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 Delivery, Organization and Markets (CDOM), (http://www.ahrq.gov/about/cdom/)

Title:  Building the Science of Public Reporting (R21)

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 Request for Applications (RFA).

Request for Applications (RFA) Number: RFA-HS-12-004

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: January 23, 2012
Opening Date:  February 28, 2012
Letters of Intent Receipt Date(s): February 27, 2012
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 Due Date(s): March 28, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: March 29, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This AHRQ FOA solicits R21 Exploratory / Developmental grant applications that propose to build the scientific evidence base for effective public reporting for consumers through innovative, actionable studies that address pressing questions in the field.

A number of studies suggest that consumers infrequent use of public reports of health care quality and resource use is due to reports poor design, irrelevant content, and inadequate dissemination, rather than a lack of consumer interest. Early evidence suggests that consumers want easy-to-understand, readily accessible reports that allow them to compare providers and sites of care based on quality and value at key decision points. In order for public reporting to be effective, reports need to provide consumers with transparent, timely information they can trust to help inform their conversations with providers and payers, and guide their health care decisions.

This FOA seeks to support research that will inform the development of a health care system in which every consumer has ready access to reports that allow meaningful comparison of providers based on measures of quality and resource use. This FOA will fund exploratory and developmental studies that seek to fill knowledge gaps around public reporting and establish an evidence base to inform the content, design, dissemination and use of public reports, guiding the way toward enhanced reporting practices.

• Mechanism of Support. This FOA will use the AHRQ Research Exploratory / Developmental (R21) grant mechanism.
• Funds Available and Anticipated Number of Awards.  AHRQ intends to commit up to $14,000,000 between Fiscal Year (FY) 2012 and FY 2014. AHRQ intends to fund up to 25 applications in response to this FOA, with an anticipated funding distribution of $5 million in FY 2012, $5 million in FY 2013, and $4 million in FY 2014. 

Through this FOA, AHRQ seeks to support high value, actionable research, and encourages applications of a variety of sizes and durations that emphasize efficiency of study design. AHRQ intends to fund a mix of one, two, and three year studies. 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. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and number of awards will also depend on the number, quality, duration, and costs of the applications received. 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 AHRQ staff of the annual progress report (PHS 2590).

• Budget and Project Period. Applications may be 1 to 3 years in duration, with no more than $350,000 total costs (direct and indirect costs) requested from the government in any given year, and a budget supported by AHRQ not to exceed $1,000,000 total costs over the total project period.  Applications with project periods that exceed three years, or budgets that exceed $350,000 total costs in any given year, or budgets that exceed $1,000,000 in total costs to the government over the entire project period, will not be reviewed.
• Application Research Strategy Length: The R21 Research Strategy section may not exceed 20 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project 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/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.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct. 
• Resubmissions: Resubmission applications are not permitted in response to this FOA.
• Renewals: Renewal applications are not permitted in response to this FOA
• Special Date(s): This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936. 

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

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives
1. Mechanism of Support
2. Funds Available

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. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
2. Technical Assistance
    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
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

Definitions

For the purposes of this FOA, the following definitions apply.

Public Reporting: Public reporting refers to any effort to provide a broad audience of health care consumers with information that allows rating or comparison of providers according to certain performance standards of quality, resource use, or a combination of the two. Public reporting is a process that may involve voluntary or mandatory data collection from a combination of health care providers, plans, payers, and consumers; processing of that data into measures and comparison to standards of quality and resource use; and final dissemination to a public audience.

Consumer: Any actual or potential recipient of health care services.

Provider: Any person, organization, or facility directly involved in the delivery of health care services, including, but not limited to, individual or groups of physicians, nurses, physician assistants, pharmacists, home health professionals, hospitals, nursing homes, dialysis facilities, and pharmacies.

Background

Health care quality and resource use continue to vary widely among providers, and disparities in care faced by the poor, certain minorities, and other priority populations have not improved.¹ Public reporting is one method of bringing these differences to light, informing consumers and allowing comparison of provider performance. Public reporting began in earnest 25 years ago with the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services, or CMS) reporting hospital mortality rates. With the growth of information technology and rising public and governmental demand for information on health care quality and resource use, measurement and reporting of provider performance has grown and diversified rapidly.

