National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is part of a Common Fund initiative (http://commonfund.nih.gov) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by a trans-NIH team led by Fogarty International Center (FIC).
Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Research Training Program (U2RClinical Trial Optional)
U2R International Research Training Cooperative Agreements
This Funding Opportunity Announcement (FOA) seeks applications for Research Training Programs as part of a broader initiative entitled Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa). The goal of DS-I Africa is to spur new health discoveries and catalyze innovation in healthcare, public health, and health research on the continent through application of data science.
Through this FOA, DS-I Africa aims to increase capacity to carry out data science health research and innovation in Africa through the support of at least 4 institutional research training cooperative agreement awards. Applicants should propose long-term data science health research training through graduate degree (master's and/or doctoral) training and faculty development. Grantees will train cohorts of African investigators who will have the skills to become independent investigators, research leaders, and research collaborators.
The cooperative agreements can either be direct awards to African institutions or awards to U.S. institutions in partnership with African institutions. Regardless of the applicant organization, the training programs must focus on building institutional capacity at one or more African institutions and train African researchers. Partnerships with additional organizations, including for-profit or governmental organizations, are encouraged as a means to provide applied research experiences for the trainees.
This Funding Opportunity Announcement (FOA) allows appointment of Trainees proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
July 24, 2020
October 23, 2020
October 23, 2020
December 18, 2020
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.
New Date December 19, 2020 per issuance of NOT-RM-21-009. (Original Expiration Date: November 25, 2020)
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
The overall goal of the DS-I Africa Research Training Programs is to increase data science capacity related to health research in Africa by producing data scientists that can serve as research leaders and multidisciplinary collaborators and by enhancing institutional capacity at African academic institutions. These U2R awards support long-term data science health research and innovation training, which must include graduate degree training (master's and/or doctoral) and institutional faculty development and can also include post-doctoral training where appropriate. Faculty development can include training of African faculty through the proposed degree training or other means of enhancing the capabilities of faculty from diverse disciplines to teach and mentor in data science.
Recent technological advances in Africa and around the world have enabled researchers to collect enormous volumes of data. From rural clinics to the most sophisticated genomics laboratories—data are central to our ability to improve health, from delivering care to conducting biomedical research. The ability to fully extract useful knowledge from these data will lead to accelerated discoveries and innovations that can impact health in Africa and globally.
In the next decade, rapid advances in data science, including new approaches to the description, collection, storage, integration, and analysis of large, heterogeneous, structured and unstructured data sets, and new computational methods such as advanced deep learning, digital phenotypes, machine learning and artificial intelligence, and 3D imaging are expected to transform biomedical and behavioral research and lead to improved health for individuals and populations. Traditional datasets (e.g. national health systems, surveillance, surveys) are becoming deeper and richer while new sources of data based on new technologies and sensors (e.g. social media, geospatial data, mobile phones, wearables, electronic medical records, bioimaging, and genomics) are emerging that may be of greatest value when linked to data science. Progress in development of new large data sets and advanced methods for mining them underpin advances in diagnostics, technology development, and the potential for precision public health. The Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program is designed to spur discoveries and innovations through application of data science in the African context that will ultimately promote significant improvements in health for African individuals, communities, and populations. We define data science as “the interdisciplinary field of inquiry in which quantitative and analytical approaches, processes, and systems are developed and used to extract knowledge and insights from increasingly large and/or complex sets of data” (NIH Strategic Plan for Data Science).
Decades of infrastructure building and training in Africa have provided compelling opportunities for research to address the disproportionate share of the global burden of disease that Africa bears. Data science has the potential to significantly impact both quantitative and qualitative research and health on the continent. By leveraging existing digital infrastructure, new solutions can be developed that are relevant, affordable, acceptable, and scalable. For example, extensive mobile phone coverage in Africa has led to major innovations in banking and agriculture and similarly has the potential to rapidly advance health care delivery systems, bringing the clinic to the patient through point of care technologies and self-management systems, with applications to rural and underserved populations worldwide. Additionally, this initiative is synergistic with and leverages the substantial investments NIH, the President's Emergency Plan for AIDS Relief (PEPFAR), and other US government entities have already made in research and research training in Africa. NIH funds more than 1,600 active grants working in Africa and has catalyzed well-developed clinical and academic research networks through prior investments by the NIH Common Fund and its partners in the Medical Education Partnership Initiatives (MEPI) and the Human Health and Heredity in Africa (H3Africa) consortium.
