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 (AHRQ)

Funding Opportunity Title

Electronic Data Methods (EDM) Forum: Second Phase (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HS-13-004

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 FOA solicits Research Demonstration and Dissemination grant (U18) applications from organizations that propose to continue and expand the work of the Electronic Data Methods (EDM) Forum. The Forum will convene investigators from projects similar in scope and capability to those in three programs: PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies), scalable distributed research networks, and enhanced registries for QI and CER (for further details please visit: http://www.edm-forum.org/publicgrant/About/projectprofiles/), experts in health information technology and in outcomes research, practicing clinicians, patients, representatives from relevant organizations, and other relevant stakeholders. 

The Forum, through a series of meetings, workshops, webinars, a dedicated website to engage with the public, and other relevant communication methods, will identify and prioritize challenges to conducting PCOR and CER using electronic data, including but not limited to scientific, technical, organizational, clinical, legal, and ethical issues, and challenges related to compliance with the Health Insurance Portability and Accountability Act.  Dissemination of the Forum’s work will occur through peer-reviewed journals, electronic publications (such as the eGEMS), webinars, meeting presentations, and other products posted on the Forum’s website.  

Key Dates
Posted Date

February 14, 2013

Open Date (Earliest Submission Date)

March 18, 2013

Letter of Intent Due Date(s)

March 15, 2013  

Application Due Date(s)

April 18, 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 dater

Expiration Date

April 19, 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


A. Background

The Electronic Data Methods (EDM) Forum was established in 2010. Its goals were to assist the electronic data infrastructure development of large, multi-site American Recovery and Reinvestment Act (ARRA) funded projects (please see previous FOA: http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-006.html); to advance the national dialog and understanding of challenges in linking and analyzing information across disparate databases and different care delivery settings to conduct comparative effectiveness research (CER), and the potential solutions to these challenges.  One of the hallmarks of these projects is their focus on AHRQ priority conditions and populations and to collect prospective, patient-centered information and other clinical data that can be used for research, quality improvement (QI), safety surveillance, and clinical care.  The EDM Forum has engaged investigators from these projects and a diverse group of stakeholders using a variety of formats, including large symposia, small workshops, web-enabled seminars and conference calls.  It has created a public website and a password-protected website to disseminate timely and relevant information, commissioned research papers and issue briefs, developed webinars, and used social media techniques to engage a wide and diverse audience. It has also created a new electronic publication platform called eGEMs (Generating Evidence & Methods to improve patient outcomes). Its work covers topics in four separate, yet related, domains: analytic methods, clinical informatics, governance, and learning health system.  Further details on the work of the EDM Forum and of the projects that collaborate with the Forum can be found at: www.edm-forum.org

B. Purpose 

This FOA is intended to support work to build on and expand the activities and products created by the EDM Forum under ARRA funding. The next phase of the EDM Forum is expected to further clarify common challenges, and propose realistic solutions, to advance the methods needed to develop the electronic data infrastructure and for collecting and analyzing patient-centered data, especially prospective and patient-reported outcomes data, for patient-centered outcomes research (PCOR), CER, QI, and support of routine clinical care.  Definitions on CER and PCOR can be found at: http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf and http://www.pcori.org/research-we-support/pcor/.  It will engage a broader set of stakeholders and projects, tackle more topics, and create a greater quantity and variety of products compared to the first phase of the EDM Forum. Its work is anticipated to encompass three categories of activities:  engage a broad group of experts and relevant stakeholders, conduct collaborative methods projects that propose and empirically test new solutions, and create diverse, high-quality and useful products for broad dissemination.

Project Requirements:

1. The EDM forum will convene investigators who are conducting studies similar to those affiliated with the EDM Forum (please see http://www.edm-forum.org/publicgrant/About/projectprofiles/), other relevant experts, practicing clinicians, patients, privacy and governance experts, representatives from relevant organizations including large employers and health insurers, and other relevant stakeholders, in order to identify and prioritize challenges to conducting PCOR, CER, QI and support of clinical care when using data from networks linking diverse electronic data systems and across delivery settings.  These challenges include scientific, technical, organizational, clinical, legal, and ethical issues that encompass four domains: research analytic methods, clinical informatics, governance, and learning health system.  The EDM Forum is expected to work closely with AHRQ program staff to identify relevant individuals as well as the topics for discussion and analysis.

