Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
Fogarty International Center (FIC)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional)
Activity Code
R21/R33 Phased Innovation Award
Announcement Type

New

Related Notices

NOT-OD-19-128 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NOT-OD-19-137 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Funding Opportunity Announcement (FOA) Number
PAR-19-376
Companion Funding Opportunity

None

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

93.399, 93.286, 93.865, 93.173, 93.242, 93.853, 93.313

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative mobile health (mHealth) interventions or tools specifically suited for low- and middle-income countries (LMICs) that utilize new or emerging technology, platforms, systems, or analytics. The overall goal of the program is to catalyze innovation through multidisciplinary research that addresses global health problems, develop an evidence base for the use of mHealth technology to improve clinical and public health outcomes, and strengthen mHealth research capacity in LMICs. Applicants are required to propose partnerships between at least one U.S. institution and one LMIC institution.

This FOA provides support for up to two years (R21 phase) for technology development and feasibility studies, followed by a possible transition to expanded research support (R33 phase) for validation, larger-scale feasibility, and effectiveness studies. Transition to the R33 depends on the completion of applicant-defined milestones, as well as program priorities and the availability of funds. All applicants must address both the R21 and R33 phases.

Key Dates

Posted Date

September 13, 2019

Open Date (Earliest Submission Date)
October 19, 2019
Letter of Intent Due Date(s)

October 19, 2019; August 24, 2020

Application Due Date(s)

November 19, 2019; September 24, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)
December 3, 2019; Dec 3, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review
February/March 2020; February/March 2021
Advisory Council Review
May 2020; May 2021
Earliest Start Date
July 2020; July 2021
Expiration Date
December 04, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Definition of mHealth

    In the context of this FOA, mHealth is defined as the use of mobile and wireless devices (cell phones, tablets, etc.) to improve health outcomes, health care services, and health research. The mHealth technology studied in proposed projects may include external hardware and/or software components for mobile or wireless devices. New or emerging technology, platforms, systems, or analytics should be incorporated.

    Background

    The enormous potential for mobile technology to transform health care, personal health management, and basic health research has led to the rapid development of new health-related phone applications, sensors, and devices. The potential of mHealth is especially relevant to LMICs, where cell phone ownership is rising rapidly, but access to health care and providers is often limited. While this promise of mHealth is leading to a large increase in interventions that use mobile technology, research on these interventions is often lacking.

    FIC created the first iteration of this program in 2013 (funded grants can be found on the FIC mHealth program website), based on the need for a larger mHealth evidence-base in LMICs, as cited, for example, in a 2011 report by the World Health Organization (WHO; mHealth: New Horizons for Health through Mobile Technologies, Global Observatory for eHealth Series – Volume 3). This need for further research regarding effectiveness has again been emphasized in the 2019 WHO Guideline:? Recommendations on Digital Interventions for Health System Strengthening. Additionally, advances in cell phone and tablet computing have increased the potential for artificial intelligence (AI) to improve healthcare delivery and health in LMICs. As a developing field, significant research is still needed to understand how AI can be best utilized and whether it can be effectively incorporated into health systems in the LMIC context, as discussed in the recent USAID report Artificial Intelligence in Global Health: Defining a Collective Path Forward.

    US-LMIC Partnerships

    All applications submitted to this FOA are required to involve partnerships between U.S. and LMIC researchers and should develop mHealth or mHealth-related research capacity in the research teams and/or at LMIC institutions. The individual and institutional research capabilities and international research networks that are developed should enable future mHealth research, beyond the time period of the grant. Additional partners may be included in applications as relevant, such as non-governmental organizations (NGOs), hospitals, for-profit organizations, and government entities.

    Research Objectives

    This FOA encourages research projects that study the development, feasibility, validation, and effectiveness of mHealth tools and/or interventions for the prevention, diagnosis, management, and treatment of specific health conditions or for disease agnostic/cross-cutting applications. Applicants are encouraged to propose research projects that have the potential to provide an understanding of principles underlying effective mHealth interventions or tools that are generalizable to the field. Research projects may include some mHealth technology development along with feasibility, acceptability, usability, validation, and effectiveness studies. User-centered and iterative design are highly encouraged during development stages. Applications should include as rigorous study designs as possible.

