Department of Health and Human Services


Part 1. Overview Information
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)

Funding Opportunity Title

Limited Competition:  Enhancing Investments in Comparative Effectiveness Research Resources (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-13-011

Companion Funding Opportunity

None

Number of Applications

Only one application per current institutional awardee is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.226 

Funding Opportunity Purpose

This FOA is a limited competition for AHRQ ARRA-funded large research grants, specifically awardees currently funded under the: CHOICE, PROSPECT, Enhanced Registries for Quality Improvement and Comparative Effectiveness Research, and Scalable Distributed Research Networks for Comparative Effectiveness Research funding programs.  Further details on these programs can be found below in Part 2, Section I of this FOA.

The goal of this FOA is to extend the usefulness and further improve the capabilities and patient-centered use of existing research and/or clinical infrastructure now and in the future.  The primary objectives of the project are to use a stakeholder engagement process to:

1) understand stakeholder needs in order to develop new comparative effectiveness research questions for which future research could fill important knowledge gaps and generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions; and

2) enhance the current data infrastructure and move towards sustainability through developing the ability to address these additional stakeholder-relevant questions.   

Applications must also delineate plans for making the resources developed in this and the prior ARRA programs more sustainable for future research and/or clinical funding support.

Key Dates
Posted Date

May 9, 2013

Open Date (Earliest Submission Date)

May 28, 2013

Letter of Intent Due Date(s)

June 7, 2013

Application Due Date(s)

June 28, 2013, by 5:00 PM local time of applicant organization.

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

June 29, 2013

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.

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

Objectives

In 2010, AHRQ released several large research grant Funding Opportunity Announcements (FOAs) supporting comparative effectiveness research (CER) as part of the American Recovery and Reinvestment Act (ARRA) CER investment.  These FOAs were:

Recovery Act 2009 Limited Competition: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants (R01) - RFA- HS-10-003 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-003.html)

ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01) - RFA-HS-10-005 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-005.html)

ARRA OS Recovery Act 2009 Limited Competition: Enhanced Registries for Quality Improvement and Comparative Effectiveness Research (R01) - RFA-HS-10-020 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-020.html)

ARRA OS: Recovery Act 2009 Limited Competition: Scalable Distributed Research Networks for Comparative Effectiveness Research (R01) - RFA-HS-10-015 (see  http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-015.html)

The grant programs noted above represented large investments aimed at answering pressing CER questions and developing infrastructure that could be used for CER and PCOR. Notwithstanding the success of these programs, AHRQ recognizes that the 3 year time-frame of these awards limits the full benefits of the research investments that have been made as well as the type and intensity of stakeholder engagement needed to fully develop the potential of the data infrastructure.  The purpose of this FOA is to conduct of a limited competition to increase the capacity and impact of the projects funded under the FOA's listed above, to improve the opportunities for sustainability of the resources these projects funded represent by improving responsiveness to stakeholders, to further promote the use of patient-centered outcomes in CER and PCOR, and to provide infrastructure for future research aimed at enhancing real-world decision making.  The immediate goals are to enhance the data resources and relevant analytic methods and to enhance the stakeholder engagement in order to understand their needs that can be met by the infrastructure.  Examples of these needs may be stakeholder-relevant research questions that improve patient decision making and shared decision-making, improve workflow and health care practices, and/or address issues of interest to policymakers.  This FOA provides for the development of CER/PCOR infrastructure and not the conduct of research, but the new development of infrastructure should be guided by specific, stakeholder-driven research questions to insure the utility of the resources developed.  The ultimate goal of this FOA is to develop a comprehensive and sustainable data infrastructure that has capability and flexibility to address a range of current and future stakeholder needs related to CER and PCOR.  Current recipient organizations funded under the above FOAs are eligible to apply for the current FOA.  The PD/PI of the proposed project may be the current PD/PI of the grant funded under the above FOAs or be a qualified individual from the applicant organization endorsed by the current PD/PI.

Projects resulting from the four FOAs noted above involved developing research infrastructure, whether for recruiting participants into a clinical trial, a condition oriented registry, or a linkage of clinical data systems.  The projects were also designed to use this infrastructure to answer relevant and targeted questions centered around comparative effectiveness.  In the current FOA, we request applications that enhance the capability and extend the usefulness of the research and/or clinical infrastructure to improve the ability to address new questions in comparative effectiveness or PCOR.  For the purpose of the current FOA, examples of applicable infrastructure include research databases and data structures, linkages across data sets within and across diverse organizations, mechanisms for enhanced patient recruitment, and patient-reported outcome data.  This FOA aims to enhance all or part the infrastructure developed from the original investments to improve the capacity for new comparative effectiveness research or PCOR to meet the relevant needs of diverse stakeholders.  An explicit and comprehensive approach is needed to understand stakeholder needs.  In order to understand the capability of the data infrastructure to meet stakeholder needs, new, stakeholder-relevant questions should be developed and the capability of the network to address these questions should be evaluated.

