It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

 

This Funding Opportunity Announcement (FOA) seeks to solicit applications from interdisciplinary teams to participate in the Cooperative Centers on Human Immunology (CCHI) program. The program supports mechanistic and hypothesis-testing studies to discover novel molecules, mechanisms, or regulatory pathways governing function of the human immune system in both healthy and vulnerable populations (i.e., across lifespan, organ/tissue transplant recipients, pregnant women). Studies of interest include immunity related to prevention or treatment of infectious diseases, immune-mediated pathogenesis/sequelae associated with infectious disease, and/or immune-mediated diseases. This FOA also supports technology development to advance studies of the human immune system. The overarching goal of the CCHI is to provide foundational information on human immune system function to support translation of immunology research into clinical benefits.

 

It is more difficult to dissect mechanisms of immune response and regulation in humans than in animal model systems. Experimental approaches are more limited in humans, and genetic and environmental heterogeneity make it more difficult to draw definitive conclusions. Although much has been learned from animal models, not all aspects translate directly to human applications, making studies in humans essential. Furthermore, human immunological research can now be conducted using sophisticated methods that permit analysis of tissue-specific and systemic responses. The recent advances in "omics" technologies have enabled system biology approaches that provide deeper interrogation of the molecular changes in human immune responses to infection, vaccination, and immune-mediated diseases. Large datasets from human samples are available in public repositories and knowledgebases, providing opportunities for more hypothesis-driven studies to better understand the immune mechanisms.

To foster research in human immunology, NIAID established the CCHI program in 2003. Complementary to other data-gathering and hypothesis-generating programs supported by NIAID such as the Human Immunology Project Consortium (HIPC), the CCHI focuses on understanding the mechanisms underlying human immune system functions and how these processes impact other physiological systems. NIAID expanded the scope of the initial CCHI program to address research needs in infectious diseases and immune-mediated diseases, operating as a tightly interactive and collaborative network of eight research centers. Each center supports a centralized infrastructure that promotes and coordinates multi-disciplinary research. CCHI investigators are actively contributing to a fundamental understanding of human immunology, particularly in the areas of immune activation and memory responses to infection and vaccinations, including those of SARS-CoV-2 infection and COVID-19 disease. They are also at the forefront of technology development, which includes tissue imaging techniques, cluster based TCR repertoire analysis methods, and development of organoids derived from human tissues that offer ex vivo platforms for dissecting immune response.

The COVID-19 pandemic has highlighted the importance of understanding host immune responses against emerging pathogens. Many advances have been made in characterizing the immunopathogenesis of COVID-19, providing foundational information for the discovery of therapeutic targets. NIAID recently published its Pandemic Preparedness Plan and hosted a workshop to introduce NIAID’s strategy and request feedback from the scientific community on prioritizing prototype pathogens within viral families of highest pandemic potential for medical countermeasure development. Studies of the human immune system are vital for preparing for future pandemics and are a key aspect of NIAID's mission. CCHI-supported studies will advance our understanding of the human immune system, enabling development of next generation vaccines and therapeutics to strengthen pandemic preparedness.

 

The primary objective of the CCHI program is to support research on human immune system regulation and function for the discovery and characterization of new principles of human immunology for the prevention and treatment of infectious and immune-mediated diseases. This research may entail the development of new technologies to support studies of the human immune system. The program will include support of a centralized infrastructure needed to coordinate multi-disciplinary research in human immunology; continuing recruitment of outstanding immunologists to the study of the human immune system; and promotion of public data access and the flexibility to support new research opportunities as they arise.

Each application is expected to be synergistic, with projects and cores being connected by a common theme that produces scientific gains beyond those achievable if each project were pursued independently. All applications must include at least one Research Project focused on understanding host defenses to infectious diseases, pathogen-specific vaccination, or adjuvants.

All applications must propose studies on primary human cells or tissues; animal studies may be included only to extend or guide mechanistic analyses of human samples. This program will support clinical studies using U. S. Food and Drug Administration (FDA)-approved interventions (e.g., licensed vaccines) that are used per indications in the product label and are exempt by regulatory authorities from needing an Investigational New Drug (IND) application.

