National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the Fogarty International Center (FIC) on behalf of the NIH.
U01 Research Project – Cooperative Agreements
This Funding Opportunity Announcement (FOA) seeks applications for Partnership for Innovation Research Projects as part of a broader ongoing 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.
DS-I Africa Partnership for Innovation Research Projects are meant to support discrete research projects led by investigators in Africa to expand the DS-I Africa consortium. Applicants will propose innovative health data science research and solutions in Africa with the ability to advance population-relevant, affordable, acceptable, and scalable data science solutions and, in the long-term, demonstrate the ability of these solutions to improve health in Africa. Applications should propose partnership with a non-academic partner that enhances the potential impact of the research. Since one goal of this FOA is to expand the DS-I Africa consortium, either the applicant organization or proposed partner should not be a current member of the consortium. Additionally, these projects are aimed to enhance the career pipeline and retention of health data scientists in Africa by supporting a minimum number of new and early-stage investigators.
Applications must be submitted from African academic or other non-profit organizations. Proposed partnerships with organizations outside the applicant institution can include all types of organizations in Africa, the U.S., or other countries.
August 29, 2022
|Application Due Dates||Review and Award Cycles|
|New||Renewal / Resubmission / Revision (as allowed)||AIDS||Scientific Merit Review||Advisory Council Review||Earliest Start Date|
|September 28, 2022||Not Applicable||December 06, 2022||March 2023||May 2023||September 2023|
All applications are due by 5:00 PM local time of applicant organization.
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.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
The NIH Common Fund’s Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program leverages data science technologies and prior NIH investments to develop solutions to the continent’s most pressing health problems through a robust ecosystem of new partners from academic, government, and private sectors. In the next decade, rapid advances in data science are expected to transform biomedical and behavioral research and lead to improved health for individuals and populations. While data science applications are under-developed in Africa, there are opportunities to utilize data science to impact health outcomes on the continent and around the world.
In 2021, NIH issued 19 DS-I Africa awards to advance the program's goal of spurring new health discoveries and catalyzing innovation in healthcare, public health, and health research on the continent through application of data science. The current DS-I Africa consortium consists of a data science platform and coordinating center, seven research hubs, seven data science research training programs and four projects focused on studying the ethical, legal, and social implications of health data science. Research funded through the DS-I Africa Partnership for Innovation Research Projects will serve to advance the overall goals of DS-I Africa and applicants should be familiar with the DS-I Africa consortium and the additional objectives of the program, as discussed at the end of this section. Applicants should note that data science-related research training will also be facilitated through the companion funding opportunity announcement, DS-I Africa Research Education Program.
In this program, 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).
The overarching goal of the DS-I Africa program is to advance data science and related innovations in Africa through creation of a multisectoral and multidisciplinary ecosystem that can begin to provide local solutions to countries’ most immediate biomedical and public health problems through advances in research. It is expected that the DS-I Africa Partnership for Innovation Research Projects will support discrete research projects led by African investigators to expand the DS-I Africa Consortium. Applicants will propose innovative health data science research and solutions in Africa with the ability to advance population-relevant, affordable, acceptable, and scalable data science solutions and, in the long-term, demonstrate the ability of these solutions to improve health in Africa. Applications should propose partnership with a non-academic partner that enhances the potential impact of the research. Since one goal of this FOA is to expand the DS-I Africa consortium, either the applicant organization or proposed partner should not be a current member of the consortium. Prior history of collaboration is not required for this FOA.
These projects are aimed at enhancing the career pipeline and retention of health data scientists in Africa by supporting a minimum number of new and early-stage investigators. It is vital to establish and maintain a robust cadre of interdisciplinary data scientists on the continent capable of not only building the foundation for long-term data science research and innovation but also for sustaining these programs into the future as these fields rapidly evolve and impact human health. By intentionally supporting both established and early-stage investigators, there is increased likelihood of fostering effective long-term research strategies that drive public health benefit. Please see the NIH Early Stage Investigator Policies for further information on eligibility criteria.
Partnership for Innovation Research Projects must provide the complete capacity needed to carry out research on a health topic important to Africa. There are many areas of data science that may be engaged by the Research Projects, which will be expected to collect and/or utilize appropriate data types and sources, including but not limited to clinical, public health, genomic, imaging, geospatial, mobile, and environmental data. Projects should leverage existing, African-based information and communication technology infrastructure, such as cell coverage and mobile phones, satellites, high-performance computing infrastructure and other digital information systems, wherever feasible.
