Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations     
Center for Primary Care, Prevention and Clinical Partnerships (CP3)
                                                                                                    
Title Ambulatory Safety and Quality Program: Improving Management of Individuals with Complex Healthcare Needs through Health IT (R18)

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

Announcement Type
This is a new RFA.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-HS-08-002

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: November 16, 2007
Opening Date:  January 21, 2008
Letters of Intent Receipt Date(s):  January 18, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). 
Application Submission/Receipt Date(s):  February 21, 2008
Peer Review Date(s):  Generally four months after receipt date
Earliest Anticipated Start Date(s):  Generally two months after peer review date
Expiration Date:  February 22, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Applicant institutions are expected to: describe the specific health IT application and intervention to be studied, and the expected effect on safety and other domains of quality; develop a project design and methodology project plan; assess primary and secondary outcomes including clinical outcomes, system-level process, and/or efficiency outcomes; provide an evaluation plan; and provide a dissemination plan for project findings.

All AHRQ-supported research, evaluation, or demonstration projects must comply with the AHRQ policy on Inclusion of Priority Populations (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Investigators should consider and discuss inclusion of subjects from one or more AHRQ priority populations within the context of developing an application as appropriate to the scientific objectives of the planned study.  If priority populations are included in a project, appropriate sub-analyses should be presented that focus specifically on those populations.

Mechanism of Support. This FOA will use the AHRQ Research Demonstration and Dissemination Projects (R18) grant mechanism.

Funds Available and Anticipated Number of Awards. The total amount to be awarded is $3 million.  AHRQ intends to fund between 5 to 7 new grants. 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 number, quality, duration, and costs of the applications received.

Budget and Project Period:  The total project period for an application submitted in response to this funding opportunity may not exceed three years. Total costs are limited to $1.2 million over three years, with no more than $500,000 in total costs allowed in any single year.  An application with a budget that exceeds these limits will be returned without review.  Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation application.

Eligible Organizations:  You may submit (an) application(s) if your domestic organization is a:

Foreign organizations are not eligible under this FOA but may be a secondary partner with an eligible domestic organization.  For-profit organizations that produce health IT systems must apply in partnership with a non-profit organization.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.

Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct. 

Application Materials. See Section IV.1 for application materials.

General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites:

Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-5936. 

Special Application Submission/Receipt Date(s):  February 21, 2008

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.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information
1. Mechanism 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. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to AHRQ
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
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 Contacts
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


Section I. Funding Opportunity Description


1. Research Objectives

General Purpose of the Ambulatory Safety and Quality (ASQ) Program

The purpose of AHRQ’s Ambulatory Safety and Quality program is to improve the safety and quality of ambulatory health care in the United States. The program’s components, with the exception of projects focused on risk assessment, have an emphasis on the role of health information technology.  Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the “tip of the iceberg.” The scope of ambulatory care has increased over the past decade, as the volume and complexity of interventions has burgeoned.  Safe, high quality ambulatory care requires coordination across multiple settings and involves complex information management, especially for patients with complex healthcare needs.  The opportunity to turn the potential of health IT towards improving safety and quality in the ambulatory care setting, especially across care transitions, forms the cornerstone of the ASQ Program.

Specific Purpose of this FOA

AHRQ is interested in supporting projects that investigate novel methods or evaluate existing strategies for both clinician and patient/family use of health IT in ambulatory settings to improve outcomes through more effective decision support or care delivery for patients with complex healthcare needs and those in high risk care transitions. Applicants are encouraged to demonstrate the ability of EHRs and/or PHRs to effectively move evidence-based information to the point of care, including the development and utilization of machine actionable, evidence-based clinical information, and participation of both providers and patients/families in health information exchanges.  In particular, the role of workflow and effective use of clinical alerts and reminders, with an emphasis on prevention and chronic illness management, would be encouraged. The special focus of this FOA is on ambulatory settings and the high-risk transitions to, from, and among these settings, particularly for individuals with complex healthcare needs. AHRQ also encourages applications focusing on health IT issues associated with Medicaid Money Follows the Person Rebalancing Demonstration grants (see Section 6071 of P.L. 109-171; see also http://www.cms.hhs.gov/DeficitReductionAct/20_MFP.asp).  The long-term goal of this effort is to ensure that all patients receive the appropriate care and management for the prevention and treatment of conditions identified by the Institute of Medicine (IOM) as priority areas.