This program will support clinical trials that either do not require IND application or are IND-exempt, and that and that will advance discovery and characterization of new principles of human immunology related to infectious and/or immune-mediated diseases. However, applications that include clinical trials with high risk or disease-modifying interventions in human subjects will be considered non-responsive and will not be reviewed. Proposing a clinical trial is optional for this FOA. If a clinical trial will be proposed in the application, potential applicants are strongly encouraged to consult with the Scientific/Research Contact listed in this FOA during the early stages of preparation of the application, as well as submit a Letter of Intent 30 days prior to the application due date. To ensure eligibility for this program, applicants should contact the FDA or the equivalent non-US regulatory authority (if applicable) to discuss whether an IND (or equivalent) application or exemption/waiver is required. NIAID reserves the right to decide whether a proposed clinical trial is responsive to the FOA based on the definitions and guidance provided herein. If an application is selected for NIAID funding, any proposed clinical trials will be reviewed by the Project Scientist(s) assigned by NIAID and the NIAID Division of Allergy, Immunology and Transplantation (DAIT) Clinical Research Committee. Approved clinical protocols will be developed collaboratively as per the NIAID clinical term of award.

When clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of risk to study subjects and the complexity of the study. The full policy, including terms and conditions of award, is available at: https://www.niaid.nih.gov/grants-contracts/niaid-clinical-terms-award. If an application is selected for NIAID funding, any proposed clinical trials will be reviewed by the Project Scientist(s) assigned by NIAID and the NIAID Division of Allergy, Immunology and Transplantation (DAIT) Clinical Research Committee. Final clinical protocols will be developed collaboratively.

Examples of research areas of interest include, but are not limited to:

• Understanding of host immune responses to pathogens with pandemic potential.
• Differential effects of natural infection versus vaccination as primary antigen exposure on immune responses to subsequent exposures (in adults, teens, and the elderly).
• Analyses of immune responses to infection and vaccination in the presence of immune-modulating co-morbidities (i.e., age, diabetes, obesity, autoimmunity, transplant, and cancer)
• Mechanisms of induction and durability of immune memory.
• Mechanisms of adjuvant-guided adaptive immune responses, promoting effector vs. long-term memory response.
• Studies of immune-mediated diseases to define critical regulatory pathways and tolerance mechanisms that comprise a well-regulated functional immune response.
• Identification of mechanisms of immune dysregulation that may impact protective immunity against infection or vaccination.
• Development and utilization of unique human model systems, i.e., human organoid systems or computational modeling systems, to understand immune mediated disorders or immune responses to infection or vaccination.
• Developing and applying spatial omics assays to dissect dynamic changes in immune responses in tissues and organs.
• Computational tools for analyzing human immune responses and predicting and modeling human responses from animal studies.
• Imaging technologies for analyses of in vivo immune responses.

 

Applications meeting the following conditions will be considered non-responsive and will not be reviewed:

• Applications that are not focused on mechanisms of the activation and regulation of human immune responses.
• Applications that do not include at least one Research Project focused on understanding host defenses to infectious diseases, pathogen-specific vaccination, or adjuvants.
• Applications that are focused on vaccine or product development for infectious or immune-mediated disease indications.
• Applications that do not include the use of primary human cells, fluids, or tissue in Research Projects.
• Applications that are focused on animal studies that do not extend or guide mechanistic analyses of human samples.
• Applications that include clinical trials with high risk or disease-modifying interventions in human subjects.
• Applications that require an IND or equivalent from the U.S. FDA.
• Applications that include large scale immune profiling studies to generate hypotheses in the absence of mechanistic studies.
• Applications that include the discovery or validation of immune epitopes recognized by T cells or antibodies as the primary focus.
• Applications that include clinical trials in which the primary objective is to test the safety or efficacy of an investigational vaccine, adjuvant, or other product.
• Applications that include HIV/SIV/AIDS studies.
• Applications that develop of new animal models.
• Applications that involve cancer studies, except those examining immune responses to infectious diseases or pathogen-specific vaccines in cancer patients.
• Applications that involve behavioral research or epidemiological studies.
• Applications proposing clinical trial(s) that do not include a Clinical Core.

