Notice of Expansion of Research Scope of RFA-AI-21-004 "Tropical Medicine Research Centers (U01 Clinical Trial Not Allowed)
Notice Number:
NOT-AI-21-044

Key Dates

Release Date:

March 30, 2021

Related Announcements

RFA-AI-21-004 - Tropical Medicine Research Centers (U01 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This notice is to inform potential applicants that the National Institute of Allergy and Infectious Diseases (NIAID) has expanded the scope, effective immediately, in RFA-AI-21-004 - "Tropical Medicine Research Centers (U01 Clinical Trial Not Allowed).”

Currently Reads:

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement (FOA) solicits research applications focused on the etiology, epidemiology, pathogenesis, clinical manifestations, diagnosis, prevention, treatment and control of select Neglected Tropical Diseases (NTDs) in endemic areas. The Tropical Medicine Research Centers (TMRCs) are intended to advance NIAID’s global research effort by targeting research endeavors to: develop novel diagnostic, prevention and therapeutic strategies adapted for the unique needs of low and middle-income countries (LMICs), as classified by the World Bank; create and sustain in-country research capacity; stimulate scientific collaboration and global partnerships; provide opportunities for junior and early stage investigators to conduct research on NTDs; and facilitate sample sharing to support translational research to develop or evaluate new drugs, diagnostics, vaccines, and/or vector control strategies.

Research Objectives and Scope

The scope of the research to be supported under this FOA is limited to the following NTDs: schistosomiasis, hookworm infection, ascariasis, leishmaniasis, trypanosomiasis, Chagas’ Disease, trichuriasis, leprosy, lymphatic filariasis, trachoma, onchocerciasis, dracunculiasis, Buruli ulcer, echinococcosis, taeniasis and cysticercosis, and food-borne trematodiases. Each TMRC must design and conduct research on NTDs in endemic areas, and studies must address one or more of the following research areas: genomics, epidemiology, diagnostics, transmission, immunology, and pathogenesis. Translational research on diagnostics to support product development and inform targeted intervention strategies is encouraged. TMRCs should try to leverage recent state-of-the-art technologies for product development, modeling, and surveillance strategies.

The TMRCs are encouraged to collaborate and leverage relationships with other NIH global health research programs, including the International Centers of Excellence for Malaria Research (ICEMR), Centers for Research on Emerging Infectious Diseases (CREID), Centers for AIDS Research (CFAR), Centers of Excellence for Influenza Research and Surveillance (CEIRS), International Centers for Excellence in Research (ICER), as well as similar programs funded by other organizations.

Research may be focused on a single pathogen or multiple pathogens. Multi-disciplinary research and/or research on more than one pathogen causing NTDs is encouraged. Research to be supported by the TMRC program will require clinical and field site development, as well as access to endemic populations. Research must involve human subjects, vectors, and/or specimen collections from endemic area field sites. Research areas may include, but are not limited to, the following activities:

  • Study of biomarkers;
  • Development and/or evaluation of diagnostics;
  • Vectors, intermediate hosts and transmission;
  • Study of co-infections (excluding HIV).
  •  

NOTE: This FOA will not support the following types of research projects. Applications that propose research projects in these areas will be considered non-responsive and will not be reviewed.

  • Research on NTDs that does not require access to human subjects or specimens from disease-endemic sites in LMICs;
  • Research that is not focused on the following pathogens, except in the context of co-infections or non-NTD outcomes as a result of anti-NTD interventions: schistosomiasis, hookworm infection, ascariasis, leishmaniasis, trypanosomiasis, Chagas’ Disease, trichuriasis, leprosy, lymphatic filariasis, trachoma, onchocerciasis, dracunculiasis, Buruli ulcer, echinococcosis, taeniasis and cysticercosis, and food-borne trematodiases.
  • Research that is not focused on: genomics, epidemiology, diagnostics, transmission, immunology, and/or pathogenesis
  • Research on Select Agents (see:http://www.selectagents.gov/SelectAgentsandToxinsList.htmland accompanying regulations:https://www.selectagents.gov/regulations/index.htm).
  • Research on HIV/SIV
  • Clinical trials


