Department of Health and Human Services
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Title: AHRQ Small Research Grant Program (R03)
policies, guidelines, terms, and conditions stated in this announcement may
differ from those used by the NIH.
This is a reissue of PAR-06-448, which was previously released June 7, 2006.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.
Program Announcement (PA) Number: PAR-10-168
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: April 15, , 2010
Opening Date: May 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date(s): within 7 months of submission
Expiration Date: March 17, 2014
Due Dates for E.O. 12372
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. The applicant will be solely responsible for planning, directing, and executing the proposed project.
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. Electronic Transmission of an Application 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 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
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ strives to achieve its mission by supporting a wide range of health services research projects. However, all R03 grant applications must contain projects that fit within the current AHRQ Research Portfolio areas as described below:
Comparative Effectiveness Portfolio
AHRQ intends to support research grants focusing on comparative effectiveness, as authorized in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013. Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.
The intent of these grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system. New applicants are encouraged to partner with institutions well versed in systematic review methodologies or with research centers and integrated health care delivery systems capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decision-making. Existing examples of such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), the John M. Eisenberg Clinical Decisions and Communications Science Center, Primary Care-Based Research Network (PBRN), and the Accelerating Change and Transformation in Organizations and Networks (ACTION). A listing of these research networks under AHRQ’s Effective Health Care program can be found at: http://effectivehealthcare.ahrq.gov.
The grants can have either a clinical or methodological emphasis, but must focus tightly on the study and/or the use of comparative effectiveness research. For grants with methodological emphasis, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness studies. For grants with clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies. For studies in which randomized controlled trails may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs may be proposed. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policy-makers, providers, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study. Research projects should also be organized around a set of priority conditions of importance to the Medicare, Medicaid, and SCHIP programs as mandated by the MMA section 1013. The current list of conditions includes:
AHRQ interests in R03 pilot and feasibility studies, or otherwise self-contained small methodological and/or clinical comparative effectiveness research projects include, but are not limited to:
Emerging Issues and Innovations Portfolio
The Innovations Portfolio was created to identify and support researchers and institutions with ideas that have the potential for high impact. These ideas will be novel and span a diverse (and perhaps non traditional) array of disciplines. The portfolio will foster and nurture ideas and projects that have the potential to lead to highly innovative solutions that may lead to significant advances in healthcare practice, organization, delivery, and management. Research and activities supported under the Innovations Portfolio will reflect ideas substantially different from those already being pursued elsewhere. The portfolio will fund transformative research with a focus on projects that transform existing conditions and that solve pressing healthcare problems. The main focus of the portfolio is problem solving in order to accelerate improvement in healthcare. Under the R03 mechanism applicants are encouraged to submit pilot and feasibility studies, or otherwise self-contained small methodological studies.
Health Information Technology Portfolio
Health information technology (IT) is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management. Health IT can support patient care related activities such as order communications, results reporting, care planning and clinical or health documentation. For current R03 grant funding opportunities in the area of health IT, applicants are advised to see the Funding Opportunity Announcement PAR-08-268 (see http://grants.nih.gov/grants/guide/pa-files/PAR-08-268.html).
Patient Safety Portfolio
Patient safety research initiatives can be considered to occur in three different stages:
The Patient Safety Portfolio will support research projects that seek to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care. Proposals in this area may address important topics such as: the impact of human performance and working conditions on patient safety; the role consumers can play and how they can contribute to making care safer; health care organizational structure, leadership, communication, and teamwork; health care associated infections; diagnostic error; and the challenges inherent in transitions of care and handoffs between health care providers.
AHRQ encourages an interdisciplinary approach to research that is related to patient safety, so that the perspectives not only from the field of health care services but also from the social and behavioral sciences (such as organizational psychology) education, industrial engineering, human factors, and others are incorporated in such a way so that they contribute meaningfully to research plans.
Additionally, AHRQ supports the inclusion of approaches that address risks and hazards across various dimensions of patient characteristics and priority populations (e.g., the elderly, children, individuals with low health literacy, patients with multiple chronic conditions) settings of care (hospital, long-term care, ambulatory, home health care), and health-related conditions.
Prevention and Care Management Portfolio
The mission of the Prevention/Care Management Portfolio is to improve the quality, safety, efficiency, and effectiveness of evidence-based preventive services and chronic care management in ambulatory care settings. We are interested in grants that will support two broad strategic goals.