 

 

Highly integrated and collaborative interdisciplinary teams are encouraged for the CCHI program. The scope of this work requires interdisciplinary teams that can pursue coordinated activities that bridge scientific disciplines and expertise in immunology, infectious diseases, vaccinology, immune-mediated diseases, omics technologies, and bioinformatics. Bringing multidisciplinary groups together creates opportunities for synergy that would rarely happen otherwise. The research teams within each center may be composed of investigators located at one institution, or may be formed through a consortium of different institutions.

Administrative Core (required): Each application must include an Administrative Core, which is responsible for managing, coordinating, and supervising the entire range of the center's activities; monitoring progress; ensuring that the overall project management plan is implemented effectively and within proposed timelines; and ensuring data sharing and regulatory compliance.

Infrastructure and Opportunity Fund (IOF) Management Core (required): To capitalize on emerging opportunities consistent with the goals of the CCHI an Infrastructure and Opportunities Fund (IOF) will be made available to one institution chosen from successful applicants by NIH after award to manage for the entire CCHI. This institution must agree to take responsibility for managing the IOF, and includes establishing an administrative structure, disbursement and tracking of funds, and reporting status. Examples of activities supported by the IOF may/could include collaborative and pilot/feasibility projects; resource development and sharing opportunities; translational projects; early stage investigator projects; and development and management of a website for CCHI activities. IOF projects must be within the scope of this FOA and may be submitted by recipients or by outside investigators.

Clinical Core: A Clinical Core is optional for the applications proposing clinical studies, and it is required for applications that include clinical trials. It may provide human cells/samples to projects and must be responsible for the conduct of clinical trials (if proposed in the application). This Core will ensure a standardized approach to the recruitment and clinical characterization of human subjects in all studies that will be conducted by the CCHI center. In addition, the Core will be responsible for implementing appropriate human subject protection measures, including cGCP rules, across all studies. This will require that the Core ensures appropriate training of personnel and monitors all clinical study activities of the CCHI center. In this context, the Core will conduct functions such as clinical protocol development, informed consent form development, development of a manual of procedures for each clinical protocol that the CCHI center will conduct, development of protocol-specific case report forms, training of clinical personnel prior to protocol initiation (both cGCP and protocol-specific training), preparing IRB applications and other approval processes, preparing annual progress reports to the IRB and NIH, monitoring of the clinical component of the study, capturing and reporting adverse events related to any intervention or procedure, and handling protocol deviations.

Service Core(s) (optional): Service Cores may be included to provide CCHI investigators with pre-existing technologies or services that have already been validated and refined for use (e.g., assays, reagents, technologies, and services such as statistical, or informatics). Each Service Core must support at least two of the projects. Service Core activities must not overlap with each other or with the activities of a project.

Research Projects (2 required, including 1 infectious disease-related): Each application must propose at least two milestone-driven and hypothesis-testing mechanistic immunology Research Projects, anticipated to advance understanding of the mechanisms regulating human immune responses. At least one of the projects must be applicable to immunity to infectious diseases, pathogen-specific vaccines, or adjuvants. A project on immune-mediated disease is not a requirement but is permitted.

Technology Development Project (optional): The Technology Development Project is intended to create, validate, and refine new or significantly enhance existing technologies, assays, or computational tools for analyzing human immune responses. A Technology Development Project may be included but is not required.

Steering Committee: NIAID will establish a Steering Committee with the PD(s)/PI(s) of each award serving as the governing body of the CCHI. This committee will promote scientific collaboration and exchange of scientific findings among the centers. It will review and make recommendations for funding of applications submitted to the CCHI IOF.

External Advisory Board (EAB): NIAID will convene an EAB to review and evaluate the scientific progress of the individual CCHI recipients and the Consortium as a whole. The EAB may make suggestions to NIAID for prioritizing research of individual CCHI Centers or the Consortium as a whole. EAB members will be selected by NIAID after award and should not be proposed or contacted by applicants.

External Scientific Advisory Group (ESAG) (optional): An ESAG may be formed after award at the discretion of the PD(s)/PI(s) to evaluate and advise on scientific progress within the center.

Note: The recipients will be expected to deposit data and data analyses into ImmPort, or other public data portals as designated by NIAID.

Note: Under a public health emergency, NIAID may re-direct funds or provide additional funds to individual awards to support research of direct relevance to the emergency.

Note: Applicants are strongly encouraged to consult with the Scientific/Research Contact listed in Section VII during the early stages of preparation of the application, particularly for applications proposing clinical trials.

