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 Cancer Institute (NCI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-028

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.989, 93.395, 93.394, 93.393, 93.399, 93.286, 93.242, 93.865 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research applications that propose to study the development or adaptation of innovative mobile health (mHealth) technology specifically suited for low and middle income countries (LMICs) and the health-related outcomes associated with implementation of the technology. Of highest interest are well-designed multidisciplinary projects that focus on tools or interventions for chronic diseases or technology for disease agnostic/cross-cutting applications.

Applicants are required to propose partnerships between at least one U.S. institution and one LMIC institution. The overall goal of the FOA is to contribute to the evidence base for the use of mobile technology to improve clinical outcomes and public health while building research capacity in LMICs and establishing research networks in this area.        

Key Dates
Posted Date

December 11, 2013

Open Date (Earliest Submission Date)

January 19, 2014

Letter of Intent Due Date(s)

January 19, 2014; January 19, 2015

Application Due Date(s)

February 19, 2014; February 19, 2015, by 5:00 PM local time of applicant organization.

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

May/June, 2014; May/June 2015

Advisory Council Review

August 2014; August 2015

Earliest Start Date

September, 2014; September 2015

Expiration Date

February 20, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.


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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


Definition of mHealth

In the context of this FOA, mHealth is the use of mobile and wireless devices (cell phones, tablets, etc.) to improve health outcomes, health care services, and health research. The mHealth technology that is developed or adapted in proposed projects can include external hardware and/or software components for mobile or wireless devices.   

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 and device attachments. The potential for mHealth is especially relevant in LMICs, where cell phone ownership is rising rapidly, but access to traditional health care and providers is often limited. While this promise of mHealth has led to a large increase in interventions that use mobile phones, evaluation of health outcomes after implementation of these interventions is often lacking.

The need for a larger mHealth evidence-base in LMICs was presented in a 2011 report by the World Health Organization (mHealth: New Horizons for Health through Mobile Technologies, Global Observatory for eHealth Series – Volume 3; http://www.who.int/goe/publications/ehealth_series_vol3/en/).  The report shows that over 50% of low income and low-middle income countries surveyed identify a lack of knowledge of possible mHealth applications and their public health outcomes as a major barrier to mHealth implementation - demonstrating the need for evaluation studies and dissemination of study results. Other main barriers identified include health policies, competing priorities, high operating costs or a lack of data regarding cost effectiveness, and a lack of telecommunications infrastructure (specific to low income countries). While an mHealth research program will not be able to overcome all of the barriers to the implementation of mHealth, it could help create the knowledge base and network of leading mHealth researchers that will be critical if mHealth research and programs are going to be scaled up in the future.

In addition to building expertise in LMICs in mHealth research, this initiative aims to support projects that adapt or develop technologies that are appropriate for LMIC settings. While a plethora of mobile health applications and devices have been developed in high-income countries, these technologies are not necessarily suitable for the needs of individuals in LMICs. A focus on the problems and constraints in LMIC environments should produce more effective mHealth interventions and tools and may result in more sustainable projects, especially if there is involvement from other LMIC stakeholders, such as businesses, hospitals, or governments.

Since the prevalence of chronic and non-communicable diseases is increasing in emerging and developing countries, prevention and management of these diseases are needed for quality of life and life expectancy improvements. Mobile devices are one potential avenue for the delivery of disease management strategies, such as glucose and diet monitoring for diabetes or medication adherence for HIV. In this capacity, phones not only have the ability to facilitate communication between individuals and health care providers, but can also collect data that drives personal decision making. As sensors are developed that can add biological data to mobile information systems, the management and treatment of diseases could become a highly information-rich process.

Mobile phones and wireless devices have also been explored as enabling technologies for health maintenance and prevention. Numerous platforms have already been developed that aim to improve health by influencing behaviors, such as eating and exercise patterns, and risk-related behavior. To have a greater chance for success, interventions that aim to produce behavior change should be based on existing social and behavioral science theories and require rigorous evaluations that demonstrate whether they actually improve health outcomes. If successful, interventions that promote healthy behaviors could have an impact not only on the rates of non-communicable diseases, but also on the prevalence of multiple infectious diseases that can be transmitted through risky sexual behavior or drug use.

Additionally, mobile devices can be transformed into portable health tools through the use of intrinsic and external hardware and software. Portable health tools with wireless functionality, such as mobile microscopes and point of care devices, can aid health care workers in remote clinics by enabling information transmission to more central health facilities or by utilizing algorithms that provide decision support or diagnosis assistance. However, the usability, robustness, and effectiveness of these devices are crucial for successful implementation by health care workers and, ultimately, improved care.   

Research Objectives

This FOA encourages research projects that focus on the development, adaptation, optimization, and evaluation of mHealth tools and/or interventions for the prevention, diagnosis, management, and treatment of chronic diseases (including non-communicable and chronic infectious diseases), along with the development, adaptation, optimization and evaluation of disease agnostic/cross-cutting applications of mHealth technology. Applications should have a strong emphasis on the evaluation of health-related outcomes upon application of the tool or intervention and should include rigorous study designs. These can include randomized controlled studies, where feasible, and pilot studies that are necessary for more comprehensive future research projects.  If a specific clinical outcome is desired, applicants are expected to incorporate appropriate biological endpoints and/or observational behavioral data to measure this outcome. In addition, applicants are encouraged to develop projects that have the potential to provide an understanding of principles behind effective mHealth interventions or tools that are generalizable to the field.

Formative research that is necessary for technology development or project implementation (e.g. research on cultural acceptability or region-specific privacy and security) is also acceptable if it is followed by outcomes-based research.

