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 (http://www.ahrq.gov)

Title: Recovery Act 2009 Limited Competition: Expansion of Research Capability to Study Comparative Effectiveness in Complex Patients (R24)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a new FOA.

Request For Applications (RFA) Number: RFA-HS-10-001

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release Date: December 22, 2009
Letters of Intent Receipt Date: Not Applicable
Application Receipt Dates: January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date
Additional Information To Be Available Date: Not applicable
Expiration Date: January 21, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) issued by the Agency for Healthcare Research and Quality (AHRQ) solicits Infrastructure Development (R24) grant applications from applicant organizations that propose to build or enhance partnerships, datasets and methodologies that will improve the capacity to study, and the quality of studies, of patients with multiple chronic illnesses (referred to as Complex Patients).

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

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 - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The overall purpose of this FOA is to support the development of infrastructure that will accelerate comparative effectiveness research on patients with multiple chronic diseases and on efforts to prioritize prevention, treatment and chronic disease management interventions for this population through comparative effectiveness research.

The Department of Health and Human Services (HHS) will use the definition of comparative effectiveness research used in the Federal Coordinating Council s (FCC s) Report to Congress to guide the HHS operational plan with regard to Office of the Secretary (OS) ARRA funds. The definition is as follows:

Priority-Setting Process and Inputs for Use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS comparative effectiveness research funds: public input, an internal Departmental workgroup, the FCC report, and the Institute of Medicine (IOM) report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;

2) Potential to inform decision-making by patients, clinicians or other stakeholders;

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4) Feasibility of research topic (including time necessary for research).

The Comparative Effectiveness Research-Coordination and Implementation Team will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

1) Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),

2) Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research,

3) Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,

4) Addresses a need or is unlikely to be addressed through other organizations,

5) Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM topic recommendations;

2) An issue within one the 14 priority conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or

3) Fall into one of the AHRQ identified evidence gaps.

The current list of priority conditions includes:

Background

Persons with medical conditions, and particularly those with multiple medical conditions, are of key interest to the U.S. health care system. Advances in medical science offer an increasing menu of medical interventions designed to decrease suffering and prolong life. Professional guidelines about the use of these interventions are focused on the person with a single condition, and do not offer guidance on how to incorporate or modify the guideline within a set of different guidelines each directed at a single condition.1 The need to focus research on complex patients those with multiple chronic conditions--is becoming more urgent: this segment of the population is increasing as years of life expectancy rise. As of 2008, more than 75 million Americans meet the criteria of having 2 or more chronic conditions. The costs for the care of this population are increasing; in 2008, more than 65% of health care dollars were spent in the care of complex patients who comprise less than 25% of the total population. The challenge to the health care system, and the potential burden on individuals to simultaneously manage multiple conditions, has only begun to be quantified and has not yet been met.2 Investment in infrastructure should permit performance of high-quality comparative effectiveness research on complex patient populations in order to provide evidence to know what interventions are most valuable, and how the particular circumstances of the patient determine these relative values.

The ultimate use of the evidence developed with these infrastructure resources should be to support and facilitate informed, shared decision-making about health interventions. Persons with multiple chronic illnesses bear many risks and burdens related to medications, health provider visits, tests, and other treatments. In order to help both patients and their clinicians plan the approach to simultaneous management of multiple chronic illnesses, they require relevant evidence about the expected impact of different interventions, care processes, and management strategies on health outcomes of highest relevance to the individual patient.

Since 2008, AHRQ has funded work in this specific research area, and recognizes that there is a need for significant development. This is the motivation for this FOA. Two crucial elements have been identified to advance research of complex patients: 1) large and sufficiently complex data sets; and 2) advances in methods to facilitate the work. In order to use comparative effectiveness research to reach the goals of improving quality of care for persons with multiple chronic conditions and containing costs, AHRQ sees a need to encourage the creation of large detailed data sets, including those with priority populations, that are widely accessible for research; and a need to improve the methods used to address the questions of prioritizing care and understanding the comparative effectiveness of preventive and treatment options and their mode of delivery in complex patients. Accomplishing these ends will require collaborative research teams, partnerships (for example, between academic and other health-related organizations) and the long-term commitments of researchers and institutions to pursuing this important work.

