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

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Behavioral and Social Sciences Research (OBSSR)

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Mobilizing Research: A Research Resource to Enhance mHealth Research (U2C)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-OD-15-129

Companion Funding Opportunity

None

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

93.286, 93.853, 93.273, 93.838, 93.837, 93.233

Funding Opportunity Purpose

The purpose of this FOA is to support the development of Mobilizing Research a research resource that would allow researchers to more efficiently and rapidly evaluate mobile and wireless (mHealth) technologies. This research resource is intended to develop an infrastructure that works with wireless carriers to create a registry of potential participants to facilitate mHealth research across a variety of observational and clinical research studies and settings, and for a range of diseases and populations. This FOA supports Mobilizing Research for development of the infrastructure and transition to sustainability. Therefore, the proposed integrated and centralized resource should be designed and operated in a way that will facilitate and enable its sustainable functioning in the near future.     

Key Dates
Posted Date

March 2, 2015

Open Date (Earliest Submission Date)

April 8, 2015

Letter of Intent Due Date(s)

April 8, 2015

Application Due Date(s)

May 8, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

Not Applicable  

Scientific Merit Review

June 2015

Advisory Council Review

October 2015

Earliest Start Date

December 2015

Expiration Date

May 9, 2015

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


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

The purpose of this FOA will be to create a research resource that uses mobile phone technology to create a registry of demographically and geographically diverse individuals interested in potential research projects. This resource would allow researchers rapid access to potential study participants and reduce the time and cost of mHealth research. Successful applicants will develop a wireless resource in conjunction with the mobile telecommunications industry and in consultation with researchers and wireless device and application industry experts, and regulatory authorities (e.g., Food and Drug Administration and the Federal Communications Commission). The resource will include and not be limited to the following:

  • a secure website that is accessible for researchers and potential participants
  • a cloud-based database system appropriate for health research
  • a system of outreach in conjunction with telecommunications providers
  • a consent and screening system for potential participants
  • a backend data collection system for managing common data elements
  • an appropriate privacy and ethics framework and
  • a standard architecture to support integration with diverse research software and data systems.
Background and Rationale

Mobile and wireless health (mHealth) technologies offer the potential to transform and advance research, prevent disease, improve diagnosis, treatment, and adherence, reduce disparities, increase access to health services, and lower healthcare costs in ways previously unimaginable.  Real-time, continuous biological, behavioral and environmental data collected by mHealth technologies will improve our understanding of the etiology of health and disease, particularly when integrated with other data such as genomics, biomarkers, electronic medical records and patient-reported outcomes.  This data is important for answering the difficult questions of the gene-environment-behavior relationship in health and disease, understanding the developmental origins of disease, and providing data to inform the development of treatments and prevention programs that are preemptive, personalized and adaptive over time.  Further, mHealth has the potential to transform clinical trials.  Remote monitoring and sensing can allow researchers to recruit and follow participants without the need or cost to transport them to a research or healthcare setting. This will increase participant access and decrease burden while increasing sample representativeness and the quantity and quality of follow-up data, all at decreased cost. 

While development of mHealth technologies is currently progressing at a rapid pace, research designed to capitalize on these advances is moving much more slowly. The discrepancy between the tremendous growth of industry products in this area and the small number of grants funded by NIH, led to a Common Fund hosted  mThink Forum that brought together  leaders from  research, industry and government in February 2013 to assess the barriers to mHealth research. The major finding of this meeting was that, although there is no lack of innovative and potentially transformative research ideas, doing work in this area involves the unique challenges of utilizing consumer technologies that have not been developed for research and wireless carrier systems whose business models do not include science, all in an environment where there is no research infrastructure to provide coordinated support (http://obssr.od.nih.gov/scientific_areas/methodology/mhealth/mThink.aspx). Thus, researchers are trying to develop studies for multiple incompatible devices or purchasing phones to decrease device heterogeneity, as well as purchasing service plans for participants because there is no system to facilitate this science.  Similar issues and challenges with a lack of a research infrastructure in mHealth were echoed in the international community. In December 2011, FIC staff met with a group of international mHealth researchers. This group also discussed the lack of mHealth infrastructure in the global community and the challenges of working within a consumer technology sector, despite seeing this area as one of huge scientific potential. They noted that research is in a phase of "death by pilot" where small, one-off studies are proliferating with no infrastructure available to scale-up promising work. Thus, data from around the world indicates that to generate meaningful mHealth research will require investment in infrastructure. 

