Part I Overview Information

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Department of Health and Human Services

Issuing Organization
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Outcomes and Evidence (COE), Office of Communication and Knowledge Transfer (OCKT), (http://www.ahrq.gov)

Title: Partnerships for Sustainable Research and Dissemination of Evidence-based Medicine (R24)

Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type

This Funding Opportunity Announcement (FOA) is a new RFA

Request For Applications (RFA) Number: RFA-HS-12-005

Catalog of Federal Domestic Assistance Number(s):
93.226

Key Dates
Release Date: March 9, 2012
Letters of Intent Receipt Date(s): April 27, 2012
Application Receipt Dates(s): May 22, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date
Additional Information To Be Available Date: Not applicable
Expiration Date: May 23, 2012

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This AHRQ funding opportunity announcement (FOA) solicits Resource-Related Research Project (R24) applications from applicant organizations that propose to build new and/or enhance existing capacity in research and dissemination infrastructure that will bridge the gap between clinical and health services research and everyday practice by building a knowledge base about how to improve the translation and dissemination of evidence-based health information, interventions, and clinical practices to populations not traditionally reached by such information or practice. In addition, AHRQ is aiming through this FOA to seed a sustainable infrastructure that would continue to disseminate appropriate evidence-based health information to such a population independent of research grant support. Applicants are invited to use collaborative expertise to propose innovative approaches to customizations of content and delivery mechanisms of existing evidence-based health information and/or tools for their use in the target audience(s) (as defined in this FOA under Part II Section I.1, Research Objectives section) so as to increase their use, implementation, and impact. Innovations should aim to increase the impact and effective use of evidence-based health information and/or tools by developing, implementing, and evaluating customizations that target important audiences, stakeholders, systems, or settings; these customizations should engage multiple user-stakeholders, including the target audience, and be grounded by the original evidence-based information/tools contents.
• Mechanism of Support. This FOA will use the AHRQ Resource-Related Research Projects (R24) grant mechanism.
• Funds Available and Anticipated Number of Awards. AHRQ intends to commit a total of $2.3 million annually to fund an anticipated 7-10 awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
• Budget and Project Period: The total costs for a grant awarded under this FOA will not exceed $300,000 annually for the entire project period, which may not exceed 3 years. An application with a budget that exceeds $300,000 total costs in any given year, or that exceeds 3 years in duration, will not be reviewed. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report (PHS 2590).
• Application Research Strategy Length: The Research Strategy section may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. The PD/PI must commit substantial time to the oversight of project and activities (at a minimum 15% annually).
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions: Resubmission applications are not permitted in response to this FOA.
• Renewals: Renewal applications are not permitted in response to this FOA.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

It is critical that applicants follow the instructions in the PHS 398 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

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
B. Submitting an Application to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Objectives

AHRQ seeks applications for Resource-Related Research Projects (R24) from applicant organizations that propose to: 1) build or enhance the applicant’s capacity to create an enduring sustainable infrastructure for on-going dissemination of evidence-based health information; and 2) conduct research studies that advance our knowledge of how to extend the reach and impact of evidence-based health information/tools to populations with a demonstrated need for the information.

Applicants must collaborate with stakeholders and the target population in an effort to develop and sustain an enduring infrastructure. AHRQ encourages applicants to build trans-disciplinary teams and collaborate with institutions well versed in comparative effectiveness methodologies or with research centers and integrated health care delivery systems capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decision-making, which includes pre-existing networks or organizations. The resulting infrastructure should have the ability to continue the dissemination and implementation of evidence-based health information begun in this project. An applicant, in connection with its partners, should aim to increase the impact and effective use of evidence-based health information by developing innovative approaches or strategies for disseminating this information to the target communities, populations, or clinical practice settings, and by conducting research that evaluates these strategies. Applicants should pursue adaptations, dissemination, and/or implementations focused on non-traditional settings or organizations, including, but not limited to neighborhoods, communities, or faith-based organizations. .

Applications that propose simple propagation of unchanged evidence-based information through printing and distribution, email, or listservs will not be considered as enhancing capacity or innovative and will be deemed as non-responsive to this FOA.