Specific Objectives of this Research Program

The goal of this research program is to provide funds to institutions and research teams to build enduring infrastructure that will advance knowledge about, and ultimately the care of, persons with multiple chronic illnesses.

There are two main objectives for this comparative effectiveness research program: 1) The development of comparative effectiveness research infrastructure and 2) The performance of a related specific research project to demonstrate the potential of the new infrastructure. These two objectives are explained in greater detail below.

1. Develop infrastructure to facilitate the performance of comparative effectiveness research. Both data set development and research methods development are included in this FOA’s consideration of infrastructure each type of development is further described below. Only one is required in an application.

A. Create or expand data sets to be used for research purposes. Some examples of appropriate ways to expand and build data sets of interest are listed below:

B. Develop and validate methods to improve the analytic methods for the study of important questions related to the management of complex patients. Below are listed examples of methodologic developments that could meet the goals of this FOA.

2. Performance of a specific research project

Applications must include a request for support of a single research project of a minimum of nine months duration, but not more than 14 months. Securing other, additional support for these research projects such as from a university, foundations, or other mechanisms is encouraged.

Applicants may propose either a primary research project or pilot research project. A primary research project refers to a research study that has a clear specific aim, hypothesis, method, and data analysis plan. However, this proposal is not expected to provide the level of detailed description characteristic of an R01 application; rather it is expected to be similar to a project usually addressed by an R03. A pilot project refers to a research study that seeks to establish the feasibility or merit of a particular area of inquiry. It is expected to yield findings that address, for example, confirmation of the significance of the research, feasibility of the methods, and refinement/ delineation of hypotheses. Convincing justification of the potential significance of the research proposed must be made, although methods and hypotheses may be in their early formative stages. Research projects must be clearly identified in the application as either a primary or pilot project.

The research must take advantage of the specific methodological or other substantive thrust(s) of the infrastructure development being supported by the program. The intent of this component is to support research activities that will:

Research projects must include a focus on one or more of the current priority conditions established by the HHS Secretary under Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, Pub. L. 108-173. These 14 conditions (listed in Part II, Section I-1. Research Objectives ), were identified through a process involving discussion with, and extensive input from the public as well as Federal agencies and all are relevant to the Medicare, Medicaid, and Children's Health Insurance Program (CHIP) programs.

The preceding list is not comprehensive and once the requirement to focus on one or more priority conditions has been satisfied, applicants may focus additionally on other chronic conditions not listed above (such as renal or hepatic impairment). The PI may serve as the lead investigator (also called the research project director) for the proposed specific research project. Alternatively, junior faculty (with oversight from appropriate senior faculty) or other co-investigators on the project may serve as the lead for the pilot or primary project.

Specific Instructions

Applicants must state whether the proposed research is a data capacity building project or a methods advancement project. All proposals must consist of one or the other enterprise. The following section provides instructions for A) Building data capacity and B) Building methodologic capacity

A. Building data capacity: Applicants who are creating or expanding datasets in response to this FOA must accomplish (and specifically document their plan for accomplishing) the following:

1. Assemble a study team

AHRQ strongly encourages applicants to bring together expertise in clinical care (e.g. primary care medical and nursing specialties, behavioral medicine specialists), health services research, (including patient satisfaction and patient experience expertise) and data management; and to collaborate across institutions (including community-based sources of data, such as community mental health clinics, substance abuse treatment centers, or in-home nursing services) in order to build or expand data sets. For projects that propose to work with patient-centered experience data, AHRQ encourages involvement of experts in patient-centered data sets, for example, sociologists, Quality Improvement professionals, and evaluators. If an applicant proposes to use data from external institutions/organizations, the application should document that an investigator(s) associated with the external data set is included as a consultant(s) to the research study team. Letters of support from consultants for the study are strongly encouraged.