See Section VIII. Other Information for award authorities and regulations.

 

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.

Note that the multiple PD(s)/PI(s) option may be used only for the Overall Program. Projects are limited to a single project lead per project and a single core lead per core within the multi-component application.

An investigator can serve as a PD/PI on only one CCHI award or application. This includes all PD(s)/PI(s) of a multiple-PD/PI application.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application.".  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Note that the current FOA will not allow foreign clinical trial sites. However, foreign components that will be allowed include mechanistic projects, observational studies, specialized assays, etc.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Anuja Mathew, Ph.D.
Telephone: 301-761-6911
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	6 pages
Core (use for Infrastructure and Opportunity Fund Management Core, Clinical Core, and Service Core)	6 pages each
Project (use for Research Project, Technology Development Project)	12 pages each

Additional page limits 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 a multi-component application.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

The application should consist of the following components:

• Overall: required
• Administrative Core; required; 1
• Infrastructure and Opportunity Fund Management Core: required; 1
• Clinical Core: optional for applications proposing clinical studies, but required for applications proposing clinical trials; maximum of 1
• Service Core(s): optional; maximum of 3
• Research Projects: required; minimum of 2, maximum of 3
• Technology Development Project: optional; maximum of 1

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

 

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

 

Follow standard instructions.

 

Enter primary site only.

 

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

 

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Provide evidence that demonstrates the PD(s)'/PI(s)' abilities to provide leadership, guidance, and direction over the proposed project.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

 

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

 

 

Specific Aims: Describe the central scientific theme of the proposed research, and list in priority order the broad, long-range objectives and goals of the center.

 

Research Strategy: Summarize the overall research plan for the CCHI center application and explain how the proposed program supports the study of mechanisms by which the human immune system is activated and regulated. Describe the central theme of the proposed program and explain how the proposed Research Projects and Technology Development Project (if applicable) are synergistic and fit under the overarching program theme. The CCHI application should be viewed as an alliance of interrelated projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to convey the conceptual wholeness of the overall program. Therefore, it should contain a statement of the scientific goals and lay out a broad strategy to achieve these goals. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Briefly describe the human populations and the rationale for their selection for each project and core and explain how the study of these populations will enhance the goals of the overall center. Include a schematic overview (figure) of the interactions, synergy, and collaborations among all the components. If there was no prior experience of collaboration among the investigators, explain how the proposed investigator collaborations will result in synergy.

Letters of Support: Provide any institutional letters of support specific to the Overall Component.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
• Recipients are expected to deposit data and data analyses into ImmPort (https://www.immport.org/home) or other public data portal as designated by NIAID.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

 

All instructions in the SF424 (R&R) Application Guide must be followed.

 

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

 

Enter Human Embryonic Stem Cells in each relevant component.

 

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• For institutions/organizations proposing a single PD/PI, the PD/PI must serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Lead.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the activities and services of the Administrative Core. Describe the work to be completed to address issues of program coordination, communication, and management.

Research Strategy: Provide a staffing and administrative plan that includes a discussion of the structure and roles of administrative and scientific staff for the core, and the functions to be performed; how resources will be prioritized, allocated, and managed; and how to enable compliance with the data sharing and other resource sharing policies. Provide a management plan for fiscal accountability, communication within the program, including group meetings and teleconferences. Provide a plan for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the center.

Optionally, an External Scientific Advisory Group (ESAG) may be formed after award at the discretion of the PD(s)/PI(s) to evaluate and advise on scientific progress within the center. For renewal applications: identify any current or former ESAG members. New applications should not name, recruit or contact potential ESAG members until after an award is made.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

 

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

 

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Multiple Core Leads are NOT permitted for IOF Management Core.

Budget forms appropriate for the specific component will be included in the application package.