Conversely, industry is developing mHealth technologies at an exponential rate, most without rigorous study or evaluation. However, these products are often created by small firms or consumer electronics companies, who frequently do so without a connection to healthcare professionals and scientists who can provide necessary knowledge about end users, the current evidence base and relevant outcomes. Devices and applications created in a vacuum are less likely to transform healthcare delivery and improve outcomes.  Industry representatives also recognize the challenge of conducting research in mHealth. In the mThink meeting noted above, industry experts noted that an mHealth infrastructure for building relationships with the scientific community and defining evaluation and data interoperability standards would transform the field and provide a "ecosystem" to support innovation and rigorous evaluation.   Creating a system that links the technical expertise and innovation with scientific expertise has the potential to exponentially increase the usefulness of mHealth technologies. 

Specific Research Objectives

This FOA focuses on activities required to support, maintain, and upgrade the Mobilizing Research resource and activities that enable its transition to become a sustainable resource that can function after NIH funding ends.

A. Developing an infrastructure for mHealth research

The research challenges in mHealth and high potential impact have led to the current FOA. Mobilizing Research is envisioned as a transformative wireless health research platform and database, which will allow for efficient access to populations including individuals at remote sites and allow for rapid, economical validation and integration of wireless and mobile tools into health research.  Mobilizing Research will utilize a standardized recruitment system for potential participants from the vast pool of people with mobile phones or other wireless devices like tablets. The mobile device will act as the access point and data collection tool. Wireless providers will initially contact individuals at random to consider participation in Mobilizing Research. Interested individuals will receive additional information and, if they choose, complete consent for a basic health screen and a standard non-invasive data collection protocol. This broad pool will be used as a participant registry for mHealth research, as well as a database to answer a wide range of health research and surveillance questions.  After entry into the registry, participants can be recruited into a range of other studies facilitated by Mobilizing Research.  These projects could cover any health topic and provide researchers with the potential to collect data on millions of participants, including those in remote regions or with rare diseases. In addition to being a primary data collection mechanism, participation in Mobilizing Research will include depositing harmonized, de-identified data into the database. The development of data standards that are consistent with those of ONC's HIT certification criteria will also enable a health information exchange allowing mHealth-related research to collect massive standardized data from participant encounters.  Thus, Mobilizing Research will be a data repository useful for basic, clinical and meta-analytic research. The database will serve as the foundation for a knowledge base that enhances validation and standardization of mHealth tools. This database should be designed to allow for efficient data mining that will enhance the understanding of disease pathways and develop new analytic tools and common data structures to ensure that comparison of studies over time and investigators will be facilitated.

Mobilizing Research should incorporate an open source design and a modular framework for maximum utility and flexibility to provide efficient and automatic collection of harmonized, core areas of measurement from samples and to accommodate integration of a broad range of wireless instruments. This system will allow researchers to develop data collection protocols to be deployed using wireless biometric monitoring technology and online or mobile survey and recall instruments. Additionally, data from external (non-mobile) sources such as genetic assays, images and the electronic health records should be accommodated.

In addition to the Mobilizing Research interface and database, a development environment for researchers should be planned. This will support submission and review of Mobilizing Research studies and will also facilitate the development of protocols that adhere to the Mobilizing Research format. A library of studies should be maintained so that researchers can develop new work based on previous research.  The study library should also include a library of use cases. For this announcement, a use case is defined as a list of steps, typically defining interactions between a role (an "actor") and a system, to achieve a goal (this definition is from software and systems engineering). The actor can be a human or an external system. In another word, a use case is a function or a feature of a software system. For example, search, data entry, data download, user registration and user management, etc. each is a use case. Applicants consider including use cases in their project library.

The research site should also be available, as well as links to appropriate tools for encryption, data collection, and analysis of the resulting data. Mobilizing Research should include an information feature to facilitate dissemination and exchange of information and collaboration among researchers participating in Mobilizing Research.

