Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement  

Announcement Type

New 

Related Notices
  • October 18, 2018 - Notice of Webinar and FAQs for NIAID Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) and Leadership Group for an Infectious Diseases Clinical Research Consortium (IDCRC) (UM1 Clinical Trial Required), RFA-AI-18-046 and RFA-AI-18-047. See Notice NOT-AI-19-008.
  • October 01, 2018 - Notice of Webinar and FAQs for NIAID Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) and Leadership Group for an Infectious Diseases Clinical Research Consortium (IDCRC) (UM1 Clinical Trial Required), RFA-AI-18-046 and RFA-AI-18-047. See Notice NOT-AI-18-060.
Funding Opportunity Announcement (FOA) Number

RFA-AI-18-046

Companion Funding Opportunity

RFA-AI-18-047; Leadership Group for an Infectious Diseases Clinical Research Consortium (UM1 Clinical Trials Required) 

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement is to solicit applications for the Vaccine and Treatment Evaluation Units (VTEUs) to implement clinical site protocols (clinical research, clinical trials) for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases as part of NIAID Infectious Diseases Clinical Research Consortium (IDCRC). A companion FOA solicits applications for the Leadership Group for the Infectious Diseases Clinical Research Consortium, hereafter referred to as the Leadership Group (LG), which provides for overall administrative and scientific leadership for the clinical research and clinical trials conducted. While the primary scientific focus will be on product evaluation for NIAID priority areas, including malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases, the VTEUs must also provide surge capacity to address emerging infectious diseases.     

Key Dates
Posted Date

October 01, 2018

Open Date (Earliest Submission Date)

January 15, 2019

Letter of Intent Due Date(s)

January 15, 2019

Application Due Date(s)

February 15, 2019  , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2019  

Advisory Council Review

October 2019

Earliest Start Date

December 2019

Expiration Date

February 16, 2019  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the Vaccine and Treatment Evaluation Units (VTEUs) to implement clinical site protocols (clinical research, clinical trials) for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases as part of NIAID Infectious Diseases Clinical Research Consortium (IDCRC). A companion FOA solicits applications for the Leadership Group for the Infectious Diseases Clinical Research Consortium, hereafter referred to as the Leadership Group (LG), which provides for overall administrative and scientific leadership for the clinical research and clinical trials conducted. While the primary scientific focus will be on product evaluation for NIAID priority areas, including malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases, the VTEUs must also provide surge capacity to address emerging infectious diseases.

    Background

    The ability to develop vaccines, therapeutics, devices and diagnostics to prevent, treat and identify NIAID priority pathogens, emerging infectious diseases and other infectious disease outbreaks is a critical NIAID need. Timely, prospectively generated clinical trial data is a critically important part of this process, and NIAID's Division of Microbiology and Infectious Diseases (DMID) has supported the Vaccine and Treatment Evaluation Units (VTEUs) since the 1960s. These sites have and continue to play a prominent role in supporting studies of promising vaccine and therapeutic candidates for influenza, malaria, tuberculosis, pneumonia, cholera, whooping cough and many other infectious diseases, in children, adults, and high-risk populations (e.g., pregnant women).

    NIAID has a dual mandate to both pursue a robust infectious disease research portfolio and be prepared to quickly launch a research response to newly emerging and reemerging infectious diseases. The VTEUs must address the same dual mandate.   Historically, they have designed and conducted a broad range of clinical studies and clinical trials in people of all ages and risk categories.  When a new infectious disease emerges, the VTEUs must rapidly mobilize to evaluate countermeasures against new threats. For example, in 2009, immediately upon availability of product, NIAID initiated trials of experimental vaccines against novel H1N1 influenza. The trials involved thousands of volunteers recruited by the VTEUs and other medical centers nationwide.  Subsequently, similar efforts have been repeated with stockpiled pre-pandemic influenza vaccines as part of influenza pandemic preparedness efforts.  In their most recent funding cycle, the VTEUs were able to rapidly initiate clinical trials and other studies in response to emerging epidemics, such as Waves 1 and 5 of the H7N9 avian influenza outbreaks in Asia, and in response to the Zika epidemic in 2016.

    The VTEU trials and studies have provided data that informed public health policy.  For example, data provided by the VTEUs has been instrumental in licensure decisions (e.g., H5 pre-pandemic influenza); informed policy regarding utilization of stockpiled vaccine (e.g., anthrax); informed standard of care (e.g., rotavirus vaccine); and provided data to support product inclusion in the Strategic National Stockpile (e.g., Modified Vaccinia Ankara (MVA) smallpox vaccine).

    Research Objectives and Scope

    Vaccine and Treatment Evaluation Units (VTEUs) provide the scientific, clinical, administrative, and organizational structure to support implementation of clinical trials and studies for the Infectious Diseases Clinical Research Consortium. The VTEUs will conduct interventional trials and clinical research studies for vaccines and other preventive biologics, therapeutics, diagnostics and devices targeting infectious diseases primarily in healthy outpatient populations or in patients within ambulatory clinic settings, such as sexually transmitted infection (STI) clinics, which routinely treat infections generally not requiring hospitalization.   Clinical research concepts developed into protocols and implemented by the VTEUs may arise from the LG, the research community, NIAID staff, as well as from DMID’s preclinical and early product development programs.   

    The VTEUs will be capable of implementing clinical trials testing products that address a public health need that would not be done in the private sector. Such products include pre-pandemic influenza vaccines for stockpiling, first-in-human studies of new antibiotics, and biologic countermeasures that may be deployed in a public health emergency.

