Department of Health and Human Services

Part 1. Overview Information -- 4 23 2014
Participating Organization(s)

 Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Funding Opportunity Title

Disseminating and Implementing Evidence from Patient-Centered Outcomes Research in Clinical Practice Using Mobile Health Technology (R21) 

Activity Code

R21 Exploratory/Developmental Research Grant  

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-14-010

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.226 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for developmental research projects on using mobile health technology (mHealth) to facilitate the dissemination and implementation of findings from patient-centered outcomes research (PCOR) into clinical practice.  The purposes of this FOA are to develop and evaluate the effectiveness of novel approaches that use mHealth tools to enable the timely incorporation and appropriate use of PCOR evidence in clinical practice.   

Key Dates
Posted Date

April 29, 2014

Open Date (Earliest Submission Date)

July 4, 2014

Letter of Intent Due Date(s)

June 20, 2014

Application Due Date(s)

August 4, 2014, 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

 Generally, four months after receipt date.  

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

August 5, 2014

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

Purpose

This FOA invites R21 grant applications for developmental research projects on using mobile health technology (mHealth) to facilitate the dissemination and implementation of findings from patient-centered outcomes research (PCOR) into clinical practice.  The purposes of this FOA are to develop and evaluate the effectiveness of novel approaches that use mHealth tools to enable the timely incorporation and appropriate use of PCOR evidence in clinical practice.

MHealth tools include, but are not limited to wireless devices, sensors, software, and cellular phones that are intended to be worn, carried, or accessed by health care providers, patients, and/or caregivers (see Kumar et al., 2013).  The ubiquitous nature of mobile technologies into nearly all areas of health care and the expanding number of health-related applications holds tremendous potential to facilitate better integration of scientific evidence into clinical practice for the benefit of patients' health (see Kvedar et al., 2014).  However, in most cases, developers have not incorporated PCOR evidence in the conceptualization of mHealth tools and most tools do not function in ways that accommodate the clinical use of new or existing PCOR evidence.  Consequently, developmental research is needed to improve understanding of how mHealth tools can be appropriately designed, functionally operated, and effectively used to enable PCOR evidence dissemination and implementation in practice. 

For this FOA, dissemination of PCOR findings into clinical practice is defined as the integration or use of objective scientific evidence from published PCOR studies to inform healthcare decisions so that the delivery or outcomes of health care are improved.  PCOR findings are research results published by the Patient Centered Outcomes Research Institute (see http://www.pcori.org/) and other government-funded research relevant to comparative clinical effectiveness research.  Applicants must focus on one or more key developmental issues in the design, functional operation, or use of mHealth informational tools that are intended to organize, disseminate, and/or implement PCOR findings to physicians, health care providers, patients, caregivers, payers, and/or policy makers.

The evolution and vitality of the health sciences require a constant infusion of new ideas, techniques, and points of view.  These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.  By using the R21 mechanism, AHRQ seeks to foster the introduction of novel scientific ideas, model systems, tools, and technologies that have the potential to substantially advance research on the effective dissemination and implementation of PCOR findings into clinical practice.

Background

Mobile Health Technologies and Dissemination of PCOR Findings

Advancements in computer technology and wireless communications have rapidly increased the number of mobile technologies that are available with health-related applications.  The ability to adapt the design, function, and use of mobile technologies for different communication purposes makes it an important developmental platform for new tools that may enable widespread dissemination and use of PCOR findings into clinical practice.  In addition, the capacity of mHealth tools to integrate patient-generated information with published PCOR findings holds the potential to substantially expand the use of PCOR evidence into important areas of clinical practice, particularly in treating or managing conditions that rely on repeated measures of patients' health status for informing decisions.  Through the use of mHealth tools, longitudinal measures of patients' biologic and physiologic indicators, behaviors, and health outcomes can be measured and transmitted to providers and health information systems.  Subsequently, these systems can be used to support clinical decisionmaking that is directly based on PCOR evidence and tailored to specific patient factors.  The ability to embed PCOR evidence into mHealth tools along with the patient data that clinicians need to apply evidence in practice may markedly improve the dissemination and appropriate use of PCOR evidence in health care.

