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:  Research Centers for Excellence in Clinical Preventive Services (P01)

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-11-005  

Catalog of Federal Domestic Assistance Number(s)

93.226

Key Dates
Release Date: March 11, 2011
Letters of Intent Receipt Date(s): April 29, 2011
Application Receipt Dates(s):  May 23, 2011
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date: Approximately two months after peer review date 
Additional Information To Be Available Date:  Not applicable
Expiration Date: May 24, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This FOA solicits Research Program Project Grant (P01) applications from applicant organizations to become a Research Center for Excellence in Clinical Preventive Services with a focus on one of three programmatic areas:  (1) patient safety; (2) health equity; or (3) health care system implementation.  AHRQ is providing this support for research center grants to foster innovative, synergistic, and targeted research on clinical preventive services.  These Centers will complement the efforts of other Federal investments in prevention and public health by focusing on the role of the formal health care system, and primary care in particular, in improving the health of all Americans, in increasing the effectiveness, safety, and efficiency of the health care system, and in improving patient experience, through the implementation of evidence-based clinical preventive services.  The goal of this initiative is to support high quality, multidisciplinary programs of innovative research that will move forward the nation’s emerging National Prevention Strategy.

This FOA is intended to support both necessary core Center infrastructure and two to four integrated research projects.  The projects should contribute to the overarching Center goal such that the whole is greater than the individual parts.  The projects will thus not simply be unitary investigations that would better be supported by individual R01 or R18 awards.

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.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.  While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: AHRQ and NIH are committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate multi-project programs. AHRQ and NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

2.  Programmatic Areas
3. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
    B. Submitting an Application to AHRQ
    C. Application Processing

4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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


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

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

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

The Agency for Health Care Research and Quality (AHRQ) invites applications for Program Project Grant (P01) awards to create Research Centers for Excellence in Clinical Preventive Services.

Program project awards represent synergistic research programs that are designed to achieve results that cannot be attained by investigators working independently. The program project must consist of core elements, including training, evaluation and dissemination as well as administration, and two to four integrated research projects.

Purpose

AHRQ is authorized by Congress to convene the United States Preventive Services Task Force (USPSTF), 42 U.S.C. 299b-4(a).  The USPSTF is an independent panel of non-Federal experts in prevention, primary care, and evidence-based medicine that conducts rigorous, impartial assessments of the scientific evidence and makes recommendations on the effectiveness of a broad range of clinical preventive services, including screening, counseling and preventive medications.  In many instances, the USPSTF has concluded that the evidence is insufficient to determine the balance of benefits and harms for a particular clinical preventive service.  For many clinical preventive services, the USPSTF has found limited evidence surrounding the real and potential harms related to the service.  Frequently, the USPSTF is unable to comment on the potential differential impact of clinical preventive services for specific populations, including the elderly and racial and ethnic subgroups.  One of the primary reasons AHRQ is establishing Research Centers for Excellence in Clinical Preventive Services is to strengthen our national infrastructure for addressing evidence gaps in our knowledge of clinical preventive services. 

A robust evidence-base is necessary, but not sufficient, for achieving the benefits of clinical preventive services.  In addition to knowing what services have the potential to be beneficial, health care systems and providers must know how to implement them effectively and efficiently.  The formal health care system, and primary care in particular, play a critical role in the delivery of clinical preventive services.  While other federal, state, local, and private initiatives support innovation in the many other aspects of prevention and wellness, including maximizing the ability of community and public health efforts to promote prevention, the second major intent of this initiative is to give needed focus to improving our understanding of the role of primary health care and the larger health care system in implementing clinical preventive services.

This initiative is designed to support integrated, multi-project research programs that will work with a well-defined, central research focus to contribute to addressing the research and implementation gaps identified as part of the development of the HHS National Prevention and National Quality Strategies.

The P01 is a coalition of interrelated research projects, each capable of standing on its own scientific merit but complementing one another.  The P01 application must include a minimum of two (and no more than four) individual research projects that contribute to the program objective.  Each individual research project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the project leader. In addition, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.  

The program project also must include a leadership core to manage day-to-day activities across the program project and to house important functions of the core, including training and development, evaluation and dissemination, and communication and coordination with a planned AHRQ-supported Technical Assistance Center as well as the other funded Centers.  In addition, applicants may propose one or more shared resource functions to reside in the core if needed for the proposed research; for example, statistical resources or research computing expertise. Each shared resource function must be utilized by two or more projects within the program.