Overview: Ambulatory Safety and Quality Program

The ASQ Program offers an integrated approach to improving ambulatory safety and quality of care.  Where effective strategies exist to drive ambulatory safety and quality, such as health IT, there is a need for research to demonstrate value, as well as best approaches to broader diffusion, implementation and effective use. In particular, the high risk associated with transitions in care provides some urgency for targeted risk assessment and health services interventions. This is particularly true for individuals that have complex healthcare needs, e.g., multiple chronic diseases or moderate/severe mental illness. 

To achieve measurable improvements, AHRQ sponsored four FOAs in 2007 that addressed research needs that share a common focus on ambulatory care clinicians, patients, and information technology.  AHRQ is issuing the current FOA to compliment this previously funded work.  The previous FOAs are briefly described below:

  1. Risk Assessment in Ambulatory Care:  This announcement had a broad view on ambulatory care that includes the ambulatory care clinician, as well as the patient. Unlike the rest of the ASQ program, this announcement did not include a primary focus on health information technology. (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-003.html)
  2. Improving Quality through Clinician Use of Health IT: This announcement had a primary focus on the ambulatory care clinician and a focus on health IT strategies to improve medication management and the delivery of evidence to the point-of-care. (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-006.html)         
  3. Enabling Patient-Centered Care through Health IT: This announcement had a primary focus on patients and their interaction with the ambulatory health care system.  Research will focus on strategies to improve the patient experience of care through the use of health IT.  (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-007.html)         
  4. Enabling Patient Safety and Quality Measurement through Health IT: This announcement had a primary focus on integrating patient safety and quality measurement with information technology.  (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-002.html)

Definition of Ambulatory Care and Health Care Transition

For the purpose of the ASQ program, ambulatory care refers to all types of health services provided by health care professionals on an outpatient basis, in contrast to persons who are inpatients. While many inpatients may be ambulatory, the term ambulatory care usually implies that the patient must travel to a location to receive services which do not require an overnight stay. This program will specifically focus on the following ambulatory settings: health care clinician offices; large and small practices, outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers.  Though not usually considered an ambulatory setting, home care entities are also encouraged to apply. 

For the purpose of the ASQ program, health care transitions will refer to the movement of patients between health care providers and settings as their conditions and care needs change during the course of a chronic or acute illness (Coleman and Berenson, 2004; see http://www.caretransitions.org/definitions.asp).  Non-ambulatory settings with a strong interest in fostering safe, high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization.  In particular, a focus on transitions between ambulatory care settings and hospitals, home care, assisted living centers, and nursing homes are critical to the success of ambulatory care for many individuals with complex healthcare needs, such as the elderly and chronically ill populations.

Program Purpose and Evaluation

The goal of the ASQ program is to improve the quality and safety of health care. AHRQ will measure progress toward that goal by evaluating whether patients are receiving the appropriate care for prevention, treatment and management of the Institute of Medicine’s (IOM's) priority areas (IOM, 2003); whether patients are able to access reports of ambulatory care quality and safety for their providers; whether patients report satisfaction with their care.

Each project in the ASQ program is required to have a robust evaluation plan that addresses one or more of these measures. In order to facilitate comparisons across ASQ projects, AHRQ suggests evaluation measures and instruments in this FOA. We encourage the use of these measures whenever possible and scientifically appropriate.  In addition to proposing an appropriate summative evaluation, formative evaluation plans are also encouraged including implementation plans, clinician and patient involvement in decisions about adoption and modification of health IT, training, support, and unintended consequences of implementation.

Researchers are encouraged to propose projects in low resourced rural and urban safety net settings where health IT diffusion is likely low, as well as projects that seek to improve the care provided to priority populations.  AHRQ is strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, inner-city, and low-income populations, as well as patients with special health care needs and disabilities.  If priority populations are included in a project, appropriate sub-analyses should be presented that focus specifically on those populations.  Where appropriate, the evaluation should also examine whether cultural and other variations among patients and levels of health literacy affect their response to the health IT innovations and their ability to use them for self management.  AHRQ encourages the development of strong public and private partnerships that may include the health IT vendor community.  AHRQ also encourages applications from Practice-Based Research Networks (PBRNs).  Community organizations are encouraged to partner with organization that have experience in conducting research projects such as these.