    The proposed research should be divided into the R21 and R33 phases as appropriate, with the milestone-driven R21 demonstrating initial feasibility of the mHealth intervention or tool followed by further validation, feasibility, and/or effectiveness studies in the R33 phase.

    This initiative aims to support projects that adapt or develop technologies that are appropriate for LMIC settings. A plethora of mHealth applications and devices have been developed in high-income countries, however, these technologies are not necessarily suitable for the needs in LMICs. Research that focuses on the problems and constraints in LMIC environments should produce more effective interventions and tools and may result in more sustainable mHealth use, especially if there is involvement from LMIC stakeholders, such as businesses, hospitals, or governments.

    Important Points for Consideration:

    • If the mHealth intervention or tool aims to produce a specific clinical outcome, applicants should incorporate appropriate biological variables (such as sex) and endpoints and/or observational behavioral data to measure this outcome.
    • Interventions that aim to produce behavior change should be based on existing social and behavioral science theories.
    • The interventions or tools studied should take advantage of the unique functionality of mobile and wireless devices. Utilization of real-time data collection and feedback is encouraged where appropriate.
    • New software, devices, and systems should be interoperable with existing infrastructure and resulting data should integrate with relevant health information systems where applicable.
    • The reliability, safety, simplicity, affordability, durability, and power requirements of new technology being studied should be considered in the LMIC context where it will be used. Devices, interventions, and tools should be developed with a deep understanding of the LMIC context and populations, including their differential effects on women and men or on particular groups of women and men (such as pregnant women or sexual and gender minorities). Additionally, appropriate privacy and security considerations should be made.

    Transition from R21 to R33 phase

    Each administrating NIH Institute or Center (IC) may follow IC-specific procedures and timelines. Generally, after administrative review of an R33 transition package by NIH staff, R21 projects will be prioritized and may be approved for transition to R33 funding. Grants receiving a positive R33 funding decision will be transitioned to an R33 award without the need to submit a new competing application. Criteria used to determine which R21 projects will be continued into the R33 phase include the following:

    • Successful completion of transition milestones (original or modified with prior approval) for the R21 period of the project;
    • Potential of the plan for successful conduct of the R33 phase, including established partnerships;
    • Original R21/R33 peer review recommendations;
    • Availability of funds;
    • NIH IC program priorities.

    For grants funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): No less than two months before the completion of the R21 phase, awardees may submit the R33 transition package, which includes the R21 progress report describing in detail the progress towards the R21 milestones, and a description of how research proposed for the R33 phase will be supported by the completion of the R21 phase milestones. These materials will be evaluated by NIH Program staff, per the above criteria. It is anticipated that not all R21 awardees will be transitioned into the R33 phase. Applicants must be aware that use of a no-cost extension at the end of the R21 period could jeopardize the award of the R33.

    Specific Research Interests of the Participating Institutes and Centers

    The Fogarty International Center (FIC) is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. Therefore, FIC is interested in a diversity of global health research topics that address the priority health needs of LMICs and fit the above research objectives. This initiative supports FIC's strategic plan by stimulating innovation in the development and implementation of technologies to address global health problems and by building capacity through individuals, institutions and networks to meet future and evolving global health challenges.

    Applicants proposing projects related to HIV/AIDS should ensure that the research aligns with NIH HIV/AIDS high priority research topics by reviewing the NIH HIV/AIDS Research Priorities and Trans-NIH Plan for HIV-Related Research before submitting an application.

