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 has different page limits than NIH for the application Research Strategy, which can be found within each individual FOA.

Components of Participating Organizations

Agency for Healthcare Research and Quality

Funding Opportunity Title

Limited Competition: Practice-Based Research to Improve Self-Management Support (PRISMS) (R18)

Activity Code

R18 Research Demonstration and Dissemination Projects

Announcement Type

New  

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-13-001

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.226 

Funding Opportunity Purpose

This funding opportunity announcement (FOA) solicits applications that would evaluate the effectiveness of strategies to disseminate and implement a library/toolkit of multi-media self-management support (SMS) resources. The SMS library/toolkit was developed by AHRQ to help primary care team members learn about SMS and develop their self-management support skills in working with chronically ill patients.  Although many efforts have focused on developing tools and resources to support patients in their self-care activities, this FOA solicits applications that will improve the capacity and ability of those who work in primary care practices to provide effective SMS by disseminating and implementing the resources in the SMS ‘library’.  Successful applicants must incorporate SMS tools and resources from the AHRQ SMS Resource Library into their research plan (see http://www.orau.gov/ahrq/sms_home.html). 

Only those eight primary institutions receiving an AHRQ grant under RFA-HS-12-002 (Centers of Excellence for Primary Care Practice-Based Research and Learning Networks (PCPRLN)) are eligible to apply. The Primary Investigator (Program Director/Principal Investigator (PD/PI) for the current FOA) maybe employed at another organization as long as that organization has an established affiliation with the applicant Center of Excellence for PCPRLN.   

Key Dates
Posted Date

December 7, 2012

Open Date (Earliest Submission Date)

 December 30, 2012

Letter of Intent Due Date(s)

December 31, 2012

Application Due Date(s)

January 31, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date

Expiration Date

February 1, 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

This funding opportunity announcement (FOA) solicits R18 Research Demonstration and Dissemination Project grant applications from the institutions receiving an AHRQ grant under RFA-HS-12-002 (Centers of Excellence for Primary Care Practice-Based Research and Learning Networks (PCPRLN)) to evaluate the effectiveness of strategies to disseminate and implement a library/toolkit of multi-media self-management support (SMS) resources developed by AHRQ.

Background:

In 2003, the Institute of Medicine defined self-management support (SMS) as "the systematic provision of education and supportive interventions by health care staff to increase patients' skills and confidence in managing their health problems, including regular assessment of progress and problems, goal setting, and problem-solving support." (IOM 2003)  Self-management support is a key component of the Expanded/Chronic Care Model. According to this framework, improved health care outcomes result from productive interactions between “informed, activated patients” and “prepared practice teams". (Wagner, Austin, & Von Korff 1996)  A successful self-management support program has the potential to change individuals’ behavior, improve health outcomes, decrease the burden of chronically ill patients on the health care system, and be a cornerstone of primary care transformation into the Patient-Centered Medical Home.  However, many practicing primary care clinicians and members of the primary care team in the Medical Home have not had the training, resources or support needed to deliver effective self-management support within their practices, or the opportunity to implement and embed this aspect of the Care Model into their work processes and routines.

AHRQ recently identified existing and developed new multimedia resources for members of the primary care team to help them learn about self-management support and develop their self-management support skills in their work with chronically ill patients.  The resulting SMS “library” is a multi-media (electronic, audio-visual, and print) toolkit of implementation-oriented educational resources for providers and patients including: 1) general concepts of self-management support (which include living a healthy lifestyle); and 2) specific suggestions for integrating self-management support into primary care.  The materials in this library serve to educate primary care teams on best practices for teaching their patients self-management support skills and are action-oriented for easy implementation in the primary care setting.  The materials are available on the AHRQ Prevention/Care Management Web site (see http://www.orau.gov/ahrq/sms_home.html). 

Knowledge to be gained:

In addition to learning about effective strategies to disseminate and implement this set of SMS resources and information, AHRQ is also interested understanding how the characteristics of the resources themselves relate to successful dissemination and implementation. The overall long-term goal is to develop a better understanding of patient and provider needs to guide future efforts to improve SMS in primary care.

Responsive applications will test one or more theory-based, hypothesis-driven approaches to the dissemination/implementation of SMS resources.  A variety of promising dissemination/implementation strategies are available.  Examples include, but are not limited to: practice facilitation, educational outreach visits (academic detailing), learning collaboratives, social peer norms, and positive deviance approaches.  The research design chosen should allow for hypothesis testing.  Innovative approaches such as a ‘stepped wedge’ design or other alternatives to a traditional RCT are encouraged.