    VTEU Program Elements

    VTEUs are organized to maximize flexibility to address current needs, potential surge capacity to conduct multiple clinical research projects and respond rapidly to evolving research opportunities, and the capacity to address a wide array of infectious diseases.  Through the integrated structure, the VTEUs will implement clinical research through recruitment of normal healthy volunteers and patients with common outpatient infections such as sexually transmitted infections or respiratory viral infections, in addition to performing human challenge studies in areas such as malaria, enteric pathogens and respiratory pathogens, and Phase 1 first-in-human pharmacokinetic studies.  Note that each individual VTEU will not need all capabilities; however, all capabilities will be necessary for the IDCRC to function as a complete program. All clinical trials conducted by the VTEUs must adhere to NIAID/NIH and other applicable policies and requirements and comply with Good Clinical Practice (GCP) requirements.  Additionally, VTEU PD(s)/PI(s) will contribute to the research agenda by serving on area specific expert working groups formed by the LG.

    Applications must contain the following Program Elements: Administration, Clinical Sites, Clinical Laboratory, Pharmacy, Data Management, Quality Management, in addition to an application Overview. Applications lacking one or more Program Element will be considered incomplete and will not be reviewed. Applications may optionally contain the Program Element Research Laboratory.

    Administration

    The VTEU Administrative functions consist of protocol development, implementation and management, VTEU oversight and coordination, fiscal and project management, and administrative support for all activities of the VTEU.  The VTEU provides oversight for the following clinical-related activities: adherence to regulatory compliance, coordination of data management actions, clinical staff training, and process development to conduct internal quality control and quality assurance consistent with NIAID clinical research and regulatory policies. The VTEU administration develops and coordinates multiple processes to monitor activities, budgets, timelines, and develops strong bi-directional communications practices among all participant locations, sites and functions.  In addition, the leadership of the Administrative section coordinates with NIAID to ensure integration of NIAID-supported resources and services (e.g., safety monitoring, statistical and data management, etc.) into all VTEU program elements, as required.

    The VTEU Administration will coordinate the activities related to the identification of research opportunities for junior investigators with the VTEU.  These opportunities may take the form of small clinical research projects, classroom training in clinical research and statistical analysis, participation on committees, participation as junior investigators on studies and protocol teams, and exposure to other aspects of clinical research on infectious diseases.

    Other functions may arise on a protocol by protocol basis. As part of the overall organization, management and oversight of the VTEU functions, the following assurances and functions are integral to the VTEU program elements:

    • Regulatory Assurance.  Development and adherence to compliance with all applicable regulatory requirements and maintenance of regulatory training records.
    • Staff Training.  Development and implementation of a process for ongoing assessment and delivery of training to ensure staff have the appropriate knowledge and qualifications to perform required activities in accordance with GCP, NIAID, and other clinical research consortium requirements and maintain appropriate training records.

    Clinical Sites

    A VTEU clinical site is the location(s) where clinical research is conducted, such as a hospital, academic medical center, outpatient clinic, health department, or community health center where clinical trial participant recruitment and retention occurs, and local protocol management and other clinical research activities are conducted.  International clinical sites are allowed as part of the VTEU collaboration. The VTEUs are considered the fixed sites funded through cooperative agreements with NIAID for continuous operation in implementing clinical research developed through LG activities. At times of specific need, the LG or NIAID may request the VTEU to identify and incorporate protocol-specific sites to meet goals or recruitment needs of the supported research. Protocol specific sites are clinical research sites opened for capacity to implement specific protocols when eligibility criteria cannot be met by fixed sites alone, or when surge capacity is required to respond in a high priority research area.

    Clinical Laboratory

    The VTEU Clinical Laboratory is responsible for conducting protocol-specific clinical and safety testing, specimen collection and processing, clinical data collection, storage and shipment of collected specimens from VTEU locations. Clinical laboratory services may be provided by multiple VTEU-affiliated laboratories, by locally available clinical laboratories (e.g., hospital pathology laboratory), or by a single (clinical) laboratory. All proposed clinical laboratories must meet and maintain specific requirements to ensure compliance with Good Clinical Laboratory Practice (GCLP). 

    Pharmacy

    The VTEU Pharmacy is responsible for receipt, storage, inventory, identification and processing, and dispensing study product(s), as well as records management of products in accordance with GCP, applicable United States regulations, NIAID guidelines and local requirements or regulations.  Pharmacy services are provided by multiple VTEU-affiliated pharmacies, by locally available clinical pharmacies (e.g., hospital pharmacy dispensary), or by a single pharmacy. All proposed pharmacies must meet and maintain specific requirements to ensure compliance with Good Clinical Laboratory Practice (GCLP) and provide a Pharmacist(s) of Record (PoR) responsible for overseeing all VTEU pharmacy-related activities. 

    Data Management

    The Data Management section is responsible for oversight of the data and specimens collected from the clinical sites, protocol-specific sites, laboratories and pharmacies.  The data management section will collect, record, and send the data to the LG Statistical Support Unit (SSU) (for non-Investigational New Drug [IND]/Investigational Drug Exemption [IDE] data) or the NIAID-supported Statistical and Data Coordinating Center support contract (SDCC) (for IND data). The LG will coordinate with the VTEU to provide the appropriate methods used to ensure data integrity based on IND or non-IND status. The Data Management section will develop processes and procedures that will allow for the secure, rapid transfer of clinical data, specimen data, and reports from the VTEUs, Laboratories and Pharmacies to the LG SSU or the NIAID SDCC, as appropriate.  The data management function resides within the VTEU.  In addition to QA/QC procedures inherent to the GLP and GCLP processes, the VTEU data management function will incorporate and plan for additional QA/QC processes associated with the overall VTEU, Laboratories, and Pharmacies role(s) in ensuring the integrity of data collection and transfer.

    Quality Management

    The VTEU will be responsible for development and implementation of processes for conducting internal quality control and quality assurance, consistent with NIAID clinical research policies and SOPs.