The mHealth technology that is developed or adapted should address a well-characterized need in LMICs and should be appropriate for use in the proposed LMIC setting. In addition, the interoperability of the developed system and the integration of resulting data with other health information systems are important considerations for producing effective, sustainable tools or interventions. Other factors should also be considered such as the reliability, safety, simplicity, and power requirements of the technology and the existing mobile infrastructure in the LMIC(s).

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Collaboration and Research Capacity Building

All applications to this FOA are required to involve partnerships between U.S. and LMIC researchers and should include plans to develop mHealth research capacity in LMICs. The research capacity and international research networks that are developed should enable future mHealth research, beyond the time period of the grant. The activities proposed can include research training, career development, mentoring, technology transfer and/or other models.  

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. 

Specific Research Interests of the Participating Institutes and Centers

The Fogarty International Center 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 research topics that follow the above research objectives, including, but not limited to, the prevention and management of HIV and co-morbidities, nutritional interventions and prevention strategies for diabetes and other non-communicable diseases, tobacco cessation, and tools that cut across multiple diseases.

The National Cancer Institute recognizes the utility of mobile communication technologies: (a) to prevent avoidable cancers by reducing exposure to carcinogenic agents and by promoting healthy life styles; (b) to support early detection, when the opportunities for curing or controlling the cancer are optimal; (c) to facilitate accurate diagnosis and effective treatment planning; (d) to support reliable communications between all members of the care team, including the patient, during treatment; and (e) to 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:

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 http://www.nibib.nih.gov/Research/ProgramAreas.  The NIBIB supports research from early stage technology development through first-in-human demonstrations and/or early feasibility clinical studies.

Topics of particular interest to NIBIB include:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development is seeking innovative approaches to achieving its mission. The following research topics are illustrative, but not limited to, the Institute's priorities for mHealth research in LMICs:

The National Institute of Mental Health is interested in the development or innovative application of cost-effective, sustainable, and scalable technologies to improve the accessibility, effectiveness, or delivery of mental health care in LMICs.  Illustrative research topics considered responsive to NIMH priorities under this FOA include, but are not limited to, use of mHealth technologies to:

Priority will be given to applications that propose novel applications of technology that could potentially generalize across indications and target populations, as well as multiple operating systems.  Applications that propose the simple transfer of face-to-face interventions onto mHealth technologies or the replication of proven/existing technologies with additional mental disorders or target populations will be considered less competitive.  Prospective applicants are encouraged to contact a Scientific/Research Contact list in Section VII. Agency Contacts for additional guidance on research topics.

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.

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

Applicants may request up to $125,000 direct costs per year.

Award Project Period

The total project period may not exceed 2 years.  

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Other

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.

Non-domestic entities are restricted to institutions in low and middle income countries (as defined by the World Bank according to Gross National Income per capita as low-income, lower-middle-income, and upper-middle-income; see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).

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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 to apply (with LMIC 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). Applicants are required to propose partnerships between at least one U.S. institution and one LMIC institution. Individuals from non-U.S. high income country institutions are not eligible to apply, 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


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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:

The letter of intent should be sent to:

Laura Povlich, PhD
Division of International Training and Research
Fogarty International Center, NIH
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-827-2227
Email (preferred): laura.povlich@nih.gov  

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  LMIC researchers should be substantially involved in the planning, development, and implementation of the proposed program.

Modular or R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants should budget funds for travel to the annual program network meeting in the U.S. PDs/PIs are expected to attend the network meetings and may also budget for other key personnel to attend.

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:

Research Strategy: Applications should contain the following components:

1) A plan for the coordination of research between the partner country institutions, which should include regular meetings (virtual and/or physical).

2) A future research and development pathway that details the LMIC research capacity that will be established at the end of the grant period, the sustainability plan for the mHealth research project, interventions and/or tools and, if applicable, the potential for scale-up. This pathway should also include any anticipated barriers to the implementation of mHealth research, interventions, or tools in the LMIC(s) and possible methods to overcome them.

Letters of Support: All participating institutions 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this FOA, please note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? 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 problem in the LMIC(s) involved and is the technology appropriate for the target location(s) and population? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

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?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Is there evidence that the mHealth research project, intervention, or tool could be sustainable?  

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 children, justified in terms of the scientific goals and research strategy proposed?  

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?

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.

Research Capacity Building

Does the proposed program contain a plan to develop mHealth research capacity in the LMIC institution(s)? What is the potential that the LMIC institution(s) will improve their mHealth research capacity? Will the network of researchers have the ability to continue performing and developing mobile health research projects after the grant period?  

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children 

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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

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.

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

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

Select Agent Research

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

Resource Sharing Plans

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

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 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:

Applications will be assigned 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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

Bradford W. Hesse, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6721
Email: hesseb@mail.nih.gov

Mary Rodgers, P.T., Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-402-1337
Email: rodgersmm@mail.nih.gov

Danuta Krotoski, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5576
Email: krotoskd@mail.nih.gov

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email:  bpringle@mail.nih.gov

Wendy J. Nilsen, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-0979
Email: nilsenwj@od.nih.gov

Peer Review Contact(s)

Alan B. Richon, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1024
Email: allen.richon@nih.gov

Financial/Grants Management Contact(s)

Satabdi Raychowdhury, M.B.A.
Fogarty International Center (FIC)
Telephone: 301-496-0779
Email: satabdi.raychowdhury@nih.gov

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

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6721
Email: perryc@mail.nih.gov 

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rc253d@nih.gov

Florence Turska
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4782
Email: turskaf@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 Parts 74 and 92.


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