Background: Health IT and the Management of Patients with Complex Care Needs

The burden of providing treatment and supportive services for individuals with complex healthcare needs continues to increase.  In 2000, 60 million Americans had multiple chronic conditions, and it is projected that this will rise to over 81 million by 2020 (Partnership for Solutions, 2002).  Yet care for these patients is often fragmented across multiple settings and providers, with limited, or no communication or coordination and no sense of overarching responsibility.  Patients often do not seek services until there is some crisis in their condition, a crisis that may have been avoided had they sought care earlier or if their care had been better coordinated.  Also, these transitions are often accompanied by changes in a patient’s functional status which may further complicate future care needs.

Currently, the management of the patient with complex healthcare needs is often a web of many-to-many relationships with information moving haphazardly among different providers, settings, and the patient.  The patient is often shuttled from one provider to the next and is rarely engaged directly in the management of his or her care (Wagner, 1998). Yet multiple studies have demonstrated that patients who are involved with their care decisions and management have better outcomes than those who are not (Wagner, Grothaus, et al., 2001; Wagner, Glasgow, et al., 2001; Greenfield et al., 1985; Greenfield et al., 1988).  Patient self-management, particularly for chronic conditions, has been shown to be associated with improvements in health status and decreased utilization of services (Loring et al., 1999).  By recognizing the central role of the patient, the web of many-to-many information exchanges can be transformed into a one-to-many system, the patient serving as the primary constant across interactions.  This is not to imply that there is no role for provider-to-provider communications, only that that communication can be made more efficient by incorporating the patient either as a participant or a conduit.

While research has demonstrated that health IT can improve patient safety and quality of care (Fitzmaurice et al., 2002), the rate of health IT adoption in ambulatory settings remains low, especially in small practices with fewer than five physicians, where adoption lags below 15% (Gans et al., 2005). There is evidence that the benefits of health IT differ among settings, in large part due to the implementation strategy and the degree to which organizations use health IT adoption as a trigger to redesign their care delivery processes (Wachter, 2006). However, once implemented, health IT has the potential to facilitate new interventions and new models of care delivery, including management of patients by population, engaging with patients asynchronously, e.g., through email, and linking to resources in the community.

AHRQ’s Health IT Portfolio

AHRQ funded projects span the research and development spectrum, from innovations in health IT, planning for adoption, implementation, evaluation of outcomes, and taking the systems to scale through participation in regional and statewide health information exchange. AHRQ’s projects have historically addressed issues of knowledge representation, delivery of tailored evidence, quality feedback, workflow and systems changes, and new approaches to care, including delivery in non-traditional settings.

More information about AHRQ’s health IT portfolio can be found at http://healthit.ahrq.gov.

Objectives of this FOA

This FOA builds upon two previous ASQ FOAs, Improving Quality through Clinician Use of Health IT and Enabling Patient-Centered Care through Health IT, and shares several objectives with them.  The primary goal of this FOA is to identify, promote, and disseminate models of patient-centered care that include the use of personal health data and evidence-based information to support both providers and patients in managing health and illnesses and improve health outcomes in ambulatory care for patients with complex healthcare needs and across high risk health care transitions.  AHRQ expects this initiative will inform health care professionals, payers, policy makers, and the public about the value of health IT to improve ambulatory health care quality and safety by providing coherent and appropriate care and prevention information across multiple settings and over time.  AHRQ is interested in advancing knowledge in the following areas:

The projects can span the spectrum from discovery, translation, measurement, implementation, and widespread dissemination of strategies for the use of ambulatory health IT.  AHRQ has an interest in projects in the following thematic areas, and illustrative questions are provided in each.  Projects outside these areas that address the core themes of clinician use of health IT or patient-centered care to improve quality are also welcome.

Illustrative questions include:

A.   Providing high quality care

B.  Shared decision-making and patient-clinician communication

C.   Integration of patient information across transitions in care

D.   Health IT adoption in ambulatory settings

From its earliest investments in health IT research initiatives, AHRQ has emphasized the importance of the privacy and security of personal health information – whether in electronic or other media – to individual trust in health information exchange.  Without this trust and faith in an information system, patients and other users will not use it fully, and system data will be inaccurate or incomplete.  As a result, the potential for quality and safety improvement from investments in health IT will be lost.  More importantly, assuring privacy and security are values patients should expect and receive from the health care system.  For these reasons, AHRQ will pay particular attention to efforts to enhance the privacy and security of electronic health information in proposed projects.