    The National Cancer Institute (NCI) recognizes the potential for mobile communication technologies to: (a) contribute to prevention of avoidable cancers by promoting healthy life styles and behaviors; (b) support early detection, when the opportunities for curing or controlling the cancer are optimal; (c) facilitate accurate diagnosis and effective treatment planning; (d) support reliable communications between all members of the care team, including the patient, during treatment; and (e) offer an unbroken system of support during survivorship and at end-of-life. Specific examples of relevant research objectives include, but are not limited to, the following:

    • Development and evaluation of mobile applications to promote smoking cessation, regular physical activity, and healthy diet
    • Extending mHealth platforms to include point of care technologies
    • Integrating personal surveillance data from mobile and wireless devices into e-Health records
    • mHealth adaptations including games to improve patient education, primary and secondary prevention of cancer, stigma, and treatment adherence
    • Improving clinical trial recruitment and addressing issues related to patient abandonment through mobile communication strategies
    • Utilizing the digital photography and geo-positioning capabilities of mobile technologies to aid in the early detection of cancers especially in underserved or remote areas
    • Developing capacity-building projects internationally that will offer synchronous and asynchronous management, and monitoring, of treatment plans in low resource environments
    • Creating a communication safety net for cancer survivors that will support them after treatment, while adhering to the evolving guidance of a proactive survivorship care plan
    • Developing support tools for hospice workers, home care specialists, caregivers, and patients to improve palliation and end-of-life decision making

    The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. NIBIB is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas that are appropriate for this funding opportunity can be found at https://www.nibib.nih.gov/research-funding.

    Topics of particular interest to NIBIB include:

    • Developing and testing integrated, portable imaging technologies for monitoring health and as part of point-of-care diagnosis and treatment
    • Developing and testing tools to enhance the visualization and psychophysical understanding of complicated health information on mobile devices with the local cultural context
    • Developing and testing decision support systems to provide guidance and a framework for shared decision-making with medical professionals based on best available evidence
    • Developing and testing networked, citizen-driven approaches to engaging and retaining people in improving their health
    • Developing technology that incorporates telemetry and remote access in the acquisition, analysis and monitoring of biomedical data
    • Developing software and hardware tools for telehealth studies that have broad applications

    For this Funding Opportunity Announcement, for those applications proposing research involving clinical trials, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

    The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking innovative approaches to achieving its mission. NICHD’s mission is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives. The institute also aims to ensure the health, productivity, independence, and well-being of people through optimal rehabilitation. The following research topics list the Institute's priorities for mHealth research in LMICs:

    • Use of mHealth technology for networking support systems that integrate family-focused primary healthcare and preventive services (e.g., prenatal care, infant and childhood nutrition, immunizations, maternal health)
    • Use of mHealth interventions to optimize fertility management
    • The use of the mHealth model to improve maternal and infant health outcomes focused on the major mortality and morbidity factors occurring in and around the time of delivery and during the first 24 hours postpartum in international settings.
    • Use of mHealth technologies to improve screening, assessment, prevention, treatment or management of HIV (and other infectious diseases) and associated complications in infant, children, adolescents and pregnant women.
    • Use of mHealth technologies to enhance screening for children with developmental disorders and develop community-based treatment paradigms
    • Use of mHealth technology to enhance prevention and treatment of injury and illness in children and families
    • Use of technology to respond to the needs of children exposed to and affected by such traumatic events as man-made or natural disasters, or war
    • Use of mHealth to support physical rehabilitation, health management, and community participation for people with disabilities (PWD), in settings with limited resources and clinical support. This may include remote support of therapeutic exercise, assistive devices, periodic feedback on key clinical outcome measures, monitoring of progress, and interactive communication between therapists and PWD.

    The National Institute on Deafness and Other Communication Disorders (NIDCD) conducts and supports research in 7 scientific program areas: hearing, balance/vestibular, voice, speech, language, taste and smell. The mission of the NIDCD is to reduce the burden of communicative disorders and improve public health. NIDCD is especially interested in applications focused on newborn screening of hearing ability and early identification and treatment of voice, speech, and language delay or disorders. Mobile Health applications in augmentative and alternative communication for non-speaking individuals, and applications that promote improved access to and/or affordability of hearing healthcare are also of interest to NIDCD. Applications from institutions within a geographic region which shares the same spoken language e.g. Spanish in Latin America, Arabic in the Middle East and North Africa could offer special opportunities for regional collaboration and better health outcomes. Prospective applicants are encouraged to review the NIDCD Strategic Plan for 2017-2023 https://www.nidcd.nih.gov/about/strategic-plan/2017-2021