Today, hundreds of public reports with thousands of different measures are being produced throughout the United States. At the federal level alone, CMS publishes public reports comparing the quality of hospitals, nursing homes, home health, and dialysis facilities². AHRQ does not produce public reports directly, but has a long and active role in helping those who do through measure development^3,4,improving data for public reporting⁵, building the science of public reporting⁶, and providing public reporting tools like MONAHRQ⁷. The federal government is far from alone dozens of states, communities, and organizations are actively involved in public reporting as well.

Despite all this activity, the evidence base on the content, design, and dissemination of public reports contains many unresolved issues on how to best meet the needs of consumers.⁸

Pathways to Improvement

There are two basic pathways by which public reports can potentially improve health care quality and resource use: 1) Consumer selection of high-value providers, and 2) provider efforts to improve care.⁹ First, given appropriate comparative information, consumers and payers may select high-value providers (high quality, low cost), giving more consumers access to high value care.¹⁰ Second, providers may view measurement and reporting as an incentive to change and improve their care processes, seeking to grow market share as well as maintain their professional reputation in the community and among peers.^11,12

Scope

The primary focus of this FOA is on consumer use of reports. All other potential audiences or users of reports are secondary, and should only be included as far as their relation to consumers. For example, some public report sponsors give private reports to providers. While important, these would be out of scope for this FOA. Similarly, studies of provider pay-for-performance or other provider incentives related to measurement and reporting would be out of scope. In contrast, studies of the impact of consumer use of reports on provider behavior would be in scope. Also, studies involving reports on providers produced by an insurance entity for use by enrollees would be in scope, despite the report not being available to the general public. All research proposals should take a consumer-focused approach.

Additional Background

As one of the first and most established sources of public reports on health care quality, the Centers for Medicare and Medicaid Services (CMS) is dedicated to improving the science and practice of public reporting. As part of its activities related to Section 3014 of the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148)¹³ to improve the dissemination of measures of health care quality and resource use, this initiative to build the science of public reporting is supported by funds transferred from CMS to AHRQ. AHRQ’s authority to engage in this research is provided under the PHS Act, Section 901(b)(1)(A) or (F), and PHS Act Section 902(a)(1) and (2).

For additional background on public reporting for consumers, please visit AHRQ’s Public Reports on Provider Performance for Consumers and TalkingQuality. Please also review the latest draft of the AHRQ-commissioned report Public Reporting as a Quality Improvement Strategy: A Systematic Review of the Multiple Pathways Public Reporting May Influence Quality of Health Care, ¹⁴ available upon email request to brent.sandmeyer@ahrq.hhs.gov. For examples of current public reports, visit the CMS Quality Care Finder and AHRQ’s Health Care Report Card Compendium.

Research Goals

Given the tremendous variety and changing nature of public reports, studying their design and impact has been challenging. Most research so far indicates that any quality changes related to reporting have been due to providers attention to reports, rather than consumer use.¹⁵ However, a number of studies suggest that consumers low use of reports is due to poor design and dissemination, rather than a lack of interest.^16,17,18

In order for public reporting to be effective, reports need to provide consumers with timely information they can trust to help inform their conversations with providers and payers, and guide their health care decisions. Early evidence suggests that consumers need easy-to-understand, readily accessible reports that allow them to compare providers and sites of care based on quality and value at key decision points.^19,20,21

This FOA seeks to support research that will inform the development of a health care system in which every consumer has ready access to reports that allow meaningful comparison of providers based on measures of quality, resource use, or a combination of the two. This FOA will fund exploratory and developmental studies that seek to fill knowledge gaps around public reporting and establish an evidence base to inform the content, design, dissemination and use of public reports, and guide the way forward for enhanced reporting practices. Consumers are not a uniform group, and applicants should address the varying needs and preferences of different groups, particularly AHRQ’s priority populations.

Applicants to this FOA should focus on those overarching goals while planning their studies.

Research Approaches

A wide range of research and experimental approaches may be appropriate to advance the science of public reporting, based on the area of study and primary research question. Studies may include, but are not limited to: pilot programs, products, and reports; evaluations of products, programs, and organizations; meta-analyses; theory development and testing; experiments and quasi-experiments. Qualitative, quantitative, and mixed-methods analyses are acceptable. Research designs and methodology should emphasize innovation and actionable findings, using cutting-edge technology and methods when appropriate and exploring new areas and possibilities for reporting. Developing primary data is acceptable, in addition to collecting and analyzing secondary data. Any studies introducing novel programs or products should include control groups if possible. Prospective studies of changes and innovations in public reporting are welcome, but studies of current or former reports are only appropriate if the studies are designed to provide actionable information for the design and implementation of future reports. Pilot programs and products as well as alterations to existing programs and products should include a robust evaluation of the impact on consumers, including unintended consequences, as part of the research plan and budget.