The statutory authority for the initiative that is the subject of this FOA is 42 U.S.C. 299a(a), which authorizes AHRQ to conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to clinical practice, including primary care and practice-oriented research.  See 42 U.S.C. 299a(a)4.

Definitions

Clinical Preventive Services include:

Health care providers offer clinical preventive services to find or prevent specific medical conditions in patients who have no signs or symptoms of those conditions. These services are offered to patients who may develop a condition because of their lifestyle, age, gender, personal or family medical history, or a combination of these. Some preventive services are meant to catch diseases early, and others are meant to prevent diseases entirely.  For the purposes of the FOA, clinical preventive services do NOT include screenings, counseling, or preventive medications targeted to individuals with established medical conditions as part of the management and treatment of those conditions.  For example, this FOA is not intended to address research gaps in the provision of screening for retinopathy in patients with diabetes.

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 Program Project Grant (P01) grant mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and overall execution of all proposed research studies.  While each individual study may have its own study lead, the P01 application may name only one PD/PI.

2.  Programmatic Areas

Applicants to this FOA should propose a core infrastructure and a well-integrated program of between two and four research activities that will address one of three broad programmatic areas:  patient safety, health equity, or health care system implementation.  These three areas are described below. 

Patient Safety.  It seems paradoxical that there may be harms associated with clinical preventive services.  However, there are many potential harms associated with clinical preventive services such as false positives, anxiety, labeling, physical harms, and opportunity costs such as time off from work.  These harms can result from the clinical preventive service but also from additional follow-up tests or from treatments.  In order to improve patient safety, it is imperative that we know as much as possible about the tradeoff of potential benefits and harms of clinical preventive services.  

It is equally important to understand how patients perceive these harms and how to communicate about the harms of clinical preventive services in a social environment that favors more intervention over less.   Decision-making about clinical preventive services requires the translation of population-based estimates of harms to the particular circumstances of the individual patient.  Evaluation of approaches to improve risk and other communication related to clinical preventive services should include patients from diverse backgrounds and patient with limited health literacy.

Health Equity: Providing Prevention for Priority Populations.  The purpose of this Center will be to study how to improve access, delivery and outcomes of clinical preventive services in priority populations such as children, women, the elderly, racial and ethnic minorities, and rural residents (see AHRQ priority populations at:  http://www.ahrq.gov/populations).  The ultimate goal is to generate evidence that would help increase health equity in access to and use of clinical preventive services. 

This Center may focus on constructing new data sets and/or cataloging existing datasets that have enough power to study causes of disproportional mortality in priority populations.  It may develop new methods or enhance existing methods to study priority populations.  For example, colorectal cancer screening is one of the most effective services available to prevent cancer morbidity and mortality, yet the use of screening, even among persons with equal insurance coverage, is not uniform across the population.  Screening rates among Native American/Alaskan native populations have actually decreased over time, as documented in the most recent National Healthcare Disparities Report. 

The Center also may conduct original research on the provision of clinical preventive services in groups of people with different risk factors to determine the benefits and harms of clinical preventive services in these groups which may differ from the general population.  For example, epidemiologic data tell us that African American women are disproportionately affected by aggressive breast cancers.  Screening protocols to detect these tumors early might use new technologies and may need to be done on different schedules, compared to screening in non-African American women.  Finally, the Center also may conduct research on strategies to decrease disparities in priority populations. Strategies may include community-wide approaches as well as interventions in the clinical setting.

Implementing Clinical Preventive Services in Primary Care Practice.  This Center will support basic or applied implementation research to address how primary care practices and the larger health care system can improve the delivery of evidence-based clinical preventive services based on USPSTF and the CDC’s Advisory Committee on Immunization Practices recommendations.  This may include research into how to redesign primary care to improve the delivery of clinical preventive services.  The Center may study how primary care practices can partner with community-based organizations and the public health system to enhance the delivery and quality of clinical preventive services. 

