Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
U01 Research Project – Cooperative Agreements
None
This Funding Opportunity Announcement (FOA) solicits applications for a Tropical Medicine Research Centers Coordinating Center (TMRC CC) for the Tropical Medicine Research Centers (TMRC). The TMRC CC will oversee and coordinate efforts across the TMRCs related to data management, data and specimen sharing, scientific collaboration, creation and maintenance of a virtual sample repository, organizing annual meetings, managing an Opportunity Fund to support research by junior and early-stage investigators, and liaising with United States Government (USG) counterparts and other stakeholders.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 18, 2021 | Not Applicable | Not Applicable | November 2021 | January 2022 | March 2022 |
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.
Not Applicable
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.
Purpose
This Funding Opportunity Announcement (FOA) solicits applications for a Tropical Medicine Research Centers Coordinating Center (TMRC CC) for the Tropical Medicine Research Centers (TMRC, see RFA-AI-21-004). Neglected tropical diseases (NTDs) are a major global health problem affecting nearly 1.6 billion people, most of whom live in the world’s least developed countries. NTDs are caused by a wide range of organisms and can be transmitted by a variety of vectors and intermediate hosts (mosquitoes, sand flies, black flies, tsetse flies, triatomine insects, and snails) as well as by contaminated water, food and soil. Since available medical or public health measures are currently inadequate to control most NTDs, research is urgently needed to identify and evaluate new tools and interventions. Efforts are also needed to strengthen local research capacity and infrastructure in endemic areas.
The TMRC CC will oversee and coordinate efforts across the TMRCs related to data management, data and specimen sharing, scientific collaboration, creation and maintenance of a virtual sample repository, organizing annual meetings, managing an Opportunity Fund to support research by junior and early-stage investigators, and liaising with United States government (USG) counterparts and other stakeholders. The TMRC CC will with have the following responsibilities:
Background
Neglected Tropical Diseases (NTDs) are a major global health problem affecting nearly 1.6 billion people, most of whom live in the world’s least developed countries. NTDs are caused by a wide range of organisms and can be transmitted by a variety of vectors and intermediate hosts (mosquitoes, sand flies, black flies, tsetse flies, triatomine insects, and snails) as well as by contaminated water, food and soil. Since available medical or public health measures are currently inadequate to control most NTDs, research is urgently needed to identify and evaluate new tools and interventions. Efforts are also needed to strengthen local research capacity and infrastructure in endemic areas.
The TMRC program was initiated in 1991 with the goal of building Tropical Medicine Research Centers on-site in NTD endemic countries to support clinical and field research. NIAID currently supports seven TMRCs operating in six countries: Brazil, Colombia, Ghana, India, Peru, and Sri Lanka. Historically, an outcome of this research program has been increased capacity of TMRC awardees to support independent research activities, conduct future clinical trials, and implement new treatment, prevention, and vector control strategies.
Research Objectives and Scope
The TMRC program is intended to advance global NTD research by targeting efforts to: develop prevention and therapeutic strategies adapted for the unique needs of developing countries; create and sustain research capacity in-country; 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, or vector control strategies.
The TMRC CC will provide oversight and coordination for the TMRC Program. The TMRC CC will perform the following functions:
TMRC CC Program
Administrative Team
The Administrative Team, headed by the PD/PI, will manage and coordinate the full range of TMRC CC activities, monitor progress, and ensure that project goals and timelines are met. The team will review study protocols to ensure that they follow the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and work with the TMRCs to ensure that informed consents have the necessary language to facilitate data sharing, specimen sharing, and future use of specimens.
The Administrative Team will be responsible for managing the Opportunity Fund, organizing the annual programmatic review meeting (to include securing venue space, coordinating hotel accommodations for attendees, and assisting with visas as needed), organizing ad hoc teleconference meetings based on need and guidance from NIH, communicating with NIH on programmatic issues and updates, convening and seeking input from the Scientific Advisory Group, and coordinating communication and collaboration among the TMRCs. The TMRC CC will also organize ad hoc working groups to address program-wide issues as needed. To effectively implement these responsibilities, the Administrative Team should be experienced in managing the logistics of an international research program.