    The National Institute of Mental Health (NIMH) is interested in supporting research on the development and/or innovative application of cost-effective, sustainable, and scalable mHealth technologies to improve the accessibility, delivery, quality or effectiveness of mental health care in LMICs. Applicants are encouraged to review Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research, a report that summarizes the state of the science, research priorities, and potential research pathways. NIMH encourages applications that test generalizable principles or approaches in the use of technology and encourages research attention to known challenges with the uptake and sustained use of technology-based approaches and to privacy and other safety or ethical considerations associated with use of technology for research and clinical purposes. Of lower priority for NIMH funding are applications that propose the transfer of face-to-face interventions onto mHealth technologies or the replication of proven/existing technologies with additional mental disorders or target populations.

    Research topics considered relevant to NIMH priorities under this FOA include, but are not limited to, mHealth technologies to:

    • Improve screening, assessment, treatment, or management of co-morbid mental illness and chronic disease
    • Improve patient uptake of and adherence to treatments for comorbid chronic disease management, including management of mental illness
    • Support the roles of community health workers and other adjunct caregivers in the delivery of mental health care in order to improve outcomes
    • Deliver mental health care to populations with low literacy and low numeracy rates
    • Harness social media to facilitate and improve self-care, peer support, or follow-up care related to mental health
    • Promote and monitor skill acquisition in order to enhance or sustain therapeutic benefit
    • Support providers or health care systems in monitoring and improving the quality of mental health care (e.g., clinical decision support, quality control systems)
    • Enhance data capture, real-time assessment, and prediction in at-risk and psychiatric populations (including but not limited to those with suicidal thoughts and behavior)
    • Characterize social behavior to quantify social network dynamics and social isolation for risk prediction and treatment response
    • Deliver and evaluate combined, multi-level approaches to improve outcomes at multiple levels including individual, family/caregivers, peers, providers and facilities
    • Collect and analyze paradata (auxiliary data that capture details about the process of interaction with the mobile health intervention) to determine which if any components of the intervention lead to behavior change
    • Measure engagement in the mHealth technology and implement strategies to increase engagement if needed
    • Rapidly assess psychiatric needs at a population level, such as smart sensors (camera, microphones, chemical sensors, etc.) in cities, schools, sewage systems to detect neighborhood-level consumption of psychiatric drugs; to detect violence, bullying, depression, etc.; to identify geographic areas with greater psychiatric need; or to deploy mental health interventions in spatio-temporally precise manner
    • Extend passive or active recording and monitoring of human-machine interactions to explore unobservable aspects of the individual psychiatric manifold for dense deep-phenotyping, e.g., closed-loop systems that account for the history of the human-machine interaction to inform the next steps. The goal of such an artificial intelligence (AI) could be to improve accuracy and speed of diagnosis (or generate new dimensional diagnostic categories) but also predict treatment assignment, treatment response or progress along a treatment trajectory.
    • Use reinforcement learning algorithms that gamify changes in cognition, mood, and personality through passive measures or ecological momentary assessment, providing direct bio-feedback to the patient and remotely to the doctor
    • Use machine learning algorithms to synthesize new data based on previous experience (training set). To have synthetic versions of the data describing how one bio-behavioral type is different from another and without the need of sharing prototypical individual data sets to preserve individual privacy.
    • Use machine learning algorithms optimized to effectively account for complex temporal dynamics in datasets
    • Determine coverage rates of smart phones as well as individuals’ willingness to use their device for assessing their mental health status

    NIMH encourages applicants to use existing hardware/software and data from existing commercial and open source digital health applications and online platforms, where appropriate. Researchers are also encouraged to consider collaborations with engineers, data scientists, health system experts, technology designers as well as end users (consumers, clinicians administrators). AI models should have a life-long learning framework, to prevent ‘catastrophic forgetting’ when deployed in new populations, and to keep on learning when they deal with new data beyond the training session.

