of Health and Human Services
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
of Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Title: Researching Implementation and Change while
Improving Quality (R18)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
This Funding Opportunity Announcement (FOA) supersedes AHRQ Program Announcement PA-07-247 which was released on March 9, 2007.
Update: The following updates relating to this announcement have been issued:
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-08-136
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: April 8, 2008
Opening Date: April 25, 2008 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally three months after peer review date
Expiration Date: New Date May 8, 2012 (per issuance of NOT-HS-11-005), Orginal Date: May 8, 2011
Dates for E.O. 12372
Additional Overview Content
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 facilitate the submission of grant applications by their organizations.
Table of Contents
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
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
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
The Agency for Healthcare Research and Quality (AHRQ) announces the Agency’s interest in supporting grants to rigorously study the implementation of quality improvement interventions (QII, see glossary) and provide generalizable* scientific findings about the implementation of QII and associated changes and their impact (*generalizable to other systems and settings). There is increasing evidence that success in achieving quality improvement goals is at least partially attributable to implementation processes and contexts and not just to the nature of the QI intervention.
Implementation of a QII results in a change in the way health care is paid for, organized, and/or delivered. It is AHRQ’s intent to support research on the context in which QIIs are implemented, the changes that occur during implementation (both intended and unintended), and the results of the QII associated with specific settings and setting characteristics.
AHRQ sponsored an evidence report series on “Closing the Quality Gap” to assess improvement strategies for selected health conditions and practices. The reports consistently described the dearth of data on the organizational and intervention characteristics that have reportedly influenced improvements in quality. Consequently, the reports made limited progress toward the goal of helping individuals and organizations assess the appropriateness of interventions for their specific practice or patient population.
By focusing this action-research Funding Opportunity Announcement (FOA) directly on quality improvement implementation, AHRQ intends to convey a deeper commitment to its mission of improving the quality, safety, efficiency, and effectiveness of health care for all Americans.
The objective of this FOA is to support the study of implementation of quality improvement strategies focusing on the ways in which both the nature and the contexts of implementation affect the effectiveness of the strategies. Contexts include important organizational features such as, availability of resources; organizational culture; leadership commitment; support provided to quality improvement implementation (staff support, technical support); and other factors that non-causal research has suggested are associated with variations in implementation of QIIs or with quality performance/outcomes. [Refs 1- 7] AHRQ is interested in funding studies whose findings will be generalizable to other systems and settings so that successful quality improvement strategies can be replicated or adapted.
Applicant institutions are expected to:
(1) Specify the QII that is being implemented now or that will be implemented as soon as an award is made; for the latter, describe readiness for implementation.
(2) Identify a set of clear quality measures and the data that will be used to support them in order to capture the level of improvement attained.
(3) Present a complete implementation research study plan that identifies the contextual and process variables to be analyzed and describes the method(s) of study and analysis. Use of the most rigorous research design for evaluation is required. The design should be clearly presented and approaches to dealing with threats to validity should be addressed. The analytic plan should be appropriate for the design. Valid measures of contextual variables should be used where possible. Use of explicit logic models is strongly encouraged.
(4) Identify the quality improvement implementation team(s) and the research study team. The QI implementation team and the research study team members could be the same; members of one could be members of the other; each could be completely separate. The research study team must include relevant experts in multiple fields (e.g., quality improvement implementation, engineering, behavioral science, social science, management science, business, economics, organizational theory) in the design, implementation and research evaluation of the QII.
(5) Include one or (preferably) more implementation sites as a full partner
(6) Describe a clear dissemination plan that includes activities such as publishing in peer-reviewed journals, implementation through AHRQ’s rapid cycle networks, disseminating project findings through the use of other methods, and developing an implementation toolkit. The plan should also include submission to and participation in AHRQ’s Health Care Innovations Exchange, www.innovations.ahrq.gov, if appropriate.
Each of these objectives is expanded upon below.
Objective #1: Quality Improvement Project Specification, Description of Readiness
For this FOA, AHRQ will use the six Institute of Medicine (IOM) domains to describe quality: safety, timeliness, effectiveness, efficiency, equity and patient-centeredness. [Ref. 8] QIIs must map to at least one of these domains.