Background on Comparative Effectiveness Evidence

AHRQ supports research grants and contracts focusing on comparative effectiveness of different clinical treatments and services, as authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), Pub. L. 108-173, and Title IX of the Public Health Service Act. See 42 U.S.C. 299 et seq. (see also http://effectivehealthcare.ahrq.gov/index.cfm). These grants and contracts support research on the generation, synthesis, and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system. Research projects are informed by the information needs and inputs from various stakeholders (e.g., policy-makers, clinicians, and patients/consumers) to ensure the most appropriate and important outcome measures for assessing the effectiveness of the interventions are included in the study.

AHRQ s Effective Health Care Program has invested in building a knowledge base of evidence-based healthcare through a variety of means, including research networks such as the Evidence-Based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, and the Centers for Education and Research on Therapeutics (CERTs). Researchers within these organizations help AHRQ to identify, develop, and critically appraise the most important and relevant medical research on treatments, medications, and medical technologies for different kinds of health problems. A key and inter-related component of AHRQ’s Effective Health Care Program is the John M. Eisenberg Center for Clinical Decisions and Communication Science which translates the primary scientific findings in plain, actionable language while preserving the fidelity of the more complex primary source. Additionally, to complete the evidence translation and dissemination efforts undertaken by the John M. Eisenberg Center for Clinical Decisions and Communications Science, funds from the American Recovery and Reinvestment Act (ARRA), Pub. L. 111-5, are supporting four dissemination and implementation projects from September 2010 to September 2013: The National Initiative for Promoting Evidence-Based Health Information, Regional Partnership Development Offices, Online Continuing Education, and Academic Detailing. In addition, a separate Systematic Dissemination Program Evaluation project not only develops metrics and collects data for measuring the impact of each project, but also provides continuous feedback for ongoing project improvements (see http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/).

ARRA funds also support AHRQ research on improving methods of disseminating information . The Innovative Adaptation and Dissemination of AHRQ Comparative Effectiveness Research Products (iADAPT) grant program seeks to extend the reach and impact of AHRQ Comparative Effectiveness Research (CER) products through innovative adaptations or customizations to the content presentation and/or delivery mechanisms. These grants specifically aim to increase the use of CER products in populations that are underserved by existing health care and health care information delivery systems. The grants funded under this initiative can be found at: http://www.ahrq.gov/fund/recoveryawards/awtrans.htm.

Purpose

Awards under this FOA will be made pursuant to the authority of Section 937(a)(1) of the Public Health Service Act, 42 U.S.C. 299b-37(a)(1) which provides that AHRQ shall disseminate research findings of the Patient Centered Outcomes Research Institute and other government-funded research relevant to comparative clinical effectiveness research.

The purpose of this resource-related research program (R24) is to enhance the capacity and science of dissemination and translation of evidence-based health information tools to populations, communities, and settings not currently reached by such information. This FOA will provide funds to institutions and research teams to build an enduring research infrastructure to bridge the gap between public health, clinical and health services research, and everyday practice by developing adaptations to evidence-based health information for the target populations, to conduct research to document the effectiveness of this information, and to develop the infrastructure to continue efforts to disseminate evidence-based information after the grant period. Specifically, this FOA seeks to:

1) Create and/or enhance a research and dissemination infrastructure to investigate approaches that may show effectiveness and generalizable lessons in communication, education, translation, and/or behavioral interventions related to evidence-based health information for populations often not served by such information by:

1. Establishing and maintaining collaborative linkages across multiple components of the applicant institution and/or collaborations with other institutions, networks, or partners; and
2. Assembling experts to develop comprehensive trans-disciplinary research teams.

2) Stimulate the development, application, and evaluation of multiple user-stakeholder and/or community-based approaches to increase the use and application of evidence-based health information tools among populations whose needs are not currently met or populations who are not reached by existing evidence-based health information. Specifically, these projects will:

1. Investigate novel approaches for adapting lessons in communication, education, translation, and/or behavioral interventions related to evidence-based health information/tools in a wide range of audiences and settings; and
2. Develop and evaluate multiple mechanisms to disseminate and/or implement the use of evidence-based findings among diverse populations with intent to increase the use of evidence-based information among these populations.