2. The EDM forum is expected to propose realistic solutions to such challenges, or, when this is not feasible, to outline a course of research and/or discussion that will advance resolution of these issues. 

3. The work of the EDM Forum must be balanced across four different domains: analytic methods for PCOR and CER, clinical informatics, governance (including network and data governance), and learning health system. 

4.The EDM Forum will conduct focused collaborative methods projects (two to four per year) to either clarify issues for further research or to test practical, already-identified solutions to existing challenges in order to advance methods development and knowledge in this field.  These projects will need to be carefully designed to be feasibly done within the limited time and resources of this RFA. For example, smaller projects could be limited to convening one or two workshops that culminate in one or more papers.  Larger projects may include empirical testing of tools or approaches across multiple sites that lead to publications and dissemination of other products, such as new analytical tools.  

5. The EDM Forum will convene a steering committee of adequate expertise, diversity and size to guide its work. The size of the committee is expected to range from 15-30 members. The members will be identified and selected in collaboration with AHRQ program staff.  

6. The EDM forum must convene a minimum of three small workshops and one large symposium per year in addition to two steering committee meetings. 

7. The EDM Forum will disseminate the proceedings, analyses and recommendations of the meetings and workshops of the EDM forum in a variety of electronic and paper-based formats, such as scientific articles, web-based repository of relevant materials and products (such as short summaries of affiliated projects, presentations, software programs and related technical materials), and an e-publication such as eGEMS.

8. The EDM forum will endeavor to collaborate with all major relevant national projects, especially those funded by HHS, that use electronic clinical databases for PCOR, CER, QI and routine clinical care. Broad collaboration, open access, and fair, frank and productive discussions are expected to be hallmarks of EDM Forum activities.

9. The EDM Forum will conduct relevant background research and develop materials (such as literature reviews) to support discussion and deliberation at its meetings. The materials will be shared with Forum members, other experts, AHRQ staff and others deemed relevant to the topic under discussion. 

10. The EDM Forum will facilitate electronic, phone, paper and other communications among and between EDM forum members, AHRQ program staff and relevant experts during and between meetings, and the public, as dictated by the needs of a topic.  This will include creating and maintaining a website dedicated to the Forum and posting materials and requests for comments on the website in a timely manner. The nature and mix of these products and methods will need to be tailored to the topic under discussion and the awardee will need to demonstrate flexibility and expertise in these methods and products to meet the needs of the Forum. 

11. The EDM Forum will be responsible for all meeting logistics, including the composition of workgroups, development of materials for the meetings, travel and meeting management, and the distribution of follow-up materials and action items after the meetings. The EDM Forum will facilitate communication among all relevant stakeholders using all relevant methods. These communications may include soliciting and managing peer-review of different products, collating feedback and assisting EDM forum members in revision of draft products.

12. The budget for the EDM Forum is anticipated to be used for three categories of work in the following manner:  1. Create a collaborative forum (the set of activities needed to constitute the forum include in-person and electronic meetings); 2. Conduct collaborative methods projects; 3. Dissemination (including stakeholder engagement).  The applicant has flexibility in allocating the proportion of budget to the above three categories provided the budget for any single category does not either exceed either exceed 50% of the overall total cost budget or fall below 20% of the overall total cost budget. The budget needs to clearly identify what costs are associated with what category of work.

13. The EDM Forum is expected to utilize its website to obtain relevant and timely information needed for its work from diverse stakeholders in a manner consistent with the requirements of the Paperwork Reduction Act.

14. It is expected the PD/PI will spend at least 25% (3 person months) of his or her time annually on the project.  It is expected that a named project manager will spend at least 50% (6   person months) of his or her time annually on the project.  Applications must reflect this time commitment from the project leadership.

15. The EDM Forum will engage diverse stakeholders to understand the different sustainability approaches and clarify the most- feasible approach to the long-term sustainability of its work. The application must specify its approach for long-term sustainability of the EDM Forum.   It is expected that the selection of topics for discussion, speakers, creation of products, and other dissemination activities will need to be coordinated with different AHRQ programs and program staff in order to avoid duplication and enhance synergy and impact of these programmatic activities.  This will necessitate substantive and substantial AHRQ program staff involvement in all major phases of the project.  Additionally, the nature and mix of products and methods will need to be tailored to the topic under discussion and the applicant will need to demonstrate flexibility and expertise in using a variety of methods and products to meet the needs of the Forum.