Mobilizing Research is envisioned as a learning system and should be developed iteratively over the life of the project. When initial development of the platform is complete  the strengths and limits of the system  inform  iterations of Mobilizing Research.. In addition to these initial projects, projects from the research community (funded by NIH or others) will be encouraged to further develop the system. 

Participation in Mobilizing Research should be open to researchers from academia initially and develop to support researchers from industry and NGOs around the world. Interested researchers will be able to identify the potential number of participants that meet their specific eligibility criteria across numerous variables (i.e., by disease, demographic, geographic, carrier or mobile device type).  This will allow for efficient research designs that do not require the purchase of plans/devices and remove time-consuming interactions with wireless providers.

B. Transition to Sustainability 

NIH's support of Mobilizing Research is designed to facilitate the development and transition of the system to increase accessibility, widespread adoption, and sustainability over the long-term. NIH funding is intended to support the research resource base and related activities that allow researchers to conduct mHealth research. Utilization will require a fee to cover telecom costs and upkeep of the system. This would be significantly more efficient for researchers and will extend funding resources because they would not need to fund interface with the telecoms, purchase devices and/or create contracts. Support of Mobilizing Research should become financially sustainable in the long-term and ultimately enhancing existing and future research. Extension and sustainability of this research resource is expected to provide a solid basis for continued research and the development and evaluation of new components as they are needed.

Examples of research projects that are not appropriate for this FOA  include, but are not limited to: 

Individual research projects on a specific disease condition

Development of mHealth measures

Validation of existing measures in new participant groups or populations

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

OBBSR, NHLBI, NIAAA, NIBIB, and NINDS intend to commit a total of $2,000,000 to fund one (1) award.

Award Budget

Award budgets are limited to $1,250,000 in direct costs per year. Future year amounts will depend on annual appropriations. .

Award Project Period

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 in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Wendy Nilsen, PhD
Telephone: 301-496-0979
Fax: 301-402-1150
Email: nilsenwj@od.nih.gov


Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core 

6

Core (Use for Resource Core )

12  

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required
  • Resource Core: required
Overall Component

When preparing your application in ASSIST, use Component Type 'Overall'.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Comprehensively address the goals of this FOA which are to create a sustainable resource for the mHealth Research community, allowing them to efficiently recruit, conduct studies and collect and pool data using a rapid and reliable system.       

Research Strategy:  Mobilizing Research will serve as a resource to the mHealth research community, allowing them to efficiently recruit, conduct studies and collect data using a rapid and reliable system. The Mobilizing Research infrastructure will support scientific discovery by bringing a common structure and language to mHealth research by providing researchers with a streamlined system that has minimal respondent and researcher burden and cost, as well as a database for harmonized data collection.

To ensure efficient performance of these activities, the Mobilizing Research structure shall allow for continuance and expansion of the current research infrastructure supporting mHealth, including an overview of software, security and backup, database and analytic capabilities.

As part of this section, describe the following elements:  

  • Background and Progress: Briefly summarize previous experience with research recruitment, databases and interfaces and with the web-based platforms needed to deliver a system for researchers and participants that works through mobile devices; Overall goals for the Mobilizing Research as a resource. Summarize how the Mobilizing Research intends to meet the objectives of this FOA and identify the selected areas of focus and strategic goals related to creating a rapid and reliable recruitment research system, including).
  • Overview of all components (i.e. Administrative, Resource and Feasibility) and their integration;
  • Plans for strategic oversight and coordination of effort among components; and
  • Plans for collaboration and coordination with the broader mobile research community.

Letters of Support

Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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

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

  • The Mobilizing Research Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the Mobilizing Research Program expects the sharing of study data from system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the Mobilizing Research Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the Mobilizing Research Program steering committee post award.
  • In addition, the Mobilizing Research Program encourages sharing of resources that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or protocols

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.   

Administrative Core  

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

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

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

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

PHS 398 Research Plan (Administrative Core)

.