In order for scientific evidence to be effectively disseminated and used in clinical practice, research findings must be incorporated into the decisionmaking processes and systems used by patients, clinicians, and providers.  The principles of evidence-based health care often underlie how these processes and systems are implemented in routine clinical care.  Evidence-based decisionmaking involves clinicians tailoring treatment plans to each patient according to that patient's preferences, values, resources, and the best scientific evidence (see Sackett et al. 2000).  As new mHealth tools are developed, approaches are needed to integrate PCOR findings into these tools in ways that support evidence-based decisionmaking and improve health outcomes.  For example, in highly prevalent conditions such as diabetes, chronic obstructive pulmonary disease, and heart disease, devices such as glucose meters, medical weight scales, peak flow meters, pulse dosimeters, and blood pressure monitors are being reengineered with new mobile functionalities to collect, analyze, and transmit longitudinal patient data.  Innovative ways to integrate these patient measures with PCOR findings into clinical decision support systems (CDSS) may significantly improve decisionmaking and promote the broader use of PCOR evidence in routine clinical practice.

In addition, the use of health information technology applications that leverage mobile platforms holds potential to significantly increase the number of physicians, health care providers, patients, caregivers, payers, and policy makers who can access PCOR findings, while also decreasing the time that important research results are available to these key stakeholders.  For instance, mHealth tools may facilitate the rapid dissemination of new discoveries, innovations, and breakthroughs as soon as PCOR studies are published in the health sciences literature.  This also includes facilitating the dissemination of a wider spectrum of research findings about patient outcomes including humanistic measures like patients' quality of life and functional status, which are increasingly the focus of new patient-centered studies.  The ability to routinely disseminate the wide range of factors that are studied in PCOR may significantly expand the appropriate use of PCOR findings in decision making and the implementation of research in clinical practice. 

Furthermore, the universal nature of mobile technologies like cell phones may facilitate the rapid dissemination and implementation of PCOR findings in patient populations whose health care providers often lack timely access to high quality scientific evidence.  This includes the potential to implement PCOR research findings across socioeconomic conditions, geographic locations, and languages; and in many more vulnerable populations such as children, people with disabilities, and individuals with low literacy.  Likewise, for people living with rare diseases, mobile devices provide new opportunities to connect patients to the latest scientific evidence as well as create novel databases that can be used to expand knowledge about the effects of treatment on health outcomes.

The emergence of mHealth holds tremendous potential to facilitate the use of PCOR scientific evidence in clinical practice in ways that improve patient health outcomes.  This may be accomplished through the expansion of evidence-based decisionmaking in health care, the more effective management of chronic conditions, improved communication, and the promotion of healthy behaviors.  Equally important is the potential mHealth holds to support new innovations in the implementation of research findings, especially to better measure health outcomes that are most meaningful to patient treatment decisions like functional status, symptoms, and quality of life.  Yet, despite the rapid growth of mHealth and its increasing sophistication, these technologies have not been widely applied or examined in supporting evidence-based health care, particularly for the dissemination and implementation of PCOR evidence.  

AHRQ Dissemination Programs in PCOR

An important objective of AHRQ's PCOR dissemination programs are to make new scientific evidence accessible to decisionmakers, particularly about the comparative effectiveness of different treatments and appropriate clinical approaches to difficult health problems (see http://effectivehealthcare.ahrq.gov/).  Achieving these key goals encompasses reviewing, synthesizing, generating, and translating scientific evidence primarily through the conduct of systematic research reviews and new research.  In addition, the AHRQ programs disseminate plain language research summaries for patients and clinicians about the benefits and risks of different treatments for different health conditions.  These summaries are available in English and Spanish online at http://effectivehealthcare.ahrq.gov/index.cfm/research-summaries-for-consumers-clinicians-and-policymakers/.  

