eligible LMICs" do not include G20 countries in the "upper-middle-income country" category (UMIC) for funding (except for Sub-Saharan Africa). G20 UMIC sites may be involved as additional training sites if no faculty or trainees from that G20 UMIC institution are supported by the proposed D43. For details on the D43 definition of "eligible LMIC" used in this FOA see Notice of Change in Country Eligibility for Fogarty International Training Grants.
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 by
the NIH Grants Policy Statement, are allowed.
Applicant Organizations
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 training program as the
Training Program Director/Principal Investigator (Training 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.
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 SF 424 (R&R) Application Guide.
The PD(s)/PI(s) must be an established investigator with research and training experience in the LMIC country they seek to work with.
The PD(s)/PI(s) listed in the application must be designated as the PD/PI of at least one active research award that is relevant to the research training proposed in the LMIC. The research awards may be funded by the NIH or by other national or international organizations.
Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI is available at https://grants.nih.gov/grants/multi_pi. All PD(s)/PI(s) must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see https://era.nih.gov/reg-accounts/register-commons.htm for instructions).
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 programmatically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Non-U.S. faculty from other high-income countries (HICs) may be included only as consultants if their participation is well justified to fill a unique research training expertise not available among U.S. or LMIC investigators. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.
It is expected that most, if not all, faculty mentors will have research and/or research training experience in the LMIC and on topics which are the focus of the application.
Trainees may be U.S. citizens, U.S. permanent residents, U.S. nationals, or citizens/nationals of LMICs who are committed to a career in global cancer research.
Trainees may be pre-doctoral students, postdoctoral and clinical fellows, and clinicians in residency training.
U.S. citizens and permanent residents may only train at the postdoctoral level. This includes trainees who are clinical fellows and clinicians in residency levels.
LMIC citizens may train at the predoctoral and postdoctoral level.
The program is not an individual training fellowship program. Potential trainees are appointed by the PD(s)/PI(s) of the award and not by NCI/NIH.
Pre-doctoral trainees must be enrolled in a program leading to a master’s degree, Ph.D. or an equivalent research doctoral degree program.
Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution.
Postdoctoral trainees must have protected time to conduct proposed research training.
All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.
In the training program plan, applicants are encouraged to achieve a balance of U.S. and LMIC trainees so that the goals of strengthening institutional capacity to conduct global cancer research can be achieved. By the end of the five-year program period, it is expected that at least 50% of trainees completing the medium- and long-term training will be from LMICs.
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 Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
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 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:
Sudha
Sivaram, DrPH, MPH
Telephone: 240-276-5804
Email: [email protected]
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
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.
Follow all instructions provided in the SF424 (R&R) Application
Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral), and intended trainee outcomes.
Include the name of the LMIC institution and cancer focus of the proposed research training. Describe the public health relevance of the proposed research training to the named LMICs in Project Summary.
Other Attachments.
Advisory Committee: An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file Advisory_Committee.pdf .
LMIC institutions should provide letters of support and collaboration that also describe research partnerships with U.S. institutions and expected outcomes from the proposed collaboration. Support for trainees as described in the scope of project and commitment to their career development in the LMIC institution should be strongly indicated. If the LMIC institution collaborates with other regional institutions and seeks to train researchers from other countries, letters of support from institutions in these countries are to be included in the application. This will achieve the goal of building capacity in additional LMICs where cancer research is not as established as the primary collaborating LMIC.
The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application.
Follow all instructions provided in the SF424 (R&R) Application.
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:
The PHS 398 Research Training Program Plan Form is comprised of the following sections:
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Particular attention must be given to the required International Program Training Data Tables: https://grants.nih.gov/grants/forms/data-tables.htm. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.
Training Program
Program Plan
Background and Rationale:
In addition to the instructions in the SF424 (R&R) Application Guide, briefly discuss the following points:
Program Administration:
In addition to the instructions in the SF424 (R&R) Application Guide:
Program Faculty:
In addition to the instructions in the SF424 (R&R) Application Guide:
Proposed Training:
In addition to the instructions in the SF424 (R&R) Application Guide:
Institutions with existing training programs:
Applicants should in addition:
In addition to the instructions in the SF424 (R&R) Application Guide:
Institutional Environment and Commitment to the Program.
The U.S. applicant institution and collaborating LMIC institution(s) must assure support for the proposed program. Appropriate institutional commitment to the program includes assurance that sufficient time will be allowed for the PD(s)/PI(s) and other Program faculty to contribute to the proposed program and protected time for trainees selected in the program to complete all proposed training activities. This commitment may also include PD(S)/PI(S) or faculty salary, stipend or tuition support for individuals involved in the training program, or other resources essential to a successful training program.
Applicants must include letters of support from all participating institutions and should:
Plan for Instruction in the Responsible Conduct of Research
Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.
Appendix
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:
Study Record: PHS Human Subjects and Clinical Trials Information
DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
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).
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.
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. Note, however, that pre-award costs are not allowable
charges for stipends or tuition/fees on institutional training grants because these
costs may not be charged to the grant until a trainee has actually been
appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research
elective credit for short-term research training are not allowable charges on
an institutional training grant.
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.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the 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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, 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 the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Training Program and Environment
Cancer Research Relevance to LMIC
U.S.-LMIC Collaborative Research Capacity Strengthening
Content of Training Program
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
For applications designating multiple PD(s)/PI(s):
Trainees
For applications that are built on previous research training programs:
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.
Protections for Human Subjects
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not applicable
Not applicable.
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.
Recruitment Plan to Enhance Diversity
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 prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCI in accordance with NIH peer review policy and procedures, using the stated review criteria. 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 response to this FOA.
Applications will be assigned to the National Cancer Institute. . 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide to NIH copies of documents related to all major changes in the status of ongoing protocols.
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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
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.
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.
Not Applicable
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.
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.
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.
A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees are required for closeout of an award as described in the NIH Grants Policy Statement.
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.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help 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 grant resources)
Email: [email protected] (preferred method of
contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration
and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Sudha Sivaram, DrPH, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5804
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.