In order to achieve these objectives, applications for research projects must include the following six key components:

1. Infrastructure Development for Translation and Dissemination of Evidence-based Information

The complexity of and technical language typically used to convey scientific research findings mandates a concerted effort in ensuring the information is communicated in a format that is understandable to those beyond the research community. The translation and adaptation of evidence-based research into health information products requires an understanding of the needs, culture, etc. of the target population in addition to knowledge of techniques and strategies that generate health information products. As shared decision making inches forward from an appealing idea to a tenable goal in clinical practices, the expectation that consumers and patients understand evidence and use the information to help improve their health also rises.

One of the objectives of this FOA is to build upon the various efforts AHRQ has made in support of the development, dissemination and implementation of evidence-based health information products. As the expertise required to address the aforementioned resides in various disciplines, the applicant is expected to develop a multi-discipline infrastructure that will facilitate access to and use of evidence-based information by the target audience(s). Such a multi-disciplinary infrastructure likely will include familiarity with and/or expertise in some combination of: clinical care, health services research, systematic reviews and other evidence-based information, health communication, marketing, information science, clinical decision-making, organizational and management theory, individual and systems-level behavioral change, anthropology, learning theory, and public health.

Many entities do not contain the requisite skill set in-house to conduct translations, dissemination and implementation activities. To that end, applicant organizations must create and/or enhance an existing research infrastructure and outreach networks to develop the capacity to carry out research, as well as implementation efforts, in the adaptation and dissemination of evidence-based health information to populations that are not currently served or are under served by existing evidence-based information.

AHRQ is especially interested in partnerships at the local and/or community level to facilitate the engagement of the target population. Responsive applications must include descriptive plans for developing partnerships with stakeholders, including, but not limited to: community organizations, patient support organizations, senior citizen centers, community health centers, federally- funded health centers, American Indian or Alaskan Native organizations, regional or state health organizations, etc., and provide support for such partnerships. These partnerships are expected to facilitate collaboration among stakeholders, including, but not limited to, multiple public health and/or clinical practice organizations and consumers of services and their families/social networks, develop and/or test conceptual models of adaptation, dissemination and implementation that may be applicable across diverse community and practice settings, and to extend the reach and impact of evidence based health information to underserved populations. Applications must include a detailed plan to create trans-disciplinary research teams capable of research studies that effectively disseminate and implement evidence-based health information and/or tools. Applications should provide letters of support when appropriate. Further, applicants should provide an overview of their capabilities for identifying, convening, and obtaining input from a wide variety of stakeholders, including: the applicant’s relationships with academic departments, both internally and externally, professional societies, policy makers, patients, consumer organizations, and health care providers related to the research interests that will facilitate establishing a research infrastructure.

2. Sustainable Capacity for Dissemination and Translation

This FOA aims to develop and facilitate an enduring infrastructure with the capacity to conduct on-going dissemination and translational activities of appropriate evidence-based information to target populations that would be sustainable beyond the period of this proposed funding opportunity. As the capacity of the research community to generate results from patient-centered comparative effectiveness studies grows, so will the need for a dissemination and implementation infrastructure that will support the rapid diffusion and use of these findings, especially by populations who have historically had poor access to or awareness of the relevant findings. Past efforts at translating research into practice have often fallen short on sustainability beyond the initial period of grant support. A solution to this persistent challenge is unlikely to occur without building a coalition of stakeholders who have an interest in findings solutions to this problem.

Applicants must clearly define partnerships, including stakeholders, they intend to engage in capacity building and have a plan for sustainability of the dissemination activities beyond individual research grants. These partnerships are expected to engage public health and/or clinical practice organizations and consumers of services and their families/social networks, to develop sustainable and potentially scalable models of adaptation, dissemination, and implementation that may be applicable across diverse community and practice settings to extend the reach and impact of evidence based health information to underserved populations. Applicants must document their ability and experience in working with stakeholders and members of the target population and demonstrate their plans to establish enduring partnerships. Proposed partners should acknowledge the project’s goals of continuing efforts to disseminate evidence-based health information after the grant period and articulate their commitment to these goals. Applications that include partnerships with a health care delivery network, such as a primary care Practice-Based Research Network (PBRN), must include one or more local or regional community stakeholders such as those listed above. Applicants are expected to justify their choice of partnership and provide information on elements in place that secure the sustainability of the partnership and follow-through of the stated research aims.

