National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is 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 the National Institute of Mental Health (NIMH).
U01 Research Project – Cooperative Agreements
RFA-RM-20-015 - Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Research Hubs (U54 – Clinical Trial Optional)
RFA-RM-20-016 - Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Research Training Program (U2R – Clinical Trial Optional)
RFA-RM-20-018 - Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Open Data Science Platform and Coordinating Center (U2C – Clinical Trial Not Allowed)
The purpose of this funding opportunity announcement (FOA) is to support research on the Ethical, Legal, and Social Implications (ELSI) associated with a new program 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.
A primary goal of this FOA is to explore the ELSI issues impacting data science for health research from an African perspective and contribute to the policy discussions of such on the continent. Through this FOA and related announcements, it is expected that ELSI research efforts will be fully embedded and integrated components of the consortia of activities supported through related DS-I Africa FOAs. Supported DS-I Africa ELSI awardees will work closely with DS-I Africa coordinating centers and DS-I Africa research hubs in considering how to dynamically address core ethical issues that may arise as the larger research projects uncover additional opportunities in this space. The cooperative agreements made through this FOA must be direct awards to African institutions, but applications can include partnerships with organizations from other areas.
November 2, 2020
December 1, 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.
September 1, 2021
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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 ELSI research projects 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) data science training programs, 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 objectives of the awarded ELSI research projects.
This FOA seeks applications for research projects that identify, examine, and address the ethical, legal and social implications raised by Harnessing Data Science for Health Discovery and Innovation in Africa. These projects will need to initially identify key ELSI issues that are broadly relevant to data science from an African perspective but must also be designed to maintain a malleable research platform that permits rapid adaptation to emerging ELSI topics associated with activities supported through the related Research Hubs. Of particular interest are projects that propose bioethical, legal, and social science analyses of new or emerging data science issues. Examples of possible research questions to be addressed in response to this FOA include, but are not limited to, the following:
How can the unique challenges of informed consent be handled in this type of research?
How can data science researchers address changes in consent capacity among vulnerable research populations (e.g., children, cognitively impaired patients, etc.)?
How are the views from researchers, participants, and the general public similar or different when it comes to the use of data science approaches in healthcare?
Are there unique sensitivities towards the use of individual geospatial information for research and/or for public health surveillance purposes?
What are the expectations of data privacy, ownership, and how these types of data might be shared for additional research purposes?
What are the attitudes and/or expectations of research participants about sharing results generated from collecting these types of data with them?
Are there long-term obligations to patient populations that share their data for research purposes?
Do unique privacy considerations arise with regard to data about communities or other groups?
Are there unique cybersecurity/privacy considerations, such as effective security and safeguards for human data and wireless transmissions to/from devices?
What ethical and legal rights and responsibilities do/should secondary users of data have?
What are the legal restrictions on the collection, use, and sharing of these types of data?
Are there differing opinions regarding the use of these types of data for public health purposes versus the development of commercial products?
Are gaps/provisions needed in existing regulatory models that need to be considered regarding data science approaches/uses?
Given the multi-faceted nature of data potentially collected from an individual, how should issues of de-identification, privacy and unintended uses and data bias be considered?
How might further technological advances in the complexity of these data be anticipated and fully considered?
What are the attitudes of patient populations, policy makers, or the general public regarding the use of data science approaches to better understand and/or diagnose diseases and disorders?
What are the unique sensitivities related to the use of data science approaches for diseases that have known stigmas?
What frameworks can be used to inform risk/benefit analyses, informed consent, and other aspects of research ethics in data science research?
How are ELSI issues associated with data science considered in the development of national/regional policies?
Critically, it is incumbent upon the applicant to provide evidence that the proposed ELSI questions are germane to core data science issues that can be addressed through partnerships with the DS-I Africa Research Hubs and Open Data Science Platform (see Companion Funding Opportunities). In the development of ELSI applications for the DS-I Africa program, it is important to consider both how these ELSI topics intersect with and inform the Research Hubs. Specifically, the interdisciplinary Research Hubs will focus on critical health research areas to be addressed through data science approaches. A primary goal for ELSI projects, and by definition those investigators conducting such research, will be to fully embed these efforts in the Research Hubs so that the ELSI efforts not only inform outcomes and the implications of this research, but also strengthen the research conducted in these Hubs. As such, it is expected that these awards will work closely with the DS-I Africa Open Data Science Platform, Coordinating Center, and Research Hubs to advise on policies and in considering implementation strategies for the research findings. It will be important that these ELSI projects also consider how to best address core ethical issues that may arise as the larger research projects uncover additional opportunities.
Of importance, Research Hubs may collect and utilize a wide range of data types and sources, including but not limited to clinical, public health, personally generated, genomic, imaging, sensor-generated, geospatial, demographic, behavioral, and environmental data. These Hubs will have a focus on a specific health area of importance to the country or region of focus, which may be disease-specific, data-specific, or cross-cutting. As such, it is expected that ELSI applications will detail how they will consider the uniqueness of a Hub and how these ELSI projects will consider the different types of data that will be available through the DS-I Africa Open Data Science Platform.
Additional Objectives of DS-I Africa Program
As noted above and in the companion FOAs, 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 adhere to these 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, Ph.D., 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.
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.