Potential Areas of Study

This research initiative seeks to fill three major gaps in the public reporting evidence base in order to:

1)    Improve the design and presentation of public reports to meet the needs of consumers, including subgroups such as AHRQ’s priority populations and Medicare and Medicaid beneficiaries.

2)    Increase consumer use and the dissemination of public reports, including subgroups such as AHRQ’s priority populations and Medicare and Medicaid beneficiaries.

3)    Improve the underlying data and methodology of public reports to make them more credible, meaningful, and useful.

Illustrative research questions are included below, but this list is not intended to be exhaustive or exclusive. AHRQ is primarily interested in applications designed to yield actionable findings that have a clear potential impact on public reporting practice.

Designing Public Reports for Consumers

• What are the top consumer-valued report content areas? What measures are most relevant for consumers in selecting high value care (low cost, high quality)?
• How can provider ratings be customized in response to individual consumer characteristics or preferences?
• What are the best practices for framing and presentation of public reports?
• How can public reports be designed or implemented to target key consumer decision points to better aid their decision-making?
• How can public reports address the varying information needs of population subgroups, especially AHRQ’s priority populations (see Section III.6) and Medicare and Medicaid beneficiaries, such as differences in language, physical and cognitive abilities, health literacy, and health numeracy?
• How can health improvement or disease management information be integrated with public reports to improve consumer health behaviors?
• How can CMS public reporting tools such as Hospital Compare be improved to better inform and engage consumers?

Consumer Use and Dissemination

• How can cutting-edge technologies such as mobile applications and social media be used to improve report dissemination and engage consumers?
• How can intermediaries such as clinicians, patient navigators, or decision support software assist consumers in their use of reports?
• How can public reports address varying levels of consumer activation and interest in health care decision-making?
• What are effective strategies for increasing consumer awareness and use of public reports (e.g. community outreach, traditional and social media, search engine optimization, social networking, integration with or promotion by health systems, employers, or insurers)?
• How can consumers use public reports of provider quality and resource use to select health insurance plans?
• How can health insurance plans be designed to allow consumers to easily use public reporting information to choose providers?
• How can a local or statewide public report such as MONAHRQ be efficiently and effectively implemented in an area without current local public reporting efforts?

Improving Data and Methodology

• How can reports accurately attribute patients care to multiple providers?
• How could new sources of data be used to improve public reports quality, validity, or consumer relevance?
• How can measure data be combined over time to show meaningful trends? What methodological issues need to be considered in deciding how to display trends?
• What methods or tools could be developed or modified to improve the quality of data used in public reporting?

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 Exploratory / Developmental grant (R21) award mechanism. The individual researcher sponsored by the applicant organization will be solely responsible for planning, directing, and executing his or her proposed project.

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

2. Funds Available

AHRQ intends to commit up to $14,000,000 between Fiscal Year (FY) 2012 and FY 2014. AHRQ intends to fund up to 25 applications in response to this FOA, with an anticipated funding distribution of $5 million in FY 2012, $5 million in FY 2013, and $4 million in FY 2014. Applications may be 1 to 3 years in duration, with no more than $350,000 total costs (direct and indirect costs) requested from the government in any given year, and a budget supported by AHRQ not to exceed $1,000,000 total costs over the total project period.  Applications with project periods that exceed three years, or budgets that exceed $350,000 total costs in any given year, or budgets that exceed $1,000,000 in total costs to the government over the entire project period, will not be reviewed.

Through this FOA, AHRQ seeks to support high value, actionable research, and encourages applications of a variety of sizes and durations that emphasize efficiency of study design. AHRQ intends to fund a mix of one, two, and three year studies. 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. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and number of awards will also depend on the number, quality, duration, and costs of the applications received. 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 AHRQ staff of the annual progress report (PHS 2590).

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:

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

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, 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 not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

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

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 can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, up to a maximum of two, provided each application is scientifically distinct and the proposed projects would each be able to meet the FOA requirements. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

AHRQ will generally support no more than one meritorious application per academic-degree granting institution and its affiliate organizations.  Support for two applications per applicant organization and/or its affiliates will be considered when this arrangement is fully justified and achieves programmatic balance across AHRQ priorities.  

