and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Issuing Organization
Agency for Healthcare Research
and Quality (AHRQ), (http://www.ahrq.gov)
Components of
Participating Organizations
Office of Extramural Research,
Education and Priority Populations (OEREP), (http://www.ahrq.gov)
Title: Infrastructure Development Program in Patient-Centered Outcomes Research (PCOR) (R24)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
Announcement Type
This Funding Opportunity Announcement (FOA) is a new Program Announcement and will use the R24 grant mechanism.
Update: The following updates relating to this announcement have been issued:
Program Announcement (PA) Number: PA-12-114
Catalog of Federal Domestic Assistance Number(s)
93.226
Key Dates
Release Date: February 23,
2012
Letters of Intent Receipt Date(s): Not
Applicable
Application Receipt Date (s):
June 19, 2012,
December 19, 2012, December 19, 2013, December 19, 2014
Peer Review Date(s): Generally
four months after receipt date
Earliest Anticipated Start Date: Generally
four months after peer review date
Additional
Information To Be Available Date: Not Applicable
Expiration Date: Now June 12, 2014 per NOT-HS-14-015 (Originally December 20, 2014)
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Section 6301(b)) of the Patient Protection and Affordable Care Act , Public Law 111-148 (the Affordable Care Act ), enacted Section 937(e) of the Public Health Services Act authorizes AHRQ to establish a grant program that provides for the training of researchers in comparative effectiveness methods and states that, [a]t a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act. This FOA addresses the Affordable Care Act’s requirement. The initiative solicits Resource-Related Research Project (R24) grant applications from emerging academic and applied research organizations to enhance and expand their existing research methodology capacity to address comparative effectiveness research within the context of patient-centered outcomes. AHRQ encourages submission of applications from minority serving institutions.
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.
It is critical that applicants follow the instructions in the PHS 398 application guide except where instructed to do otherwise (in this FOA or in a Notice published by AHRQ in the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
B. Submitting an Application
to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award
Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The Patient Protection and Affordable Care Act, section 937 (a) (1) & (2) provides funding to AHRQ to build capacity for comparative effectiveness research (CER) by establishing grant programs that provide development of researchers. This FOA responds directly to this requirement. The intent is to enhance existing research capacity in emerging academic and applied research institutions to address CER within the context of patient-centered outcomes research (PCOR).
PCOR involves the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions, as well as the delivery of health care in real world settings.
In line with the definition provided by the Patient-Centered Outcomes Research Institute (PCORI), PCOR aims to help people make informed health care decisions and allows their voice to be heard in assessing the value of health care options. PCOR:
Specifically, this FOA seeks to provide support to institutions which currently have some existing health services research capacity related to the mission of AHRQ (as defined by such criteria as: the existence of faculty, researchers, departments or centers with expertise in the area; research and training grants and/or contracts directly related to health services research; graduate programs producing doctorally-prepared researchers in the area, etc.) However, these institutions (or their affiliate components) cannot be centers of excellence in comparative effectiveness research or possess investigators who currently receive large-scale research support from such components as AHRQ or NIH in comparative effectiveness research. Applications from minority-serving institutions are encouraged.
The overall goals of this FOA are to: 1) provide faculty/research staff methodological expertise in CER through the conduct of research projects and other professional development activities; and 2) strengthen the underlying institutional infrastructure needed to support PCOR research, as defined in this FOA. The core infrastructure activities should be designed to support not only the proposed work, but also allow the future development and conduct of additional projects and activities with other funding sources and partners.
Each application must have a thematic research focus around which all research and developmental activities are planned. There must be a common research issue or question that unites proposed infrastructure activities and research projects. The FOA is intended to support novel programs and lines of research. It is not intended to support minor modifications of existing established lines of inquiry for which the institution has received considerable prior support to establish and test through large-scale research, center, or research infrastructure grants/contracts previously or currently awarded.