The NIH Common Fund intends to commit an estimated total of $8,000,000 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.
Application budgets are limited to $400,000 in total costs in any budget year and need to reflect the actual needs of the proposed project..
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Non-domestic (non-U.S.) Entities (Foreign Institutions), specifically:
o African Public/State Controlled Institutions of Higher Education
o African Private Institutions of Higher Education
o African Nonprofits Other Than Institutions of Higher Education
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 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 are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI(s) should be established investigators in the ELSI topics that the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research program. The PD/PI(s) will be responsible not only for the direct supervision/leadership of the proposed ELSI research project, but also for directly coordinating with the DS-I Africa Research Hubs, Open Data Science Platform, and Coordinating Center. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.
The Contact PD/PI must be affiliated with the African institution(s) where the proposed ELSI research will occur 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 may be proposed. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed research.
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. This means that the NIH will not accept:
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.
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:
James D. Churchill National Institute of Mental Health (NIMH)
Telephone: (301) 443-3621
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
If applicable, include at least one person as key personnel from each collaborating institution who will serve as the primary collaborator for that location.
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget should include funds to support PD/PI(s) travel to the biannual DS-I Africa Consortium meetings in rotating locations in Africa. Funds may be budgeted to support attendance of additional key personnel, as applicable.
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: A concise set of specific aims that clearly state the research objectives and explain the overall goals and expected outcomes of the research is required.
Research Strategy: The application should describe a well-conceived plan for the investigation of one or more ELSI topics related to data science research. The application should provide a description of the impact of the focus of their research in Africa, and the relationship (if any) to similar issues in other parts of the world. The applicant should present a well-considered plan for accomplishing the goals of the research application and give timelines and milestones, where applicable. Relevant community or stakeholder engagement strategies should be incorporated in the research plan. ELSI applications should also include details regarding how the development of junior investigators versed in ELSI topics will have meaningful roles in these projects, along with any other capacity building features.
Applicants should include the standard sections defined in the SF424 (R&R) Application Guide (Significance, Investigators, Innovation, Approach and Environment), along with 2 additional sections as described below: Integration with DS-I Africa and Sustainability.
Integration with DS-I Africa Consortium: Applicants should describe how the ELSI research project relates to the objectives of the DS-I Africa program. Additionally, applicants should present a flexible framework and process for integration of the research project with the DS-I Africa Research Hubs and for collaboration with the Open Data Science Platform and Coordinating Center. Awardees should have the capacity to rapidly adapt to address evolving ELSI issues in the Consortium and inform on-going data science research.
Sustainability: The DS-I Africa program should enable African investigators to become more productive and develop skills that will lead them to becoming internationally competitive for support in the future, increase the number of high quality publications, and become leaders in data science and ELSI research. It is hoped that this will in turn lead to increased investment in research by African governments and private sources. Applicants should discuss the issue of future sustainability of their ELSI research beyond the DS-I Africa program.
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 all collaborating institutions to substantiate the institutions' commitment to the proposed plan. Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional 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 faculty who participate in associated skill-building programs. It should also address commitment to DS-I Africa policies and procedures, including collaborating and sharing data, as appropriate. The letter should also briefly discuss the institution's plans for sustaining an active program of ELSI related research subsequent to the end of the funding period.
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.
The following modifications also apply:
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.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
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. 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 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).
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?
Will the proposed research strengthen the understanding of ethical, legal and social issues of data science research in Africa? Does the proposed research project adequately address the objectives of DS-I Africa? Will the proposed research be effective in enhancing the competitiveness of African investigators? Will the project support the capacity building objectives 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?
Do collaborations proposed suggest viable long-term partnerships?
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?
Does the proposed program sufficiently promote and support innovation that will strengthen and sustain ELSI research in Africa? Does the project describe innovative strategies for community or stakeholder engagement?
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?
Do the specific aims clearly state the research objectives and explain the overall goals and expected outcomes of the research? Does the application describe a well-conceived plan for the investigation of one or more ELSI topics related to data science research? Does the application provide a framework by which it is clear there are plans to rapidly adapt to address evolving ELSI issues that arise from the DS-I Africa Research Hubs? Does the application provide a description of the impact of the focus of the proposed research in Africa, and the relationship (if any) to similar issues in other parts of the world? Is there a well-considered plan for accomplishing the goals of the research application and give timelines and milestones, where applicable? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project? Does the project describe a strategy for community or stakeholder engagement with clear objectives of what they expect to achieve? Is the sustainability of the proposed ELSI efforts beyond the DS-I Africa funding period appropriately addressed?
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?
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?
Do the letters of collaboration and institutional support show strong commitment to the project and to the PD(s)/PI(s)? Do the letters of support suggest that the environment is conducive to a sustained research enterprise? Does the institution clearly state its commitment to overcoming any administrative obstacles to the implementation of the application? Does the institutional support letter discuss the plans for sustaining an active program of ELSI related research subsequent to the end of the funding period? Will the project be well-positioned to apply for other sources of funding at the end of the project period?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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.
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).
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).
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.
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 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.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. IRB/IEC review is not needed at the time of application submission.
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 products 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.
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.
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.
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
James D. Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Seetha Bhagavan, Ph.D.
Center for Scientific Review (CSR)
National Institute of Mental Health (NIMH)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.