The budget for Infrastructure and Opportunity Fund (IOF) Management Core is not expected to exceed $900,000 direct costs per year, of which $150,000 may be budgeted for management of the core. IOF Management Core application budgets must include the following costs:

• A maximum of 1.2 person months' salary for the IOF Management Leader.
• A minimum of 6 person months' salary for an IOF administrator and a maximum of 6 person months for Information Technology staff (if required) to be included in the Other Personnel category.
• IT computing supplies, if required.
• Costs for pilot/feasibility projects per year to be included in the Other Direct Costs category for the remaining funds.
• IOF travel for either the IOF administrator or IT staff member to attend the annual program Steering Committee meeting (one-day meeting) in Bethesda/Rockville, Maryland area.
• Include travel funds for the core lead and up to one (1) additional staff member to participate in the CCHI annual face-to-face meeting, to be held in the Bethesda/Rockville, MD area (two days per annual meeting).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Specific Aims: List in priority order the proposed activities and services of the IOF Management Core. Concisely and realistically describe the work to be completed to address issues of program coordination, communication, and fiscal management.

Research Strategy: The IOF management plan is expected to include:

• an administrative structure;
• plans for the logistics for solicitation, review, and award of pilot projects, including receipt of applications;
• proposed procedures to support the Steering Committee in the timely award of consortium agreements, including the time interval for establishment and renewal or consortium agreements
• tracking and monitoring of timely submission and payment of invoices, and plans for handling consortium agreement administration delays;
• plans for interacting with the institutions that will receive IOF funds;
• reporting on the status of the funds and consortium agreements awarded;
• providing an administrative assistant to coordinate these activities with the NIAID, Steering Committee and the institution’s grants and contracts staff;
• providing IT support for the maintenance and/or development of an internal website, if required;
• include a statement of commitment from the Institution’s signing official agreeing to take fiscal responsibility for the management of the Infrastructure and Opportunities Funds, if chosen by NIAID to administer the fund.

This section should only include information about the management of the IOF and should NOT include any IOF proposed research projects.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

• Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

 

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

• Include funds to support all functions of this core including clinical protocol development, informed consent form development, development of a manual of procedures for each clinical protocol that the CCHI will conduct, development of protocol-specific case report forms, training of clinical personnel prior to protocol initiation (both cGCP and protocol-specific training), monitoring of the clinical component of the study, capturing and reporting adverse events related to any intervention or procedure and handling protocol deviations.
• Include travel funds for the Core Lead and up to three (3) additional scientific staff to participate in the CCHI annual face-to-face meeting, to be held in the Bethesda/Rockville, MD area (two days per annual meeting).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Specific Aims: List in priority order the proposed activities and services of the Clinical Core. Describe the work to be completed indicating the core’s relationship to the program’s goals. The Clinical Core must support the activities of at least two of the projects.

Research Strategy:

• Explain how the core will serve the proposed research projects. For example, describe core activities to provide a uniform screening and characterization of potential participants in the studies proposed by each of the center’s research projects.
• Describe the clinical outcomes that will be captured and the methodologies that will be used.
• Describe processes and procedures for clinical protocol development, informed consent form development, development of a manual of procedures for each clinical protocol that the center will conduct, development of protocol-specific case report forms, training of clinical personnel prior to protocol initiation (both cGCP and protocol-specific training), preparing IRB applications and other approval processes, preparing annual progress reports to the IRB and NIH, monitoring of the clinical component of the study, capturing and reporting adverse events related to any intervention or procedure, and handling protocol deviations.
• Describe and justify any incentives provided to subjects to participate in the proposed study, if in addition to those under the parent clinical trial.

Letters of Support: Provide any institutional letters of support specific to the Clinical Core.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

Include the following:

• blank informed consent forms for the parent clinical trial(s)
• blank informed consent forms for the proposed additional studies, if different from the parent trial(s)

It is recommended that applications submitted under this FOA have clear language in the informed consent form(s) that distinguishes proposed immune profiling studies from the clinical trials with which they are linked. It is also recommended that the following items be clarified in the consent form: 1) additional blood or tissue that will be collected as part of the proposed profiling study; 2) the right of the subjects to refuse to participate in the proposed profiling study and still participate in the parent clinical trial; 3) that no charges to the subject for participation in the proposed profiling study are incurred; and 4) agreement to share the subject s de-identified data obtained from the immune profiling study as well as the parent trial.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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, with the following additional instructions:

For all clinical research or trial protocols and procedures that span multiple Research Projects, enter requested information in the PHS Human Subjects and Clinical Trials Information section associated with the Clinical Core, not the Overall component. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms across components. Human subject details that are specific to a particular Research Project should be entered in the PHS Human Subjects and Clinical Trials Information Forms in the appropriate Research Project component.