DS-I Africa Research Training Programs will serve as a core component within the larger DS-I Africa program, which will also consist of 1) data science and innovation research hubs, 2) research on the ethical, legal, and social implications (ELSI) central to data science health research and innovation in Africa, and 3) an open data science platform and coordinating center. As a group, awardees will constitute a collaborative consortium, made up of all programs funded through the broader DS-I Africa program, and will work collectively toward strategic objectives designated by the consortium, beyond the individual research and training objectives of each award. Representatives from each DS-I Africa Research Training Program will be expected to participate fully in the DS-I Africa Network and cross-network technical and education working groups.
The DS-I Africa Research Training Program cooperative agreements can either be direct awards to African institutions or awards to U.S. institutions in partnership with African institutions. Regardless of the applicant organization, the training programs must focus on building institutional capacity at one or more African institutions and train African researchers. Partnerships with additional organizations, including for-profit or governmental organizations, are encouraged as a means to provide applied research experiences and internships for the trainees that demonstrate the value of data science in developing innovative solutions to health-related problems in Africa.
Each training program should provide:
Proposed institutional research training programs may complement other ongoing research training and career development programs at the African institution(s), but the proposed program must be clearly distinct from related programs currently receiving U.S. government support.
Additional Objectives of DS-I Africa Program
As noted above and in the companion FOA's, there are several specific objectives that the DS-I Africa Program is trying to achieve. Successful applicants will become members of the DS-I Africa Consortium, and will be expected to contribute to the overall goals of the program and adhere to program policies.
DS-I Africa Consortium Participation: DS-I Africa will be organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The DS-I Africa Consortium will include all participants of research, training, ELSI, and open data science platform/coordinating center programs funded through DS-I Africa, as well as responsible NIH staff. Groups funded under this initiative will be expected to participate in the DS-I Africa Consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. Each funded applicant is expected to participate directly or via proxy in Consortium Working Groups that establish rules, guidelines, and resources for the Consortium or that develop cross-network research projects. Each project is expected to comply with applicable consortium policies and procedures. In addition, the PD/PI(s) will be active members of the DS-I Africa Steering Committee, which will meet regularly via virtual or teleconference meetings. The DS-I Africa Consortium will generally hold two in-person meetings per year, usually in Africa at Consortium member sites.
DS-I Africa Data Sharing Policies: Data sharing is an increasingly important aspect of contemporary biomedical research, and the Consortium will develop a Data Sharing and Access Policy within year 1 of the award that applies to data and resources funded with NIH support. The policy will address the data sharing needs of the Consortium while safeguarding the privacy of research participants and protecting confidential and proprietary data and resources. One of the roles of the associated DS-I Africa Open Data Science Platform is to facilitate data and resource access and sharing, and all DS-I Africa awardees will be expected to work closely with the Open Data Science Platform team to facilitate appropriate alignment of activities. The NIH Office of Data Science Strategy (ODSS), guided by the NIH Strategic Plan for Data Science, is committed to ensuring that data-science activities and products supported by the NIH are Findable, Assessible, Interoperable, and Reusable (FAIR). Data, analytical, educational, and other resources generated by a DS-I Africa awardee are expected to conform to the FAIR Principles, where possible. Additionally, guidance may be developed by the Consortium to inform data acquisition, collection and curation, including appropriate consent for data sharing, as appropriate for the Consortium member projects and their relevant standards or schemas.