AHRQ and its partners, including NIH and the Patient-Centered Outcomes Research Institute, produce a large collection of clinical and research resources for patients, clinicians, health policy experts, and researchers to learn about CER/PCOR and the current evidence base for treatments used in several health conditions.

AHRQ’s Health Information Technology (HIT) Programs

AHRQ also has an active portfolio of research and informational tools on health information technology (health IT).  The health IT portfolio develops and disseminates evidence about the impact of health IT on health care quality and evidence-based tools on how to use health IT to improve health care quality.  More information about AHRQ’s Health IT Portfolio can be found at http://healthit.ahrq.gov, including the reports from the portfolio’s research grants and contracts.  In particular, applicants may wish to consider barriers and drivers of use of consumer health IT in designing mHealth technologies that are easy to use, useful, and utilized by patients (see http://www.ahrq.gov/clinic/tp/hitbartp.htm

Specific Areas of Research Interest

This FOA is intended to support studies that break new ground or extend previous discoveries toward new directions or applications.  This includes high risk, high reward studies that may lead to a breakthrough in a particular area, or result in new perspectives and conceptual frameworks, techniques, methodologies, models, or applications for improving patient health outcomes through the dissemination and implementation of PCOR evidence in clinical practice. 

PCOR includes research findings that are published by the Patient Centered Outcomes Research Institute (PCORI) established under section 1181(b) of the Social Security Act and other government-funded research relevant to comparative clinical effectiveness research.  PCOR is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or healthcare delivery approaches.  This definition is based on the PCOR definition used in section 6301(a) of the Patient Protection and Affordable Care Act (ACA) of 2010. 

This FOA encourages research resulting in new paradigms for using mHealth tools in the practice of evidence-based health care, particularly to improve patient health outcomes through the dissemination and the appropriate implementation of PCOR evidence.  Under this FOA, research examining novel approaches for improving the speed, efficiency, and effectiveness of PCOR evidence dissemination into health care through mhealth tools is strongly encouraged.  As a result, this FOA supports the conceptualization, pilot testing, and evaluation of innovative uses of mHealth tools or critical components of these tools that are designed to improve patient health outcomes, enable informed decisionmaking by patients, enhance communication between patients and clinicians, improve shared decisionmaking by patients and clinicians, and/or increase health behaviors associated with better patient outcomes.  This includes, but is not limited to, using mhealth informational tools with clinical decision support systems, electronic health record (EHR) systems, or other decision support aids used by patients, caregivers, providers, and health care systems.  In addition, AHRQ encourages applications that are relevant to patients living with complex medical conditions, rare diseases, or populations disproportionately affected by the burden of disease in the United States.

Responsive applications must explain in non-technical terms, the problem(s) the project addresses, its innovation, and how the results can be applied if successful.  Applicants must also explain how their approach to enabling dissemination and implementation of PCOR evidence in clinical practice using mHealth tools is expected to improve patient health outcomes, enhance patient and clinician communication, improve shared decisionmaking, increase health behaviors associated with better patient outcomes, or support the appropriate implementation of PCOR evidence into clinical practice.  Applications may be limited to developing a critical piece of a multifactorial problem, but the applicant must explain how the project will catalyze future research and development activities.  All applications must also describe how the proposed approach incorporates findings from PCOR studies or systematic research reviews and will advance the dissemination and implementation of PCOR evidence into clinical practice.  Given the developmental nature of this FOA and the increasing number of PCOR studies that are anticipated to be published in the upcoming years, applicants may develop generalizable approaches and are not limited to projects involving currently published PCOR studies. Although applications are required to have an evaluative component, applicants are encouraged, but are not required, to include human subjects or use protected health information.

Examples of topics relevant to this FOA include, but are not limited to, the following:

References

Kumar S, Nilsen WJ, Abernethy A, Atienza, A, Patrick K, Pavel M, et al. Am J Prev Med 2013;45(2):228–236.

Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9.

Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine; how to practise and teach EBM. 2nd ed. Edinburgh: Churchill Livingstone; 2000.

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

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

Funds Available and Anticipated Number of Awards

AHRQ intends to fund approximately 10 to 15 awards, for a total of up to $1,500,000 per year. 

Total costs (direct and indirect) are limited to $300,000 for a project period that may be up to two years.  A maximum of $150,000 total costs may be budgeted in a given year.  An application with a budget that exceeds any of these limits will not be reviewed.

The number of awards is contingent upon the submission of a sufficient number of meritorious applications.  Future year amounts will depend on availability of funds.

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $150,000 in any given year or $300,000 for the entire project period. 

Award Project Period

 The project period may not exceed 2 years. 

Title 42 USC 299b—37(a)-(c) authorizes AHRQ to make these awards to support the agency’s dissemination of comparative clinical effectiveness research findings. 

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and  http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

You may submit an application(s) if your institution/organization is a (an):

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application.  There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Foreign Institutions

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

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 Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account.  The PD/PI should work with his/her 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, he/she 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/Principal Investigator (PD/PI) 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 AHRQ support.

The PD/PI is expected to contribute a minimum of 15% annual effort (1.8 calendar months) in each year of the grant.  If less time is allocated, an explicit justification of the lower level of effort must be included.

Only one PD/PI may be designated on the application. 

2. Cost Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort.  An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.  Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments.  Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request. 

3. Additional Information on Eligibility

Number of Applications

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

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, 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 AHRQ 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 is to be sent electronically to:

Scott R. Smith, Ph.D.
Center for Outcomes and Evidence
Email: Scott.Smith@ahrq.hhs.gov

Page Limitations

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

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, with the following additional instructions:

R&R Budget

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

Budget Component:  Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

Software, Hardware, Supplies, and/or Equipment Purchases: Combined purchases for software, hardware or any other supplies or equipment needed to conduct the project are expected to be less than 20% of the total direct costs of the project over the duration of the project.  These purchases may include modest incremental software development to enable implementation of existing health IT in a new setting or to improve health IT functionality.  The 20% limit excludes personnel costs. 

Under unusual circumstances, the applicant may request such purchases to be above 20% of the overall total direct costs budgeted for the duration of the project.  However, pre-approval from AHRQ is required prior to submission of an application that exceeds the 20% limit on combined purchases of software, hardware, supplies and equipment.  Such requests for additional costs must be well justified and explained in detail in a Letter of Request sent by email to the AHRQ Referral Officer Program at:  Gerald.Calderone@ahrq.hhs.gov.  Any request to exceed the 20% limit must be submitted to AHRQ no later than June 23, 2014.  Investigators will receive a response from AHRQ by July 21, 2014.   For any such request, AHRQ will consider such factors as the following:

If the request to exceed the 20% limit is approved, the approval letter from AHRQ should be included with the application as an Appendix.

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 that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

Specific Aims:

Research Strategy:

Research Design and Methods:

Privacy and Security Protections in the Development and Implementation of Health IT Systems:

Project Administration:

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, with the following modification:

An appendix should be used to include a detailed project Gantt chart.

If the request for Software, Hardware, Supplies, and Equipment exceeds 20% of the total direct costs of the project over the project period, a letter of approval for submission for AHRQ should be included.

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. 

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

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

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:
The PD/PI must include his/her 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/AHRQ. 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, and for responsiveness by AHRQ.  Applications that are incomplete and/or non-responsive will not be reviewed.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations.  Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  42 USC 299(c).  Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities.  Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied.  Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules, if applicable, and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401. 

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

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.  As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system. 

AHRQ's priority areas of focus are:

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.  Only the review criteria described below will be considered in the review process.

Administrative Criteria:  Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria:  Merit Review Criteria, as described below, will be considered in the review process.