Levels of Change
As identified by the IOM in its “Crossing the Quality Chasm” report, improvement in these six domains requires change at multiple levels. In a user’s manual to this IOM report, Berwick notes an “underlying framework analyzes the needed changes in American health care at four different levels: the experience of patients (Level A); the functioning of small units of care delivery (“microsystems”) (Level B); the functioning of the organizations that house or otherwise support microsystems (Level C); and the environment of policy, payment, regulation, accreditation, and other such factors (Level D), which shape the behavior, interests, and opportunities of the organizations at Level C. The model is hierarchical because it asserts that the quality of actions at Levels B, C, and D ought to be defined as the effects of those actions at Level A, and in no other way.” [Ref 9].
In planning QI projects, investigators should pay attention to research indicating that without facilitative changes at the payment, policy and organizational levels, individual providers and small provider units are unlikely to be able improve quality or sustain efforts for their patients through individual actions. [Ref. 1-7]
For this FOA, QIIs may target health policy environments (Level D), health care delivery organizations (Level C) and/or the clinical units of work that actually give the care that patients experience (e.g., outpatient clinics, emergency departments, hospitals and hospital units; Level B), or a combination of all three.
However, we encourage applications focusing on large system changes (level C) and/or policy-level interventions (level D) or that collect and analyze data on the impact of factors at Levels C and/or D in any Level B implementation. For example, studies of QII implementation in or across primary care offices could collect and use data on factors currently associated with quality and quality improvement, such as leadership, clinician participation, infrastructure, nurse staffing levels, reimbursement patterns, and participation in other quality improvement strategies (e.g., pay for performance, office redesign). [Ref. 2]
Use of Health IT
QIIs focusing solely on health information technology (HIT) implementation are not eligible for this funding opportunity. However, use of existing HIT to facilitate a broader QII is encouraged. In such cases, the type of HIT and level of resources needed to support its operation and maintenance should be included as part of the infrastructure context.
Types of QIIs
QIIs may be evidence-based or theory-driven. AHRQ encourages the use of interventions and changes with a strong evidence base. Realizing that few QIIs exist with a strong evidence base and that evidence has been conflicting or absent for a number of other interventions studied, theory-driven approaches to producing major quality improvements in health care are also encouraged as long as they can be supported by a strong theoretical justification.
QII Projects Underway
For those QII projects currently underway, descriptions of continued project operation should identify team member availability (quality improvement project team, researcher team, etc), include letters of commitment from principals of each organization participating in or contributing staff to the study along with evidence of commitment from the staff, discuss information system support (for data design, collection, parsing, computing, etc), and comment on other organizational resources needed to continue work (including managing change) and how the applicant will assure those resources are available upon grant award and throughout the study. Providing a work breakdown structure (see glossary) that is deliverables-oriented, time-phased, resource-loaded and milestone-based is encouraged but not required.
Readiness for New QII Projects
For those QII projects that will begin upon grant award, descriptions of implementation readiness should identify team member availability (quality improvement project team, researcher team, etc) on day 1 of award, include letters of commitment from principals of each organization participating in or contributing staff to the study along with evidence of staff commitment, discuss information system support (for data design, collection, parsing, computing, etc) needed from day 1, and comment on other organizational resources needed to begin work on day 1 (including managing change) and how the applicant will assure those resources are available on that day and throughout the study. Results and conclusions of formal assessments of organizational readiness for implementation using valid and relevant instruments are encouraged. Providing a work breakdown structure (see glossary) that is deliverables-oriented, time-phased, resource-loaded and milestone-based is encouraged but not required.
Quality improvement project areas of emphasis
Preference will be given to studies focusing on clinical or organizational areas of focus for quality improvement identified in one or more one of the following sources:
QIIs that apply to more than one clinical condition or use meaningful and complementary combinations of strategies are preferred. AHRQ also encourages applicants to study implementation of care coordination activities within and across settings of care (care coordination defined below).
Inclusion of entities that provide care or set policies for priority populations is expected. AHRQ’s priority populations are children, women, elderly, racial and ethnic minorities, individuals with special health care needs, those living in inner city or rural areas, and those with low income.