Partnerships and Collaborations: One of the major goals of the DS-I Africa program is to enhance the impact of data science on health in Africa and spur innovation through support of new African and global partnerships. These partnerships are expected to contribute to the sustainability of African data science programs and the advancement of product development. Awardees are expected to maintain and strengthen existing partnerships that are proposed in applications and engage new partners throughout the duration of the award funding. Collaboration within the DS-I Africa consortium will also be facilitated through the DS-I Africa Coordinating Center. The DS-I Africa Research Hubs will have the opportunity to develop cross-consortium research projects enabled by the DS-I Africa Open Data Science Platform. DS-I Africa Research Training Programs will have the opportunity to collaborate with the DS-I Africa Research Hubs through mentored training experiences for trainees. Finally, DS-I Africa ELSI awardees will collaborate with the Research Hubs to explore and address issues that are specifically relevant to the data science projects within the consortium.
Community Engagement: NIH recognizes ongoing community engagement and the building of trust relationships with research participants as an essential feature of effective and ethical biomedical and population-based data science research involving human subjects. DS-I Africa awardees are expected to incorporate relevant community engagement activities into data science research and research training activities. Community engagement can include a variety of activities, including those that empower communities to contribute to and become partners in data science research and activities that engage diverse stakeholders to learn about and contribute to DS-I Africa efforts in data science.
Data Science Capacity in Africa: Another major objective for the DS-I Africa program is to increase capacity at African institutions to use and develop data science approaches in health research and innovation. The DS-I Africa Research Training Programs will build individual and institutional data science capacity through development of new data science curricula and training of data science research leaders in master’s, PhD, post-doctoral, and faculty development programs. Research in DS-I Africa Research Hubs and DS-I Africa ELSI awards provide a variety of training and career enhancement opportunities to students, postdoctoral researchers, and young investigators in diverse disciplines through mentored research experiences. Additionally, Research Hub pilot projects should provide opportunities for early career data scientists to initiate small research projects that could launch their careers. The DS-I Africa Open Data Science Platform and Coordinating Center will enhance activities conducted by the other awardees by developing short courses relevant to data science and innovation that fill training gaps in the consortium and have potential to reach the broader African research community. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the DS-I Africa program.
Technical Assistance and DS-I Africa Virtual Symposium
All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their application with the goals of this FOA, and with the DS-I Africa program. Technical Assistance Sessions and teleconferences will be held for potential applicants to this FOA and companion FOAs. NIH staff will be available to answer questions related to this FOA. Location, time, date, and connection information will be announced in an NIH Guide Notice and will be posted on the DS-I Africa website: https://commonfund.nih.gov/AfricaData. During the Technical Assistance Sessions, NIH staff will present an overview of these FOAs and answer questions from prospective applicants. Additionally, these technical assistance sessions will be part of a larger DS-I Africa Virtual Symposium, which will examine the state of data science in Africa and facilitate networking across disciplines, sectors, and geographies to promote data science for health in Africa. Registration and other details will be posted on the Virtual Symposium website: https://commonfund.nih.gov/africadatasymposium. All virtual events are free and open to all prospective applicants, but participation is not a prerequisite to applying.
Scientific Focus and Structure
Foundational training proposed should include curriculum in three scientific areas (computer science/informatics, statistics/mathematics, and biomedical science/public health), reflecting the student's background and need. Additionally, programs should include active participation of training faculty from all three scientific disciplines in the delivery of courses and collaborative mentoring of trainees. Courses should include knowledge that is deep in data science and broad in the application domain of biomedical science and each of the trainees should acquire a common, core set of competencies in data science. Awardees will be expected to collaborate with the other DS-I Africa Research Training Program PIs toward harmonization of curricula and mapping of curricula on core competencies.
Research Training Programs may develop various data science and health tracks or themes and should establish programs that provide core foundational data science and health knowledge and skills along with experiential learning through applied, interdisciplinary research projects. The collective data science research capacity of the applicant institution and their partners should be high, so that research training programs can offer a variety of applied research experiences and mentors for trainees. Additionally, the DS-I Africa Open Science Platform and Coordinating Center will provide opportunities to connect trainees with research experiences in the DS-I Africa Research Hubs (see Related Announcements).