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

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

Section IV. Application and Submission Information

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

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four to six weeks. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

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

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

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

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons. 
• The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• The PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

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 301-710-0267; 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.  See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 28, 2012
Letters of Intent Receipt Date(s): February 27, 2012
Application Due Date(s): March 28, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

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

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

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

Brent Sandmeyer
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1441
FAX: (301) 427-1430
E-mail: Brent.Sandmeyer@ahrq.hhs.gov

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

3.A.2. Technical Assistance

AHRQ encourages potential applicants to review the Frequently Asked Questions (FAQ) website for this FOA prior to contacting an AHRQ representative, to see if their question has already been answered. AHRQ will update the FAQs as common questions are identified. The FAQs will be available at http://www.ahrq.gov/fund/grantix.htm.

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/applicants/apply_for_grants.jsp and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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

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

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

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 reviewed.

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

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.  The applicant should obtain an estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

PD(s)/PI(s) should demonstrate familiarity with the current science and practice of public reporting, and, if relevant, health care quality and resource use measurement.

Through this FOA, AHRQ seeks to fund rapid, actionable research, and encourages efficient study design. AHRQ intends to fund a mix of study durations from one to three years, which will best serve the need to quickly build the evidence base and translate research into practice. Reviewers will particularly consider whether research duration is appropriate in their ratings.

PD(s)/PI(s) are encouraged to partner with or plan studies involving entities already engaged in public reporting, such as state governments, Chartered Value Exchanges and other community quality collaboratives, business coalitions, and federal agencies such as the Centers for Medicare and Medicaid Services (CMS).

AHRQ seeks to connect grantees with one another and with various public reporting stakeholders in order to encourage connections between research and practice in the field. To that end, for each year of funding, the applicant’s budget must include funding to allow the PI and one other key project member to attend three or more days of the AHRQ annual meeting and one other two-day meeting to be determined by the program officer, both in the Washington, D.C. area. The PI or a key project member must be available for at least one telephone conference per quarter with AHRQ staff, contractors, and various public reporting stakeholders, as well as additional correspondence with staff and contractors as necessary. PIs should be prepared to share basic information about their research and preliminary findings as appropriate at meetings and on calls.

Applicants should review Section IV.6 ( Publications Transmittal, Consumer Products, and Plan for Sharing Research Data, and Section V.2.C ( Sharing Research Resources: Rights in Data ) of this FOA to ensure that their research plan adequately addresses plans to publicize and disseminate research findings. The budget must include funds for an appropriate member of the PI’s team to work remotely (via telephone, email, and internet) for a total of at least 2 days annually with AHRQ’s Office of Communications and Knowledge Transfer staff and/or with AHRQ contractors.

In order to ensure rapid development of the public reporting evidence base, study extensions are strongly discouraged, and will be reviewed strictly on a case-by-case basis.

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.

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.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 20 pages.

Budget Component

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

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

Appendix Materials

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 comply with the required page limitations may be delayed in the review process.

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

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

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

Consumer Products

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information

1. Criteria 

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

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. 

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

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

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Public reporting is one strategy to help realize these overall aims. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria  

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does this study address an important public reporting problem or evidence gap in the public reporting research? If the aims of the application are achieved, how will the science or practice of public reporting be advanced? What will be the effect of this study on the concepts, methods, technologies, design, services, and delivery that drive the public reporting field?

Investigators. Are the PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PI and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project? Does the PI demonstrate familiarity with the current science and practice of public reporting? If the PI proposes a partnership with other organizations such as report sponsors or government agencies, does the application document evidence of the organization’s interest in such a partnership?

Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or practice, or address an innovative hypothesis or critical barrier to progress in the field of public reporting? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies in public reporting?

Approach. Are the conceptual framework, design, methods, and analyses in the study 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 their choice of study duration and resources needed? 

Environment. Does the scientific environment 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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Does the PI have access to the study’s populations of interest (consumers, clinicians, priority populations, etc.) and the data needed to conduct the study?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating.

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? To what extent will the potential findings be readily applied to improving public reports?

Budget and Period of Support: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? In order to ensure sufficient breadth and depth of study and the best return on investment, AHRQ reviewers will consider investigators efforts to control study duration and cost through efficient study design.

Inclusion: Are there adequate plans to address the needs of different genders, racial and ethnic minorities, and other population subgroups? Is there adequate 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.) and Medicare and Medicaid populations?

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 study will be assessed.