Specific Aims:  Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives

Research Strategy:  The Administrative Core will provide overall administrative and organizational oversight and management of the Mobilizing Research Resource and the usability and Feasibility Core.  It will also serve as the primary interface between Mobilizing Research Program and the research community

As part of this section, the applicant should address the following:  

Overall leadership and personnel capacity that may include but is not limited to the following:

  • Administrative, operations, and meeting support staff;
  • Business and/or legal expert staff; and,  
  • Other staff required to support the Mobilizing Research program as a whole
  • Support for internal evaluation and self-assessment, including:
  • Ability to generate progress reports;
  • Ability to assess and anticipate researcher needs; and
  • Ability to prioritize and incorporate improvements into operations and software that enhance its utility for research.
  • Anticipated challenges/obstacles and alternative strategies to surmount potential obstacles

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

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

Appendix: 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  (Administrative Core)

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 (Administrative Core)

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

Resource Core

When preparing your application in ASSIST, use Component Type 'Core.'

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

SF424 (R&R) Cover (Resource Core)

Complete only the following fields:

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

PHS 398 Research Plan (Resource Core)

Enter Human Embryonic Stem Cells in each relevant component .

Research & Related Other Project Information (Resource Core)

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

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

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

Project /Performance Site Location(s) (Resource Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Resource Core)

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

Budget (Resource Core)

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

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

PHS 398 Research Plan (Resource Core)

Specific Aims: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.  

Research Strategy:  The Resource core will describe the development of Mobilizing Research, including usability and feasibility, the capacity to address system standards and upgrades, training and outreach, strategic planning, and development of a public-private partnership model of sustainability.

Applications should describe the following:

  • The overall vision of the Mobilizing Research Resource Core and its components and how this meets the Mobilizing Research objectives;
  • Overall approach and methods to establish a data portal for user-friendly access to data (both raw and processed datasets), metadata, and visualization tools. This web-based interface should provide controlled access to both Mobilizing Research participants and the broader scientific community, enable federation to relevant external databases and data resources.
  • Ability to allow researchers to identify the demographics of a target population for a given study
  • Ability to allow participants to identify ongoing research
  • Ability to generate participant and researcher portals that are created using user-centered design principles. Portals should contain wikis for reporting research findings and updates
  • Ability to store and report participant data to the researcher or clinician via a secure, password protected system compliant with applicable federal data security standards (for example, see http://csrc.nist.gov/groups/SMA/fisma/index.html for FISMA standards and http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html for HIPAA standards)
  • Ability to export data consistent with data interoperability standards, including HL7 capability for integration into electronic health records (EHRs)
  • The proposed process for creating a resource with the capability to store/aggregate all primary and processed data and associated metadata generated by the mobile health research community;
  • Ability to ensure data security and maintain confidentiality of personally identifiable information;
  • Ability to execute a series of feasibility and usability tests that progressively assess the functioning of the system before it is available to the broader research community;
  • Online training modules and tutorials for data access and visualization by a variety of users (naïve users, computer scientists, and researchers from a variety of disciplines);
  • Self-administered methods for researchers to distinguish among the tools and to determine which tools are best for their particular studies;
  • Description of server maintenance, software maintenance and upgrades, and security and backup processes; and,
  • Technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future, even under limited or no funding. If appropriate, describe plans for public-private partnership (PPP) development, including but not limited to:
  • Ability to devise, implement, and adapt business plans on a quarterly basis
  • Generation of additional funds in years 4 to 5 to replace NIH funding, as well as revenue generation beyond year 5
  • Either (a) potential to leverage existing or anticipated partnerships with private entities capable of establishing a PPP or (b) an explanation of why a PPP is not applicable and what other sources of revenue will allow the Mobilizing Research to be fully sustainable without targeted NIH funding by 2020.
  • Develop a detailed plan to separate federal government funds (from this announcement) and revenue stream (generated by this award) that is in compliance with federal appropriations law.

As part of this section, the applicant should address the following specific aspects:

Personnel capacity that may include but is not limited to the following:

  • Programmers, data analysts, network and software engineers, and other computing support staff;
  • Data privacy and security experts;
  • Standards logistics manager; and
  • Other staff required to support the needs of the Resource Core and without whom Mobilizing Research would be unsuccessful.    

Operations management, including:

  • Ability to ensure efficient and effective day-to-day administrative operations; and
  • Coordination with other components of the Resource.