The three objectives of this FOA are to:

1. Enhance existing data infrastructure.  To enhance data infrastructure, applicants could propose, for example:

2. Enhance stakeholder engagement to understand their needs.  To enhance stakeholder engagement, the applicants could add to diversity and number of existing stakeholders, increase intensity of engagement and explicitly ask questions to better understand their needs.  This is necessary to move the data infrastructure to a model that moves towards economic sustainability of the research infrastructure by being useful for clinical practice and/or quality improvement. Expanding the multi-functional capability of the infrastructure to meet the needs of diverse stakeholders will support long-term stakeholder participation and the ultimate sustainability of the infrastructure.  The infrastructure capability to address research questions includes clinical effectiveness and comparative clinical effectiveness of health care interventions for prognostic, preventive, diagnostic, therapeutic, or palliative purposes, and the interventions could include drugs, devices, surgical procedures, behavioral, or health system interventions  

3. Assess the capability of the data infrastructure to meet stakeholder needs.  The resources  for this FOA will not allow for the conduct of a research study.  Applications that propose the conduct of research will not undergo peer review or be considered for funding.  However, pilot projects to test the completeness and accuracy of the infrastructure in order to ascertain the validity of the infrastructure will be helpful in evaluating and planning for future use and development of the infrastructure as a resource for CER or PCOR to meet stakeholder needs.  The pilot study will not be a research study, i.e. the aim of the pilot study is to evaluate the capability of the resources for conduct of future research to answer the relevant research questions guiding infrastructure development rather than to answer these research questions.  In order to test that capability, it is important to know whether the infrastructure can collect or is collecting relevant and valid data.  Examples of evaluating the capability of the infrastructure include, but are not limited to evaluation of: the diverse patient subgroups that are included in the network; the linkages between different databases (e.g. diagnostic, pharmacy, claims, EHRs); the ease of extracting information from these databases; the completeness and accuracy of the data elements; the analytic and clinical utility of the data elements; the details on the clinical interventions  available in the infrastructure (e.g. the types of devices used in procedures or the types of patient-reported outcomes collected); and the governance and policy structures established to comply with relevant regulations.  Applicants should not budget more than 20% of total grant funds for the pilot projects.

Applications that address development of infrastructure in the absence of improved stakeholder engagement or assessing the capability to answer an explicit and relevant research question will be deemed non-responsive and will not undergo review.  The conduct of the proposed project should guide the opportunities to improve the chance for sustainability of the current research infrastructure.  Thus, as part of the project plan, the application must delineate a process to enhance the sustainability of the resource.  This process could consider, for future research purposes, issues such as maintenance of the research infrastructure (including personnel and data repositories), establishing or maintaining data linkages and data infrastructure, researcher access to and interface with data resources, and data reporting.

Sustainability maximizes the value of the investment in the original research projects.  For the purposes of this FOA, AHRQ takes a broad approach to evaluating sustainability; this could include improving either the research network aspects or the data aspects of the research resource, e.g., strengthening the data quality of current elements or expanding the breadth of data collection to meet stakeholder needs, so that the project increases the likelihood of future research and/or clinical funding for the infrastructure, or enhancing the capacity to accrue priority populations under-represented in trials for future research studies.  For those projects that do not expect to continue new participant accrual, sustainability of the resource could be enhanced by additional data collection on current participants to enhance relevance of the data resource for future research, or through the evaluation of data linkages to extend the relevance of the project data.  The aim of the efforts towards sustainability would be to increase the relevance and prominence of infrastructure to move towards a truly exceptional resource as part of the project, whether this development is aimed at future research funding or future funding by clinical health systems.

The application must also describe plans for governance of the infrastructure project (see Section IV.2 below).  Governance includes data governance and network governance.  Data governance deals with issues and policies related to data security and access in order to comply with applicable regulations and also to protect the privacy and confidentiality of a patient’s information as well as proprietary information of an organization.   Network governance involves a framework for stakeholder engagement and active involvement in shaping the infrastructure development, as well as policies to manage organizational partnerships, collaborations, and coordination of research activities.  It may included policies, personnel, and interventions to enhance recruitment of under-represented populations (when applicable).  It also includes policies to manage conflicts of interest.   

AHRQ expects that applications submitted under this FOA will:

In addition, AHRQ expects successful applicants to participate in and collaborate with other successful applicants and relevant experts through the Electronic Data Methods (EDM) Forum.  The EDM Forum is an AHRQ-supported mechanism to convene investigators, technical experts and diverse stakeholders interested in using electronic data infrastructure for CER, PCOR, QI, and support of clinical care.  Along with AHRQ’s Office of Communications and Knowledge Transfer, the EDM Forum also provides several dissemination opportunities relevant to these projects, including project snapshots posted on its website; publication of protocols, conceptual frameworks, case studies through eGEMS (an electronic, peer-reviewed publication); webinars and similar web-based dissemination activities.   Investigators are expected to attend steering committee meetings (for planning purposes, assume two investigators traveling to steering committee meetings a total of three times over the duration of the grant).  As part of this participation, applicants should propose plans to conduct one webinar for the EDM forum to occur during the duration of the grant.  Details on the EDM Forum are available at: www.edm-forum.org .