The first goal focuses on preventive services. Grants awarded in this strategic area should complement the work of the U.S. Preventive Services Task Force in terms of advancing methods for assessing the benefits and harms of preventive services, and improving the implementation of evidence-based recommendations on preventive services. We are interested in funding areas that have not traditionally been the focus of funding initiatives, such as:
Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the:
Research questions for R03 projects of interest under this strategic area include, but are not limited to:
Our second goal involves improving primary care and clinical outcomes through health care redesign, clinical-community linkages, self management support, and care coordination based on the Care Model (Wagner 1998; Barr, et. al.; 2002). We are interested in moving beyond condition-specific research to support grants that are focused on system redesign in ambulatory care, the results of which would be generalizable across health conditions. Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the effectiveness, efficiency, and/or implementation of:
Research questions of interest for R03 applications related to the second strategic goal include, but are not limited to:
Wagner EH. Chronic disease management: What will it take to improve care for chronic illness? Effective Clinical Practice. 1998;1(1):2-4.
Barr V, Robinson S, Marin-Link B, et. al. 2002 Adapted from Glasgow R, Orleans CT, Wagner E, Curry S and Solberg L. (2001). Does the Chronic Care Model also serve as a template for improving prevention? The Milbank Quarterly, 2002; 79(4).
AHRQ seeks to support research to develop, disseminate, and translate rigorous evidence that can be used by public and private policymakers, by health system and community leaders, and by managers of healthcare organizations who want to improve the delivery of healthcare services by reducing unnecessary costs (waste) and increasing efficiency, while maintaining or improving healthcare quality, i.e., increasing the value of health care for all Americans. In addition to applications of systematic quantitative research methods, qualitative and mixed-methods research are also encouraged. Research priorities include:
Scope of this FOA:
The common characteristic of the small research grant is provision of limited funding for a short period of time. Some examples of the types of projects that R03 research involves include the following:
The AHRQ R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed within two years and that require limited levels of funding. Because the research plan is restricted to 15 pages, an R03 grant application may not have the same level of detail as that found in an R01 application. Accordingly, appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
Applicants are strongly encouraged to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, and the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This Funding Opportunity Announcement (FOA) invites applications for small research (R03) projects. The individual researcher sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
The budget limit on small project grant applications is $100,000 total costs (i.e., direct costs plus Facilities and Administrative (F&A) costs) for the entire project period. A project period of up to two years may be requested. Applications requesting more than $100,000 total costs or longer than 24 months of support will not be reviewed.
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 and foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply as Project Director/Principal Investigator (PD/PI) for AHRQ programs. AHRQ also encourages new investigators to apply as PD/PIs.
2. Cost Sharing or Matching
AHRQ does not require cost sharing for applications submitted in response to this FOA.
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 may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Renewals: Applicants may not submit a renewal application.
Projects must be self-contained. They may be conceptually linked to future or past projects, but must contain all the elements of a stand-alone effort that can be reviewed and evaluated on its own for both scientific merit and budget.
The request may not be used to supplement currently supported projects,
provide interim support for projects under review by the PHS, or obtain funding
as a competing continuation of a small grant. Requests for support for
thesis or dissertation research will not be considered under this small grant
program. Applications to support dissertations should be submitted for
consideration under the AHRQ Small Grant Program for Health Services
Section IV. Application and Submission Information
To download an Application Package and SF424 (R&R) Application Guide
for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site in accordance with the
SF424(R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
A one-time registration is required for institutions/organizations at both:
Project Directors/Principal Investigators (PD/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 institution/organization can submit an electronic application, as follows:
1) Organization/Institutional Registration in Grants.gov/Get Started
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/PI and Authorized Organization Representative/Signing Official (AOR/SO) need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the “Attachment” files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
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. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated
Opening Date: May 16, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date: within 7 months of submission
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Electronic Transmission of an Application to AHRQ
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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 AHRQ application. The “AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications” was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
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, previously called Health Care Financing Administration (HCFA), 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 6 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 INQUIRIES.
To avoid double counting, applicants should not include the cost of the CMS data in the budget. Small research grant applicants should be aware that the costs of the grant, including the cost of CMS data, cannot exceed $100,000 total costs. In the event the total costs of the project plus the cost of CMS data is greater than $100,000, 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 $100,000.
4. Intergovernmental Review
This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.
5. Funding Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
Pre-award costs are allowable. A grantee may, at its own risk and
without AHRQ prior approval, incur obligations and expenditures to cover costs
up to 90 days before the beginning date of the initial budget period of a new
award if such costs are necessary to conduct the project and would be allowable
under the grant, if awarded, without AHRQ prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
AHRQ approval before incurring the cost. AHRQ prior approval is required for
any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.