The proposed Research Project should be aligned with the overarching goals of the DS-I Africa program, which include leveraging open data science, biomedical domain knowledge, technology, interdisciplinary capacity building, and community/stakeholder engagement to advance health discovery and innovation in Africa. Projects should propose problem-based, solution-oriented research that is designed to address contextually-relevant research questions and health needs. This can include, for instance, the development, advancement, and/or adaptation of a product (software or hardware) or new technology that is either needed for the collection of new data types or translates initial data science research into a new health innovation. While new data can be collected where necessary, projects should primarily focus on use of pre-existing data. In the long-term, DS-I Africa aims to demonstrate the potential for data science-driven research projects to impact health, healthcare, or health research. While clinical trials are not allowed for this particular FOA, applicants should have a plan for follow-on research that would provide evidence of enhanced health outcomes. See "Potential Areas of Research" below for further information about applicable areas of research.
Potential Areas of Research
While the specific area(s) a Research Project application proposes to address will be determined by the applicant, potential topics that could be considered include, but are not limited to:
Applicants are encouraged to consider the unique opportunities for African research, including:
All applications proposing research to improve the understanding of HIV/AIDS prevention, diagnosis, treatment, cure and related complications will be considered in accordance with the NIH AIDS Research Priorities document found at the following link (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html).
Applications submitted in response to this FOA may propose research that is cross-cutting or more specifically focused on a disease or health area that falls within the broad areas of data science for health discovery and innovation. Applications may fall within the mission of any NIH institute, center, or office and additional information is provided regarding specific areas of interest of members of the DS-I Africa working group on the DS-I Africa program website: https://commonfund.nih.gov/AfricaData.
Additional Objectives of the DS-I Africa Program
As noted above, successful applicants will become members of the DS-I Africa Consortium, and will be expected to adhere to these policies.
DS-I Africa Consortium Participation: DS-I Africa is organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The DS-I Africa Consortium includes all participants of research, training and education, and open data science platform/coordinating center programs funded through DS-I Africa, as well as responsible NIH staff. Groups funded under this initiative are 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. Requirements related to consortium participation are detailed in the Cooperative Agreement Terms of Award in Section VI.
DS-I Africa Data Sharing Policies: The DS-I Africa Consortium is developing a Data Sharing and Access Policy 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 to ensure that data-science activities and products supported by the NIH are Findable, Accessible, Interoperable, and Reusable (FAIR).
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 around the world. Awardees are expected to maintain and strengthen existing partnerships that are proposed in applications and new partners within and outside the Consortium may be engaged through the duration of the program. Collaboration within the DS-I Africa consortium will be facilitated through the DS-I Africa Coordinating Center and associated working groups. The DS-I Africa Research Projects and Research Education Programs will have the opportunity to leverage the broad expertise of the current DS-I Africa Consortium, as well as potentially leverage a variety of data assets through the DS-I Africa Open Data Science Platform.
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. Bidirectional community engagement is encouraged and 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 different 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 (see Companion Funding Opportunity) are building 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, DS-I Africa Partnership for Innovation awards and DS-I Africa ELSI awards provide a variety of training and career enhancement opportunities to students, postdoctoral researchers, and early-stage investigators in various disciplines through mentored research experiences and career development. The DS-I Africa Open Data Science Platform and Coordinating Center is developing data science activities that have potential to reach the broader African research community. The DS-I Africa Research Education programs will complement and enhance the above efforts by addressing educational needs through short courses.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
The NIH Common Fund intends to commit $8,200,000 over three years to fund up to 12 awards. It is anticipated that half of funded projects will be awarded to new and early-stage investigators.
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. DS-I Africa Partnership for Innovation Research Project applications are limited to $250,000 per year in total costs.
The scope of the proposed DS-I Africa Partnership for Innovation Research Project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Non-domestic (non-U.S.) Entities (Foreign Institutions)
African applicants may propose partners from all types of organizations in Africa, the U.S., or other countries, including for-profit and government entities.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities in the US (see, e.g., Notice of NIH’s Interest in Diversity, NOT-OD-20-031) and in the eligible LMIC are always encouraged to apply for NIH support..
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
While PI(s)/PI(s) at all career stages are eligible to submit applications in response to this FOA, NIH plans to support a minimum number of new and early-stage investigators. Please see the NIH Early Stage Investigator Policies for further information on eligibility criteria.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 188.8.131.52 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
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.