Project Requirements

The applicant, or its partner(s), must be an ambulatory health care provider organization, or be implementing a health IT system in an ambulatory health care provider organization.  Applicant institutions are required to:

The applicant must address the following project requirements in the Research Plan portion of the application.

In the Specific Aims section:

Project aims must reflect the specific objectives for this FOA as indicated above.  The applicant must select a health IT system to be implemented and evaluated for their project. In addition, the applicant must identify the clinical issues addressed by the intervention, the setting of care, the health professional roles that use and are impacted by the health IT system (note that interdisciplinary teams are encouraged whenever possible), and the anticipated patient population that will benefit.

In the Background and Significance section:

The applicant must demonstrate an understanding of the nature of the ambulatory care, the current challenges to the provision of patient-centerd care, and how health IT can enable better quality of care.  The narrative should include a brief review of the salient literature with respect to the focus area and the anticipated benefits, limitations, and scientific, clinical or performance-based significance of the proposed research, the purpose and expected impact of the intervention, objectives or hypotheses to be evaluated, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.

In the Research Design and Methods section:

The applicant should describe the health IT intervention. The applicant should describe the development of the intervention and the methodology for implementation. When possible, the health IT intervention should conform to interoperability standards and use certified products (see http://www.hitsp.org and http://www.cchit.org).  Given the project objectives, and taking into account practical constraints, the applicant needs to describe the methodology and timeline to realize the project objectives, including major milestones.

Applicants must specify the project’s primary and secondary outcome measures and how these will be evaluated.  These may include health outcome, patient experience of care, process measures, costs, and measures of patient safety.   (Please refer to the next two sections below for AHRQ’s recommendations for outcome measures.)  The narrative should also include data collection plans, instruments and tools to be used, and a well-developed analysis plan. Applicants are encouraged to incorporate into the project  a strategy for monitoring and assessing salient reportable financial and organizational dimensions of implementing health IT under the initiative and to develop strategies to report estimates of the rate of return on investments required for implementation under the initiative. To the extent possible, applicants should discuss any anticipated limitations or cautions needing to be exercised in generalizing results.

The applicant should describe how the intervention could be integrated into the delivery of ambulatory care throughout the applicant organization and potentially into sites across the nation. The applicant should discuss the future sustainability of the intervention by their organization after the grant funded period has ended. Applicants must include a project dissemination plan within the project plan and budget. The dissemination plan may include activities in cooperation with AHRQ's National Resource Center on Health IT, http://healthit.ahrq.gov.  While AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects, these dissemination supplements will only be considered should future funds become available.

The applicant must describe how, in the development and implementation of the intervention, privacy and security issues related to the exchange of sensitive health information will be identified and addressed.  Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information.  New concerns arise, such as who has access to and use of electronic data, disclosure to patients regarding the collection and use of the data, patient consent requirements, the ability of patients to decline participation in electronic data collection, patient access to audit records, what happens to data after research is completed, and informing patients of any security breaches. 

Developers of electronic health information systems have promulgated policies for consideration with participating consumers and patients in order to assure patient awareness of, comfort with, and participation in electronic data collection and use. While privacy and security solutions are not intended to be the focus of projects under this announcement, interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://healthit.ahrq.gov/hiepolicyissues). Applicants should describe the resources and processes they will use to assure that these privacy and security concerns are being met throughout the project period.  These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.

Outcome metrics

In order to facilitate evaluation across projects in AHRQ's portfolio, AHRQ requires applicants to measure and report on the following outcomes when appropriate to the project aims:

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism.  The individual researcher sponsored by each organizational awardee 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 be returned without review.

2. Funds Available

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. 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.   Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

AHRQ intends to commit approximately $3 million dollars in FY 2008 to fund 5-7 applications.  Should additional funds become available, AHRQ may fund additional meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will range from $200,000 to $400,000 in total costs per year. Total costs are limited to $1.2 million over a three-year period, with no more than $500,000 in total costs allowed in any single year. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.  Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation report.