Potential for overlap across the programmatic areas.  Each application must identify a single programmatic area for its proposed research center that represents the focus of its research and activities.  While all proposed research projects and supporting activities must directly support the main focus of the Center, AHRQ recognizes that individual proposed projects may also be relevant to another programmatic area.  For example, a Research Center focused on patient safety may propose to examine an aspect of the implementation of a particular clinical preventive service in primary care practices.  While this type of overlap is not required, it is permitted.  AHRQ anticipates many opportunities for cross-Center synergy.

3. Funds Available

AHRQ  anticipates making three awards, one in each programmatic focus area. The number of awards is contingent upon availability of funds and the submission of a sufficient number of meritorious applications.

Applications are limited to a budget of $1.5 million total costs per year and a project period no longer than 3 years.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

The total costs for a grant awarded under this FOA will not exceed $1.5 million annually for the entire project period. Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation progress report.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following types of organizations/institutions are eligible to apply: 

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.

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 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. It is expected that the PD/ PI will make a substantial commitment of time and effort to the Center and commit at least 20 percent effort annually to Center administration.  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 should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

3. Other-Special Eligibility Criteria

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

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

Renewals.  It is anticipated that a one-time renewal application will be 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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

See Section IV.3.A below for details. 

3.A.Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s):  April 29, 2011
Application Receipt Date: May 23, 2011 
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date(s): Approximately two months after peer review

3.A.1. Letter of Intent

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

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

The letter of intent can be sent electronically, and should 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

Email:  Gloria.Washington@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 applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff.  The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA.  The conference call will take place on April 14, 2011 at 1:00 p.m. EDT.  To register to participate in the conference call, please send an e-mail request to Gloria.Washington@ahrq.hhs.gov) by April 8, 2011.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB April 12, 2011.  Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply.  Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to Gloria.Washington@ahrq.hhs.gov by April 8, 2011.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be posted on the AHRQ web site. 

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
Email: Gloria.Washington@ahrq.hhs.gov

3.C. Application Processing

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

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

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

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

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

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

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 categories.  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 requested and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements and Information

Guidance on Application Structure

Each application must describe two specific components:

1.    Core Infrastructure

2.    Two to four distinct Research Projects

The merit of each application will be determined through review of both of these component sections.

Core Infrastructure.  Each application must clearly describe the essential organizational and administrative characteristics of the proposed Center.  The application should justify the proposed configuration, number, and resourcing of the core infrastructure and demonstrate how the proposed center infrastructure will facilitate integration and synergy among the proposed research projects.  The proposed core infrastructure must be capable of providing leadership, administration, management, evaluation, and dissemination activities for the Center.

AHRQ recognizes that applicants may be able to produce powerful synergy and efficiency by leveraging existing organizational infrastructure in the establishment of a Center in response to the FOA.  Applicants are encouraged to propose collaborations.  It is critical that applications that build on existing infrastructure demonstrate that the full intention of this FOA will be realized and that resources made available through this FOA will not be diverted to other purposes.  In developing the budget for core Center infrastructure, applicants should take into account funds currently available through existing collaborating grants.  The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

Each Center is expected to have a scientifically and administratively qualified PD/PI (Center Director) with responsibility for the scientific, administrative, budgetary, and operational aspects of the center. The Center Director should be an established senior researcher with expertise in prevention.  The Center Director is responsible for overall coordination and for the development of the Center.  The Center Director must participate in coordinated activities with the Technical Assistance Center and other P01 sites, including attending two meetings each year in the Washington DC area. It is expected that the Center Director will make a substantial commitment of time and effort to the Center and commit at least 20 percent effort annually to Center administration.  However, 15 percent effort as Center Director would be permissible if the Center Director is also project lead on one of the proposed research projects, with a minimum of 20 percent effort annually on the research project above and beyond the 15 percent annual effort devoted to Center Director duties. 

As part of its core infrastructure, applications may include contributions from multiple researchers, educators, clinicians, evaluators, and administrative and management staff members.  The organizational structure of each center should include a committed core of investigators who each have relevant experience either in methodologic approach or in work within the chosen programmatic area. The application must demonstrate the availability of personnel with the necessary multidisciplinary expertise to study a wide range of topical areas in prevention, and have experience in the areas of dissemination, implementation, and evaluation of such.  This team should ensure the scientific, administrative, budgetary, and operational aspects of the core in coordination with the Center Director.