2. Content and Form of Application SubmissionIt is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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:
Brad Newsome, Ph.D.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should include all institutions where research will occur as performance sites, including relevant U.S. and foreign institutions.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget should include funds to support travel for Consortium activities, including but not limited to supporting the participation of PD/PI(s) and additional staff members at the annual Consortium meeting. It is expected that each Partnership for Innovation Research Project recipient will bring at least one person to each DS-I Africa Consortium meeting.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Applicants must provide Specific Aims describing the objectives and goals of the Partnership for Innovation Research Project, including how they relate to the overarching goals of the DS-I Africa Program.
Research Strategy: The Research Strategy section should highlight the significance of the research project, the expertise of the research team, the innovation of the science, the details of the experimental approach (including a rationale for the methodology), and the strengths of the research environment. As such, the following subsections are recommended: Significance and Relevance to the DS-I Africa Program; Investigators; Innovation; Approach; and Environment.
Applicants should include an overview of the Research Project that clearly describes the problem(s) being addressed, the problem's contextual relevance, and how the project contributes to resolving the problem(s) related to data science for health discovery and innovation in Africa. The problem being addressed could be a discreet but critical gap in the larger context of a complex issue, or it may answer a discrete question that, if left unanswered, would create an impediment to effectively protecting public health. This section should also include background information and a description of how the Research Project addresses the broad objectives of the DS-I Africa program. While new data may be collected, it cannot be the main focus of the research project; the proposed project should incorporate re-use of data as much as possible. As such, Research Projects should leverage existing, African-based information and communication technology infrastructure, such as cell coverage and mobile phones, satellites, high-performance computing infrastructure and other digital information systems whenever possible. If new data are to be generated by the Research Project, the costs of generating the data should be addressed, as should the availability of supplies and any issues of long-term maintenance and servicing of necessary equipment. Research Projects should demonstrate the long-term potential for data science-driven research products to impact health, healthcare, or health research and translate beyond the research lab.
Applicants should introduce the leadership and key personnel of the Research Project, highlighting the interdisciplinary research personnel assembled for addressing the contextualized research problem. Applicants should also highlight how the institutional environment supports the Project's problem-solving goals, provides institutional support including unique data science capabilities, enhances interdepartmental/interinstitutional cooperation needed to carry out the multi-disciplinary activities, and enables a move toward sustainability during and beyond the period of funding requested. If proposed, include a description of in-kind support being provided by the institutions or partners. Applicants should describe the contributions of their non-academic partner and how this collaboration will enhance the impact of the research proposed. While prior collaboration(s) between various partners may be highlighted within the application, along with evidence of partnership activities, prior research collaboration is not required and may be newly established to execute proposed research activities. At least one organization involved in an application must be new to the DS-I Africa Consortium.
A description of the innovative aspects of the Research Project should be included. Applicants should describe how the proposed data science-driven approaches lead toward a novel solution to critical health barriers or advance understanding of critical health challenges facing Africa. Applicants should highlight how related theoretical concepts, approaches or methodologies, available data sets and infrastructure, and/or existing interventions (including novel adaptations of technologies from one field to another) can be leveraged to answer associated critical research questions. The experimental plan that will be employed should be discussed in detail, including methods, technologies, and innovative approaches that will be employed by the DS-I Africa Research Project. The impact of those methods/technologies/approaches on the future of African science, public health, and/or medicine should be described. The data to be analyzed should be identified and the research strategy must include a plan for data acquisition (where applicable), storage, etc. Whether the data are new, previously generated, or publicly available, and whether new data are produced in-house or obtained externally, the applicant should describe how they will be analyzed, as well as the research team's experience with the relevant data science methodologies. If technology/solution development is proposed, the applicant should describe how it will be assessed and validated, as well as the research team’s experience developing related technology platforms and implementing associated solutions or interventions. Applicants should state their willingness to work with the DS-I Africa Open Data Science Platform and other grantees to ensure data is discoverable and accessible, where appropriate, for the specific questions being studied that have cross-cutting relevance. Ideally this will occur early in the progression of the award, so pertinent new data are able to be harmonized from the beginning.
The data science and innovation needs of the project should be clearly described, including issues of data acquisition, data management, data storage, analytical capability, technology development, intervention validation, etc.; the data science- and/or innovation-related tools that will be used or developed, and the relevant investigators' multidisciplinary experience. Innovative approaches that will be developed or employed by the project should be identified and the impact of those methods/technologies on the future of African science, public health and/or medicine should be briefly discussed.