Applications requesting more than $500,000 in total costs in any one year, more than $1.2 million over 3 years, or longer than 36 months of support will be returned to the applicant without review.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

AHRQ’s authorizing legislation does not allow for-profit organizations to lead applications under this research mechanism, thus for the purpose of this FOA, 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 the ASQ program is to improve the safety and quality of ambulatory health care in the U.S., foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations and foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

The Project Director/Principal Investigator should devote at least 20% time to the project over the course of the award. If the Project Director/Principal Investigator devotes less than 20% time to the project, an explicit justification must be provided.

Due to the requirements of these grants, expertise in evaluation is also a critical need that can be met through the requisite experience of the PD/PI or another member of the project team.  Community, or other organizations not routinely engaged in research are encouraged to partner with organizations that have experience in conducting research projects such as these.

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.

3. Other-Special Eligibility Criteria

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.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons.  AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components.  Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist (See Section IV.6., “Special Instructions,” regarding required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on January 10, 2008 at 1pm EDT. To register to participate in the conference call, please send an e-mail request to Ms. Angela Lavanderos (ComplexPatients@ahrq.hhs.gov) by January 7, 2008.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB January 9, 2008.   Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to Ms. Lavanderos by January 7, 2008Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be sent to all participants via e-mail by January 18, 2008If interested applicants are not able to participate in the call, please send requests for a copy of the notes to ComplexPatients@ahrq.hhs.gov

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  January 21, 2008
Letters of Intent Receipt Date(s):  January 18, 2008
Application Submission/Receipt Date(s):  February 21, 2008   
Peer Review Date(s):  Generally four months after receipt date
Earliest Anticipated Start Date(s):  Generally three 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 to this document.

The letter of intent can be sent electronically, and should be sent to:

Angela Lavanderos
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301 427-1505
FAX: (301) 427-1597
E-mail: ComplexPatients@ahrq.hhs.gov

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

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and AHRQ.  Incomplete or non-responsive applications will not be accepted.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of applicants to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to this FOA 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.

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.

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.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  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 confidentiality provisions of the AHRQ statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, included in the DUA is the requirement that the user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

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 the 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 principals, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Pre-award Costs

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.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

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

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating “Just-in-Time” information concepts, and with the following additional requirements:

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 instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will be returned without review.

APPENDIX MATERIALS

AHRQ has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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.

All attachments must be provided in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Application Characteristics:

Budget

Applications in response to this FOA will use the Research & Related budget components, with a maximum allowable request of up to $1.2 million in total costs over three years and a maximum of $500,000 in any one year.  Provide a narrative justification for each proposed personnel position, including role and proposed level of effort.  All other budgeted costs should also be justified.  

The budget must include funding to allow at least two members of the project team to attend at least three days of an annual AHRQ grantee meeting in the Washington DC area. 

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also found at 42 USC 299.  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, the 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 and 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 two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), 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, noninstitutionalized population.  MEPS is comprised 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.

Plan for Sharing Research Data

Not Applicable

 Section V. Application Review Information


1. Criteria 

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

Merit Review Criteria are described below.  The 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 be returned to the applicant without further consideration. 

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

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:

The AHRQ R18 provides support for projects designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge, in order to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem in high quality care transitions, complex disease management, or the delivery of clinical information to providers or patients in ambulatory settings? Does it advance our knowledge of how health IT changes and improves care delivery, or have a novel design of a health IT system? If the aims of the application are achieved, will it demonstrate how current clinical knowledge or patient-specific information can be integrated into health care delivery and workflow? Will the project, if successful, result in meaningful improvements in patient safety, health outcomes, and/or satisfaction for its target population?

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? Does the applicant address areas of interdependence outside of the project scope, and have a plan for integrating with existing organizational initiatives in health IT? Does the study measure outcomes of interest, including appropriate clinical outcomes? Where possible, does the applicant make maximum use of existing standards and measures, particularly in regard to patient privacy and data confidentiality? Is the evaluation plan sufficient to illuminate the effects of the intervention? To the extent feasible and appropriate to the study aims, does the applicant describe plans to address outcome metrics as described in Section I.1?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms in health IT; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?   

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the investigative team cross-disciplinary? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is there evidence of institutional support, integration with existing health IT infrastructure, and is the timeline reasonable in the institutional context? Are there strong partnerships with organizations such as third-party providers of technology?

Environment: Will the proposed study benefit from the unique features of the selected ambulatory sites and patient populations?  Have the ambulatory practices involved in the project demonstrated their interest in participating in this study?   Does the intervention foster interdisciplinary ambulatory care teams? Does the study involve critical roles, settings or patient populations where change would have a large impact?