3. Targeted Stakeholder/Community Groups/Study Population/Settings

AHRQ seeks applications that target diverse groups across diverse settings, address unmet needs, offer generalizable lessons, and afford the greatest possible public health impact in terms of disease burden and the quality, safety, effectiveness, and efficiency of health care. Applicants should describe the significance of their proposed target(s) in these terms for their application.

Applicants must clearly define target audience(s), system(s), and/or setting(s) that they intend to target for research. If more than one group or setting is proposed, the feasibility of accomplishing the scope of proposed work should be specifically addressed in the application. Populations and/or settings for targeted adaptation or dissemination of evidence-based health information may be conceptualized by geography, urban/rural/MSA residence, demographics, organizational unit(s), social or other networks, or other schema. Examples include integrated healthcare delivery systems, primary care PBRNs, faith-based communities, regional health information organizations, hospital chains, policymakers including governments and health departments at the state, regional, county, or Federal level, and clinicians and other providers who serve underserved populations or those with special needs. AHRQ welcomes and encourages applications that address the needs of populations whose needs are not currently being met through traditional methods.

Applicants should document their ability and experience in working with the proposed target audience(s), system(s), and/or setting(s). This may be provided through robust partnerships with a variety of organizations and stakeholder groups as described in the preceding section. For the proposed target audience(s), system(s), or setting(s), the proposed work must be based upon a demonstrated need identified by gaps, barriers, or limitations in the use or application of currently available evidence-based health information by the proposed target(s). Applications must provide at least preliminary evidence to support the feasibility and receptivity of the proposed target(s) for evidence-based health information. Need may be based upon the recognition of locally high disease burden, morbidity, mortality, financial or emotional burdens, uncertainty in decisions being made in typical health care encounters, community or other types of surveys, key informant interviews, or other factors.

4. Sources and Translation of Evidence-Based Health Information

Applicants must apply or develop one or more new or innovative customizations or mechanisms of delivery to the content of evidence-based information and/or tools in order to enhance their use and value in decision-making by key audiences, including patients/consumers, clinicians, and policy makers. Comparative effectiveness information/tools must be chosen from trusted sources, including, but not limited: AHRQ, Institute of Medicine (IOM), Cochrane Collaborative, and the U.S Preventive Services Task Force. Adaptations must preserve the fidelity of the original product(s) contents, and the application must describe methods of adaptation.

A wide range of mechanisms, media, and communication channels may be considered, including but not limited to:

• Paper-based products, such as brochures, narratives, or case studies that are adapted in design, format, or language to colloquial usage or cultural sensitivities
• Electronic or technology-based dissemination channels or tools, such as internet, TV, radio, cell phone, social networking sites, listservs, health avatars, and others
• Adaptation to electronic health records, personal health records, electronic medical records, or clinical decision support aids attached to these systems
• Personal interactions occurring through one-on-one interactions (such as academic detailing, kitchen table meetings) or group discussions (such as focus groups, social or health care professional meetings, town hall meetings), or routine settings such as work, school, or health care clinics.

These and other mechanisms may be combined, as long as the combined feasibility is addressed and supported in the application. Simple propagation of unchanged material through printing and distribution, email, or listservs will not be considered innovative or responsive to this FOA and will not undergo peer review.

Applicants must describe and support all proposed methods or mechanisms for adapted presentation and/or delivery of evidence-based health information. Applications must include a clear rationale and approach for the proposed adaptation(s) of materials, such as media requirements, cultural sensitivities, literacy and numeracy, English language proficiency, visual/educational/cognitive competencies of the targeted audience or stakeholder group members, information processing and burden, conflicting health beliefs or information sources, issues with authority or trust of information provided by the government, or other considerations. Applicants are encouraged, but not required, to assess the utility of the original evidence-based health information/tool to the proposed target(s) for adaptation, so as to identify key, generalizable gaps in content presentation or formatting, acceptance, understanding, or willingness to apply the materials in actual use situations. Such assessment would provide evidence to guide subsequent adaptation or modification of the primary material to a specific audience, system, setting, communication channel, or expanded purpose.