Specific Objectives of this FOA:

The purpose of this FOA is to evaluate dissemination and implementation strategies for the library/toolkit of SMS resources created by AHRQ, to determine the effectiveness of the strategies in creating “prepared proactive” patient care teams with the knowledge, skills and attitudes to provide effective SMS to patients with one or more chronic illnesses. 

References:

Institute of Medicine. Priority areas for national action: transforming health care quality. Washington, DC: National Academies Press; 2003 

Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q 1996;74(4):511-543

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Sci 2009;4:50.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.

AHRQ intends to make $500,000 available in fiscal year 2013 for one award over an 18-month period.

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $500,000 for the entire project period.  

Award Project Period

 The project period may not exceed 18 months. 

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

This Funding Opportunity Announcement (FOA) is a new FOA and is a limited competition.  Only those eight primary institutions receiving an AHRQ grant under RFA-HS-12-002 (Centers of Excellence for Primary Care Practice-Based Research and Learning) are eligible to apply.  Due to their recognized experience and track-record of research in primary care practices within a Practice-Based Research Network, these Centers are uniquely qualified to propose and conduct large multi-practice practice-based research studies in a scientifically rigorous, efficient, and timely fashion to address this topic.  For this FOA, only one application per Center will be accepted.  See: http://www.ahrq.gov/research/rescenters.htm.

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

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

Foreign Institutions

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Program Director/Principal Investigator)

The Program Director/Principal Investigator (PD/PI) may come from a variety of disciplinary backgrounds and training, including, but not limited to: nursing, pharmacy, medicine, health service research, and health system administration.  Any individual with the skills, knowledge, and resources necessary to carry out the proposed research may be proposed as a project PD/PI.  Only one PD/PI may be designated on the application.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

The PD/PI is expected to contribute a minimum of 10-percent effort throughout the course of the grant. 

Centers of Excellence for Primary Care Practice-Based Research and Learning Networks (PCPRLN) are consortia which are designed to foster highly collaborative, interdisciplinary research environments at the awardee institution and the other requisite affiliated PBRNs (i.e., other organizations).  Given the fact that key personnel affiliated with the Centers for Excellence of PCPRLN are from a variety of organizations, individuals with a recognized affiliation with one of the Centers of Excellence for PCPRLN may serve as Principal Investigator for applications submitted in response to this FOA.  Initial organizational affiliations within the eight Centers of Excellence for PCPRLN are identified at http://www.ahrq.gov/research/rescenters.htm.

If the proposed PD/PI is not an employee of the applicant institution, Appendix A must include a letter from the PCPRLN Principal Investigator, or the Dean or Business Officer of the PCPRLN home institution, describing the relationship between the institution and the PI and documenting that the institution has the necessary controls in place to assure accountability of the PI and the commitment of the institution to complete the proposed work.

2. Cost Sharing

This FOA does not require cost sharing.

Although 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, institutionally-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.

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:

Nikon Hill-Colston
Center for Primary Care
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: Nikon.Hill-Colston@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 as noted below in the PHS398 Research Plan Component:

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:

Specific Aims

Section 1: Specific Aims is limited to 1 page.

Research Strategy Section: 

Section 2: Research Strategy, including tables, graphs, figures, diagrams, timeline for completion, and charts, is limited to 12 pages.

Successful applications will evaluate the effectiveness of strategies to disseminate and implement a library/toolkit of multi-media self-management support (SMS) resources. This library/toolkit was developed by AHRQ to help primary care team members learn about SMS and develop their self-management support skills in working with chronically ill patients.

The research strategy section must incorporate the SMS tools and resources from the AHRQ SMS Resource Library into the research plan (see http://www.orau.gov/ahrq/sms_home.html).

The research strategy must identify the approach that will be used to evaluate the effectiveness of one or more strategies to disseminate and implement AHRQ's library of self-management support resources in primary care practices.  The research strategy must include a description of the diverse practice settings in which the study will be carried out and address the implications of practice diversity for interpreting study findings.  