    The National Institute of Neurological Disorders and Stroke (NINDS) encourages innovative applications with the goal of identifying mobile health tools, technologies or intervention strategies that aid in the prevention, diagnosis or treatment of neurological disorders and stroke, and that are a priority health concern to LMICs. Meritorious applications will involve synergistic partnerships that propose affordable and scalable approaches, with attention to extending and strengthening the technological capacity for neurological care and considerations for long-term sustainability. Research areas of interest include, but are not limited to, technologies for:

    • Strengthening remote patient care and monitoring for chronic neurological conditions in rural and/or urban settings
    • Improving training for patients, clinicians, and allied health workers through the use of mHealth technologies
    • Further refinement of point of care diagnostics and screening tools for early and accurate disease detection
    • Enabling greater access to more timely and continuous neurological care
    • Improving the remote transmission and clinical utility of imaging technologies to rural hospitals and clinics
    • Implementing or strengthening mHealth data collection, standardization or reporting for patients and research participants

    High priority disease areas include stroke and other cerebrovascular diseases, epilepsy, migraine, nervous system infections, Parkinson's disease and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS (NINDS Disorder Index http://www.ninds.nih.gov/disorders/disorder_index.htm). Projects that build upon previously funded NINDS activities in the Medical Education Partnership Initiative (MEPI), Human Heredity and Health in Africa (H3Africa), and the Global Brain Disorders program are also encouraged.

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

    Section II. Award Information

    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed
    New
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?
    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Award Budget

    The R21 phase may not exceed $125,000 in direct costs in any single year of the R21 phase. The R33 phase may not exceed $200,000 in direct costs in any single year of the R33 phase.

    Award Project Period

    The project period is limited to 2 years for the R21 phase and up to 3 years for the R33 phase. The total project period may not exceed 5 years.

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

    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)
    • U.S. Territory or Possession
    Other
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)

    Non-domestic applicant organizations are restricted to higher education institutions and other non-profit organizations in LMICs, which are defined by The World Bank as low-, lower-middle-, or upper-middle-income economies - http://data.worldbank.org/about/country-classifications/country-and-lending-groups. At least one institution in the U.S. and at least one institution in a LMIC must be involved as partners in the grant application.

    Foreign Institutions
    • Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply
    • Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply
    • Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
    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) – 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.
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active 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.

    Individuals from U.S. and LMIC institutions are eligible PDs/PIs. The main collaborating individual(s) from the proposed U.S. and LMIC institutions must serve as PDs/PIs or other key personnel. Individuals from non-U.S. high income country institutions are not eligible as PDs/PIs, but may participate as partners or collaborators in proposed programs.

    2. Cost Sharing

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

    3. Additional Information on Eligibility

     

    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

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in 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.

     

    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:

    Laura Povlich, PhD

    Telephone: 301-827-2227

    Email:laura.povlich@nih.gov

    Page Limitations
    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
    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.

    Applicants should include all institutions where research will occur as performance sites, including relevant U.S. and foreign institutions.

    SF424(R&R) Other Project Information
    All instructions in the SF424 (R&R) Application Guide must be followed.
    SF424(R&R) Senior/Key Person Profile
    All instructions in the SF424 (R&R) Application Guide must be followed.

    All applications must have at least one LMIC researcher and at least one U.S. researcher as key personnel. Since the mHealth field is multidisciplinary and cross-sector in nature, applicants should consider appropriate collaborations with researchers from diverse disciplines such as behavioral science, engineering, computer science, business, medicine, public health, and/or other relevant fields. In addition, applicants should consider partnering with individuals in public or private organizations, including health system entities, which could enable future research or implementation efforts within the relevant LMIC.

     

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

    Applicants should budget funds for travel to the annual 2-day program network meeting in the Bethesda, MD. PDs/PIs are expected to attend the network meetings and may also budget for other key personnel to attend.

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

    Where feasible, applicants are encouraged to budget funding to their partner institution through the formation of a subaward.

    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: Applicants must provide a single attachment of Specific Aims that includes separate aims for the R21 and R33 phases

    Research Strategy:

    In preparing the R21/R33 application, investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the milestones are critical. Applications should include the subsections described below.