Awards will support the development of new data science health research training capacity at African institutions, but a partnership-based training model may be proposed. This could involve faculty from partner institutions with specific data science or health expertise needed to offer curriculum and relevant mentored research training. This partnership model may evolve over time as capacity increases at the African institution(s).
Where justified and necessary to begin recruiting students in the first year of the awards, applicants may propose training of individuals in existing master’s or doctoral degree training programs at the applicant or partner institutions. However, awards may not exclusively support these training slots in existing programs since new capacity should be established.
Training programs should practice and teach open data science and data sharing in keeping with FAIR data principles. To ensure that DS-I Africa training efforts have maximum impact and reach, educational resources should be also be shared following FAIR principles. The DS-I Africa Open Science Platform and Coordinating Center (see Companion Funding Opportunities) aims to develop a gateway for the sharing of data resources and will collaborate with the training programs to facilitate appropriate sharing of data and training resources.
Research training grants must be used to support a program of full-time research training. The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in the evaluation of the success of institutional research training programs. The proposed program should make appropriate skills training available so that trainees are prepared to apply for subsequent independent support for their training or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage. Training programs should provide career development advising and skills development opportunities (e.g. workshops, discussions, Individual Development Plans). Through such opportunities, trainees should be expected to obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.
Programs are expected to identify trainees from a variety of backgrounds such as the biomedical and behavioral sciences, computer science, engineering, informatics, mathematics, physics, and statistics. All trainees are expected to acquire a core set of knowledge in data science, but their primary application areas may differ. Trainees should be prepared to enter the training level proposed by the program, which can include master's, pre-doctoral, or post-doctoral level training.
Attention should be given to recruiting and retaining women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the African context.
Trainees emerging from proposed masters, doctoral, and postdoctoral programs should be able to conduct original basic or applied research at the intersection of computer, statistical and information sciences with one or more biomedical applications. Successful trainees from these programs should be prepared for research roles in African academic institutions, not-for-profit research institutes, governmental and public health agencies, pharmaceutical and biomedical companies, and health care organizations. This initiative is not intended to prepare trainees for careers primarily focused on the planning, deployment, maintenance, or administration of computer systems in health care, public health, or medical education. The emphasis in this program is on the development of trainee capabilities to pursue new knowledge that advances biomedical research and data science.
Note: This Funding Opportunity Announcement (FOA) allows appointment of trainees proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
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 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. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s)
The NIH Common Fund intends to commit an estimated total of $7,000,000 over five years to fund up to 4 awards.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The requested budget needs to reflect the actual needs of the proposed project. Applications are limited $350,000 total costs per year.
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 and support
the cost of tuition and fees at U.S. or foreign institutions. Trainees may be
paid a stipend comparable to their professional experience.
Trainee travel to participate in training experiences at other institutions or to present their research results at scientific meetings that the institution determines to be necessary for the individual's research training experience is an allowable trainee expense.
Applicants may include costs to support mentored research projects for trainees. One-time advanced in-country research training support of up to $20,000 direct costs per trainee for mentored research to be undertaken by a trainee in his/her country may be included. Awards will provide funds to help defray other research training expenses, such as trainee health insurance, staff salaries, consultant costs, research supplies, and faculty/staff travel directly related to the research training program.
Other training-related expenses (e.g., books, laptop computers, and English language proficiency courses, etc.) may be included.
Support from this award should not be used to acquire major infrastructure (purchase of capital equipment costing more than $5,000 is not allowed). Software and platform subscription or license costs may be included, as well as internet or cellular connectivity costs that are necessary for establishing the proposed training program.
Senior/Key Personnel Salary: The salary for the PD(s)/PI(s), other key personnel, training faculty and administrative staff must be 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. Collaborators may receive appropriate compensation for significant activities on the program. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described and justified.