For this particular announcement, 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 health services research.  An R21 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? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will this project provide new understanding or develop new paradigms for utilizing mobile health technology tools to enable the dissemination and implementation of evidence from patient centered outcomes research (PCOR) into clinical practice?  Does this application demonstrate that an important challenge or gap in the mHealth literature or health IT field will likely be addressed through the conduct of this study or lead to future research activities that would?  Does the application adequately demonstrate how findings will inform the conduct of future mHealth research activities?

Investigator(s)    

Are the PD/PI, collaborators, and other researchers appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Is the leadership approach, governance and organizational structure appropriate for the project? Is the PD/PI devoting a minimum of 15% annual effort (1.8 calendar months) in each year of the project? If not, is there a well-justified explanation and allocation of leadership during the course of the research project?  Does the research team include at least one team member with health IT expertise?  Does the application include a multidisciplinary research team drawing from diverse fields?  Does the application demonstrate the investigators’ aptitude to identify and address weaknesses encountered during the conduct of the research project?  Does the application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduct of the proposed study?

Innovation

Is the project original and innovative? For example: Does the project challenge current research or seek to shift clinical practice paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  Does the project break new ground or extend previous discoveries toward new directions or applications?  Could the project lead to a breakthrough in a particular area, or result in new perspectives and conceptual frameworks, techniques, methodologies, models, or applications for improving patient health outcomes?  Does the project represent an innovative use of mobile technology that incorporates PCOR evidence to enhance patient and clinician communication, improve shared decisionmaking, or increase health behaviors associated with better patient outcomes?

Approach

Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are 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?

Does the project study mobile technologies that disseminate and implement PCOR evidence?  Does the approach incorporate findings from PCOR studies or systematic research reviews?  Will the approach advance the dissemination and implementation of new or existing PCOR studies?  Does the application contain an evaluative component that will validly assess the approach?  Does the application adequately recognize and describe the limitations in the generalizability of the results?   

Environment

Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

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.

Privacy and Security Protections in the Development and Implementation of Health IT Systems

Is a section entitled “Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems” included in the Research Strategy section of the application?  Has the applicant identified if it is necessary to have a Privacy and Security Protections Plan in place to conduct the research project?  If the applicant states such a plan is not necessary, is adequate justification provided?  If a plan is necessary, has the applicant adequately described the privacy and security policies and features of the health IT system being designed, implemented, or used in the proposed study?  Has the application adequately described the process for identifying and addressing privacy and security issues related to the exchange of personal health information and encouraging the involvement of patients to the extent appropriate?  Has the application adequately considered patient access to an accounting of certain health information disclosures, patient consent process for sharing information electronically, ability for patients to decline participation in electronic data collection, patient access to audit trails or logs, and patient notification of security breaches?

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.

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this FOA.  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements”).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research.

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Additional Review Considerations

Not Applicable

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ 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 initial merit review, all applications will:

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  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

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once all administrative and programmatic issues have been resolved, 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 AHRQ 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.  See also Section IV.5., “Funding Restrictions.”

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of  Award.

A standard term and condition of award will be included in the notice of award; all applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions.  For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports.  In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends.  All final reports are due within 90 days of the project period end date.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

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
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 Center Telephone: 800-518-4726

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

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Scott Smith, Ph.D.
Agency for Healthcare Research and Quality
Center for Outcomes and Evidence
Telephone: 301-427-1511
Fax: 301-421-1520
E-mail address: Scott.Smith@ahrq.hhs.gov

Peer Review Contact(s)

Direct your questions about peer review issues of grant application made in response to this FOA to:

Nghia Vo, M.D.
Agency for Healthcare Research and Quality (AHRQ)
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: 301-427-1191
Fax: 301427-1562
E-mail address:  Nghia.Vo@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Brian Campbell
Agency for Healthcare Research and Quality
Office of Management Services
Grants Management
Telephone: 301-427-1266
Fax: 301-427-1462
E-mail address:  Brian.Campbell@ahrq.hhs.gov

Section VIII. Other Information

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.


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