Modified to Read (changes shown in bold italics and strikethrough):

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement (FOA) solicits research applications focused on the etiology, epidemiology, pathogenesis, clinical manifestations, diagnosis, prevention, treatment and control of select Neglected Tropical Diseases (NTDs) in endemic areas. The Tropical Medicine Research Centers (TMRCs) are intended to advance NIAID’s global research effort by targeting research endeavors to: develop novel diagnostic, prevention and therapeutic strategies adapted for the unique needs of low-income, lower-middle-income, and upper-middle-income economy countries (LMICs) as classified by the World Bank; create and sustain in-country research capacity; stimulate scientific collaboration and global partnerships; provide opportunities for junior and early stage investigators to conduct research on NTDs; and facilitate sample sharing to support translational research to develop or evaluate new drugs, diagnostics, vaccines, and/or vector control strategies.

Research Objectives and Scope

The scope of the research to be supported under this FOA is limited to the following NTDs: schistosomiasis, hookworm infection, ascariasis, leishmaniasis, trypanosomiasis, Chagas’ Disease, trichuriasis, leprosy, lymphatic filariasis, trachoma, onchocerciasis, dracunculiasis, Buruli ulcer, echinococcosis, taeniasis and cysticercosis, and food-borne trematodiases, mycetoma, chromoblastomycosis, paracoccidioidomycosis, sporotrichosis, and talaromycosis. Each TMRC must design and conduct research on NTDs in endemic areas, and studies must address one or more of the following research areas: genomics, epidemiology, diagnostics, transmission, immunology, and pathogenesis. Translational research on diagnostics to support product development and inform targeted intervention strategies is encouraged. TMRCs should try to leverage recent state-of-the-art technologies for product development, modeling, and surveillance strategies.

The TMRCs are encouraged to collaborate and leverage relationships with other NIH global health research programs, including the International Centers of Excellence for Malaria Research (ICEMR), Centers for Research on Emerging Infectious Diseases (CREID), Centers for AIDS Research (CFAR), Centers of Excellence for Influenza Research and Surveillance (CEIRS), International Centers for Excellence in Research (ICER), as well as similar programs funded by other organizations.

Research may be focused on a single pathogen or multiple pathogens. Multi-disciplinary research and/or research on more than one pathogen causing NTDs is encouraged. Research to be supported by the TMRC program will require clinical and field site development, as well as access to endemic populations. Research must involve human subjects, vectors, and/or specimen collections from endemic area field sites. Research areas may include, but are not limited to, the following activities:

  • Study of biomarkers;
  • Development and/or evaluation of diagnostics;
  • Vectors, intermediate hosts and transmission;
  • Study of co-infections (excluding HIV).

NOTE: This FOA will not support the following types of research projects. Applications that propose research projects in these areas will be considered non-responsive and will not be reviewed.

  • Research on NTDs that does not require access to human subjects or specimens from disease-endemic sites in LMICs;
  • Research that is not focused on the following pathogens, except in the context of co-infections or non-NTD outcomes as a result of anti-NTD interventions: schistosomiasis, hookworm infection, ascariasis, leishmaniasis, trypanosomiasis, Chagas’ Disease, trichuriasis, leprosy, lymphatic filariasis, trachoma, onchocerciasis, dracunculiasis, Buruli ulcer, echinococcosis, taeniasis and cysticercosis, and food-borne trematodiases, mycetoma, chromoblastomycosis, paracoccidioidomycosis, sporotrichosis, and talaromycosis.
  • Research that is not focused on: genomics, epidemiology, diagnostics, transmission, immunology, and/or pathogenesis
  • Research on Select Agents (see:http://www.selectagents.gov/SelectAgentsandToxinsList.htmland accompanying regulations:https://www.selectagents.gov/regulations/index.htm).
  • Research on HIV/SIV
  • Clinical trials

All other aspects of the FOA remain the same.

Inquiries

Please direct all inquiries to:

Malla Rao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3352
Email: mrao@niaid.nih.gov


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