Customer support capacity that may include the following:

  • Basic technical support for Investigators participating in Mobilizing Research;
  • Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms); and
  • Ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.
  • Description of server maintenance, software maintenance and upgrades, and security and backup processes.

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

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

Appendix: 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  (Resource Core)

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 (Resource Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.

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.

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in 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.

Overall Impact - Overall

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 - Overall

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?

Specific for this FOA: Does the proposed plan provide for a resource that will allow accessibility of mHealth across the research communities? Will the proposed plan facilitate research in this area?  

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?

Specific for this FOA: How familiar are the investigators with mHealth, remote recruitment or working with mobile telecom carriers in research? Do the investigators have experience with setting up web portals and databases for large user systems? Do the investigators have experience with training users on web portal systems, especially as they relate to research? Do the investigators have the technical expertise relevant to support the system? 

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?

Specific for this FOA: What novel approaches have been/will be used by the investigators to capture relevant information for research purposes? What innovative outreach approaches will be used to ensure extensive use of the Mobilizing Research by the scientific community? Does the proposed plan allow for technological advances during the project period?     

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?

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?  

Specific for this FOA: Is the existing technical capacity (servers, web-based portals, database) adequate for continued support and for expansion of the Mobilizing Research? What is the likelihood of successful expansion and uptake of the Mobilizing Research by engaging investigators from academic centers and other research settings?

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?

Specific for this FOA: What are the capabilities of the lead institution to provide effective technical and administrative support for the proposed resource?  Does the research team have experience with transdisciplinary/multisectorial projects? Does the scientific environment have demonstrated hardware and server capacity to support the proposed resource?  

Additional Review Criteria Overall

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.

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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.

Scored Review Criteria for the Administrative Core
 
Overall Impact - Administrative Core

Reviewers will provide an overall score for the Administrative Core to reflect its likelihood for exerting a sustained, powerful influence on the field(s) involved. The consideration of the following review criteria should also be included.

 
Review Criteria - Administrative Core

Has the applicant provided a well-reasoned and appropriate strategy for managing and coordinating the Program's activities and providing administrative support for the Research Resource activities?

Does the Administrative Core describe a plan to oversee improvements in the Mobilizing Research infrastructure?

Does the Administrative Core provide a plan to participate in dissemination and outreach activities to promote use of Mobilizing Research to the scientific community?

Is a plan described to ensure training of Mobilizing Research personnel as needed for standardization of collaborative protocols across components?

Are the Center PD/PI (Core Lead) and other leadership and staff qualified to effectively manage the Program? Have the Director(s) demonstrated an ongoing record of accomplishments related to the objectives of the Core?

Is the percent effort of the Director adequate?

Review Criteria for the Mobilizing Research Resource
 
Overall Impact - Mobilizing Research Resource

Reviewers will provide an overall score for the Mobilizing Research Resource to reflect its likelihood for exerting a sustained, powerful influence on the field(s) involved. The consideration of the following review criteria should also be included.

Review Criteria - Mobilizing Research Resource

Does the Director of the Mobilizing Research Resource and other Resource staff cover relevant expertise (e.g., technical development of mobile data standards; managing a community-driven standards development process) needed to achieve goals of the Mobilizing Research Resource?

Are plans for identifying and implementing data and metadata standards adequate? Are they designed to allow input from other components as well as other appropriate members of the broader scientific community?

Are the proposed interfaces/tools to be developed likely to facilitate access to information on mobile standards? 

How well does the proposed plan delineate steps for developing continued support beyond the term of the grant? Does the proposed plan include strategic business directives that will allow for funding support in the final years of the funding period and beyond?  Does the sustainability plan also should include a detailed plan to manage the separation of the federal government funds (from this announcement) and revenue stream (generated by this grant) that is in compliance with federal appropriation law?

Will tools developed support interoperability with deposited data and other databases?

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?

Are the proposed personnel, resources, and organizational structure adequate for maintaining and enhancing dissemination and implementation efforts?

Will the project benefit from unique features of the scientific environment or collaborative arrangements? 

 
2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 submitted in response to this FOA. 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.

Availability of funds.

Relevance of the proposed project to program priorities.  