Research project milestones must be included, defining quantitatively and qualitatively how the applicants propose to achieve the key goals of the project. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. An associated timeline should provide further information regarding the timeframe of each element associated with each project milestone. The applicant should also identify potential major challenges or problems that might be encountered in conducting the proposed research and discuss how these would be addressed should they arise.
Furthermore, applications should discuss how the Research Project fits within the overall objectives of the DS-I Africa program. Applications should highlight plans for the translation and delivery of the research findings to appropriate audiences through broad stakeholder engagement and include plans for ongoing and future community engagement activities and their potential benefits to relevant communities. Applicants should also describe how the Research Project will facilitate research capacity building and career enhancement activities for researchers across the career spectrum. For new and early-stage investigators serving as PIs, the capacity building-focus can relate to their own career development.
Letters of Support: Applicants must include letters to demonstrate the support of, for example, research collaborators, stakeholders, and/or entities whose resources may be utilized as part of the Project (e.g. data set sharing, shared research infrastructure, etc.). Letters from appropriate stakeholders vital to the success of the proposed research project should also be included. 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 all collaborating organizations to substantiate the organizations' commitment to the proposed DS-I Africa Research Project. Each organization should state its commitment to overcoming any administrative obstacles to the implementation of the application, 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. Where applicable, the letter should address institutional commitment to any new faculty who participate in associated skill-building programs or whose labs are established within the DS-I Africa Research Project. It should also address commitment to DS-I Africa policies and procedures, including collaborating and sharing data with the DS-I Africa Consortium and Open Data Science Platform, as appropriate. The letter should briefly discuss the institution's plans for sustaining an active program of scientific research in the areas of this application following the end of the funding period. Where applicable, the letter should address corporate interests and commitment to the proposed research project, applicable in-kind support, and goals for appropriate innovation commercialization.
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.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Data represent important research products and attention is needed to provide stewardship of data and treat data as an asset. To support NIH data sharing policies (https://grants.nih.gov/policy/sharing.htm) and promote best practices, all DS-I Africa Partnership for Innovation Research Projects should propose robust systems for the secure management, integration, and interoperability (as appropriate) of data assets in alignment with the broader DS-I Africa Consortium, with facilitation by the DS-I Africa Open Data Science Platform and Coordinating Center. The Project should establish, coordinate, and monitor processes for data analysis and work closely with collaborators within the project and across the DS-I Africa Consortium to ensure high data quality throughout the entire lifecycle of the data.
Applicants shouldo provide a well thought-out plan for sharing data and resources generated by the DS-I Africa Partnership for Innovation Research Project, which should be aligned with the DS-I Africa Open Data Science Platform. Sharing of pre-existing data should be considered, where possible, for advancing consortium-level activities. Necessary exceptions to wide data sharing are allowable and should be discussed, including the need for controlled or restricted access for privacy, ethical, and intellectual property protections.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
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.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (UEI) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
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 for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
If successful, will the project result in knowledge or resources that could be utilized to improve human health and/or move the field of data science forward, especially in the low-resource settings in Africa? If successful, would the project provide data, information, and knowledge to inform the processes of harnessing data science for health discovery and innovation in Africa? If applicable, will the project provide rigorous scientific data that might be used for effective decision-making by stakeholders? Is the proposed project appropriately designed to expand the reach and impact of DS-I Africa?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
If applicable, do the investigators have the experience and ability to handle different data types and to present an integrated view of these data? Will the partnerships proposed in the application enhance the impact of the planned research?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
As applicable, does the project propose an innovative solution to a critical barrier to progress in the understanding of how data science and innovation can be leveraged to address critical health priorities in the African country or region of interest?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?
Does the project fit within the broader objectives of the DS-I Africa program, including strategies for community engagement and research translation? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project? Has the issue of future sustainability been adequately addressed? How contextually appropriate and impactful are the proposed research capacity building and career enhancement activities for researchers across the career spectrum?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
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
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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.
2. Review and Selection Process
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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
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.
1. Award Notices
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 recipient's business official.
Recipients 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: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, 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 (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 “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 2 CFR Part 200, 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 recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 recipientsfor the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Recipientand Principal Investigator Primary Responsibilities
Recipientswill 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 Scientist 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; or (c) insufficient project progress toward completion of negotiated milestones.
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 project 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, 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 recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient'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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Brad Newsome, Ph.D.
Fogarty International Center (FIC)
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 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
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