To facilitate the goal of assisting institutions with expertise in health services research in increasing their capacity to conduct PCOR, this program provides support for two types of primary activities: 1) Institutional research development support, to strengthen the institutional infrastructure and enhance the capability of individual faculty members to undertake health services research; and 2) Three to five multi-year individual investigator research projects related to the thematic research focus of the application’s proposed program. These projects can be of differing sizes and duration.
Applicants must include an external advisory committee comprised of appropriate expertise to guide the implementation of the proposed work. This committee should convene at the beginning of the project, be consulted regularly throughout the project, and re-convene as needed (either virtually or in person).
Applications must also include formative and impact evaluation plans, including appropriate expertise and time and resource allocations.
Infrastructure Development Core Plan
Research Infrastructure Development Plans can include an array of justifiable components, such as:
Any funds requested in the application for support of these items or activities must be allocated appropriately between direct costs and indirect costs.
The above infrastructure investment can be leveraged with support obtained from other sources noted in the application to allow the conduct of related studies/activities with greater speed or reduced cost.
Infrastructure and Individual Research Project Objectives
The purpose of PCOR is to improve health outcomes by developing and
disseminating evidence-based information to patients, clinicians, policy
makers, and health care administrators, responding to their expressed needs
about which clinical and health system design interventions are most effective
for which patients under specific circumstances. Programs must focus the
content on health care delivery within the United States.
For purposes of this solicitation, AHRQ operationalizes the definition of PCOR to include any potential medical intervention, whether prognostic, preventive, diagnostic, therapeutic, palliative, or delivery-oriented. PCOR includes assessments of comparative effectiveness and/or safety and the active involvement of stakeholders in defining research questions, thereby establishing a ready audience poised to act upon research findings. PCOR can also include the development and application of methods to assess benefits or harms, or the integration of benefits, harms in therapeutic decision-making and choices. PCOR can include the synthesis of existing evidence, the generation of new evidence, or educational/translational or systems interventions to apply evidence to clinical practices and behaviors. AHRQ is particularly interested in PCOR projects focused on eliminating health care disparities. For all projects, it is important to include populations that are sufficiently large and diverse to allow for sub-group comparative effectiveness analyses.
Applicants also need to actively engage new stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of their research, and to the extent necessary, the implementation and dissemination of the research. Also, applicants must demonstrate their ability to collaborate with institutions and networks well versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for health care practice and decision-making. Existing examples of such 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), Practice-Based Research Networks (PBRNs), the John M. Eisenberg Center for Clinical Decisions and Communications Science, the Medicaid Medical Directors Learning Network; the Accelerating Change and Transformation in Organizations and Networks (ACTION), and Chartered Value Exchanges (CVEs).
Special Methodological and Program Objectives for Consideration
As noted above, Section 937(e) of the Public Health Service Act authorizes AHRQ to establish a grant program that provides for the training of researchers in comparative effectiveness methods and states that, at a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act.
The Methodology Committee of PCORI was established to develop and improve the science and methods of comparative clinical effectiveness research. Legislation charges the Committee to develop a translation table that is designed to provide guidance and act as a reference for the Board to determine research methods that are most likely to address each specific comparative clinical effectiveness research question. The Committee is also charged with producing a report by May 2012. Information on this activity can be found at www.pcori.org. Grant applicants must be responsive to recommendations made by the Committee in their grant applications if these are released by the application receipt date (i.e., applicants must, at a minimum, meet PCORI methodological standards that are developed.). If these recommendations are released subsequent to the application receipt date and before the scheduled peer review date, AHRQ will issue notification that the PCORI standards have been released and will include any additional submission requirements.