5. Dissemination of Research Findings

The application must include a plan for dissemination of research findings and products to AHRQ and external audiences. Work products may be in the form of a product, tool, customer needs assessment and/or evaluation report, or other mechanism that is publicly shareable by AHRQ through its Effective Health Care Program or other sponsored Web sites; these work products are distinct from the required final progress report for the project. Applicants should anticipate and be responsive to requests from AHRQ to share preliminary findings with AHRQ as well as other grantees funded under this FOA; if such requests are made, AHRQ will provide an AHRQ-sponsored venue so that important findings from needs assessments, focus group testing, or other feedback can be shared and applied in a timely fashion. In particular, AHRQ is interested in the timely application of information to remediate findings about what does not work or what is inappropriate for specific audiences.

6. Evaluation Plan

Applicants must describe an evaluation approach for all proposed dissemination and implementation activities. The evaluation plan must be based on an accepted conceptual framework or theory that would inform the measures chosen, data collection, and evaluation of the data. Ideally, the plan would include valid outcome measures. Health- or patient-centered outcome measures are preferred but may be difficult or infeasible to obtain. To this end, candidate outcome measures (or endpoints) should be specified in the application and their validity described, along with proposed data collection methods or data sources that are planned for use in evaluation. While changes in patient health outcomes (such as reduced admissions for poorly controlled chronic illnesses) or close surrogates of health outcomes (such as serum cholesterol or hemoglobin A1c) are desirable outcome measures, they may be impractical or unobtainable within the scope and timeframe of efforts proposed under this FOA. Accordingly, peer reviewers and AHRQ will consider the relative strength of the applicant’s proposed outcome measures. These may include, but are not limited to:

(a) Changes in established or otherwise validated patient-centered measures (such as satisfaction with medical care or its processes);

(b) Changes in process measures (such as the number of individuals who made use of evidence-based information in medical care;

(c) Changes in patient activation or improvement in locus of control in disease management;

(d) Changes in the target(s) knowledge, skills, or attitudes regarding evidence-based health information products;

(e) Changes in use parameters (such as number of visits, downloads, mentions in blogs, and others); or

(f) Changes in health care provider behavior as measured by process measures, prescribing behaviors, or surrogate patient evaluations of provider behavior.

Close surrogates of health outcomes should be sought wherever possible, but if these are infeasible, applicants are urged to seek the best possible measures of change(s) in the targeted groups (such as changes in knowledge, awareness, activation, behaviors, satisfaction with care decisions, etc.) Any process measures that are proposed as evaluation measures (such as the volume used in practice or that is distributed, requested, downloaded, or propagated through secondary channels) should describe the nature and strength of their relationship to desired health behaviors, outcomes, or surrogates.

The evaluation design (i.e. pre/post, interrupted time series, etc.) and analytic plan should be described and justified in sufficient detail to permit independent assessment of their strength and suitability for the intended evaluation. Mixed methods that include qualitative assessments of lessons learned as well as quantitative results are encouraged. If mixed methods are proposed, applicants are encouraged to follow the guidance given in the NIH guide for Best Practices for Mixed Methods Research in the Health Sciences. (http://obssr.od.nih.gov/scientific_areas/methodology/mixed_methods_research/index.aspx)

See Section VIII, Other Information Required Federal Citations for policies related to this announcement.

Section II. Award Information

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1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Resource-Related Research Projects (R24) grant mechanism. The individual researcher sponsored by each organizational applicant will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

2. Funds Available

This initiative is supported by funds provided to AHRQ pursuant to 26 U.S.C. 9511(d)(2), which provides for the transfer of funds from the Patient Centered Outcomes Research Trust Fund to carry out Section 937 of the Public Health Service Act. AHRQ intends to commit $2.3 million total costs annually to fund 7-10 grants of up to 3 years duration, contingent upon the submission of a sufficient number of scientifically meritorious applications. Resubmissions are not allowed under this FOA. Applicants are encouraged to accelerate and complete work in less than 3 years, when appropriate.