    Research Laboratory (optional)

    The VTEU Research Laboratory is responsible for conducting research on specimens, and clinical data collected.  Research laboratory services might consist of, for example, immunogenicity assay development and characterization; identification, qualification, and verification of biomarkers; or pharmacokinetic analyses and assays. All proposed research laboratories will ensure the application of rigorous research methodology, QC verification, and appropriate transfer of outcomes from data or sample analyses to the data management facility.   All proposed research laboratories must meet and maintain specific requirements to ensure compliance with Good Laboratory Practice (GLP). 

    Additional resources provided by NIAID:

    • NIAID will provide additional support services for VTEU trials that must be conducted under an IND or IDE. These services, provided through NIAID contractors, may include domestic regulatory sponsorship (NIAID Regulatory Support Contract), data management and statistical support (SDCC), management of clinical agents and specimens (NIAID Clinical Material Services Contract), and clinical site monitoring (NIAID Clinical Research Operations and Management Support Contract). Each study will be evaluated for the need for an IND/IDE by NIAID. Support services required through contracts will be determined on an individual study basis. For clinical trials that do not require an IND/IDE, the VTEU should be prepared to provide all support services other than safety oversight. For clinical studies that do not meet the NIH definition of a clinical trial, the VTEU will need to provide all resources and expertise necessary for the conduct of the study.
    • NIAID will provide a variety of training activities to appropriate VTEU personnel to help the VTEU ensure that consistent standards for protection of human subjects and clinical trial conduct and documentation are achieved across the NIAID-supported clinical trials networks.  Training areas include, but are not limited to, regulatory requirements, GCP, adverse event reporting, human subject protections, informed consent, and NIAID and NIH policies and procedures.

    Annual Program Meetings

    The Program Directors (PDs)/Principal Investigators (PIs) of the VTEU, collaborators, and key personnel will participate in annual program meetings of all VTEU awardees.  These meetings may be held in conjunction with the LG annual program meeting.  These meetings provide a forum for program and progress updates from each VTEU to the consortium members, and the LG (if applicable), and the sharing of ideas, procedures, and research outcomes.

    This FOA solicits applications for Vaccine and Treatment Evaluations Units (VTEUs).  A companion FOA solicits applications for RFA-AI-18-047, the Leadership Group for the Infectious Diseases Clinical Research Consortium.

    Note: For further information, please visit the following website for general information and questions and answers.

    https://www.niaid.nih.gov/research/future-infectious-disease-research/questions-answers

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.      

    Application Types Allowed

    New   

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Required: Only accepting applications that propose clinical trial(s)    

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

     NIAID intends to commit up to $29 million in FY 2020 to fund 8-10 awards under this FOA and 1 award under the companion FOA. This funding amount will cover both Core Funds and Protocol Funds.

    Award Budget

    Budgets for direct costs up to $400,000 per year may be requested for Core funds.     

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 7 years.      

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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)
    • 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
    Foreign Institutions

    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.

    Required Registrations

    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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – 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. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    Applicants may be PD(s)/PI(s) on only one application to this FOA. 

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • 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:

    Maryam Feili-Hariri, PhD
    National Institutes on Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5026
    Email: haririmf@niaid.nih.gov    

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

    Subsection A. Overview of the VTEU Research Program - required - 12 pages

    Subsection B. Administration - required - 30 pages

    Subsection C. Clinical Sites - required - 30 pages

    Subsection D. Clinical Laboratory - required - 12 pages

    Subsection E. Pharmacy - required - 12 pages

    Subsection F. Data Management - required - 6 pages

    Subsection G. Quality Management - required - 6 pages

    Subsection H. Research Laboratory - optional - 12 pages

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    Describe the applicant organization's experience with the management and execution of single IRB studies and/or reliance agreements. Include the plans, processes and communication strategies to meet the requirements of sIRB.

    Facilities & Other Resources:

    Clinical Sites: Describe the unique facilities and features of the VTEUs.   Describe the unique facilities available at the clinical sites to recruit, screen, and enroll in a timely manner as well as follow, retain and provide the clinical care required for the proposed and potential research areas. Describe the facilities available for emergency care of research subjects should the need arise.

    Clinical Laboratory: Describe the unique facilities and features of the Clinical Laboratories that will support the collection, identification, coding, and storage of patient data, including biological specimens. Describe the storage facilities appropriate for various specimens or reagents, and how the facilities will be monitored and secured based on the nature of the data.   

    Pharmacy: Describe the unique facilities and features of the Pharmacies that will support the request, receipt, identification, manipulation and handling and storage of study products or devices.   Describe the storage facilities appropriate for various study products and pharmacy supplies and how the facilities will be monitored and secured based on the nature of the study product.   

    Data Management:  Describe the unique facilities and features of the data management section to support the processes for the reliable and accurate collection and recording of the data, and the features of the facilities that will enable rapid and secure transfer of all data types to the SDCC or the LG SSU, depending on the IND status.

    Research Laboratory (optional): Describe the unique facilities and features of the Research Laboratories that will support the receipt, storage and handling of data and the performance of various biologic, genomic or pharmacokinetic assays as requested by the LG. Describe the storage facilities appropriate for various specimens or reagents, and how the facilities will be monitored and secured based on the nature of the data.    

    SF424(R&R) Senior/Key Person Profile

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

    Describe the leadership team of the VTEU, including the PD(s)/PI(s), key personnel and collaborators, in terms of previous experience with implementation, oversight, and overall management of a complex project of this scope.  Expand on the specific skills of the PD/PI that will contribute to the success of collaborative and synergistic activities. 

    Describe the PD(s)/PI(s) experience with conducting clinical research in the following populations: healthy adults (age 18-64), healthy adults (age =/>65), healthy children, pregnant women, those with STIs/at risk for STIs, those with infections routinely treated in outpatient settings (e.g. respiratory infections), and any relevant experience with controlled human infection models. Include in your description the type of study (observational, clinical trials, clinical trial under IND), the duration of the study (in years), and the number of subjects enrolled and retained.  