The materials from the independently-funded clinical trials should identify the Research Projects they will provide with tissue samples.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

 

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

 

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

• Include travel funds for the Service Core Lead and up to two additional scientific staff to participate in the CCHI annual face-to-face meeting, to be held in the Bethesda/Rockville, MD area (two days per annual meeting).
• For cores obtaining samples from independently funded clinical trials, include the following costs, when such costs are not included in the Projects: additional clinical trial-related activities such as the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the activities and services of the Service Core. In addition, state the core’s relationship to the center’s goals and how it will support the research proposed by two or more individual research projects in the application.

Research Strategy: Indicate the specific projects to be served by the core and explain why the Core resources are not otherwise available. Describe the reagents, resources, technologies, or other services to be provided by the core. Describe how it will serve multiple projects and explain how requests will be prioritized and coordinated. Any proposed development of new technologies, assays, etc. must be presented within a research/technology development project and not in a Service Core.

If the Service Core proposes clinical studies designed only to collect and provide samples for two or more research projects, this section must describe the following aspects of the proposed trial(s)/study(ies):

• Discuss the role of the study in the overall research strategy of the application. Outline the objectives and concisely describe the design of the proposed study, include rationale and process for the selection of the participant population, choice of intervention (if applicable), choice of study sites, and duration and schedule of events.
• Discuss the study's feasibility. If applicable, include general concepts for sample size determinations and statistical methodologies, and provide study-specific details in the PHS Human Subjects and Clinical Trial Information Forms.

Note: Specific details for clinical trials and clinical studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

If the data management activities are included in a Service Core, describe the data management infrastructure that will support the proposed activities and how the services of this core will support and advance the outcomes from the proposed research program.

Staffing Plan: Include a description of a staffing plan that will support the functions associated with this core, including any professional staff or staff with specialized skills to fully address the extent of core needs and submission of data, meta-data, and related data analyses to the ImmPort database (or other appropriate public databases designated by NIAID) (https://www.immport.org/home).

 

Letters of Support: Provide any institutional letters of support specific to the Service Core.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

• Include travel funds for the Project Lead and up to three (3) additional scientific staff to participate in the CCHI annual face-to-face meeting, to be held in the Bethesda/Rockville, MD area (two days per annual meeting).
• If samples for the proposed studies are to be collected from a CCHI-funded clinical trial or study include the following costs, when such costs have not been included under a Service Core or Clinical Core: clinical protocol development, informed consent form development, development of a manual of procedures for each clinical protocol that the CCHI center will conduct, development of protocol-specific case report forms, training of clinical personnel prior to protocol initiation (both cGCP and protocol-specific training), monitoring of the clinical component of the study, and capturing and reporting adverse events related to any intervention or procedure and handling protocol deviations.
• If samples for the proposed studies are to be collected from an independently funded clinical trial include the following costs, when such costs have not been included under a Service Core: the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the center’s goals and how it is related to other projects or cores to create synergy.

Research Strategy: Describe how the proposed studies will utilize primary human immune cells, fluids, or tissues and, if needed, relevant animal models, to provide mechanistic insights that will advance our understanding of human immune function or regulation applicable to (1) the innate, adaptive, and mucosal immune responses to infection, vaccination, and adjuvants, or (2) immune-mediated diseases (if applicable).

• Explain the rationale for selecting the methods and approaches to accomplish the specific aims, including the selection of sample sources.
• State the biological significance of the research. Explain how the Research Project addresses the common immunological theme of the application and how the project contributes to the overall goals of the center.
• Include a data and/or statistical analysis plan that describes how data will be analyzed. For clinical trials, applicants will provide specific statistical design and power information under the PHS Human Subjects and Clinical Trials Information, and these should not be duplicated under the Research Strategy.
• Explain how animal studies will provide mechanistic insights into immune function or regulation, and discuss how they will extend/complement the findings of proposed human studies.

Milestones and Timelines: In a clearly labeled section, describe annual milestones and timelines for the Research Project. For clinical trials, applicants will provide specific clinical trials timelines under the PHS Human Subjects and Clinical Trials Information, and these should not be duplicated under the Research Strategy.