Senior/Key Personnel Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible), lodging and per diem for training responsibilities and to attend necessary meetings, including biannual DS-I Africa program meetings. PD(s)/PI(s) are expected to attend these DS-I Africa meetings (to be held in rotating locations in Africa) and may also budget for other key faculty, collaborators and trainees to attend. However, support for senior/key personnel, faculty and collaborators to attend other scientific 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
An application may be submitted by an African institution or by a domestic (U.S.) institution that demonstrates collaboration with an African institution. Collaboration should be documented by joint publications, grants or previous research training activities.
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.
The applicant institution and their partners must collectively have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the
NIH Grants Policy Statement, are allowed.
Applicant foreign institutions are limited to academic and other non-profit institutions in Africa. Applicants may propose partners from all types of organizations in Africa, the U.S., or other countries, including for-profit and government entities.
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/PI(s) should be established investigators in data science and/or the other scientific areas 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(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day to day administration of the program and are responsible for appointing members of the Training Advisory Committee and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.
At least one PD/PI must be affiliated with the African institution(s) where the proposed research training program will be established and must have citizenship in an African country. Other Multiple PD/PI(s) with relevant expertise from partner institutions in Africa, the U.S. or other high-income country institutions are encouraged. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed research training program.
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. 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.
For the purposes of this program, data science health research is interdisciplinary and includes three major scientific areas: (1) computer science/ informatics; (2) statistics/mathematics; and (3) biomedical sciences/public health. It anticipated that the training program will have a sufficient number of mentors in all three areas and will utilize the idea of multiple mentorship. The primary PD(s)/PI(s) must ensure that the appropriate faculty work collaboratively and in a sustained manner across scientific disciplines and organizational lines to jointly mentor trainees.
To the extent possible, faculty mentors should have research and/or research training experience in the African country/countries where training will occur.
Trainees must be citizens of African countries and affiliated with African institutions leading or collaborating in the application.
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.
Predoctoral and master's trainees must be enrolled in a program leading to a PhD or master's degree or in an equivalent degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.
Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.
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:
Laura Povlich, Ph.D.
Fogarty International Center (FIC)
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. Include the applicant institution and all collaborating institutions where research training will be supported.
Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:
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., master's, predoctoral, postdoctoral, faculty), and intended trainee outcomes. Identify all collaborating institutions.
Other Attachments. A plan must be provided for the appointment of a Training 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. Potential Advisory Committee members should not be invited to participate in the application and should not be named in the application. Please name your file “Advisory_Committee.pdf”.
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. If applicable, include at least one person as key personnel from each collaborating institution who will serve as the primary collaborator for that training location.
Follow all instructions provided in the SF424 (R&R) Application.
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:
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 Training Data Tables. For this FOA, applicants should use the tables listed under New International Training. 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 proposed program.
A. Background (In addition to the instructions in the SF424 (R&R) Application Guide):
Applications should document the existing data science research capacity at the African institution(s) where a new data science research training capacity will be established. Measurable parameters of increased research capacity expected as a result of the proposed research training activities at the end of the grant period should be defined.
Institutions with existing related research training programs must explain what distinguishes the proposed program from the others, how their proposed program will synergize with the others, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support an additional program.
For applications that propose a partnership training model, applicants should describe any prior research and/or research training collaboration between partners or other activities that demonstrate the ability of partners to successfully coordinate the proposed training program.
B. Program Plan
a. Program Administration (In addition to the instructions in the SF424 (R&R) Application Guide):
Applicants should describe how the proposed research training program relates to and/or integrates with the existing organizational structure of the applicant institution as well as the structure of partner institutions, where applicable. Additionally, applicants should describe how program leadership will manage any administrative barriers to interdepartmental and/or multi-institutional teaching, training, and or/mentoring activities.
Applicants should describe how decisions regarding the components of the proposed research training program will be made in consultation with the proposed faculty and Training Advisory Committee.
Applicants should describe plans for how all mentored research projects under this award will receive independent scientific review through procedures established by the applicant institution and Training Advisory Committee. In addition, applicants should describe how trainees who conduct mentored research involving human subjects will receive education in the protection of human subjects. Trainee research must receive annual approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted.
