The purpose of this Funding Opportunity Announcement (FOA) is to establish a coordinated network of Emerging Infectious Disease Research Centers (EIDRCs) in regions around the globe where emerging and re-emerging infectious disease outbreaks are likely to occur. Multidisciplinary teams of investigators will conduct pathogen/host surveillance, study pathogen transmission, including evaluating zoonotic hosts and reservoirs, study pathogenesis and immunologic responses in the host, and will develop reagents and diagnostic assays for improved detection for important emerging pathogens and their vectors. These EIDRC will conduct research project(s) and will collaborate under the direction of a separate EIDRC Coordinating Center (EIDRC CC, RFA-AI-19-029), to develop and formulate strategies for detecting, controlling and preventing emergence or re-emergence of infectious diseases. Rapid translation of these findings to development of reagents, diagnostic tools, etc. that will be provided to downstream partners to advance therapeutic and preventive interventions is key.
A core component of the NIAID mission in the 2017 Strategic Plan is to “develop flexible domestic and international capacity to efficiently undertake research required in response to newly emerging threats wherever they occur.” Clearly, recent infectious pathogens with significant potential to threaten the United States are emerging /re-emerging with increasing frequency. Most of these naturally occurring outbreaks have been caused by RNA viral pathogens characterized by zoonotic reservoirs and/or arthropod vectors propagating transmission to humans. These outbreaks have revealed gaps in the research infrastructure that impact the ability to respond rapidly and effectively to these emerging pathogens; obtaining contemporary knowledge of the pathophysiology and natural history, accurate detection/diagnosis of the infections, and development of critical research and product development reagents, were challenges during previous outbreaks.
This FOA and its companion, will serve as important components of the broader NIAID strategy for pandemic preparedness by establishing infrastructure and scientific expertise in geographical regions of the world that are prone to emerging and re-emerging infectious diseases. These Centers will draw on skills from teams of multidisciplinary scientists, including infectious disease clinicians, epidemiologists, virologists, clinical microbiologists, veterinarians, and entomologists, to conduct field studies of endemic diseases that have the greatest potential of becoming pandemic threats, such as zoonotic and vector-borne viruses, develop reagents for the broader research community and have the flexibility and ability to re-direct work among the EIDRC in the event of an outbreak to mount a rapid and effective research response.
The Emerging Infectious Diseases Program comprised of the EIDRC CC and the EIDRCs, is designed to improve our knowledge of emerging and re-emerging infectious diseases, complement and leverage existing NIAID international research efforts when possible, and allow NIAID to develop the flexibility and capacity to respond rapidly and effectively to outbreaks where they occur. The program as a whole is designed to improve our knowledge of the natural history, incidence, and prevalence of emerging/re-emerging infectious diseases. In many instances, re-emerging pathogens circulate at low levels for several years before breaking out and causing major public health problems, in other cases new pathogens emerge rapidly.
Research activities at the centers may include pathogen discovery; surveillance in humans, animal reservoirs, and vectors as it relates to assessment of prevalence and molecular epidemiology of specific pathogens in their geographic regions; evaluation of factors related to transmission, emergence and adaptation to new hosts; natural history of infection and contemporary clinical disease in humans as well as immunologic responses to the infection; development of reagents, new diagnostic methods for improved detection of infectious agents, and development of appropriate animal models, if/when necessary. Clinical cohorts with symptoms of acute infections may be used to define the pathophysiology and clinical outcomes of the infection and disease, describe the spectrum of disease presentation and severity, elucidate factors associated with disease transmission and progression, evaluate important immune responses to the emerging pathogen, determine clinical and molecular diagnostic criteria, and provide the basis for sample collection.
Importantly, the centers will provide reagents, tools and assays to NIAID and partners to support the development of translational products and will readily share information, data, samples, diagnostics, reagents and tools across the network in the event of an outbreak. In that regard, the centers will provide a clear plan for accomplishing effective coordination and collaboration with the entire network and the EIDRC CC.