2. Create an expanded data set

The application should include a detailed plan for creating a new or expanded data set including the following:

In addition to the description detailed above, the proposal must also specify:

While AHRQ is not specifying a minimum number of data sources or subjects that must be included in each linked data set, reviewers will consider the final size and complexity of the data set and its potential for performing comparative effectiveness studies on patients with multiple chronic conditions including consideration of statistical power to permit different types of analyses in the proposed data set. AHRQ encourages selection and linkage of data sets that maximize the diversity of patient populations (including insurance status and race/ethnicity), chronic conditions and outcomes (e.g., quality of life).

3. Complete a primary or pilot research study

Applicants must propose in brief the background, methods and analysis plan for a limited size research project. The research project will demonstrate the capacities of the data. This may be thought of as a proof of concept for the infrastructure development. The scope of the project would be similar to those usually addressed by an R03 grant (that is, no preliminary data will be required, an existing dataset will be used, and the project must be able to be completed in a relatively short timeframe). Specifically, this research project must not be longer than 14 months in duration. The total costs associated with the primary or pilot project must be in the range of $100,000-$150,000.

4. Create documentation for the linked dataset

Applicants must create documentation for the linked dataset to facilitate its use by other researchers. Documentation should include: a data dictionary, codebooks describing the tables, variables and the primary and foreign keys, if any, in each table.

5. Disseminate linked dataset to other researchers

Applicants are expected to include a dissemination plan which will focus on making the linked data set accessible to other researchers. The plan should include a description of how personally identifiable information will be removed from any public use version of the data set; and how the data will be made accessible to others, e.g., posted on a public Web site, posted behind an institutional firewall with specified criteria for gaining access, etc.

The details of the data-sharing plan will vary, depending on the type of data collected and how the investigator is planning to share the data. Applicants must describe 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 alternatively, through a data archive or enclave). Applicants choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing are appropriate in other sections of the application.

The reasonableness of the data-sharing plan will be assessed by peer review.

6. Plan for sustainability

Applicants are expected to justify their choice of data sharing mechanism and provide information on what elements are in place to secure ongoing maintenance of the newly assembled data set (if applicable) and follow-through of the stated plans.

B. Building methodologic capacity: Applicants who propose the development or enhancement of methodological techniques in response to this FOA are expected to:

  1. Develop relevant partnerships and assemble a capable research team

Applicants should take care to include clinical as well as methodologic expertise on study teams.

  1. Create a methodologic platform

Applicants must create and justify the creation of an enduring, reproducible technique, platform or approach that can be used by the study team as well as by others for the study of complex patients that forwards the agenda of prioritizing health interventions for particular combinations of chronic illnesses and understanding the comparative effectiveness of preventive and treatment options.

  1. Address a testable hypothesis

Applicants must propose a proof of concept investigation using this method in order to demonstrate its research readiness and usefulness.

  1. Document the methods for others to apply

Applicants must provide a discussion supported by examples of how their methodological work will be described and documented to facilitate its use by others. They should include a plan for how investigators will share coding for complex programming and specifications for models.

Applicants who propose this kind of study must describe the need for and unique contribution of the method being proposed.

Under this FOA, grant resources may not be used to make capital or building investments. Any funds requested for equipment, hardware, software, and supplies, should be uniquely required to support study aims and should be well justified.

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 Infrastructure Development Grant (R24) award mechanism. The individual researcher sponsored by each organizational applicant will be solely responsible for planning, directing, and executing his or her proposed projects.

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

2. Funds Available

This initiative is supported by funds provided under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. AHRQ has designated $ 12 million to fund 12 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget proposals are limited to $500,000 total costs per year for a total of $1 million total costs over 2 years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 2 years or budgets that exceed $500,000 total costs in any given year will not undergo peer review.

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

The total costs for a grant awarded under this FOA will not exceed $1 million

for the entire project period. Funding beyond the first year will be contingent upon a review by Agency staff of the annual progress report.