16. The EDM Forum will create brief quarterly reports and detailed annual reports to ascertain progress made in achieving major milestones in each of its four domains of work: analytic methods, clinical informatics, governance and learning health system.

Section II. Award Information
Funding Instrument

Cooperative Agreement:

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 one award, for a maximum of $1,700,000 total costs in the first budget year.  A maximum of $5,100,000 is available for the three-year duration of the project.  The award is contingent on AHRQ appropriations and the submission of meritorious applications.  

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $5,100,000 for the entire three year project period.  For each year of the project period, the maximum total annual costs requested must not exceed $1,700,000.  Any application that exceeds these amounts (annual and project period total) will not be reviewed.

Award Project Period

The project period for this award is three years

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

You may submit an application(s) if your institution/organization has any of the following characteristics: 

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 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)

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.

Only one PD/PI may be designated on the application.  The PD/PI must devote a minimum level of effort of 25% annually (3 person months) to the project.

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 can be sent electronically, and should be sent to:

Center for Outcomes and Evidence
Email: EDMFOA2013@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, with the following exceptions or additional requirements:

SF424(R&R) Cover Component, SF424(R&R) Project/Performance Site Locations Component, SF424(R&R) Other Project Information Component, SF424(R&R) Senior/Key Person Profile Expanded Component, Research &Related Budget Component, PHS 398 Cover Letter Component, PHS 398 Cover Page Supplement, Optional: Research & Related Subaward Budget Attachment


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:

Research Strategy: There must be at least four sections.

Section I. Approach to achieve specific aims.

This section must have at least four components:

1. Approach to identify, prioritize and analyze topics relevant to the four domains of the EDM Forum's work: analytic methods, clinical informatics, governance, and learning healthcare system.  These topics are anticipated to include scientific, technical, organizational, clinical, legal, and ethical issues encountered when linking disparate data systems and health care delivery sites. 

2. Approach to identify and convene relevant experts and stakeholders.  It is anticipated that ties to the existing projects affiliated with the EDM Forum will be maintained and strengthened and that new projects (such as those funded by PCOR trust funds, HHS agencies and other organizations) will be added to the EDM Forum.

3. Approach to identify topics for collaborative methods projects and the approach to conduct these projects.  The topics are expected to advance our methods to solve broad, cross-cutting challenges in using electronic clinical data for CER, PCOR, QI and clinical care. The topics for the first year should be listed, along with the rationale for choosing these topics; the approach to conduct these projects should also be specified.  The applicant may propose a set of topics for the second and third year with the knowledge these topics may change after consultation with the steering committee and public input. 

4. Approach to create and disseminate new products through a variety of methods, including eGEMS, journal supplements, webinars, social media etc. 

Apart from the program officer, staff from several AHRQ programs may need to involved in different activities of the EDM Forum.  These include staff from AHRQ's HIT program, DEcIDE Network, CERTs program, EPC program, and Office of Communications and Knowledge Transfer (OCKT).  The nature and extent of these interactions between the recipient and relevant AHRQ staff will need to be clarified after discussion with the AHRQ program officer.

Section II. Research Team:

The research team must be multi-disciplinary with adequate expertise in health services and outcomes research, clinical informatics, dissemination and electronic publication. The PD/PI must allocate 25% or more of her or his time annually for this project.  A named project manager must allocate 50% or more of his or her time annually for this project.  The initial set of consultants (who may be experts in health information technology, outcomes and effectiveness research, clinical specialties, privacy and governance, and other relevant experts) to the EDM Forum will need to be named in the application. Since the needs of the project may necessitate a few modest changes to the initial set of consultants, the applicant should specify its ability and approach to add consultants. The awardee, with appropriate input from AHRQ program staff, will be responsible for identifying and justifying the composition of the group tailored to the needs of each workgroup activity. The activities will serve the general community involved with the development of electronic health data infrastructure and the advancement of methodology for collecting and analyzing prospective data from electronic clinical databases for comparative effectiveness research.

Section III.  Past Experience:

The application must demonstrate a proven track record of organizing scientific and technical meetings and workshops in a timely and efficient manner; engaging diverse stakeholders; being inclusive of different perspectives; and rapidly creating and disseminating accurate, useful and usable paper-based and electronic products. The applicant must have experience in rapidly adding experts or other consultants on an as-needed basis.  The applicant must demonstrate experience and familiarity with the range of issues that have been addressed by the EDM Forum in the past.  The past experience can be on topics related to those addressed by the EDM Forum and not identical to those addressed by the EDM Forum.  AHRQ places a special emphasis on topics affecting populations that are underrepresented in clinical trials or underserved in healthcare or both as well as clinical topics and issues that are currently understudied.