Data and Specimen Management Team
The Data and Specimen Management team provides data management support for the TMRC CC and the TMRCs. The main functions of this team are to establish and manage a publicly accessible virtual specimen repository for a subset of publicly available specimens collected by the TMRCs; and provide data management guidance to the TMRCs to help their data systems adopt The Clinical Data Interchange Standards Consortium (CDISC) standards. The TMRC CC will proactively support TMRC field teams to ensure they can enter and save data into the TMRC CC's virtual specimen repository hosted in the cloud. The TMRCs will have full access to, and the ability to, download their data from the TMRCC CC virtual repository at all times. While each TMRC will be responsible for cloud-hosting and managing its own data locally, the TMRC CC will provide guidance on best practices in data sharing, data standards, and reporting. The TMRC CC will assist the TMRCs to develop and implement data management systems using REDCAP or similar software systems that the TMRCs would prefer to use. Where desired and requested by the TMRC, the TMRC CC will assist the TMRCs to develop, test, and implement data collection systems on handheld devices that can be synchronized with local databases and the cloud, either in real-time or in batch, per the needs and available facilities and resources at the sites.
Based on need, the TMRC CC will facilitate the retrieval and transportation of samples from the TMRCs to other repositories or users. The TMRC CC will also develop and implement a process for making specimens publicly available, with significant input from NIH and the Scientific Advisory Group.
For data sharing it is critical to enhance data-sharing and access to ensure that NIAID-funded data be Findable, Accessible, Interoperable, and Reusable (FAIR). All NIAID-funded researchers must share research data to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guideline at: https://www.niaid.nih.gov/research/data-sharing-guidelines, as appropriate and consistent with achieving the goals of the program.
NIH and NIAID support several open domain-specific repositories and knowledgebases for broad sharing of data with the larger research community. However, we recognize that not all data have domain-specific repositories or allow self-publishing. There are several generalist repositories that can fill this gap. Researchers are encouraged to use one of their choice and/or work with their institutional library-supported repository to rapidly self-publish all useful and usable data rapidly.
Opportunity Fund
To capitalize on emerging opportunities consistent with the goals of the TMRC Program, the TMRC CC will establish and manage an Opportunity Fund of at minimum of $200,000 per year, starting from the second year, for new and early-stage investigators exploring novel study questions, experimental approaches, or mechanisms not already addressed by TMRC projects. The limited funding is meant to leverage the expertise, established field sites, specimens and data collected by the TMRCs to conduct pilot studies which will provide preliminary data to develop future larger grant applications. The scope of research for the Opportunity Fund will be limited to the following NTDs and their vectors: 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. The TMRC CC will define the requirements and publicize this funding opportunity within the first year and begin issuing awards in the second year. There will be no Opportunity Fund set aside in the first year. Applications will be solicited annually, and selected to receive funds for durations of up to two years. Opportunity Fund projects must be within the scope of this FOA and may be submitted to the TMRC CC by junior or early-stage investigators through the awardees or directly by outside investigators. Opportunity Fund applications will be reviewed by the Scientific Advisory Group and approved by NIAID prior to selection and funding.
Scientific Advisory Group
The TMRC CC will convene a Scientific Advisory Group of approximately eight to ten external experts selected in consultation with NIAID to provide scientific guidance and recommendations on programmatic activities. The Scientific Advisory Group will attend annual programmatic review meetings and make recommendations on the TMRC CC’s data management plan, prioritize the subset of specimens that need to be made publicly available, and review requests for access to the specimens publicly available. The Scientific Advisory Group will also provide guidance to the TMRC CC on the Opportunity Fund’s scope and eligibility requirements, review applications, and provide recommendations on award decisions. Do not name or contact potential Scientific Advisory Group members in the application.
Annual Programmatic Reviews & Teleconferences
Starting with the first year, the TMRC CC will organize and hold a two day annual meeting of TMRC PDs/PIs and other key personnel, NIH staff, and Scientific Advisory Group members, to review progress and future plans, seek guidance, and update NIH on programmatic issues as needed. These annual meetings will be held at locations within the U.S.. The TMRC CC will also organize ad hoc teleconferences, as needed, in addition to the annual meeting. The TMRC CC will be responsible for arranging the facilities and logistics of the meeting for all the participants, as well as the travel and lodgings of the Scientific Advisory Group members. Each TMRC will budget for the travel and lodgings of its own participants.