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U2C- Research Resource Grant), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

Principal Investigator Rights and Responsibilities

The Principal Investigator of the Mobilizing Research center will have the primary responsibility for all activities, including the planning, organizing and administering the system, administration and project cores, a Research and Development program, and an internal Steering Committee. He/She will participate as a voting member of the Mobilizing Research Executive Steering Committee with NIH staff. He/She will be responsible for evaluating applications for system services, and will ensure that services are completed, and that data is placed in the Mobilizing Research database in a timely and satisfactory manner.

Awardees will retain custody of and have primary rights to the system. As discussed in the proposal, the system software developed under these awards that are not assigned to the external investigators that use Mobilizing Research should be developed to be open source design and a modular framework, which should be made available to the research community, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

He/She will participate as a voting member of the Mobilizing Research  Executive Steering Committee, and will invite members of the External Advisory Board to serve. The NIH Project Scientist will help plan and carry out Mobilizing Research activities, and will participate in all reports. He/She will act as a liaison between the Mobilizing Research team and the NIH. Additionally, an agency program official or IC program director/project official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Project Official is the NIH staff person responsible for reviewing annual progress of the Mobilizing Research, normal programmatic stewardship, and signing off on Grant Progress Reports.

Executive Steering Committee

The Principal Investigator and co-PIs must agree to participate in an Executive Steering Committee that will meet twice each year to encourage the exchange of information. The Executive Steering Committee will consist of the Mobilizing Research team, the NIH Project Scientists, the NIH Project Official, relevant HHS regulatory agencies (e.g., FDA and ONC) and Mobilizing Research personnel as needed. If voting is necessary for an action item, the Mobilizing Research Center and the NIH hold one vote each. The Chair will be chosen from among the members.

The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of Mobilizing Research. The Executive Steering Committee may form and charge other subcommittees as needed. A major goal of Executive Steering Committee meetings is to facilitate progress by providing a forum for sharing skills, ideas, technology, and data. At the meetings, participants will also discuss quality assurance, data management and analytics, project coordination, protocol consistency, and training. The Executive Committee will discuss and evaluate Mobilizing Research activities and provide feedback to leaders at least bi-annually, implement changes in membership or direction if needed, discuss and evaluate new projects for existing cores, as well as new collaborative projects, and the pilot and feasibility program.

External Advisory Board

Mobilizing Research PIs must indicate their intention to be responsive to recommendations provided by an independent External Advisory Board (EAB). Members of the EAB will be nominated by the Executive Steering Committee in collaboration with the NIH, and will be invited by the NIH. A chairman will be chosen from among the 4-5 members, who will be accomplished senior scientists from academia and industry with backgrounds in mobile health, technology, databases, and devices. The EAB will meet annually in conjunction with one of the semi-annual meetings of the Executive Steering Committee to review interim progress of Mobilizing Research and provide an annual report and recommendations to NIH and to the Executive Steering

Committee. The Executive Steering Committee will discuss implementation of recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to the EAB. This ESC will oversee the Mobilizing Research website and database and act as secondary review for the Pilot/Use case projects. They will work together to establish training programs and write consortium publications as appropriate. The Executive Steering Committee and External Advisory Board will decide in those rare instances if new tests should be exempted from the fee-for-service model, or should be allowed to be conducted routinely as collaborative research.

Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16

3. Reporting

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

A final 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)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-710-0267

Scientific/Research Contact(s)

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

Erin Iturriaga, RN, BS
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0403
Email: iturriae@mail.nih.gov

Daniel Falk, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0788
Email:   falkde@mail.nih.gov

Mary Rodgers, Ph.D., PT
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-402-1337
Email: mary.rodgers@nih.gov

Wendy Galpern, MD, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: galpernw@ninds.nih.gov

Peer Review Contact(s)

Gabriel Fosu
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: fosug@csr.nih.gov

Financial/Grants Management Contact(s)

Ann Marie Brasile Mejac, AA, CRA,
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301435-0164,
Email: brasilea@nhlbi.nih.gov

Deborah A. Hendry
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301443-0915,
Email:  dhendry@mail.nih.gov

Angela Eldridge
National Institute of Bioimaging and Bioengineering (NIBIB)
Telephone: 301451-4793
Email: ae49k@nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301496-9231
Email: decostert@ninds.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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