The EIDRCs will complement and leverage existing NIAID international research efforts- such as the Centers of Excellence for Influenza Research and Surveillance (CEIRS), International Centers of Excellence for Malaria Research (ICEMR), Tropical Medicine Research Centers (TMRC), and Centers for AIDS Research (CFAR)- and/or other US Government or internationally funded research infrastructure as needed to conduct proposed research and exhibit the flexibility to expand capacity in response to outbreaks in their geographic area, as directed by NIAID and the EIDRC CC. Each EIDRC will have the flexibility to study any emerging pathogen (viral, bacterial or eukaryotic), however, the initial focus will be on infectious pathogens that are most likely to emerge/remerge including, but not limited to: Flaviviruses, Filoviruses, Alphaviruses, Coronaviruses, Bunyaviruses, and Enteroviruses that are not already studied by other NIAID funded networks (e.g. HIV, influenza, malaria) and for which countermeasures are not developed or are sub-optimal.
Each EIDRC will have relevant scientific expertise and experience working in one or more geographic areas located within the tropical or subtropical regions of the world (Tropics: latitude between 23.5o -Tropic of Cancer and Capricorn-Subtropics: between tropic and temperate zones (35-66.5o N and S of the equator) with the goal to establish multiple sites in targeted areas of the globe such as South and Central America, West/Central Africa and Southeast Asia. In an effort to train the next generation of investigators, develop expertise in emerging infectious disease research and expand regional capacity in these countries, the centers will be required to conduct a pilot project research program, that will be coordinated, including the awarding of projects, by the EIDRC CC.
Administration and Leadership Team
The Administration and Leadership Team, led by the Program Director(s)/Principal Investigator(s), will be responsible for organizing, coordinating, and providing oversight for the implementation of activities that facilitate progress and completion of the research project(s) and conduct of pilot research projects, if awarded. This team will provide administrative oversight, coordination and facilitated communications with other EIDRCs and interact directly with the EIDRC CC and NIAID.
Data Management and Analysis Team
The Data Management and Analysis Team will be responsible for implementing standard procedures provided by the EIDRC CC for the collection, oversight and inventory of data and biological samples, including; harmonization, quality control, and uniformity of data collection processes, troubleshooting data system problems and developing solutions. Team members will also work with the Administration and Leadership Team, to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses for the study. This team will serve as the hub for expertise with sharing data portal(s) as approved by NIAID. This team is responsible for directly depositing all relevant data, samples, reagents, tools, etc. as outlined to the EIDRC CC
Clinical Research Support Team
The Clinical Research Support Team will be responsible for coordinating the functions at all enrollment sites to recruit, enroll, and collect data and biological samples from participants. This Team will ensure adherence to NIH and EIDRC CC guidelines on research and data quality and all local and other regulatory oversight pertaining to all human subjects’ research. This team will serve as the process and procedure hub for the interaction among the clinical sites and other functional work areas.
External Advisory Committee (EAC)
One External Advisory Committee, comprised of experts in the field outside of the EIDRCs and EIDRC CC, will be established after award to review progress for the Emerging Infectious Diseases Program (EIDRCs and EIDRC CC) and to share recommendations for the program with NIAID as part of the annual programmatic meeting. Note that applicants should not name or contact potential EAC members in their application.
Annual Programmatic Meetings
Each EIDRC will attend a combined kick-off meeting and annual program meetings under the leadership of the EIDRC CC to articulate and establish the major roles and functions of the program and to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID on issues of need. These meetings will be attended by the PD(s)/PI(s), Key personnel, NIAID staff, and the EAC membership and will be held in the Washington DC area.
Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:
- Applications that focus on pathogens that are not on the NIAID list of Emerging diseases (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). Research focus should be emerging/remerging viruses, but if studying coinfected population with a pathogen not on the Emerging Diseases list, application should include a strong justification and rationale for inclusion.
- Pathogens already studied by other NIAID funded networks, such as influenza, tuberculosis, malaria and antibiotic resistant bacteria. Please contact the Scientific/Research Contact if further clarification is needed.
- HIV, SIV or AIDS studies.
- Genome-wide association studies (GWAS).
- Behavioral research.
Deadline: June 28, 2019 (letters of intent due 30 days prior to deadline)
URL: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-19-028.html
Filed Under: Funding Opportunities