The Center is expected to have appropriate and effective administrative and organizational capabilities to conduct multidisciplinary research, to foster synergy, to disseminate findings and to plan and evaluate Center activities.   Applications must demonstrate core infrastructure that provides general administration, coordination, and oversight of the Center’s activities. 

There should be clear evidence of the applicant institution's commitment to the Center.  The Center may include consortium institutions.  Generally it is expected that the applicant institution and any consortium institution will have worked collaboratively in the past.  Each Center must include documentation of any planned contributions of partnerships for which the partner contributes substantial resources (e.g., shared publications, conferences, educational tools or other products), especially with potential collaborators and users of research findings. Collaborations may include arrangements with partners such as other governmental agencies, professional groups, consumer groups, foundations, and the private sector.

Administrative and organizational arrangements should promote joint planning, training and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the Center. This should include an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research, publications, and generation of future grant applications, and also takes maximum advantage of the Center's prevention research capability.  The core should also include an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources.  Administrative support might also include plans for recruitment, training, and supervision of staff.

Salaries and support may be provided for a limited number of administrative and clerical personnel for time and effort devoted specifically to Center activities. However, salary and support for central administrative personnel usually paid from institutional overhead charges, including but not limited to budget and financial officers, grants assistants, and building personnel, are not allowable.  

Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment, when not covered by institutional overhead charges, are permitted.

Core infrastructure is expected to provide support to the specific proposed research projects of the Center.  Infrastructure needs that are specific to only one project should be described and budgeted as part of the specific project. 

AHRQ expects Centers will build additional research efforts in the future, utilizing the strong foundation of the core Center infrastructure to pursue and conduct additional studies.   The core infrastructure should support stakeholder input, research priority setting, pilot and feasibility studies, team development, and other activities that promote the mission of the Center and the field of clinical preventive services.  Applicants are encouraged to describe how they could engage broad input from stakeholders regarding activities of the Center.

Shared resources and services intended to support the overall Center and to enhance the productivity of the proposed integrated research projects are encouraged.  These may include data management, biostatistics, quality assurance support and similar needs.  Computer hardware and software may be included but must be well-justified and must not exceed 5 percent of total direct costs over the entire project period.

Costs for the use of ad hoc scientific and technical consultants when appropriate and for the conduct of seminar series designed to promote interdisciplinary interaction, education, and center cohesiveness may be requested.

Costs of center planning and evaluation, including the costs of an external advisory committee, may also be requested.  Plans for an evaluation of important Core functions must be included in the research plan description of the core.

As part of this initiative, AHRQ will support through a contract mechanism a Clinical Preventive Services Research Technical Assistance Center and two cross-Center collaborative meetings each year.  The work of the Technical Assistance Center and of the meetings will draw upon the aggregated thematic expertise of the individual Centers. 

A primary goal of the Technical Assistance Center and the regular meetings will be to respond to emerging issues and priorities identified by the National Prevention Strategy (see detail at http://www.healthcare.gov/center/councils/nphpphc/index.html) and the USPSTF.  Accordingly each application must propose one investigator within their Center to serve as the dedicated collaborative scientific lead (CSL). The proposed CSL must be a qualified and experienced investigator who is capable of serving as the Center’s scientific liaison and principal contributor to collaborative projects under this initiative, and who would commit to participating in quarterly conference calls.    The CSL will communicate with, collaborate with, and support other Centers, the Technical Assistance Center and  AHRQ  in the specified programmatic area.  Potential activities may include: (1) preparing presentations and discussion topics for cross-Center meetings; (2) developing research agendas or other recommendations for future research or education needs and activities; (3) drafting white papers, perspectives, opinion pieces, or other publications; (4) organizing all or part of other meetings with government entities or other relevant partners in prevention.  Applicants must propose at least 20% effort for the CSL and budget for CSL travel to at least two two-day meetings in the Washington, DC area each year.  

Proposals must include a plan and budget for dissemination activities. Investigators must affirm their willingness to work with the Technical Assistance Center on cross-Program dissemination activities.    

AHRQ encourages applicants to consider devoting approximately 30% of annual direct cost requested funds to support core Center infrastructure.  Any significant deviation from this amount, higher or lower, must be well-justified.  Applicants must provide a specific budget for core infrastructure that describes funds requested under this FOA and funds provided through other grants and in-kind.