For this funding opportunity, AHRQ is especially interested in QII projects implemented outside of the hospital environment, such as those implemented in, but not limited to, ambulatory and long-term care environments. To be considered for this funding opportunity, hospital-oriented quality improvement projects must be those where the site(s) of the implementation is a hospital(s) with limited resources (e.g., hospitals with negative margins, public hospitals), provides crucial services for priority populations (e.g., safety net provider), or otherwise meet the characteristics described in the next paragraph (i.e, are part of a cross or comparison study).
QIIs that cross or compare settings or entities (e.g., can one successful strategy be applied to additional settings or entities?) and cross or compare QII benefits to different populations (can one successful strategy be adapted to settings or entities serving other populations?) are encouraged. For example, interventions that aim to improve coordination of care across ambulatory care settings (including, but not limited to, primary care/specialty coordination, primary care/school-based care, primary care/worksite care), inpatient settings, and long-term care settings are encouraged. QIIs that are tested in more than one practice or policy setting (e.g., multiple hospital or ambulatory settings, multiple States or localities, multiple health pans, multiple purchasers, multiple coalitions) and that can compare contexts and results across those settings are strongly encouraged to increase the knowledge base on the impact of context.
Objective #2: Quality measures and data to support them
Improvements in health care quality should be measured using available recognized measures of quality at the appropriate levels of intervention. Quality measures must map to one of the six Institute of Medicine domains to describe quality: safety, timeliness, effectiveness, efficiency, equity and patient-centeredness. [Ref. 8] Appropriate data sources must be available. Development and use of new measures must be justified by showing that evidence-based, consensus or widely used measures are not available.
Baseline information should be used for comparisons if available. Benchmarking is also encouraged. Study partners must agree upon targets for each measure, and AHRQ encourages the alignment of these targets with state and local strategies for improving health care quality.
Objective #3: Implementation research study plans and their effects
Implementation study plans should clearly specify the types of activities to be conducted under the proposed grant project, individuals who will be responsible for each activity, and the anticipated effects of each activity. AHRQ is interested in a wide variety of research methods among the projects funded under the FOA.
Research evaluations of the proposed QIIs may use alternatives to random assignment designs as long as they are rigorous enough to permit generalizable causal inferences at a high level of confidence. Research incorporating Plan-Do-Study-Act approaches (small tests of change) in the context of a rigorous design (e.g., cluster randomized controlled trials, interrupted time series, multiple baseline) are welcomed. Observational studies, evaluations of natural experiments, qualitative research and mixed-method studies are also welcomed. Sufficient information about the systems and/or organizational contexts of the changes needed to improve quality and the nature, depth and intensity of the change should be collected and linked to the QII and findings so that the generalizability of findings to other systems and settings can be inferred and so that successful interventions can be replicated or adapted. Use of comparison groups is required.
Note 1: Implementation research for QII projects that will begin at award will be able to account for/test contexts relative to each phase of implementation on a prospective basis. For those QII projects currently underway, the research method chosen must address collection and analysis of contextual data/information for the phase(s) of implementation that have already passed. This will assure capture of all potential relevant details that could influence results and conclusions.
Note 2: A retrospective analysis of implemented QIIs to study contextual factors and generate conclusions or hypotheses about causal inferences is acceptable only when it is accompanied by a prospective application of the results or hypotheses generated from the results in a QII implementation study.
For additional guidance, see section below “Guidance on Implementation Research Methods.”
Tools and strategies to facilitate interventions may come from existing findings of completed research projects or research syntheses, from other tools and resources that are readily available, or may be newly developed. We encourage the use of reliable and validated (evidence-based) tools to measure important aspects of context although we realize that few such tools exist and that projects may have to develop their own.
Development of such tools de novo should be based in theories of organizational behavior, and should be developed with intent to include them as parts of future QIIs and continuous quality improvement (i.e., as potential future structural measures of quality).
If a work breakdown structure is being submitted (see section on “Quality improvement project specification, description of readiness”) it must be expanded to incorporate the implementation research tasks, resources, milestones, and deliverables and to show interdependencies of QII tasks with implementation research tasks.