    R&R Budget

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

    Beginning in Year 01, include funds for travel by the PD(s)/PI(s), collaborators, and key personnel to attend annual meetings in the Bethesda, MD area for 1.5 days to update NIAID on progress and future directions.

    In the budget section, applicants should request funds to support the infrastructure and operations of the VTEU (Core Funds - CF) under the heading Core funds.  Applicants should not request funds for the implementation of protocols (Protocol Funds - PF) in response to this FOA.  Instead PF will be determined and provided to the VTEUs and LG as protocols are approved through a collaborative process among the IDCRC, LG, VTEU and NIAID. 

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: Describe the specific aims of the VTEU with respect to the uniqueness of the organization to address the priority scientific areas to be supported by the IDCRC. 

    Research Strategy:  The Research Strategy must consist of a single attachment including subsections A-H, as designated below.

    Subsection A: Overview

    • Summarize the overall functional role of the VTEU in the implementation of collaborative clinical research with the LG, NIAID, and the extramural research community of infectious diseases experts.
    • Discuss at a high level the overall structure of the VTEU to perform clinical research in support of the scientific priorities of the LG.  Provide an organizational chart for the VTEU integration of clinical sites, including any potential international sites, Laboratories, Pharmacies, and Data Management elements to show interactions and direction of work flows.
    • Drawing on successful plans implemented previously, describe efforts to carry out clinical research with similar scope and magnitude, including clinical trials, with respect to strategy and   resources (e.g. funds, people) needed to implement the operations of the proposed project.
    • Provide a plan for prioritization and assignment of the approved concepts for clinical research.  
    • Describe how the leadership of the VTEU will coordinate the day-to-day activities of the VTEU.
    • Describe how the VTEU collaborations will maximize flexibility to address scientific priorities of the clinical research.
    • Discuss  the range of potential trial participants that the VTEU can access as part of the proposed VTEU site(s) (e.g. incidence of STIs, healthy volunteer populations, pregnant women)
    • Provide a site management plan for the VTEU in terms of project timelines and reporting deadlines.
    • Describe the process for interacting with the LG in terms of proposing, developing and implementing VTEU clinical research protocols.
    • Describe the plans for development, implementation and periodic review of VTEU bylaws, policies, and standard operating procedures.
    • Describe the relationship among the multiple VTEUs in terms of how the various awardees will work together to implement approved clinical research concepts.  

    Subsection B: Administration

    • Provide an organizational chart describing the overall VTEU structure which demonstrates a cohesive, integrated approach to supporting the scientific priority areas of the LG; include detailed description of lines of authority.
    • Summarize how the functions of the Administrative element will be prioritized, assigned and managed.
    • Describe the protocol implementation process in terms of the entire VTEU structure and components. Discuss how the VTEU will interact with the LG to refine processes for the implementation of approved protocols. Include a discussion of the oversight procedures for protocol implementation for IND studies.
    • Describe proposed approaches to efficient utilization of resources and infrastructure, avoidance of redundancies, resource sharing strategies, and cost-containment measures which support the proposed VTEU configuration.
    • Describe how activities will be coordinated across multiple clinical sites, if applicable.
    • Describe the approaches for optimizing efficiencies to support the VTEU within the scope of the LG to maintain continuity of research protocols and studies.
    • Provide a project plan including oversight of clinical activities, safety, budgets, timelines, protocol development (if applicable), and VTEU resource management.
    • Regulatory Assurance.  Describe regulatory requirements for protocol approval and implementation.  Include details such as IRB regulatory requirements, protocol approval development times, challenges and other unique issues that may have impacted protocol approval and implementation, and strategies to mitigate risk from regulatory hurdles, if applicable. Describe the plan for ensuring compliance with GCP, local, national, and other applicable regulatory requirements.
    • Staff Training.  Describe the plans for staff training, how training content will be developed/decided, how training will be reviewed, evaluated, and modified, and how training records will be stored and maintained. Provide a plan for training new staff and providing continuing education for existing staff.
    • Research Opportunities. Provide plans to incorporate clinical research opportunities for junior clinical investigators into the VTEU structure. This may take the form of small clinical research projects, formal training in clinical research and statistical analysis, participation in LG committees and protocol teams, participation as junior investigators on studies and trials, and exposure to other aspects of clinical research on infectious diseases. Outline the process for soliciting research topics from junior investigators and involving them in the clinical research experience.
    • Financial Resource Management. Describe the policies and procedures for establishment and implementation of consortia agreements, including timelines and responsible parties; how resource utilization will be monitored and adjusted as needed; the process for allocating resources to each clinical site in a transparent manner; and the plan to provide budgets and timely financial status information to the LG and NIAID, including effort reports of VTEU funded staff. Describe the financial management plan for the VTEU, in broad terms of how core VTEU operation funds and clinical trial protocol funds would be allocated to various tasks and activities associated with the implementation of clinical research at the VTEU.
    • Communication. Describe proposed VTEU communication and collaboration plans, including the roles and responsibilities of involved individuals related to performance expectations, consequences for poor performance, clinical site selection and resource allocation, and study halting events.  Describe how the VTEU will establish and maintain clear lines of communication and procedures within the VTEU. 
    • Evaluation. Describe the process including metrics and frequency for assessing operational performance and capacity of all components of the VTEU.
    • Include the process, metrics, frequency of evaluation and documentation of findings, and how modifications to quality management will be determined and implemented.