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?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Is the budget allocated toward health IT hardware, software, and support appropriate?

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in Section IV.6 “Other Submission Requirements”, 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 Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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. 

2.B. Additional Review Considerations

Not Applicable.

2.C. Sharing Research Data

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are now civil monetary penalties for violation of this 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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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 of 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 awardee 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. 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; and 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 the 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).

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information


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 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).  AHRQ will also conduct an administrative and budgetary review of the application and request additional information, if necessary, from the applicant.

A formal notification in the form of a Notice of Grant Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NOA will be generated via email notification from the awarding component to the grantee business official.

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.”

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 and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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 U.S.C. Ch. 35).  Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected awardees 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 and sometimes much longer if submissions are incomplete or the justifications for the proposed data collection plans are questioned during the clearance process.  Information collection that requires PRA clearance may not begin until awardees 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/infocolsub.html.    

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the AHRQ grants policies as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).

The Progress Report must include Sections a through f as described on pages 11-15 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 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.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs.  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

A final Progress Report and Financial Status Report are required when an award is terminated.

Projects funded under this announcement are considered part of the AHRQ’s Health IT Initiatives. AHRQ has established the National Resource Center (NRC) for Health IT to support activities of the AHRQ Health IT Initiatives. When appropriate and feasible, AHRQ expects awardees to work with each other in collaborative opportunities that can contribute to the success of their projects and AHRQ’s portfolio initiatives. These collaborative relationships may be facilitated by the NRC, and awardees will be expected to cooperate with the NRC.

Section VII. Agency Contacts


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

1. Scientific/Research Contact(s):

AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA.  Written and telephone inquiries concerning this FOA are encouraged.

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

Robert Mayes
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1492
Fax: (301) 427-1597
E-mail address:  ComplexPatients@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Rebecca Roper
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) 427-1535
Fax: (301) 427-1562
E-mail address:  Rebecca.Roper@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Michelle Burr
Office of Performance Accountability, Resources and Technology
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address: Michelle.Burr@ahrq.hhs.gov

Section VIII. Other Information


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 45 CFR 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 Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information" regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which 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. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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 under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 USC 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information.  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 the 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 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," 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 2010" 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 authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing 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 PHS mission to protect and advance the physical and mental health of the American people.

References

Referring to Section I under “1.”(Research Objectives):

Coleman EA, Berenson RA. "Lost in transition: challenges and opportunities for improving the quality of transitional care." Ann Intern Med. 2004 Oct 5;141(7):533-6.

Fitzmaurice JM, Adams K, Eisenberg JM. "Three decades of research on computer applications in health care: medical informatics support at the Agency for Healthcare Research and Quality." J Am Med Inform Assoc. 2002 Mar-Apr;9(2):144-60.

Gans D, Kralewski J, Hammons T, Dowd B. "Medical groups' adoption of electronic health records and information systems." Health Aff (Millwood). 2005 Sep-Oct;24(5):1323-33.

Greenfield S, Kaplan S, & Ware, JE. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med, 1985; 102(4):520-8. 

Greenfield S, Kaplan SH, Ware, JE, Yano EM, & Frank HJ. Patients' participation in medical care: effects on blood sugar control and quality of life in diabetes. J Gen Intern Med, 1988; 3(5):448-57.

Institute of Medicine, Priority Areas for National Action: Transforming Healthcare Quality. Washington, DC: National Academy Press, 2003.

Lorig KR, Sobel DS, Stewart AL, Brown BW, Bandura A, Ritter P, Gonzalez VM, Laurent DD, & Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Medical Care, 1999; 37(1):5-14.

Partnership for Solutions, Chronic Conditions: Makine the Case for Ongoing Care. Baltimore, MD: Johns Hopkins University, 2002

Wachter RM. "Expected and unanticipated consequences of the quality and information technology revolutions." JAMA. 2006 Jun 21;295(23):2780-3.

Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Effective Clinical Practice, 1998; 1(1):2-4. 

Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, Carver P, & Sixta C. Quality improvement in chronic illness care: a collaborative approach. Joint Committee Journal of Quality Improvement, 2001; 27(2):63-80.

Wagner EH., Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, & Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care, 2001; 24(4):695-700.


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