Guidance on Implementation Research Methods
It is AHRQ’s intent to fund QII implementation research studies using methodologically rigorous design. The emphasis is on the use of a design where generalizable causal interpretations can be made. There are a number of possible designs to consider (e.g., group randomized controlled trials and quasi-experiments) and each has strengths and limitations. AHRQ offers the following publications as examples that include guidance and discussion on study design issues:
Objectives #4 and #5: Teams, Experts, Partnerships
AHRQ is seeking applications from partnerships involving one or (preferably) more organizations that are interested in obtaining grant funding to rigorously study the effectiveness of health care quality improvement projects in their communities, regions, or states. Partnerships are defined as collaborative working relationships among organizations formalized through one or more written agreements. Agreements should involve, at a minimum, the substantial and meaningful contributions of personnel, expertise, money, equipment, facilities or other important resources to and from each of the partners, and appropriate data-sharing agreements. Partner organizations must represent at least two different sectors (including, but not limited to, purchasers, providers, payers, public health entities, community groups, etc.). Although partnerships may include major research institutions and individuals who primarily conduct research, they also must include institutions and individuals that are primarily engaged in either the provision, coordination, or purchasing of health care or the payment for health care services. AHRQ encourages partnerships that include: (1) rural areas, (2) public hospitals and primary care programs such as community health centers, or (3) strong involvement of a diverse group of lay citizens.
All projects should emphasize cooperation among partners, continuous learning, building capacity for sustainable quality improvement and data collection and analysis at the appropriate (local, regional, and/or state) level.
In addition to health care delivery and clinical expertise, AHRQ strongly encourages applications to include experts in the fields of quality improvement, behavioral science, social science, cultural anthropology, operations management, systems engineering, business, economics, or organization psychology in the study team.
Objective #6: Dissemination plan
Dissemination of implementation findings is particularly important for quality improvement projects because it serves as an important contributor to experiential learning. Indeed, sharing lessons from partial successes and failures with future QII implementers and others doing continuous quality improvement is invaluable. Publication in peer-reviewed journals is often viewed as the main dissemination vehicle for research projects. Roadblocks exist in reporting partial successes and failures in traditional, peer-reviewed journals.
Additional strategies are required in order to reach a wider audience of individuals and organizations that have potential interest in replicating successful aspects of QIIs. Additional approaches may include non-technical articles in trade press and media outlets, monographs published by partner organizations, and educational efforts and outreach. In particular, AHRQ encourages the development of implementation toolkits to help other organizations adopt successful aspects of the intervention(s) and a commitment to submit to and participate (lead a community of practice, for example) in AHRQ’s Health Care Innovations Exchange, if appropriate.
In the selection of applications, AHRQ will emphasize rapid turnaround time from the start of the project until results are available. AHRQ intends to fund a combination of projects that will yield clear results in 12 months, others that will yield clear results in 24 months, and yet others that will provide clear results at 36 months. In order to accomplish this, applicants are encouraged to submit applications that focus on new initiatives, as well as those that expand or complement ongoing efforts.
AHRQ expects early, ongoing collaboration and transparency of efforts among successful applicants in order to further the larger goals of this research initiative. This may take place in the form of multiple conference calls with all grantees and sharing of documents and information throughout the duration of the projects. The development of a “learning community” among grantees is an important AHRQ strategy for developing and sustaining this research initiative. Applications should include in the budgets sufficient resources for two trips to Washington, DC area for the PI and other key partners.
Care coordination: Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshalling of personnel and other resources needed to carry out all required patient care activities, and is often managed by the exchange of information among participants responsible for different aspects of care. (Source: Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies: Volume 7—Care Coordination, Structured Abstract. Publication No. 04(07)-0051-7, June 2007. AHRQ, Rockville, MD. http://www.ahrq.gov/clinic/tp/caregaptp.htm)
Implementation research: the scientific study of how specific sets of activities and strategies are used to integrate evidence-based or evidence-informed policy- organizational- or provider-oriented interventions within specific settings toward a goal of improving the quality of health care. It includes the study of influences on healthcare professional and organizational behavior. (Adapted from Source: http://www.implementationscience.com/info/about/)
Project: a temporary endeavor undertaken to create a unique product, service, or result. (Source: A Guide to the Project Management Body of Knowledge (PMBOK® Guide) Third Edition. ©2004 Project Management Institute: Pennsylvania, Newtown Square)
Quality Improvement Intervention: an effort to enhance the extent to which health care is safe, timely, effective, efficient, equitable, and patient-centered, and results in the best possible patient outcomes. It can occur at the policy, delivery system, or clinical microsystem levels and will enhance the way care delivery is structured, organized, and operationalized to ensure that patients receive care based on the best available evidence. (Source: AHRQ, provisional definition)
Work Breakdown Structure: A deliverable-oriented hierarchical decomposition of the work to be executed by the project team to accomplish the project objectives and create the required deliverables. (Source: A Guide to the Project Management Body of Knowledge (PMBOK® Guide) Third Edition. ©2004 Project Management Institute: Pennsylvania, Newtown Square.)
VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism. The individual researcher sponsored by each organizational applicant will be solely responsible for planning, directing, and executing his or her proposed projects.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.
The total costs (direct plus associated facilities and administrative costs) awarded under this FOA will not exceed $300,000 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 report. An application with a budget that exceeds $300,000 total costs per year will be returned without review.
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 FOA is to improve the quality of healthcare in the U.S., foreign institutions are not eligible to submit applications. Foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
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. 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.
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 may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Renewals: Applicants may submit a competing renewal application.
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.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the 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
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD(s)/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
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:
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
Research & Related Budget (See Section IV.6., regarding appropriate required budget component.)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
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.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 25, 2008 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally three months after peer review
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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/web/grants/applicants/apply-for-grants.html and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.
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.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
Use of CMS Data
Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.
Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.
Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.
In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.
CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.
Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).
To avoid double counting, applicants should not include the cost of the CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principals, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
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.
AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “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 are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Special Instructions for Modular Grant applications
AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will be returned without review.
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.
The Healthcare Research and Quality Act of 1999, in amending the PHS Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is also found at 42 USC 299. To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
HCUP & MEPS
Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population. MEPS is comprised of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
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.
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
Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)
Only the review criteria described below will be considered in the review process.
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness.
Criteria are described below. The review criteria described below will be
considered in the review process.
2. Review and Selection Process
Applications that are complete 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 applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration.
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
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, in consideration of the following five core 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 problem? If the aims of the application are achieved, how will scientific knowledge, clinical or organizational practice, or quality improvement be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or quality improvement interventions and strategies that drive this field?
Investigators: Is the PD/PI, and other key quality improvement and research personnel, appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and others on the quality improvement and research team(s)? Does the PD/PI, and implementation and research team(s), bring complementary and integrated expertise to the project (if applicable)? Are the roles and relationships among the quality improvement implementation team(s) and the research study team(s) clear and reasonable?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or 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?
Approach: Are the conceptual or organizational framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project and will they yield findings that are generalizable to other systems and settings? Does the applicant acknowledge potential problem areas and consider alternative tactics?
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?
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
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).
Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements”, and Inclusion Criteria included in section VIII of Required Federal Citations, below).
Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?
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.
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?
Applications (formerly “revised/amended” applications): Are the responses to comments from the
previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?
Additional Review Considerations
Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute 42 USC 299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/
The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA websites in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).
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:
Anticipated Announcement and Award Dates
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
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.
application is under consideration for funding, AHRQ will request
"Just-In-Time" information from the applicant. Just-In-Time
information generally consists of information on other support and
certification of IRB approval of the project's proposed use of human subjects.
For details, applicants may refer to the "AHRQ Revised Policy for
Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant
A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official. The NOA signed by the grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).
As necessary, Terms and Conditions will be incorporated into the award statement.
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 a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.
The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.
Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs 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.
your inquiries concerning this funding opportunity and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
1. Scientific/Research Contact(s):
AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA. Written and telephone inquiries concerning this FOA are encouraged.
Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:
Senior Advisor for Quality Improvement
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1868
Fax: (301) 427-1562
E-mail address: Denise.Dougherty@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:
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) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov
3. Financial/Grants Management Contact(s):
Direct inquiries regarding fiscal matters to:
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) 427-1806
Fax: (301) 427-1462
E-mail address: Kevin.Hornbeak@ahrq.hhs.gov
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 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:
regulations 45 CFR 46 require that applications and proposals involving human
subjects research must be evaluated in accordance with those regulations, with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.
Access to Research Data through the Freedom of Information Act:
The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA. It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 U.S.C. 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.
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, Federal Regulation, 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 PHS mission to protect and advance the physical and mental health of the American people.
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17. Institute of Medicine (IOM) 2007. Advancing quality improvement research: Challenges and opportunities, workshop summary. Washington DC: The National Academies Press.
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