Section IV. Sustainability:

The application must outline a plan for sustainability of the EDM Forum after the end of this funding.

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.

NOTE:  The applicant will need to clearly identify in its proposed budget how it has allocated requested costs among three required categories: Create a collaborative forum; Conduct collaborative methods projects; Dissemination.

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. 

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.  

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 AHRQ.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness 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 reviewed by AHRQ for completeness and responsiveness.

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.

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? Does 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 there adequate expertise of the project team in all relevant areas, including health services and outcomes research, clinical informatics, learning health system and governance? Has the PD/PI budgeted at least 25% annually of his or her time? Has the project manager budgeted at least 50% annually of his or her time?

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?  Are there innovative approaches to efficiently ascertain current challenges in the field and to disseminate information to a broad group of stakeholders?

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?

Will the approach to collaborative methods projects advance the methods and overcome existing challenges? Does the approach to identify current challenges include efficient interactions with a broad group of stakeholders? Is the approach to identify and prioritize topics balanced between different domains: analytic methods, clinical informatics, governance and the learning health system?   Will the approach ensure creation of high-quality, credible, useful and timely products on its website and in peer-reviewed publications?

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? [Are all four domains of topics: analytic methods for CER and PCOR, clinical informatics, governance, and learning healthcare system, adequately addressed?  Are all three categories of activities: convene meetings with adequate expert and stakeholder representation, conduct collaborative methods projects, and broad dissemination, adequately described with appropriate resource allocation to achieve FOA goals?

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 reasonable and is the requested period of support appropriate in relation to the proposed research? [Is there appropriate budget allocation for each category of activity: convening meetings, collaborative methods projects and dissemination (including stakeholder engagement) with none of these exceeding 50% and none below 20%?].

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 will be assessed. (Note: use this as appropriate)

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 PHS 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 Notice of Award.

If activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, the applicant should be aware that such activities are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521).  Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances.  It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process.  Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained.  Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the Notice of Award  
These terms of award are in addition to otherwise applicable OMB administrative guidelines:  DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), and other DHHS, PHS, and AHRQ grant administration policy statements.  AHRQ will use these procedures in evaluating and administering this cooperative agreement.   

The administrative and funding instrument used for this program is the cooperative agreement A cooperative agreements is an "assistance" mechanism (rather than an "acquisition” mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities.  Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, although specific tasks and activities may be shared between a grantee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by the AHRQ Program Officer. These include, but are not limited to, the selection of topics and approach for conducting collaborative methods research, choice of the appropriate dissemination products, choice of steering committee members and stakeholders to be engaged, size and type of various meetings.  

2. A.1. PD/PI Rights and Responsibilities

The PD/PI will have the primary responsibility for interacting with experts and stakeholders, planning and convening meetings, planning and oversight of collaborative methods projects, creation of websites and dissemination products, editorial process of the eGEMS, and planning for sustainability. The PD/PI will ensure allocation of adequate project personnel time and use comprehensive project management systems to ensure adequate oversight, tracking, and timely completion of all important tasks and steps relevant to its activities. .

2. A.2. AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

2.A.3. Collaborative Responsibilities

The EDM Forum steering committee will include a broad group of experts and stakeholders as well as AHRQ staff and EDM Forum project staff.  The final list of committee members will be jointly decided by EDM Forum staff and AHRQ.  The list of topics for discussion at meetings and for collaborative methods projects will be jointly decided by AHRQ and EDM Forum staff.  The follow-up activities from the steering committee meetings, collaborative methods projects, and other scientific meetings will be jointly decided by AHRQ and EDM Forum staff.  The list of stakeholders for engagement, and the means of engagement, will be jointly decided by AHRQ and EDM Forum staff. 

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 4/30/2013, 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.  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 EDMFOA2013@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.

Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
E-mail address:  EDMFOA2013@ahrq.hhs.gov

Peer Review Contact(s)

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

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

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Anna Caponiti
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1402
Fax: (301) 427-1446
E-mail address:  Anna.Caponiti@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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