Proposed Research Projects.   Applications must propose two to four distinct research projects to be conducted and completed within the available funding and within the initial three-year grant period.  No more than four projects may be proposed.  Each project must be related to the Center’s programmatic theme.

The proposed projects may be independent, interrelated, linked, sequential, or conducted in parallel as long as each one affords good independent feasibility and probability of success.  Individual projects are not required to begin at the start of the grant and are not required to last the entire duration of the project period, but the proposed start and end of each project must be clearly stated, and must be budgeted appropriately. Overall the series of research projects must span the entire project period.

At least two proposed projects should represent substantial research undertakings that will result in at least one final product that can be made publicly available.  Other projects may include pilot studies, feasibility studies, and hypothesis generating activities.  Programs developed for this application should show plans for how the research will be translated into specific, measurable outcomes. It must include a plan that describes the steps required to progress from developmental pilot programs to national programs that measurably affect outcomes.  This plan should identify how this goal will be achieved.  A high priority must be given to translational activity that results in education, outreach, and uptake into clinical practice. The final goal of this activity is measurable improvement in health outcomes, as measured by commonly accepted indicators, such as mortality, hospitalization rates, quality of life, or reduced resource utilization.

A project may be a single large research study or may be divided into a few smaller and interrelated components.  

Applications must clearly describe each proposed research project including a brief background with rationale and hypothesis, specific aims, research design, and analytic plan.  A separate detailed budget must be provided for each research project as part of the application budget section.  Applications must also identify the specific research team that will conduct each study.  Each specific research project must have an identified project leader.  Individual project leaders must be listed as key grant personnel, but are not considered to be co-PIs for the Center.  Each Program Project (P01) application must have one and only one Center Director who must be listed as the PI for the grant application.           

With regard to Center programmatic themes, below are some examples of projects that might be proposed within each theme area.

As an example, the Center might leverage multi-disciplinary teams to address a related suite of original research projects, that address the differential epidemiology and presentation of disease in populations that differ by race combined with research to analyze barriers to use of preventive screening in that same population. These studies could then be used to design an interventional trial to increase appropriate use of the screening test in the relevant population.  For example, epidemiologic data tell us that African American women are disproportionately affected by aggressive breast cancers.  Screening protocols to detect these tumors early might use new technologies and may need to be done on different schedules, compared to screening in non-African American women.

AHRQ expects applicants to devote approximately 70% of requested funds annually to research projects.  Applications must provide individual project budgets for each proposed research project.

Research Strategy Page Limitations

All application instructions outlined in the PHS 398 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:

Applicants should follow the directions below to assure that their Center theme, core infrastructure, and series of specific projects are adequately captured for review in the appropriate sections of the PHS 398.  Note that the page limits described in this FOA supersede the default page limits of the PHS 398.  

Specific Aims/ Overview:  This section of the PHS 398 must not exceed 1 page.  This section must describe the programmatic area identified by the center, describe important Core functions and capacities and briefly describe each of the Research Projects   Applicants should describe how the individual projects are linked to the overarching goals of the Center and how together they form a meaningful whole.   

Research Strategy:  This section may not exceed 30 pages.  The research strategy must contain two separate sections describing 1) core infrastructure and 2) proposed specific research projects.

The description of the core infrastructure should describe all of the elements detailed above in lines 693 to 837.  It is recommended that this component not exceed 6 pages. The description of the specific research projects should describe the proposed two to four research projects.  Each project should be separately described with information as noted above.

Budget Component

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using the detailed budget format.  Applications submitted in the Modular format will not be reviewed.

The multi-project grant application should be assembled and paginated as one complete document.

Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that applications will be scientifically reviewed as to their overall theme, 2 to 4 projects, and planned core infrastructure, applicants should prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component.

The detailed Table of Contents should include a page reference for the budget for each component.  Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader.  For separate Infrastructure Cores (if applicable), each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."   Separate proposed budgets for proposed components are required as described under Budget Component. 

Composite and Component Budgets

Do not use Form Page 4 of PHS Form 398 to create the composite budget.  Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for budget elements should not be presented here, but in the individual budgets of the projects and cores.)  FOR EXAMPLE:

Component

Year 1

Year 2

Year 3

 

 

All Years

Project 1.

125,000

130,000

135,200

 

 

  390,200

Project 2.