Selection Process

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

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities and programmatic balance
• PD/PI experience and qualifications
• Value of study: balance of cost, duration, and expected findings

2.B. Additional Review Considerations

The tremendous variety and localization of existing public reports may limit applicants ability to generalize findings or scale up results, particularly for smaller pilot programs or products. While reviewers may consider the potential to generalize and scale results, the level of innovation and other review factors will take precedence.

2.C. Resource Sharing Plan(s)

Data Confidentiality

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

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

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

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 NIH eRA Commons. 

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

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

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

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

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

Section VII. Agency Contacts

We encourage 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 Contact(s):

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

Brent Sandmeyer
Center for Delivery, Organization and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1441
Fax: (301) 427-1430
E-mail address: brent.sandmeyer@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:

Ileana Ponce-Gonzalez
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) 427-1769
Fax: (301) 427-1562
E-mail address: Ileana.poncegonzalez@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Nicole Williams
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) 427-1015
Fax: (301) 427-1462
E-mail address: Nicole.Williams@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 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 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:

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

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

Healthy People 2020:

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

Authority and Regulations:

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

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

References

1. Agency for Healthcare Research and Quality. 2010 national healthcare quality report. 2011. Available at: http://www.ahrq.gov/qual/qrdr10.htm

2. Centers for Medicare and Medicaid Services. Quality Care Finder. Accessed November 1, 2011. Available at http://www.medicare.gov/quality-care-finder/index.html

3. Agency for Healthcare Research and Quality. Consumer Assessment of Healthcare Providers and Systems. Accessed November 1, 2011. Available at https://www.cahps.ahrq.gov/

4. Agency for Healthcare Research and Quality. Quality Indicators. Accessed November 1, 2011. Available at http://www.qualityindicators.ahrq.gov/

5. Elixhauser A, Parker J, Pine M, Andrews R. Improving administrative data for public reporting. September 9, 2008. Available at http://www.ahrq.gov/about/annualmtg08/090908slides/AndrewsElix2.htm

6. Agency for Healthcare Research and Quality. Public reports on provider performance for consumers. Accessed November 1, 2011. Available at http://www.ahrq.gov/path/publicreporting.htm

7. Agency for Healthcare Research and Quality. MONAHRQ. Accessed November 1, 2011. Available at http://monahrq.ahrq.gov/

8. Public Reporting as a Quality Improvement Strategy: A Systematic Review of the Multiple Pathways Public Reporting May Influence Quality of Health Care. Draft Report. December 2011. Rockville, MD: Agency for Healthcare Research and Quality. Contact brent.sandmeyer@ahrq.hhs.gov for a copy of the draft report.

9. Berwick DM, James B, Coye MJ. Connections between quality measurement and improvement. Med Care 2003; 41(1 Suppl):I30-8.

10. Ibid.

11. Ibid.

12. Hibbard JH, Stockard J, Tusler M. Hospital performance reports: impact on quality, market share, and reputation. Health Aff 2005; 24(4): 1150-60.

13. H.R. 3590--111th Congress: Patient Protection and Affordable Care Act. 2009. Available at http://www.govtrack.us/congress/bill.xpd?bill=h111-3590&tab=reports

14. Public Reporting as a Quality Improvement Strategy: A Systematic Review of the Multiple Pathways Public Reporting May Influence Quality of Health Care. Draft Report. December 2011. Rockville, MD: Agency for Healthcare Research and Quality. Contact brent.sandmeyer@ahrq.hhs.gov for a copy of the draft report.

15. Fung CH, Lim Y, Mattke S, Damberg C, Shekelle PG. Systematic review: the evidence that publishing patient care performance data improves quality of care. Ann Int Med 2008; 148:111-23.

16. Ibid.

17. Kolstad JE, Chernew ME. Quality and consumer decision making in the market for health insurance and health care services. Med Care Res Rev 2009; 66(1 Suppl):28S-52S.

18. Bardach NS, Hibbard JH, Dudley RA. Users of public reports of hospital quality: who, what, why and how?: An aggregate analysis of 16 online public reporting web sites and users and experts suggestions for improvement. Draft Report. October 2011. Rockville, MD: Agency for Healthcare Research and Quality.

19. Ibid.

20. Kling JR, Mullainathan S, Shafir E, Vermeulen L, Wrobel M. Comparison friction: experimental evidence from Medicare drug plans. National Bureau of Economic Research Working Paper 17410. September 2011.

21. Robert Wood Johnson Foundation. Consumer Decision Points of Health Care Information. July 2010. Available at http://www.rwjf.org/files/research/71844.pdf