    1) Significance - in addition to the SF424 (R&R) Application Guide, include the following:

    • Justify the relevance of the proposed research to the health of the LMIC research population(s).
    • Justify the suitability of the proposed technology usage in LMICs. Part of this justification should include a description of the existing mobile infrastructure at the LMIC research location(s).
    • If relevant, describe how the proposed mHealth research addresses high priority HIV research interests of NIH and is relevant to the needs of the LMIC.

    2) Innovation - in addition to the SF424 (R&R) Application Guide, include the following:

    • Explain how the proposed mHealth intervention or tool utilizes innovative technology, platforms, systems, or analytics that are new or emerging and describe any advantages over existing technology, platforms, systems or analytics used to address the same or similar problems. Consideration should be made regarding how the intervention or tool addresses the health problem in the LMIC context and whether the proposed research offers potential advantages related to effectiveness, affordability, usability, accessibility, or sustainability within this context.

    3) Approach - divided into two parts corresponding to the R21 and R33 phases. In addition to instructions in the SF424 (R&R) Application Guide, include the following:

    • For the R21 phase, transition milestones and a timeline are required and should be described at the end of the approach section. The milestone subsection should include a discussion of the suitability of the proposed milestones for assessing success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Transition milestones should be well-defined, specific, quantifiable and scientifically justified; they should not be simply a restatement of the R21 specific aims.  
    • For the R33 phase, include a timeline at the end of the approach section. Also, describe strategies that may enhance the likelihood for the mHealth intervention or tool to be implemented, sustained, and/or scaled, if the results of the proposed research are positive.
    • Any available preliminary data that will support or justify the proposed research may be included. However, preliminary data are not required for an R21/R33 application.

    4) Collaboration Management and Research Capacity Strengthening, include the following:

    • Delineate the roles of each key personnel and provide plans for the coordination of research activities. US and LMIC key personnel should contribute intellectually to the development of the research proposal and planned research activities for the R21 and R33 phases.
    • If working with non-academic organizations (such as hospitals, government entities, for-profit organizations, Non-Governmental Organizations (NGOs), community organizations, etc.) describe how collaborations have been or will be established and coordinated.
    • Highlight factors in the investigators' background and/or institutional circumstances that will facilitate successful collaboration across partner institutions.
    • Describe how the proposed research will integrate strategies for research capacity strengthening in the research team and/or LMIC institutions for both the R21 and R33 phases. The individual and institutional research capabilities and international research partnerships that are developed should enable future mHealth research, beyond the time period of the grant. Specific strategies that are proposed should be tailored to the research project and team and may include capacity building around technology development/integration/validation, data science and analytics, intellectual property, implementation science related to mHealth, or other scientific areas relevant to the proposed mHealth research.

    Letters of Support: All collaborating institutions and key personnel should provide letters of support for the proposed research program.

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

    The following modifications also apply:

    • 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.

    with the following modifications:

    • Applicants must include relevant screenshots or diagrams in the Appendix that convey the function of their mHealth tool or intervention.
    PHS Human Subjects and Clinical Trials Information
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Section 3 - Protection and Monitoring Plans

    3.1 Protection of Human Subjects

    If electronic data is being collected or transmitted, include strategies to minimize risks related to privacy and security.??  

    Delayed Onset Study

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

    PHS Assignment Request Form
    All instructions in the SF424 (R&R) Application Guide must be followed.  

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

    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.

    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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant 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.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    For this particular announcement, note the following:

    The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

    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.

     

    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?

    Does the project address an important health problem in the LMIC(s) involved? Is the mHealth technology appropriate for the LMIC location(s) and population(s) ?

    In addition, for applications involving clinical trials

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

     

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

    Do US and LMIC investigators appropriately contribute to the proposed research activities? Based on the investigators' backgrounds, institutional circumstances, and proposed collaboration management, is there potential for successful collaborations within the research team and with any other proposed partners?

    In addition, for applications involving clinical trials

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

     

    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 proposed mHealth intervention or tool utilize technology, platforms, systems, or analytics that are new or emerging that have an advantage over more conventional technology, platforms, systems or tools that are used to address the same or similar problems? Does the project incorporate innovative strategies for strengthening mHealth/mHealth-related research capabilities at the LMIC institution?