125,000

130,000

135,200

 

 

  390,200

Project 3.

100,000

104,000

108,160

 

 

  312,160

Core A. Admin. Core.

50,000

52,000

54,080

 

 

  156,080

Core B.

25,000

50,000

52,000

 

 

  127,000

Totals

425,000

466,000

484,640

 

 

1,375,640


Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

Detailed budgets and budget justifications for each year of support are required within the descriptions of each project and core.  The budget justifications must clearly explain and detail any budget fluctuations in future years.  Please use Form Pages 4 (for each year of support for each project) and 5 of PHS Form 398 for each individual project.

Note that core budget must include travel for both the PD/PI and the Collaborative Scientific Lead to attend two 2-day meetings each year in the Washington area.

Appendix Materials

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

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

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. 

Outreach and Dissemination:  Additional Guidance

The Centers and the Technical Assistance Center will work with AHRQ’s Office on Communications and Knowledge Transfer (OCKT) and the AHRQ program official in product dissemination, including the development of marketing plans, launch and press release activities, media outreach and partnership development, with a focus on the first 30 days following publication or product release.  OCKT staff and the AHRQ program official will work in consultation with the parent institution of the RC to determine the extent of outreach and target audiences for each publication or product.  This additional support from AHRQ is intended to complement and not replace specific dissemination plans required in all applications.

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 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:

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ under this FOA to support research centers of excellence in clinical prevention 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(s) involved, considering 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 Research Center program theme and set of projects address one of the three defined programmatic areas for this FOA? If the overall and project-specific aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? How will the development of this multidisciplinary Research Center, including activities of the core, promote the field of its stated programmatic areas? What will be the effect of these individual proposed studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?  Will the proposed work make an important contribution to the stated programmatic interest areas in the FOA? 

Investigators. Are the PD/PI and the CSL, as well as other key personnel, appropriately trained and well suited to carry out this work? Are the PD/PI and CSL devoting at least the minimum required levels of annual effort?  Is the work proposed appropriate to the experience level(s) of the project director/principal investigator and other researchers?  Do the PD/PI and investigative team bring complementary and integrated expertise to the project?  Does the proposal create new linkages within the applicant institution?  Does the investigator proposed to be the collaborative scientific lead and major contributor to collaborative activities in the Center’s designated programmatic interest area(s) possess the necessary skills to work collaboratively and effectively with AHRQ and the other Centers? 

Innovation.  Is the proposed Research Center original and innovative? For example: Does the Center create synergies within an institution by drawing members of the investigative team from across departmental or division lines? Do the project(s) challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?   Do the proposed project(s) employ novel partnerships, approaches, or technologies to optimize best practices in use of clinical preventive services?  Do the projects offer a novel mechanism for translating research to penetrate difficult-to-reach audiences and populations and thereby inform clinical decision making? 

ApproachAre the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the projects? Are the collective projects feasible and do they together afford a good probability of successful completion?  Does the applicant acknowledge potential problem areas and consider alternative tactics?    Is the research question, design, or analysis adequately informed by key partners or stakeholders who are involved in the application of the proposed studies or activities? 

Environment.  Does 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? Do the proposed core activities provide important value to the proposed Center studies.  Is the proposed infrastructure adequate in its configuration and funding support to permit the proposed work as well as the conduct of other work with additional funding? Does the applicant demonstrate a likelihood of continuing work and sustainability in the Center beyond the period of initial funding?

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 ResponsivenessHow 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 and programmatic interest areas, noted in the FOA?

Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? If the overall budget allocation differs from 30% for core and 70% for projects, is this well-justified?  Are the proposed projects staged in relation to each other so as to assure their value and contributions should changes or new developments occur in the field during the course of the grant award?  Is the proposed Center infrastructure appropriate to the proposed work?

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

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

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

Selection Process

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

2.B. Additional Review Considerations

None

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.  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 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 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 regarding the latter, 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 endorsed by the AHRQ grants management officer is the authorizing document.

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.

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 Section 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.

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

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

Section VII. Agency Contacts


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
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:

Mitra Ahadpour
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) 427-1012
Fax: (301) 427-1561
E-mail address:  Mitra.Ahadpour@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to: 

Brian Campbell
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) 427-1266
Fax: (301) 427-1462
E-mail address:  gmi@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 HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. 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 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.


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