    Subsection C.  Clinical Sites

    • Describe the overall structure and staffing plans of the clinical site(s), including potential populations for recruitment and articulate how the clinical site structure and function contributes to the success of the research.
    • Describe the approach for identifying and assessing capacity and capability of a clinical site.  Describe the onboarding and site activation processes for all named clinical sites within the VTEU.
    • Describe the determination of feasibility for implementing LG proposed studies within the VTEU sites.
    • Describe the compliance procedures related to participant safety, treatments and outcomes, and environment to ensure regulatory aspects are implemented.
    • Describe the capability of the clinical site to conduct clinical research related to IND submissions as related to the proposed scope of research, including safety oversight procedures, regulatory compliance (including IRB compliance and other regulatory compliance), FDA interactions, protocol amendments, protocol oversight, clinical site monitoring, safety reporting, data management and quality control, and audits.
    • Describe the processes that will support a potential surge in clinical functions, e.g. how the VTEU can rapidly expand participant enrollment in the event of an infectious disease outbreak. Also describe how the overall recruitment and retention plans per site and population demographic may facilitate this process.
    • Describe the process for collecting data and samples from participants, and the plan for labeling, storing, tracking and transfer of these data and samples to the laboratories, specimen storage facilities, LG SSU or the NIAID SDCC, as appropriate.
    • Describe the plans for identifying additional protocol-specific sites that can be utilized on a per protocol need, for example, access to special populations or geographic locations.
    • NOTE:  The application must propose at least one clinical site for enrollment of clinical research participants.  All proposed clinical sites(s), including any international components must be named and described within the application.  

    Subsection D: Clinical Laboratory

    • Describe the overall clinical laboratory structure and staffing plans, and how the laboratory structure will facilitate the research.
    • Describe the plan for laboratory operations and communications plan, and the overall laboratory structure and organization, including lines of authority; include a diagram showing the roles and relationships of each laboratory to other laboratories in the VTEU structure.
    • Describe the overall function of the clinical laboratory and provide a concise summary of the nature and types of clinical data and specimens to be collected. Include specific details on data collection for IND submission. 
    • Describe the specialized capabilities of the clinical laboratory in terms of the research conducted by the VTEU.
    • Describe the capability of the clinical laboratory to conduct clinical research related to IND submissions. Include any certifications for laboratory facilities to support capability statements.
    • Describe the plans and procedures associated with clinical sample receipt, storage, preparation, processing, local analysis and disposition.
    • Describe the clinical laboratory testing facilities and features that will support a potential surge in laboratory functions. 
    • Describe the process for developing, reviewing and implementing laboratory SOPs.
    • Describe how the clinical laboratory will receive samples from outside the country, if applicable.
    • Describe the QC processes for the clinical laboratory.
    • Describe how the clinical laboratory will optimize efficiencies to support proposed clinical research collaborations by resource sharing, centralizing activities, implementing cost-containment measures, or other innovative approaches.

    Subsection E: Pharmacy

    • Describe the overall Pharmacy structure and how this structure will facilitate the research conducted at the VTEU.
    • Describe the plan for pharmacy operations and communications, and the overall pharmacy organizational plan, including lines of authority.
    • Provide a concise summary of the nature and categories of study products to be used in the VTEU research.   
    • Describe the specialized capabilities of the Pharmacy in terms of the research conducted by the VTEU.
    • Describe the plans to increase Pharmacy services to support a potential surge in pharmacy functions. 
    • Describe the process for developing, reviewing and implementing pharmacy SOPs.
    • Describe the capability of the pharmacy to conduct clinical research related to IND submissions. Include any certifications for laboratory facilities to support capability statements.  
    • Describe the plans for study product receipt, storage, preparation, identification and processing, labeling, dispensing, final disposition, record keeping and inventory, also include any plans for providing participant counseling for specific study products.
    • Describe the QC processes for the Pharmacy.
    • Describe how the Pharmacy will optimize efficiencies to support proposed clinical research collaborations by resource sharing, centralizing activities, implementing cost-containment measures, or other innovative approaches.

    Subsection F. Data Management 

    • Describe the data management organizational structure and staffing plan.
    • Describe the data recording processes and functions to be performed by the data management section. 
    • Provide the plans for data quality assurance, security, safety, and reliability.
    • Describe how the data management section will communicate with the VTEU elements for the purpose of receiving the data for recording and transfer in the appropriate format.
    • Describe the methods to restrict access to the data, and the process to review and authorize access based on need.

    Subsection G. Quality Management 

    • Describe the overall approach to quality management for all parts of the VTEU.

    Explain the plans for staffing for quality management and demonstrate how duties and responsibilities will be assigned and executed.

    • Provide the plans for day-to-day quality checks as well as retrospective, objective, systematic, and periodic reviews of clinical trial-related activities to ensure compliance with protocols, GCP, and NIAID requirements. 
    • Include the process, metrics, frequency of evaluation and documentation of findings, and how modifications to quality management will be determined and implemented.

    Subsection H. (Optional) Research Laboratory

    • Describe the overall research laboratory structure and staffing plan, and how the laboratory structure will facilitate the research. Identify which clinical site(s) the laboratory facilities will support.
    • Describe the plan for laboratory operations and communications, and the overall laboratory structure and organization including lines of authority; include a diagram showing the roles and relationships of each laboratory with the VTEU.
    • Describe the overall function of the research laboratory and provide a concise summary of the nature and types of clinical data and specimens to be analyzed. 
    • Describe the specialized capabilities of the research laboratory in terms of the proposed areas of research within the LG and those areas of science specialty of the VTEU, including routine assays such as immunogenicity, pharmacokinetics and biomarker development and validation, for example, and discuss possible related assays that may be used to differentiate or expand on the ones listed. Describe the capability of the research laboratory to conduct research related to IND submissions. Include any certifications for laboratory facilities to support capability statements.
    • Describe the plans for research sample receipt, storage, preparation, processing, analysis and disposition.
    • Describe the research laboratory testing facilities and features that will support a potential surge in laboratory functions. 
    • Describe the process for developing, reviewing and implementing laboratory SOPs.
    • Describe how the research laboratory will receive samples from outside the country, if applicable.
    • Describe the QC processes for the research laboratory.
    • Describe how the research laboratory will optimize efficiencies to support proposed clinical research collaborations by resource sharing, centralizing activities, implementing cost-containment measures, or other innovative approaches.