    In addition, for applications involving clinical trials

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

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    Does the application present appropriate strategies to strengthen mHealth/mHealth-related research capacity in the research team or LMIC institution(s)?

    In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable:

    Study Design

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

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

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

    Data Management and Statistical Analysis

    Are planned analyses and 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? If electronic data is being collected or transmitted, are appropriate strategies included to minimize risks related to privacy and security?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

     

    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?

    Based on the available resources and potential for research capacity building, is there a high probability that the research team will be able to continue conducting mHealth research after the grant period? Is there reasonable potential for the mHealth intervention or tool to be implemented, sustained, and/or scaled by way of government support and/or other avenues in the LMIC where the research is being conducted?

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    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.

    Milestones

    Given the critical nature of the milestones for the potential R21 to R33 transition, are the proposed transition milestones well-defined with quantifiable measures that are appropriate for assessing the success of the R21 phase of the application? Do the milestones have specific quantifiable criteria that will enable clear decisions about their attainment? Is it clear how the R33 phase of the study will develop and expand once the R21 milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the transition and will the overall project advance the intervention or tool?

    Study Timeline

    Specific to applications involving clinical trials

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

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

     

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

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

     

    When the proposed 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.

     

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

     

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

     

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

     

    Not Applicable

     

    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.

     

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

     

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

     

    Reviewers will comment on whether the 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).

     

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

     

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications.

    Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Appropriateness of the proposed milestones (which may be negotiated with NIH program staff)
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Relevance of proposed project to priorities of co-funding components.
    • Geographic balance of programs.

    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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

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

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

    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.

    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.

    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 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.

    Cooperative Agreement Terms and Conditions of Award
    Not Applicable

    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 submission by the due date, and post-submission issues)

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: 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)

    Laura Povlich, Ph.D
    Fogarty International Center (FIC)
    Telephone: 301-827-2227
    Email:laura.povlich@nih.gov

    Vidya Vedham, Ph.D
    National Cancer Institute (NCI)
    Telephone: 240-276-7272
    Email: vidya.vedham@nih.gov

    Tiffany Lash, Ph.D
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Phone: 301-451-4778
    E-mail: baileyti@mail.nih.gov

    Sujata Bardhan
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NI?CHD)
    Phone: 301-435-0471
    E-mail: sujata.bardhan@nih.gov

    Lana Shekim Ph.D
    National Institute on Deafness and Communication Disorders (NIDCD)
    Phone: 301-496-5061
    E-mail: shekiml@nidcd.nih.gov

    Makeda Williams, Ph.D
    National Institute of Mental Health (NIMH)
    Phone: 301-435-4582
    E-mail: willimak@mail.nih.gov

    Richard T. Benson, MD, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Phone: 301-496-9135
    E-mail: Richard.benson@nih.gov

    Serrano, Katrina
    Office of Research on Women's Health (ORWH)
    Phone: 301-4986-8931
    Email: katrina.serrano@nih.gov

    Peer Review Contact(s)

    Gabriel Fosu, Ph.D
    Center for Scientific Review (CSR)
    Telephone: 301-435-3562
    Email: gabriel.fosu@nih.gov

    Financial/Grants Management Contact(s)

    Mollie Shea
    Fogarty International Center
    Telephone: 301-451-6830
    E-mail:mollie.shea@nih.gov

    Crystal L Wolfrey
    National Cancer Institute (NCI)
    Phone: 240-276-6277
    E-mail: wolfreyc@gab.nci.nih.gov

    Florence Turska
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone- 301-496-9314
    Email: turskaf@mail.nih.gov

    Bryan Clark
    National Institute of Child Health and Human Development (NICHD)
    Phone:301-435-6975
    Email: clarkb1@mail.nih.gov

    Myers, Christopher
    National Institute on Deafness and Communication Disorders (NIDCD)
    Phone: 301-435-0713
    E-mail: cm143g@nih.gov

    Kees, Tamara
    National Institute of Mental Health (NIMH)
    Phone: 301-443-8811
    E-mail: tkees@mail.nih.gov

    Tijuanna E. DeCoster, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Phone: 301-496-9231
    Email: decostert@mail.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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