PD/PI Credential (e.g., Agency Login)
AHRQ requires the PD(s)/PI(s) 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 and Application Characteristics
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:
Competing renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to one resubmission (formerly “revisions/amendments") of a previously reviewed small grant application may be submitted.
R03 applications will use the Research & Related budget components, with a maximum allowable request of up to $100,000 in total costs for up to two years. Provide a narrative justification for each proposed personnel position, including role and proposed level of effort.
Specific Instructions for Modular Grant applications: AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.
Appendix Materials (New and Resubmission Applications)
R03 Appendix materials may include graphic images, micrographs, etc. provided that the image is contained within the 15 page limit of the Research Strategy. No images may be included in the Appendix that are not also represented within the Research Strategy. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.
Do not use the Appendix to circumvent the page limitations of the Research Strategy. An application that does not observe these 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, 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 are to 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.
HCUPS & 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 inpatient 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 databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
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 MEPS is available at http://www.meps.ahrq.gov.
This does not preclude the use of secondary data sources or primary data collection.
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants’ understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in (45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
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
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria are described below. Only the review criteria described below will be considered in the review 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 to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
The R03 small grant mechanism at AHRQ supports discrete, well-defined projects that realistically can be completed in two years. Because the research plan is restricted to 15 pages, an R03 grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers will evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does this study address an important scientific area or critical
barrier to progress in the field of health services research? If the aims of
the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of this study on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive health services research?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Innovation: Is the project original and innovative? For example: Does the project
challenge and seek to shift existing research or clinical practice paradigms;
address an innovative hypothesis or critical barrier to progress in the field
of health services research? Does the project develop or employ novel concepts,
approaches, methodologies, interventions, tools, or technologies for the
proposed area of study?
Approach: Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will any particularly risky aspects be managed? If the project involves human subjects research are the plans for: 1) protection of human subjects from research risks and, 2) inclusion of AHRQ priority populations, justified in terms of the scientific goals and proposed research strategy?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Are the institutional support,
equipment, and other physical resources available to the investigators adequate
for the proposed project? Will the proposed studies benefit from unique
features of the environment, or subject populations, or employ useful
2.A. Additional Review Criteria:
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: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
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 discussion on Priority Populations in the section on Special Requirements, above, 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?
2.B. Additional Review Considerations
2.C. Sharing Research Data
Pursuant to section 934(c) of the (PHS) Act (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 U.S.C.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 RFA will also be obtained and managed in accordance with 42 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, for example, 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.
The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA websites in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
2.D. Sharing Research Resources
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for 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 R03 applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
Generally, applicants should anticipate 7 months between the application submission date and the earliest possible start date.
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons
If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time
information generally consists of information on other support, any additional
information necessary to address administrative issues, and certification of
IRB approval of the project's proposed use of human subjects. For
details, applicants may refer to the "AHRQ Revised Policy for
Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant
Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NoA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NoA signed by the AHRQ grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., “Funding Restrictions.”
2. Administrative and National Policy
All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and beyond that the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at http://grants.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.
As necessary, Terms and Conditions will be incorporated into the award
statement and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Department of Health and Human Services (HHS) Grants Policy Statement, found at http://www.ahrq.gov/fund/hhspolicy.htm.
The progress report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.
Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs. This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.
We encourage your inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:
1. Scientific/Research Contacts:
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 regarding specific program matters to the AHRQ staff listed at: http://www.ahrq.gov/fund/staffcon.htm.
2. Peer Review Contacts:
Direct your questions about peer review matters to:
Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov
3. Financial/Grants Management Contacts:
Direct your questions about financial or grant management matters to:
Office of Performance Accountability Resources and Technology
Division of Grants Management
Required Federal Citations
Inclusion of Women and Minorities in Research Study Populations:
Women and members of minority groups are to be 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 AHRQ Publications Clearinghouse, listed under INQUIRIES, 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 INQUIRIES).
Human Subjects Protection:
Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Compliance with the Privacy Rule for those classified under the Rule as "covered entities". Decisions about applicability and implementation of the Privacy Rule reside with covered entities. 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 of a covered entity. 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 act 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 it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by 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.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6), under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The PHS Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.
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.
 Federal Coordinating
Council for Comparative Effectiveness Research. (June 30, 2009).
Report to the President and the Congress on Comparative Effectiveness Research.
U.S. Department of Health and Human Services. http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf
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