Funding for this program is provided under the Recovery Act. The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under this Recovery Act FOA will be for up to two years.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization of one of the types listed below. The United States institution/organization must be located in the 50 states, or in the territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.

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 be eligible 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 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 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 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.

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 that plan to provide support 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 included in the detailed budget request.

3. Other-Special Eligibility Criteria

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

Resubmissions. Resubmission applications are not permitted in response to this FOA.

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

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

See Section IV.3.A below for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): N/A
Application Receipt Date: January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Technical Assistance

Applicants may submit questions to AHRQ via email at AHRQComplexPatientsFOA@ahrq.hhs.gov. AHRQ will respond to questions via email only. In addition, based on inquiries received, AHRQ will post a list of Frequently Asked Questions (FAQs) and responses to these questions, as appropriate, after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm.

Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.

3.B. Sending an Application to AHRQ/NIH

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

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

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

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

Gloria Washington
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1590
FAX: (301) 427-1595
E-mail address: AHRQComplexPatientsFOA@ahrq.hhs.gov

3.C. Application Processing

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

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

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare & 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 provision in the AHRQ statute, 42 USC 299c-3(c); the HIPAA Privacy Rule 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, the DUA will include the requirement that the data 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 identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Applications must include projected expenses for traveling the research project primary investigator, as well as the PI of the grant (if different from the primary investigators of the research projects), once each year of the project, to attend and present research findings at the AHRQ annual conference, normally held in September in the Washington, D.C. area.

Applications must include a composite budget page and separate budget pages and budget justifications for the infrastructure component and for the proposed research project.

Research Plan Requirements

The research plan is limited to 35 pages for applications (not including budget pages, letters, or biosketches). Each application’s research plan must include the following two components:

1) Research Infrastructure Development Plan. This component is limited to 25 pages and it must include:

2. Small research study proposal. Applicants must propose a research project in the form of either a primary or pilot research study. Description of primary or pilot research projects must not exceed 10 pages in length. No preliminary data may be included. The research study proposal should include:

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 PHS 398. Applications submitted in the Modular format will be returned without review.

Appendix Materials

The application must include a signed letter from an institutional official with authority to commit the institution to the establishment of the research infrastructure program. It must detail any resources the institution is willing to provide including office and laboratory space, computer and internet access, as well as library resources. The letter should also describe the institution's level of confidence that the grant, under the guidance of the proposed PI/PD, will be successful in achieving its goals. This letter does not count toward the Research Plan page limit.

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

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

No supplemental/update information will be accepted.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

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

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

Consumer Products

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

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:

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 meritorious 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: Given the goals of the research infrastructure development program, does the main theme of the application address an area of comparative effectiveness research of priority to AHRQ (see description in Section 1: Research Objectives)? Are the particular health burdens posed by the conditions under study significant in terms of prevalence, morbidity and/ or the utilization of health care resources? Given the current capacity of the institution, if the aims of the overall plan are achieved, will there be a significant impact on the institution s capacity to engage and sustain comparative effectiveness research activities that are relevant at the local, state or national level?

Approach: In the context of infrastructure development efforts, how will the overall program be tested by the performance of the included research project, both from a formative and a summative perspective? Does the applicant acknowledge potential problem areas and consider alternative tactics for the infrastructure development? Have potential barriers to building the improved data structures or models been identified and addressed? Have potential barriers or threats to sustainability of the developed infrastructure been identified and addressed?

What is the quality of the design in the individual research project? Does the applicant address both the benefits and the limitations of the research project? Is the project firmly grounded in the current literature? How will the research project contribute to the field? If pilot in nature, does the research project seek to establish feasibility, or the merit of a particular area of inquiry? What is the appropriateness of the approach described in the research project?

Innovation: What is the special value of the proposed infrastructure development in creating new opportunities for research that have not been possible before? Will important new co-morbid disease combinations (i.e., dyads or triads) be available for study? Will minority ethnic populations be represented in adequate numbers to create a novel opportunity to study particular conditions within those population groups? Regarding the individual research project, does the project address important problems?