Letters of Support: Provide any institutional letters of support specific to the Research Project, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e., sample availability corresponding to the outlined Milestones and Timelines).

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Section 2 - Study Population Characteristics

2.7 - Study Timeline

A study timeline is required for all studies utilizing human biospecimens, including studies that are not clinical trials and selecting exemption 4. For studies using human biospecimens collected from independently-funded clinical research or clinical trials, provide a timeline for obtaining these samples and implementing the proposed project.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

 

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

• Include travel funds for the Project Lead and up to three (3) additional scientific staff to participate in the CCHI annual face-to-face meeting, to be held in the Bethesda/Rockville, MD area (two days per annual meeting).
• Include costs associated with the Project's submission of data into the ImmPort (https://immport.niaid.nih.gov/home) database or other publicly accessible database approved by NIAID (as appropriate) when such costs are not included in the Administrative Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely describe the hypothesis or hypotheses to be tested, or the rationale for technology development. In addition, state the individual research project's relationship to the center’s goals and how it is relates to other projects or cores to create synergy.

Research Strategy: Describe how the proposed research will develop a new, or significantly enhance, an existing technology(ies), assay(s) and/or computational tool(s) relevant to the proposed Research Projects and the rationale for selecting the methods to accomplish the specific aims. State the biological significance of the research. Discuss how the proposed research will address an unmet need that contributes to the common theme and the overall goals of the center. Describe the potential benefit to the scientific community at large and have a variety of biomedical research applications.

Milestones and Timelines: In a clearly labeled section, describe annual milestones and timelines for the project.

For clinical trials, applicants will provide specific clinical trials timelines under the PHS Human Subjects and Clinical Trials Information, and these should not be duplicated under the Research Strategy.

Letters of Support: Provide any institutional letters of support specific to the Research Project, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e., sample availability corresponding to the outlined Milestones and Timelines).

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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, with the following additional instructions:

Section 2 - Study Population Characteristics

2.7 - Study Timeline

A study timeline is required for all studies utilizing human biospecimens, including studies that are not clinical trials and selecting exemption 4. For studies using human biospecimens collected from independently-funded clinical research or clinical trials, provide a timeline for obtaining these samples and implementing the proposed project.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NIAID, 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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center 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 center 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 center that by its nature is not innovative may be essential to advance a field.

Does the center 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 center rigorous? If the aims of the center 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?

Specific to this FOA:

How adequately does the application focus on the study of mechanisms by which the human immune system is activated and regulated?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy, or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the center? 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 center 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 center?

 

In addition, for applications involving clinical trials

With regard to the proposed leadership for the center, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Have 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 center 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 to this FOA: How cohesive is the application in terms of projects and cores fitting into a common theme? How adequate is the coordination and synergy between the individual Research Projects, Technology Development Project (if applicable), and Cores to achieve the central objectives of the application? To what extent will the integration of the individual Research Projects and Technology Development Project (if applicable) into a single application be more beneficial than pursuing each project independently?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

 

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 center proposed? Will the center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to (1) enroll the proposed numbers, (2) adhere to the protocol, (3) collect and transmit data in an accurate and timely fashion, and (4) operate within the proposed organizational structure?

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.

Significance

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?

Specific to this FOA:

For Research Projects and the Technology Development Project (if applicable): How likely are new principles of human immunology to be discovered through the proposed efforts? How relevant are the goals of the Project to the primary theme of the overall application?

For Research Projects: How likely are the proposed mechanisms to play important roles in human immune activation and regulation?

For the Technology Development Project (if applicable): How compelling is the need for the new technology within the proposed center? What potential benefit will this new technology bring to the scientific community at large and how likely is it that the new technology will have a variety of research applications?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

 

Investigator(s)

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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have 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 to this FOA:

Research Projects:

• How adequate is the focus on hypothesis-testing, mechanistic studies of the human immune system? Do the hypotheses address mechanisms of human immune function or regulation?
• How adequate are the data and/or statistical analyses plans (for non-clinical trial projects)?
• If animal studies are proposed, what is the potential of extending the findings of human studies?
• How adequate are the annual milestones and timelines proposed?
• For those studies using de-identified human biospecimens collected from independently-funded clinical research or clinical trials, how adequate and feasible are the timeline and documentation to successfully obtain the samples and implement the proposed project(s)?