Budget proposals are limited to $300,000 total costs in any one year for a total not to exceed $900,000 total costs over a period of three years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years, budgets that exceed $900,000 total costs over 3 years, or with a total cost that exceeds $300,000 in any given year, will not be reviewed.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report.

Section III. Eligibility Information

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1. Eligible Applicants

1.A. Eligible Institutions

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

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Units of local or State government;
• Eligible agencies of the Federal government.
• Indian/Native American Tribal Government (Federally Recognized);
• Indian/Native American Tribal Government (Other than Federally Recognized);
• Indian/Native American Tribally Designated Organizations.

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

Applications from health care provider organizations that directly provide services to the targeted population, such as integrated health care delivery systems or primary care Practice-Based Research Networks, interested in dissemination and implementation research in partnership with appropriate community stakeholders and members of the target population are also encouraged.

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.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. The PD/PI must commit substantial time to the oversight of project and activities (at a minimum 15% annually).

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

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. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

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1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A below for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): April 27, 2012
Application Receipt Dates(s): May 22, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions. Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent should be sent electronically to: DisseminationGrants2012@ahrq.hhs.gov

The letter of intent is to be sent by the date listed in Section IV.3.A.

3.A.2. Technical Assistance

As appropriate, AHRQ will post Frequently Asked Questions as common questions are identified. Questions and replies will be shared on the AHRQ web site at http://www.ahrq.gov/fund/grantix.htm.

3.B. Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Partnerships for Sustainable Research and Dissemination FOA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Room 6347
Rockville, MD 20850
Telephone: (301) 427-1600
FAX: (301) 427-1521Email: DisseminationGrants2012@ahrq.hhs.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete and/or non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. The applicant should obtain an estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

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

The application must include:

• How the organizational structure includes, or will include, a trans-disciplinary core of investigators and institutional capacity with expertise in dissemination, translation and implementation of evidence-based health information.
• A mechanism (such as a community advisory board) to solicit advice/feedback from the communities of the target population.
• An organizational structure that transcends a single study, including multiple systems of communication with and among all investigators, stakeholders and members of the target population.
• A plan for sustainability that would include but not be limited to:
  • Exploration of potential sources of ongoing funding for the dissemination infrastructure, including professional organizations, academic institutions, governmental sources, foundations and other private sources.
  • Development of a 3-year business plan demonstrating how core administrative functions for the on-going dissemination and translation activities can be supported even in the absence of major funding for project-specific research.

Applications must clearly articulate a plan for building and/or expanding capacity in four key areas:

• development and/or strengthening trans-disciplinary research and outreach capacity devoted to dissemination and translational research;
• expanding the reach and strength of relationships between investigators, stakeholders and the target population;
• building an enduring infrastructure for dissemination and translational non-research activities; and
• developing a plan for sustained dissemination/translation activities independent of research grant support.

The PD/PI will have the primary responsibility for providing strong scientific leadership, for the organization and operation of the project; liaison with the research community and outside entities such as professional societies, subcontractors, and consumer groups; and communication with AHRQ on scientific and operational matters.

Applicants should also have a planning/advisory group with membership from all stakeholders and the target population. The planning/advisory group should evaluate the current strengths and weaknesses of the planned research and development of the infrastructure for dissemination activities in the key identified areas and consider all available resources in the planning process. Appropriate outside consultants may be called upon to assist.

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may not be reviewed if it does not comply with these requirements.

Research Strategy Page Limitations

All application instructions outlined in the PHS398 Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy section, including tables, graphs, figures, diagrams, and charts is limited to 15 pages.

Budget Component

Special Instructions for Modular Grant 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 the detailed budget format. Applications submitted in the Modular format will not be reviewed.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to 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. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see 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.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

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.

Section V. Application Review Information

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1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

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

2. Review and Selection Process

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:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

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. This FOA will help to support this mission by developing sustained dissemination and translation capacity for extending the reach and impact of AHRQ produced evidence-based health information across diverse communities, populations and clinical settings.