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.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit $700,000 in FY 2022 to fund one award and includes a minimum of $200,000 direct costs annually beginning in the second year to support an Opportunity Fund.
For this funding opportunity, budgets totaling up to $500,000 in direct costs per year may be requested. Beginning in year 2, a minimum of $200,000 of that $500,000 direct costs per year will be designated for the Opportunity Fund. Application budgets should reflect the actual needs of the proposed project.
The 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
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. #160; 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.
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:
Eleazar Cohen, Ph.D.
Telephone: 240-669-5081
Email: [email protected]
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
, with the following additional instructions:
In the biographical sketches, highlight staff experience in managing working groups and troubleshooting administrative problems, managing data systems for complex international field-based research programs, and developing data systems based on CDISC standards.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed
, with the following additional instructions:
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:
Research Strategy: Include the following clearly labeled sections in the Research Strategy:
Administration and Leadership Plan
In this section, describe the proposed organizational and management structure of the TMRC CC and describe how this structure supports the main functions and responsibilities of the TMRC CC. Also describe how the structure incorporates adequate scientific and administrative expertise to manage an international program with multiple sites and research projects. Describe the approach for communicating with NIAID, engaging with the Scientific Advisory Group, and facilitating collaboration among the TMRCs. Describe the experience and resources available to organize and facilitate large meetings and ad hoc virtual meetings.
Data and Specimen Management Plan
In this section, provide a plan for implementing the virtual specimen repository system. Describe the knowledge and experience of the team and the institution in developing data systems in accordance with CDISC standards. Describe the information system that will be used for the virtual specimen repository. Describe how the TMRC CC will provide for data coordination across the TMRCs and ensure data quality and integrity. Include a description of the applicant organization's unique capabilities and competencies that enable it to establish and manage a virtual repository of specimens from multiple international research sites. Also describe how the TMRC CC will support TMRCs to develop harmonized data systems (to the extent possible) that are consistent with CDISC standards. Note that the TMRC CC will, in the first 3 months of award, develop a comprehensive plan for specimen management, with guidance and input from the Scientific Advisory Group, which will define in greater detail how and which specimens will be publicly available.
Opportunity Fund Management Plan
In this section, describe the plan for implementing the Opportunity Fund. Describe the proposed process for targeting junior and early-stage investigators. Also describe the assistance that will be provided to develop study protocols, ensure all necessary approvals are in place and how projects will be monitored. Describe the support resources that are available at the TMRC CC for the early-stage investigators. Note that the Scientific Advisory Group will be involved in reviewing applications, and NIAID will approve applications before award.
The management plan must include:
This section should only include information about the management of the Opportunity Fund and should not include any proposed Opportunity Fund research projects.
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.
Important reminders:
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?
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?
Specific for this FOA: How experienced is/are the PD(s)/PI(s) in managing working groups and troubleshooting administrative problems? How experienced is/are the PD(s)/PI(s) in managing data systems for complex international field-based research programs? How adequate is/are the expertise and experience of the PD(s)/PI(s) to develop data systems based on CDISC standards?
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?
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?
Specific for this FOA: How adequate is the plan for data coordination across the TMRCs? How adequate is the investigator's explanation of how a public virtual repository of specimens, collected by TMRCs, will be established and maintained?
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?
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.
Opportunity Fund: How adequate are plans for soliciting, reviewing, and selecting the projects that will be supported by the Opportunity Fund. Are sufficient processes in place to attract qualified applicants and provide administrative support to junior and early stage investigators who receive these funds?
Data Sharing Plan: Are the plans for data sharing appropriate and adequate to ensure that NIAID-funded data will be Findable, Accessible, Interoperable, and Reusable (FAIR) and consistent with achieving the goals for the program?
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.
Vertebrate Animals
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.
Biohazards
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.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
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) Sharing Model Organisms; and (2) 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, 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 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 Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient'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: 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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. 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 recipients 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.
The PD(s)/PI(s) will have the primary responsibility for:
NIAID staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
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. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of an Executive 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: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Malla Rao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3352
Email: [email protected]
Eleazar Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5081
Email: [email protected]
Laura Pone
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2951
Email: [email protected]
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.