In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).
b. Program Faculty (In addition to the instructions in the SF424 (R&R) Application Guide):
Describe the specific role of each proposed faculty mentor in the proposed research training program. Briefly describe any relevant research, including any current research collaborations with the PD(s)/PI(s) or other faculty, and research training record, in particular, for trainees from Africa. Applicants should explain how the relevant research grant support and activities of the PD(s)/PI(s) and proposed faculty mentors may contribute to the proposed data science research training plan.
If any mentors will supervise a trainee proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines
c. Proposed Training (In addition to the instructions in the SF424 (R&R) Application Guide):
The research training proposed should instill advanced data science expertise and research leadership capabilities through rigorous and innovative didactic, practicum and mentored research activities designed to address the health needs of African countries. Applicants should describe in detail the research masters, doctoral, postdoctoral, and faculty development research training proposed, including the scientific focus, faculty, institutional location and duration for curriculum components, practicum experiences and mentored trainee research. The numbers of trainees expected to participate in each training component should be stated. While new curriculum should be developed, as described below, the plans described must include details for how trainees will be recruited in the first year of the award and trained either at an African institution or through a partnership model.
Applicants should include plans that describe new curriculum and courses that will be developed, which should expose trainees to the basic concepts and working knowledge in the three scientific areas of data science health research (computer science/informatics, statistics/mathematics, and biomedical science/public health). It is incumbent on the applicant to define a set of core concepts that graduating students will master, even if their research projects are highly specialized. Applicants are expected to work with the other DS-I Africa Research Training PIs and Coordinating Center to develop methods for curriculum harmonization or standardization.
Since data science is an interdisciplinary field with applications that cut across academia, private sector, and government, applicants are strongly encouraged to incorporate elements into their training program that foster interdisciplinary and cross-sectoral collaboration, including: team science approaches to problem-based learning; applied research experiences or internships in a variety of academic, industrial, government, or other relevant settings; and joint mentorship of trainees by mentors with expertise in diverse scientific areas and multisectoral experience.
If a partnership structure is proposed, applications should describe how each collaborating institution will contribute to the specific objectives of the research training plan including how the African institution(s) will gain the data science training capacities initially provided by partners to eventually establish a sustainable training program.
Applicants should describe how the proposed application meets the objectives of the DS-I Africa program described earlier in this funding opportunity, including incorporation of FAIR principles in data science training. Applicants should discuss how the program will integrate with the DS-I Africa Open Data Science Platform and Coordinating Center in the sharing of data resources, including educational material.
Applicants are encouraged to include plans for strengthening the associated skills and knowledge necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in research administration and management of intellectual property. Training in English as a second language may be supported, if needed. Applicants are encouraged to develop plans to foster the creation of Individual Development Plans for each student.
Research training by interactive distance learning technology may be proposed, if appropriate and sustainable for the African trainees and institutions involved. Applicants should describe the availability of distance learning facilities, equipment, internet connectivity, and technical support.
Applicants should provide specific milestones during the requested grant period to meet the proposed research training objectives. A timeline should be included.
In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by trainees.
d. Training Program Evaluation (In addition to the instructions in the SF424 (R&R) Application Guide):
In the evaluation plan provided, included metrics for evaluating improvements in institutional capacity at the African institution(s).
e. Trainee Candidates (In addition to the instructions in the SF424 (R&R) Application Guide):
Applicants should describe plans for how the most qualified African trainees from diverse scientific fields will be recruited for the proposed research training programs. The specific criteria and decision-making process for selecting trainees should be delineated. Strategies that will be used to retain trainees in master's and doctoral degree programs and postdoctoral mentored research projects as well as facilitate sustainable biomedical data science research and training careers in African institutions should be characterized.
Plans should include details for the recruitment of women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the African context.