Technology Development Project (if applicable):

• How likely will the proposed research develop a new or significantly enhanced technology, assay, or computational tool?
• To what extent does the project address an unmet need that contributes to the common immunological theme amongst all the proposed Research Projects?
• How adequate are the annual milestones and timelines proposed?
• For those studies using de-identified human biospecimens collected from independently-funded clinical research or clinical trials, how adequate and feasible are the timeline and documentation to successfully obtain the samples and implement the proposed project(s)?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and the statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to (1) enroll the proposed numbers, (2) adhere to the protocol, (3) collect and transmit data in an accurate and timely fashion, and (4) operate within the proposed organizational structure?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to meet its intended goals in consideration of the following review criteria and additional review criteria (as applicable for the core proposed).

Reviewers will consider each of the review criteria below, as appropriate for the individual Core, in the determination of scientific merit and provide an overall impact score for each Core but will not give separate scores for these items.

Administrative Core

• How adequate are the staffing and administrative plans to facilitate attainment of the objectives of the proposed program?
• How adequate is the plan to organize communications, group meetings, and teleconferences?
• How appropriate are the plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the program?
• Are the plans for resource allocation within the program adequate and appropriate?
• How appropriate is the management plan for fiscal accountability and communication within the program?
• How sufficient are the designated personnel to enable compliance with the data sharing and other resource sharing policy?

Service Core(s) (if applicable)

• How adequate is the provision of the proposed core services to the Research and Technology Development Projects?
• How well is the core connected to the central focus of the overall center?
• How appropriate are the quality of the relevant facilities or services provided (including procedures, techniques, quality control) and criteria for prioritization and usage?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

 

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

As applicable for the cores or projects 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.

Infrastructure and Opportunity Fund (IOF) Management Core

• How adequate is the provision of the proposed services? How well qualified are the personnel charged with managing the IOF?

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 cores or projects 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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period

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.

Not Applicable

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 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:

• 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.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All recipient-selected projects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy).  This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

 

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accomodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Being a member of the Steering Committee, one voting member from each center.
• Accepting and implementing policies approved by the Steering Committee.
• For clinical trials and other human subject research, implementing current Good Clinical Practice guidelines and specific NIAID/DAIT policies.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Coordinate NIAID staff assistance, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, etc.
• Facilitate collaborations with and access to other NIAID-supported research resources and services.
• Provide oversight for human subjects protections and provide monitoring for any studies that involve more than minimal risk for participants or that involve vulnerable populations.
• Provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies and monitoring any clinical trials developed via the IOF.
• Promote coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.
• Establish an EAB to review and evaluate the scientific progress of the individual CCHI recipients and the Consortium as a whole.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

 

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will serve as the governing body of the CCHI and will assist in making recommendations for applications submitted for CCHI Infrastructure and Opportunities Fund (IOF).

Infrastructure and Opportunities Fund: The Steering Committee will oversee the Infrastructure and Opportunities Fund, consistent with the goals of the program. The Steering Committee will device and implement procedures, practices, and subcommittees as needed, for the IOF solicitation, receipt, review, development, evaluation, and recommendation of feasibility, pilot, resource development, or collaborative projects or potential resource sharing opportunities and other collaborative needs. The Steering Committee will also assess additional professional and administrative staffing needs beyond the administrative support provided as part of the requirements to manage the IOF budget and activities (e.g., for review activities or IT needs as required) and provide recommendations to the NIH Project Scientist. In addition, the Steering Committee will be responsible for an annual report of progress of projects, status of funds, and other activities funded by the IOF program, including outcomes of all completed projects.

• Each CCHI center will be represented by one PD/PI as a voting member of the Steering Committee. NIAID Project Scientists will be non-voting members.

External Scientific Advisory Group (ESAG)

The Administrative Core may support an External Scientific Advisory Group, to be formed after award at the discretion of the PD(s)/PI(s). The ESAG will evaluate scientific progress within the CCHI center and provide advice to the center on an annual basis.

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 the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://grants.nih.gov/support/index.html(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]

Chao Jiang, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7802
Email: [email protected]

Anuja Mathew, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6911
Email: [email protected]

Nicole Guidetti
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6934
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 and 2 CFR Part 200.