Overall Impact

Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 this study address an important problem or unmet need? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What is the significance of the described gaps/limits on the use of evidence-based tools by the target group(s)? Will findings about the group(s) be generalizable to other important groups? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions in comparative effectiveness, and the adaptation of such for diverse community and clinical settings? How will these research findings improve an understanding of the gap between knowledge and application of evidence-based health information/tools to populations with a demonstrated need for the information? Does this new understanding aid future adaptation, dissemination, implementation, or evaluation of evidence-based health information to promote quality, effectiveness, safety, and/or efficiency of health care delivery across diverse community and clinical settings?

Investigators. Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? For example, is the research team trans-disciplinary and is/are the institution(s) with which they propose to collaborate for the purpose of carrying out the proposed activities well- versed in comparative effectiveness methodologies and/or have demonstrated experience in comparative effectiveness methodologies or capability of performing accelerated clinical effectiveness and outcomes research, and the translation and dissemination of such? Do the trans-disciplinary team and/or collaborative institution have demonstrated experience in working with stakeholders and members of the target population?

Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; 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 dissemination of evidence-based health information to populations with demonstrated need for this information? For example, does the project extend evidence-based health information beyond current formats for communication, education, translation, and/or behavioral intervention, and dissemination of such information by using a new outreach mechanism or technology, by targeting a special subpopulation or community, practice setting, community- or other-based setting, or by conducting an adaptation and evaluation of its impact that goes beyond process measures? Does the project go beyond simple propagation of unchanged evidence-based health information through printing and distribution, email, or listservs?

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 tactics? Are the key variables of the research included and sufficiently described? Has the applicant adequately documented that the intervention, policy, etc. is evidence-based or, at a minimum, conceptually sound, based upon other dissemination and translation activities? Has the applicant adequately documented that the innovative customization will be derived from content that is evidence-based and from a trusted source or sources? Has the applicant sufficiently described and justified the target audience(s), stakeholder(s), system(s), or setting(s)? Is there a plan for evaluating the intervention and estimating its translatability to other evidence-based tools or targets? How closely do the proposed outcome measures approximate actual health outcomes? What is the strength and validity of the proposed evaluation outcome measures? Are there plans for capacity building, including creating and maintaining partnerships, and a sustainability plan appropriate for the planned target(s) and aims of the project? Does the applicant address the need to disseminate the findings of their research publicly? Does the applicant include a plan to share important interim findings with AHRQ and other awardees?

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? Is there evidence of support and commitment from the partner(s) or institution(s) proposed to be involved in the research? Is there evidence of prior effective interactions or accomplishments in any proposed partnerships?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? Does the application include an adequate description of how they will build and/or enhance the capacity and research infrastructure for conducing dissemination and implementation research AND a clearly defined research objective which aims improve the translation and dissemination of evidence-based health information, interventions, and clinical practices to populations not traditionally reached by such information or practice?

Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

Inclusion. 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, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects section of the application.

Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities and portfolio balance

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)

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. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

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 National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. 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 worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. 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.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

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1. Award Notices

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 NIH eRA Commons.

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 the Notice of Award (NoA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NOA signed by the AHRQ grants management officer is the authorizing document.

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, CCR Registration, and Transparency Act requirements as noted on the 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, 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 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 annual 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. Do not limit the Progress Report to two pages. 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. Generally, the annual Progress Report is due 4 months prior to the budget period start date of the next budget period. The Notice of Award will include information regarding the due date.

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 4/30/2012, the annual FFR is due 9/30/2012 (90 days after the end of the calendar quarter of 6/30/2012).

A final Progress Report, Federal Financial Report, and Invention Statement (Form HHS 568) are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.

Section VII. Agency Contacts

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We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contacts:

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

Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
Fax: (301) 427-1639
E-mail address: DisseminationGrants2012@ahrq.hhs.gov

2. Peer Review Contacts:

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

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427- 1362
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to:

Carol Harris
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1448
Fax: (301) 427-1462
E-mail address: Carol.Harris@ahrq.hhs.gov

Section VIII. Other Information

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Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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 are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm, which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

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.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.