In the event that a clinical trial may be proposed, discuss the potential of prospective trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.
f. Institutional Environment and Commitment to the Program (In addition to the instructions in the SF424 (R&R) Application Guide):
Details on the institutional environment and commitment to the program (as instructed in the SF424 Guide) should be provided for each institution where training will take place in the proposed application.
Sustainability: Dedicated funds for DS-I Africa by the NIH Common Fund will provide 5 to 10 years of support. Beyond that, any support for continuation of the research training programs and research careers initiated under the auspices of DS-I Africa will be dependent on other funding. Applicants should discuss the future sustainability of their research training program beyond the 5-years of funding provided by these awards and how the research training program will contribute to success in continuing the research efforts of its participants. This section of the application should refer to relevant letters of support.
g. Qualifications of Trainee Candidates and Admissions and Completion Records
Follow instructions in the SF424 (R&R) Application Guide.
Faculty, Trainees, and Training Record
In addition to the instructions in the SF424 (R&R) Application Guide
Letters of Support: Applications should include a letter of support from the appropriate institutional or organizational official (University or Medical School President, Dean or Director, or the head research administrator, company leader, government representative, or equivalent) from the applicant and all collaborating organizations to substantiate the organizations' commitment to the proposed DS-I Africa Training Program. Each organization should state its commitment to overcoming any administrative obstacles to the implementation of the proposal, such as accommodation for participation by multiple schools at a university or collaboration with other institutions within or outside of the applicant’s country. Appropriate organizational commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. It should also address commitment to DS-I Africa policies and procedures, including collaborating and sharing data and resources with the DS-I Africa Consortium and Open Data Science Platform, as appropriate. Where applicable, the letter should also address corporate interests and commitment to the proposed research project and any applicable in-kind support. The letter should also briefly discuss the institution's plans for sustaining the Research Training Program.
Faculty who agree to serve as faculty/mentors should provide letters indicating their willingness to participate and specific contribution to the training proposed.
The programmatic activities of this initiative will support national and international collaborations. Where relevant and attainable, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component are strongly encouraged. The letter should briefly describe the national policy concerning scientific research and health funding priorities.
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.
Applicants are encouraged to incorporate instruction related to contemporary ethical, legal, and social issues specifically related to data science health research in Africa.
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.
If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.
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
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. 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.
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 components of participating organizations, 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.
In addition, for this FOA:
In addition, for this FOA:
In addition, for this FOA:
In addition, for this FOA:
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.
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..
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.
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.
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 the Center for Scientific Review 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 Fogarty International Center 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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
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.
Awardee and Principal Investigator Primary Responsibilities
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 (including, but not limited to, Project Scientists, Program Officers, Intramural Scientists, and Program Analysts) have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
NIH Project Scientists roles include:
NIH Program Officer roles include:
The government, via NIH Program Scientists, will have access
to all data generated under this Cooperative Agreement and may periodically
review and analyze the data for the preparation of internal reports related to
the Cooperative Agreement.
An NIH intramural scientist may not serve as the PD/PI of a project awarded under this FOA but may participate as a collaborator or consultant. For applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy ?-? https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations.
The NIH reserves the right to withhold funding or curtail studies in an individual award in the event of (a) substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination; (c) or insufficient project progress.
A Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC and adoption of such policies and procedures requires a majority vote. Membership on the SC will include the PI(s) of each award and associated NIH program officers and projects scientists. On voting matters, each funded project will have one vote for determining appropriate collaborative activities, with NIH providing final approval for consortium activities. The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair, in collaboration with the associated program Coordinating Center staff, is responsible for preparing meeting agendas, for chairing meetings, and for approving minutes in a timely manner. NIH staff may not serve as Chair of the SC.
Steering Committee responsibilities include:
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 and a Dispute Resolution Panel will be convened. The Panel 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.
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.
Recipients are requested to annually update and maintain data on trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/).
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 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: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration
Contact Center Telephone: 800-518-4726
Laura Povlich, Ph.D.
Fogarty International Center (FIC)
Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
Fogarty International Center (FIC)
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.
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