    Letters of Support: Provide a letter signed by the appropriate institutional official(s) from the applicant institution documenting specifics of institutional commitment for the duration of the award. Provide letters of support from clinicians or collaborators whose support is necessary for the successful conduct of the scope of research, including letters from proposed sites where participants will be recruited, if not part of key personnel. Provide letters of support from collaborating laboratories and pharmacies. Applicants must include letters of support from any proposed consultants or contractors.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.  

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Although applicants must be prepared for clinical trials, definite plans for such involvement will not be possible at time of application.  A Study Record should not be completed

    Delayed Onset Study

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

    Note: Applicants must enter at least one delayed onset study record and check the box "Anticipated Clinical Trial?".   

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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.

    • Awards issued under this FOA will be incrementally funded awards for project periods of up to seven years.  Multi-year funded grants will not be awarded. 
    • Grants awarded under this FOA will be excluded from automatic carryover – all carryover requests must be approved. 
    • Grants awarded under this FOA will not be provided the authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date shown in the Notice of Award – all extensions, including the first extension, will require approval.
    • Progress and financial reporting will be required and reviewed annually.
    • All funds must be expended within the approved project period.
    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    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.   

    Overall Impact

    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).

    Scored Review Criteria

    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?

    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?

    Specific to this FOA: Will the proposed VTEU provide adequate structure and function to engage in the priority scientific areas proposed by the IDCRC for the duration of the award? Are the plans for future surge capacity sufficient to ensure smooth and orderly transition of priorities, such as funding, staffing resources, and site selections?    

    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? 

    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?

    Specific to this FOA: Are the proposed investigators established in their respective areas of research and/or administration, and will their collective experience as a team ensure appropriate oversight and execution of the research?

    Do the PD(s)/PI(s) have research experience in designing, implementing, conducting, analyzing, and completing clinical research to evaluate diagnostics, therapeutics, devices, and vaccines for the diagnosis, treatment, and prevention of infectious diseases?   

    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? 

    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?

    Specific to this FOA: Are the proposed approaches for the efficient utilization and sharing of resources, and/or other cost-containment measures appropriate and feasible to support the proposed VTEU configuration?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?  Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

    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) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?? 

    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?

    Specific to this FOA:

    • Administration:
    • Is the organizational structure of the administrative section designed to provide support and synergy for the implementation of the clinical research protocols? Is there sufficient integration of the necessary functions across the VTEU to support the completion of complex clinical trials?
    • Are the proposed project plans adequate for tracking project activities and monitoring progress, timelines and budgets, including project plan controls to keep multiple project tasks on time and on budget?
    • Are the plans for communications within the VTEU adequate?
    • Is the plan for coordination among VTEUs and the LG adequate to maintain continuity of research from concept development through clinical research completion?
    • Is the financial management plan, including the proposed staffing plan adequate, with respect to the size and scope of the VTEU?  Are appropriate fiscal management plans and processes proposed to establish consortia agreements, to allocate resources/protocol funds in a transparent manner, and to provide financial reports to NIAID and the LG?
    • Is the protocol implementation plan appropriate for the scope of proposed research and for conducting research that will be included in IND submissions?
    • Are there plans to incorporate junior investigators in clinical research and does the plan cover a range of opportunities?
    • Specific to the Clinical Sites:
    • Is the organizational structure and staffing plan appropriate for the clinical sites?
    • Is at least one clinical site proposed, and is the overall description of the clinical site functions and access to special populations adequate to support the proposed research areas?
    • Are the sites able to recruit a range of research participants required for the proposed clinical research, including healthy volunteers?
    • Are there adequate plans for surge capacity, and how well do the overall recruitment and retention plans facilitate this activity?
    • Are the plans for collecting data and specimens from the participants well-articulated and appropriate for the type of clinical research performed?  Are the plans for labeling, storing, tracking, and transfer of these data to the respective entity (e.g. laboratory, Data Management section, LG SSU or NIAID SDCC) well-planned and collection appropriate for the protocols?
    • Are there appropriate plans to perform safety oversight procedures, including activities required prior to study initiation, study initiation, regulatory compliance (including IRB compliance and other regulatory compliance), FDA interactions, protocol amendments, protocol oversight, clinical site monitoring, safety reporting, data management and quality control, and audits?
    • Specific to the Clinical Laboratory:
    • Is the organizational structure and staffing plan appropriate for the clinical laboratory?
    • Are the plans for receipt, storage, preparation, and local analyses of the specimens appropriate for the planned research outcomes?
    • Are the plans to collect specimens appropriate for IND submissions?
    • Are the plans to transfer the results of the analyses adequate and appropriate?
    • Are the QC plans appropriate for the type of data collected?
    • Are the plans to address surge capacity sufficient to demonstrate capability?
    • Specific to the Pharmacy:
    • Is the organizational structure and staffing plan appropriate for the Pharmacy?
    • Are the plans for receipt, storage, preparation, and disposal of the study products appropriate for the planned research?
    • Are the plans to use the study product compliant with procedures necessary for IND submissions?
    • Are the plans to inventory and verify study product adequate and appropriate?
    • Are the QC plans appropriate for the type of study product utilized?
    • Are the plans to address surge capacity sufficient to demonstrate capability?
    • Specific to the VTEU Data Management:
    • Is the organizational structure and staffing plan appropriate for the data management section?
    • Are the plans and procedures associated with the data quality assurance, security, safety, reliability and receipt from the various VTEU elements appropriate?
    • Specific to the Quality Management:
    • Are the quality management plans appropriate for the planned research scope?
    • Are the proposed evaluation processes and metrics sufficient for quality management plan implementation and evaluation?
    • Specific to the Research Laboratory (Optional):
    • Is the organizational structure and staffing plan appropriate for the research laboratory?
    • Are the plans for receipt, storage, preparation, and analyses of the specimens appropriate for the planned research?
    • Are the plans to process and analyze specimens appropriate for IND submissions?
    • Does the laboratory have the capability to perform routine assays, such as, immunogenicity, pharmacokinetics and biomarker development and validation? Are the plans to transfer the results of the analyses adequate and appropriate?
    • Are the QC plans appropriate for the type of analyses performed?
    • Are the plans to address surge capacity sufficient to demonstrate capability?
    Environment

    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? 