Responsive applications will test one or more theory-based, hypothesis-driven approaches to the dissemination/implementation of SMS resources.  A variety of promising dissemination/implementation strategies are available.  Examples include, but are not limited to: practice facilitation, educational outreach visits (academic detailing), learning collaboratives, social peer norms, and positive deviance approaches. 

 The research design chosen should allow for hypothesis testing. Innovative approaches such as a ‘stepped wedge’ design or other alternatives to a traditional RCT are encouraged.  When considering study designs and tests of the effectiveness of the strategy chosen, applicants should keep in mind that the purpose of this research is to evaluate the effectiveness of dissemination/implementation strategies on the knowledge and behavior of primary care teams, not patients. The research strategy should include approaches that make it possible to identify characteristics of AHRQ's SMS library/toolkit that are related to successful dissemination and implementation and which are not.   

Given the relatively short period of support for this activity, it is not expected that investigators will document improvements in self-care or clinical outcomes among patients. Instead, investigators should consider measures of the effectiveness of the intervention with respect to the knowledge and behavior of members of the primary care team.  Measures that might be considered include, but are not limited to: self-efficacy/confidence in providing SMS, understanding of the conceptual underpinnings of effective SMS, changes in roles or team composition, and changes in team functioning and job satisfaction/burn-out.  Some direct or indirect measurement of rates of provision of SMS might also be considered as well as patients’ reports of their experience of SMS during the office visit.

The Consolidated Framework for Implementation Research (CFIR; Damschroder et al. 2009) could be used, as appropriate, to identify domains that predict successful dissemination and implementation. The CFIR defines five major domains and offers an over-arching typology to promote understanding about what works, where and why, across multiple contexts. The five domains are: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation.

The CFIR also includes considerations of how the characteristics of the intervention, in this case, strategies to disseminate the SMS library/resources, affect implementation.  As with many interventions, improving SMS is complex and multi-faceted with many interacting components.  It is important to understand what SMS tools/resources are easily adapted and predict successful uptake and which are not.

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:

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.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness 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

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).  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 February 2003 policy 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. 

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

If the proposed aims of the application are achieved, how will scientific knowledge or clinical practice regarding the provision of effective SMS in primary care settings for patients with chronic illnesses be advanced?  What effect will the proposed study have on the concepts, methods, approaches or theories that drive this field of dissemination and implementation in primary care in general? 

Investigator(s)

Are the PD/PI and other key personnel appropriately trained, well suited, and ready to initiate this work?  Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers?  Does the PD/PI demonstrate a realistic strategy to manage the project and the research team, which takes into consideration key personnel's organizational affiliation, including the possibility that the PD/PI may not be from the applicant institution? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Innovation

Is the project original and innovative?  For example: Does the project challenge existing       paradigms or clinical practice about how SMS in primary care can and should be strengthened; does it address an innovative hypothesis or critical barrier to progress in the field of improving SMS for chronic illness?  Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for disseminating and implementing resources designed to improve SMS in primary care? 

Approach

Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to address all of the Specific Research Requirements?  Does the applicant acknowledge potential problem areas with dissemination and implementation of SMS tools and resources across diverse primary care settings and consider alternative approaches?  Are benchmarks for successful and effective implementation and dissemination of SMS resources presented? Are there appropriate measures of SMS resource characteristics that might predict successful implementation and dissemination efforts?

Environment

Does the Center environment in which the work will be done contribute to the probability of success?  Does the proposed approach benefit from unique features of the Center environment, 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.  Reviewers will assess how responsive the application is to the special eligibility criteria, including the project requirements, noted in the FOA. []

Inclusion of Priority Populations 

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

Budget and Period of Support

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

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed. (Note: use this as appropriate).

Additional Review Considerations

If the proposed PD/PI is not employed by or affiliated with the submitting institution, has the application provided assurance that the institution has the necessary procedures and controls in place to assure successful implementation of the project?

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 and budgetary 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.      

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

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, 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/.

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.  All final reports are due within 90 days of the project period end date.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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:

Janice Genevro, Ph.D.
Agency for Healthcare Research and Quality
Center for Primary Care, Prevention, and Clinical Partnerships
Phone: (301) 427-1627
E-mail address: Janice.Genevro@ahrq.hhs.gov

Peer Review Contact(s)

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

Kishena C.  Wadhwani, Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Phone:  (301) 427-1556
Fax: (301) 427-1562
E-mail address:   Kishena.Wadhwani@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) 427-1462
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.

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

Authority and Regulations

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


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