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the lead for the pilot or primary research project well suited to carry out the work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Is there evidence of new collaborative relationships? Is the team comprised of diverse and appropriate members? Given that the PI/PD is critical to the sustainability of research efforts at the institution, how well does the PI/PD demonstrate commitment to comparative effectiveness research and to research on complex patients and to faculty and student development? Are there clear indicators of institutional support (i.e., release time, letters from university leadership, courses already taught), and evident availability to lead the effort and mentor faculty and students? How adequate is the letter of institutional commitment, and does it address protected time for faculty to engage in research, and research mentoring; opportunities to recruit and retain quality faculty and students; and opportunities for career development for faculty, as needed? How well can the PI/PD provide direction and leadership in the research proposed?

Environment: To what extent will the proposed research change/alter the environment, facilitate the institutions ability to conduct, expand, and improve health services research, and/or secure institutional support for commitment to the conduct of comparative effectiveness research on complex patient populations? Are research administration, collaborative arrangements, and data management and analysis support adequate? Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? What is the quality of the available resources at the institution, including data capacity, equipment and research space, and how is it linked to capacity development plans? What is the current faculty and student interest in complex patient research and professional development activities? What is the probable long-term impact of the program? Are there available resources and support for the investigators leading the primary or pilot research project?

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 for both infrastructure development and the research project noted in the FOA?

Plan for making data/infrastructure available: How complete and feasible is the data sharing plan proposed by the applicant?

Plan for sustainability: How likely is it that the developments made possible through this grant will continue after the grant has ended? How does the engagement of the involved institutions suggest future success?

Budget: Is the proposed budget reasonable? Is the type of infrastructure development (data set development versus methods development) reflected in the budget? Is the requested period of support appropriate in relation to the proposed research? Does the budget adhere to FOA-specific requirements?

Inclusion: Adequacy of plans to identify and include women and members of minority groups and their subpopulations. 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 infrastructure development will be assessed.

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:

This R24 FOA provides support for development of infrastructure aimed at facilitating the performance of high quality research on patients with multiple chronic conditions in order to improve the quality, safety, efficiency and effectiveness of health care for this population.

Appeals will not be permitted. See Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process (see NOT-HS-09-011, http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).

2.B. Additional Review Considerations

Not Applicable.

2.C. Resource Sharing Plan(s)

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 civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:

Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

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 eRA Commons.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

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

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (see http://www.ahrq.gov/fund/arraterms.htm).

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 the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

3. Reporting

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 items 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.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). 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.

Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section 1512 of the Recovery Act requires prime recipients of the ARRA funds to submit quarterly reports, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10). Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ Website at http://www.ahrq.gov/fund/arraterms.htm.

In addition, AHRQ is currently developing AHRQ-specific reporting requirements. Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Grant Award and incorporated into AHRQ Terms and Conditions of Award.

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

Section VII. Agency Contacts

This FOA is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (also including submission of a letter of intent) by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

For additional information see: http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

Please note, the President’s memorandum applies to communications prior to the award of a grant or other Recovery Act funding; it does not apply to communications with officials regarding the administration of a grant that has already been awarded.

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

1. Scientific/Research Contacts:

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

Mary Barton, M.D.
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1638
Fax: (301) 427-1595.
E-mail address: Mary.Barton@ahrq.hhs.gov

2. Peer Review Contacts:

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

Kishena Wadhwani, Ph.D., M.P.H.
Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to:

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address: George.Gardner@ahrq.hhs.gov

Or

Michelle Burr
Office of Performance Accountability, Resources and Technology
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

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

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

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

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

The HHS "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) which governs the protection of individually identifiable health information. It is administered and enforced by the HHS 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. Program Officials will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA (3). 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", 5 USC 552(b)(4) for example, if it constitutes 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 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 authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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

References

1. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005;294(6):716-24.

2. Werner RM, Greenfield S, Fung C, Turner BJ. Measuring quality of care in patients with multiple clinical conditions: summary of a conference conducted by the Society of General Internal Medicine. J Gen Intern Med. 2007;22(8):1206-11.

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