Section II. Award Information
Funding Instrument

Grant

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 commit $4.8 million in FY 2013 and fund up to 7 awards. The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.  AHRQ may add additional funds and fund additional awards should further funds become available.

Award Budget

Application budgets are limited to total costs (including direct and indirect costs) of $750,000 for the proposed project period.

Award Project Period

The proposed project period must not exceed 18 months.

These projects are being funded pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

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

This FOA is a limited competition.  The goal of this FOA is to extend the usefulness of research and clinical infrastructure developed within the four grant programs listed in Section I to answer new research questions in comparative effectiveness.  Thus, only those primary recipient institutions that currently hold grants funded under one of the four FOAs listed above in Section I are eligible to apply.  Institutions having multiple current awards funded under the FOAs listed above in Section 2, Part I may submit one application for each current award.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus 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 must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

For the current FOA, the PD/PI is limited to the current PD/PI of a project funded through one of the four FOAs listed in Section 2, Part I, or a qualified individual from the applicant institution who is endorsed by the current PD/PI.  The skills, knowledge, and resources to carry out the proposed research should be well justified in the application.  If the PD/PI is not the original PD/PI, the Appendix must contain a letter of support from the original PD/PI or the Dean or Business Officer of the eligible institution describing the relationship of the proposed PD/PI to the original research study, and his/her qualifications for and commitment to the completion of the proposed work.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

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

Only one application per institution (normally identified by having a unique DUNS number) per current   awardee is allowed.   Institutions having multiple current awards funded under the FOAs listed above in Section 2, Part I may submit one application for each current award.

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 can be sent electronically, and should be sent by e-mail to: Email: CERDataResourcesFOA@ahrq.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

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.

In the PHS 398 Research Plan Component, the following two additional sections must be included after the Research Strategy section (and do not count against the 12 page limit stated above for the Research Strategy Section).

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:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline 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/fund/hhspolicy.htm

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.

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 theSystem 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 by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.  Applications that are incomplete and/or nonresponsive 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 at 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 (see HIPAA website in prior paragraph) 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.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401. 

Grantees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and AHRQ policies.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.:

;Section V. Application Review Information


1. Criteria

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 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. 

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. 

As part of the initial merit review, all applications will:

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.

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? Does the proposed infrastructure development address clinical effectiveness and comparative effectiveness of health care interventions?  Has a research question guiding infrastructure development been identified as a need by a stakeholder?  Will the proposed infrastructure development clearly address the identified need?  

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?   

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?  Is the approach to meeting stakeholder evidentiary needs and/or the approach to enhancing the infrastructure innovative?  Does the topic(s) proposed for the EDM forum webinar represent an innovative contribution to knowledge and experience about electronic data infrastructure?   

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 applicant provide an adequately developed plan to enhance the sustainability of the infrastructure?  Are the plans for network governance and data governance adequate for the questions and proposed use of the established resources?

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.

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 Human Subjects Protection and Inclusion Guidelines

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? [Does the applicant provide a clear plan for data governance and network governance for the research resources?  Has a plan for engaging relevant stakeholders been adequately detailed?  Has the applicant provided an adequate and innovative plan for a webinar or webinars to be presented through the EDM forum?  ]

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  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 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 issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, 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/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.  

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

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 will provide the timetable for these 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 4/30/2014, the annual FFR is due 9/30/2014 (90 days after the end of the calendar quarter of 6/30/2014).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends.  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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to CERDataResourcesFOA@ahrq.hhs.gov .  For reasons of equity and consistency, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email.  A compilation of frequently asked questions and answers will be posted at: http://www.ahrq.gov/fund/grantix.htm.

Agency for Healthcare Research and Quality
Center for Outcomes and Evidence
E-mail address:  CERDataResourcesFOA@ahrq.hhs.gov

Peer Review Contact(s)

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

Ileana Ponce-Gonzalez, MD, MPH, CNC
Agency for Healthcare Research and Quality (AHRQ)
Office of Extramural Research, Education and Priority Populations (OEREP)
Division of Scientific Review
Telephone: (301) 427-1769
Fax: (301) 427-1562
E-mail address:   Ileana.PonceGonzalez@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Carol Harris
Agency for Healthcare Research and Quality (AHRQ)
Office of Performance Accountability, Resources and Technology
Grants Management
Telephone: (301) 427-1448
Fax: (301) 427-1462
E-mail address:  Carol.Harris@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.

AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

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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