    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?

    Specific to this FOA: Do the proposed facilities support the nature and type of clinical research to be conducted by the VTEU?  Are the plans for physical security and storage within clinical and research (optional) laboratories and the data management recording and transfer functions adequate to ensure confidentiality of data?  Are there adequate, available, and appropriate facilities to recruit, screen, enroll, follow, retain and provide the clinical care required for the proposed research areas?   

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Study Timeline  

    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)?   

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.

    For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable     

    Renewals

    Not Applicable     

    Revisions

    Not Applicable   

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.  

    Applications from Foreign Organizations

    Not Applicable  

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    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.
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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 grantee’s business official.

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

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

    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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/   

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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). 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    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 other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    • Overseeing all aspects of studies supported through this award, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of studies supported by this award as stated in these terms and conditions.
    • Facilitating collaboration and communication, to accomplish the objectives of the VTEU.
    • Adhering to NIAID policy for the conduct of clinical trials. Website: https://www.niaid.nih.gov/research/dmid-clinical-research-policies
    • Managing involvement of industry or any other third party in studies supported by this award.
    • Establishing policies and procedures for decision-making to adapt to evolving research priorities over time and to address emerging public health needs.
    • Establishing and providing by-laws, policies and standard operating procedures to NIAID Program Staff within 90 days of issuance of an award, to include, at a minimum, the following:
    • Assure compliance with NIAID Clinical Research Policies and Standard Operating Procedures and to ensure adequate protection of the rights and safety of subjects involved in the research.
    • Detailed lines of authority and communication plans within elements of the VTEU, among all VTEUs, with the LG, units within the LG with NIAID program staff and other key groups including NIAID-supported clinical research support service contracts, including how the VTEU will coordinate and collaborate with the LG to ensure performance monitoring and evaluation of site, how improvements in performance will be achieved and close-out procedures for poorly performing VTEU elements.
    • Detailed communication plans for how the VTEU will collaborate with the LG SSU and NIAID SDCC to determine procedures for data entry and transfer, as appropriate, to maintain data integrity appropriate for IND status, communications plan and data transfer schedule of activities associated with the various data types shared between the VTEU and the LG SSU, and the NIAID SDCC, as appropriate.
    • Identifying, qualifying, and approving protocol-specific sites to address specific VTEU needs after award.
    • Clinical Quality Management Plan, developed in accordance with DMID CQMP policy and to be approved by DMID, including a detailed description of lines of authority and risk mitigation plans.
    • Determine the distribution of funds, monitor expenditures, communicate with the clinical research sites, and provide budgets and financial information to the LG as needed.
    • Coordinate and collaborate with NIAID and NIAID clinical research support programs to facilitate collection of site essential regulatory documents, activation of study sites, clinical site monitoring and quality assurance services, pharmacovigilance (SAE reporting) and safety oversight, in adherence with NIAID standards and processes.
    • Providing a protocol to NIAID Program Staff for each clinical research study prior to study start.
    • Ensuring the following are provided to NIAID Program Staff for each clinical trial:
    • Project Management and communication plans.
    • Composition of the study team, including roles and responsibilities.
    • Timelines and budgets.
    • Recruitment and Retention plan.
    • Working closely with NIAID Program Staff to ensure the research foci are consistent with NIAID’s infectious diseases clinical research priorities.
    • Awardees 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:

    The NIAID Project Scientist will coordinate the activities listed below. NIAID staff assistance will be provided by an NIAID Program Officer, Clinical Project Manager(s), and Medical Officer(s). These staff will be identified at the time of award.

    • Provide specific guidance on expectations for clinical research.
    • Ensure that VTEU research efforts are consistent with NIAID priorities for VTEU clinical research and complement other NIH and NIAID programs.
    • Facilitate coordination among the NIAID- and NIH-supported clinical trials networks and research groups, clinical research support programs, and other U.S. Government agencies, promoting collaborations and facilitating information exchange.
    • Review and accept processes for identifying, qualifying, and approving protocol-specific sites to address specific VTEU needs after award.
    • Serve as members of study teams.
    • Track protocol development, implementation, and study conduct.
    • Serve on protocol development teams.
    • Participate in meetings, training activities, and conference calls.
    • Serve as resources for scientific and policy information.
    • Share information regarding promising new agents, strategies, and developments when appropriate.
    • Identify scientific gaps and organize meetings to facilitate exchange of scientific and regulatory information, including during VTEU meetings.
    • Periodically conduct an independent review of the constituent parts of the VTEU for reliability and compliance with clinical and regulatory requirements.
    • Coordinate contract resources that facilitate the provision of support services for clinical research.
    • Participate on LG Expert Working Groups as a voting member.
    • Participate in the presentation of research results, including publications.
    • Implement, monitor, and update the clinical research agenda for the VTEU to ensure consistency and relevance with NIAID’s infectious diseases research scientific priorities.
    • Develop and implement an evaluation and remediation plan to address performance metrics for the VTEU program elements.
    • Under urgent public health situations, the NIAID may re-direct funds or provide additional funds to individual awards to support research of direct relevance to the emergency.
    • Clinical Trials Agreements. For trials requiring IND/IDE, NIAID will lead the negotiation of Clinical Trials Agreements (CTAs) with pharmaceutical companies (or other providers of investigational agents). NIAID will provide copies of signed CTAs to the VTEU.
    • Trial Sponsorship. NIAID will have the option to independently file an IND on investigational agents or an IDE on investigational devices evaluated in NIAID-supported clinical research.  Responsibility for Investigational New Drug (IND) sponsorship will be determined on a case-by-case basis and may rest with either the PD(s)/PI(s) or with the NIAID -- the NIAID will make this determination. NIAID will advise the investigators on the specific regulatory requirements for IND/IDE sponsorship.  In situations where NIAID is the IND sponsor, NIAID through its contractors will also assemble, review, and submit the required regulatory documents to the FDA.  When holding an IND or IDE, NIAID has responsibility for the data management and reporting of safety information in accordance with FDA requirements and preferences.  To provide for consistent reporting of serious adverse events across the NIAID-supported clinical trial networks, NIAID will provide current policies and procedures that govern the reporting of adverse events in NIAID-supported trials.
    • Pharmaceutical Support.  For studies in which NIAID is the IND or IDE sponsor, NIAID staff and/or contractors will provide consultation on study treatment-related issues, including manufacturing, preparation, administration and availability of active dosage forms and placebo. NIAID staff and/or contractors may also interact with pharmaceutical company collaborators to facilitate adequate and timely supply of study product; and oversee the distribution of study product to the VTEU pharmacies and/or clinical sites.
    • Trial Monitoring. NIAID will oversee an external clinical site monitoring contract that evaluates GCP, regulatory compliance, protocol implementation, internal quality assurance, and study product accountability at the clinical sites for clinical trials conducted under IND/IDE.  The monitoring contractor, with or without accompanying NIAID staff, will visit the clinical sites periodically to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.
    • Laboratory Oversight. NIAID staff and NIAID contract resources will provide oversight and monitoring of clinical sites for GCLP and for the quality of subject diagnosis and safety tests (e.g. hematology, chemistry, liver function), as well as the quality of pharmacological tests (e.g. drug levels, drug interactions), end point tests and blood processing. 
    • Concept and Protocol Approval. NIAID will review all concepts and protocols and must approve all clinical trial protocols before implementation.  The Clinical Project Manager or designee will return comments and recommendations on concepts and protocols to the VTEU after review.  The VTEU must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAID to the satisfaction of NIAID before participant enrollment can begin under a protocol.  If a protocol is disapproved, NIAID will not provide investigational products or permit expenditure of NIH funds for the proposed investigation.  If a protocol is not initiated within twelve months of NIAID approval, re-review and approval by NIAID will be required.
    • Safety Monitoring. NIAID will oversee an external contract that will develop appropriate safety monitoring plans for all planned clinical trials. NIAID must approve the plan for all trials involving investigational drugs, devices, or biologics.  The frequency and intensity of safety monitoring will be based on individual study characteristics and experience with study products and may require review by an Independent Safety Monitor, Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB).  NIAID Medical Monitors will be part of protocol safety review teams to monitor the safety and efficacy of the intervention(s) for ongoing studies and will be provided with appropriate reports.  Medical Monitors will be responsible for the disposition of Serious Adverse Events. Approval of the final monitoring plan, including the composition of the review committee, by NIAID is required prior to study initiation.  NIAID independently supports Data and Safety Monitoring Boards (DSMB) that oversee Phase IIb/III and other select clinical trials at the discretion of NIAID.
    • Study Termination.  NIAID reserves the right to terminate or curtail clinical research for any of the following reasons, but cause for termination is not limited to the items below:
    • Risk to subject safety.
    • The scientific question is no longer relevant, or the objectives will not be met (i.e. slow accrual).
    • Occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity.
    • Risks that cannot be adequately quantified.
    • Ethical concerns raised by the community or medical care/health care authorities.
    • Failure to remedy deficiencies identified through site monitoring.
    • Substandard data.
    • Reaching a major study endpoint substantially before schedule with persuasive statistical significance.
    • 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.

    Data Access. The awardees retain the rights to the data, consistent with current DHHS, PHS, NIH and NIAID policies; however, NIH will have access to all data generated (raw and analyzed) and may periodically review it.  This includes a review of data as recorded on the case report forms or in the central database, and external checking against the original source documentation as required by federal regulation and NIAID as the IND/IDE sponsor.  NIAID may request from the VTEU specific data analysis needed for programmatic activities or for issues related to NIAID plans with other partners.  The NIH may provide public access to selected data sets generated with the use of public funds within a reasonable time after primary analysis and publication. Awardees 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.

    Areas of Joint Responsibility include:

    • Reviewing the VTEU research activities and goals on an agreed upon schedule (but no less than once every year).
    • On an ongoing basis, the VTEU, LG and NIAID staff will jointly evaluate the progress of clinical trials, including enrollment milestones, site quality, and data quality. NIAID and NIAID-supported resource contractors may audit sites, LG SSU, and laboratories to assess GCP and data quality and integrity.
    • On an ongoing basis, assess the capacity and performance of the VTEU and the units of the VTEU. Protocol specific sites that fail to meet performance standards may be subject to withdrawal of funding.

    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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.      

    3. Reporting

    When multiple years are involved, awardees 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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application processes and NIH grant resources)
    Email: GrantsInfo@nih.gov (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: support@grants.gov

    Scientific/Research Contact(s)

    Seema Nayak, M.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301.761.7930
    Email: seema.nayak@nih.gov      

    Peer Review Contact(s)

    Maryam Feili-Hariri, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5026
    Email: haririmf@niaid.nih.gov

    Lian-Yong Gao, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5048
    Email: GAOL2@niaid.nih.gov  

    Financial/Grants Management Contact(s)

    Vandhana Khurana
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2966
    Email: khuranav@niaid.nih.gov

    Section VIII. Other Information

    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.

    Authority and Regulations

    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.

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