Note that the Methodology Committee has developed a preliminary translation framework that will inform the development of the translation table. Components include:
Required Areas of Emphasis
Applicants responding to this FOA must focus their planned programs in one or both of the two following areas:
Applicants are strongly encouraged to emphasize and address the following:
See Section
VIII, Other Information Required Federal Citations for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the AHRQ Resource-Related Research Project (R24) award mechanism. The individual researcher sponsored by each organizational grantee 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
Applications may be up to five years in duration with a budget supported by AHRQ not to exceed $1 million per year in total costs to the government. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed five years or budgets that exceed $1 million total costs in any given year will not be reviewed. Infrastructure components of applications should constitute at least of the total projected budget costs. Applicants must propose between 3 and 5 multi-year research projects. Total costs for each research project must not exceed $250,000 annually. Budgets associated with stakeholders or inter-organizational partnerships with existing centers of excellence cannot exceed 1/3 of the total average annual total costs.
Direct costs that are not allowable include:
All costs must be individually listed and justified. Total costs for each project must be clearly presented and justified.
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.
Section III. Eligibility Information
1. Eligible Applicants
You may submit an application(s) if your institution/organization has any of the following characteristics:
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. A minimum time commitment of 1.8 calendar months (i.e. 15%) annual effort is required from the PD/PI.
2. Cost Sharing or Matching
This program does not require cost sharing for applications in response to this FOA.
While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support could include: donated equipment and space; institutionally-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. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown / included in the detailed budget request.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, 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. No more than one application from a degree-granting institution and/or its affiliate organizations will be funded.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).
Renewals. Renewal applications are not permitted in response to this FOA.
Other Criteria. Applicant institutions must have some existing health services research capacity related to the mission of AHRQ (as defined by such criteria as: the existence of faculty, researchers, departments or centers with expertise in the area; research and training grants and/or contracts directly related to health services research; doctoral graduate programs producing doctorally-prepared researchers in the area, etc.). However, these institutions (or their affiliate components) cannot be centers of excellence in comparative effectiveness research or possess investigators who currently receive or have received large-scale research contractual, grant, or cooperative agreement support (e.g., R01, R18, U01, U18) or served as PD/PI on a component of a larger award, such as a center grant (e.g. P30) from such organizations as PCORI, AHRQ or NIH in comparative effectiveness research. A large-scale project is defined as one in which total costs exceed $100,000 annually for more than one year.
Section IV. Application and Submission Information
1. Address to Request
Application Information
The PHS 398 application instructions are
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face
page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A below
for details.
3.A. Receipt, Review and Anticipated Start Dates
Application Receipt Date(s):
June 19, 2012,
December 19, 2012, December 19, 2013, December 19, 2014
Application Receipt Date(s):
June 19, 2012,
December 19, 2012, December 19, 2013, December 19, 2014
Peer
Review Date(s): Generally four months after receipt date
Earliest Anticipated
Start Date(s): Generally
four months after peer review date
3.A.1. Letter of Intent
Not Applicable.
3.A.2. Technical Assistance
Not Applicable.
3.B. Sending an Application to AHRQ/NIH
Applications must be prepared using the forms found in
the PHS 398 instructions for preparing a research grant application. Submit a
signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications
are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, one additional copy of the
application, including appendix material (double-sided, if possible) must be
sent to:
Kay Anderson, Ph.D.
Office of Extramural Research, Education, and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555
FAX: (301) 427-1562
Email:
[email protected]
3.C. Application Processing
Applications must be received
on or before the application receipt date described
above in Section IV.3.A. If an application
is received after that date, the application may be delayed in the review
process or not reviewed. Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete
and/or non-responsive applications will not be reviewed.
AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
Use of CMS Data
Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. The applicant should obtain an estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.
Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.
In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.
CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.
Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).
To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
6. Other Submission Requirements and Information
Research Strategy Page Limitations
All application instructions outlined in the PHS398 Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
The Specific Aims and Research Strategy component of the application that is related to the Infrastructure Development Core Plan is limited to a total of 20 pages. Under Research Strategy, address all proposed activities related to the Infrastructure Development Core Plan. The following must be addressed under the Research Strategy for this component:
Individual investigator research project plans are limited to 10 pages for each project. Include the following components in each 10 page plan:
Other required components listed in the PHS 398 do not count against the page limits noted above.
Budget Component
Special Instructions for Modular Grant applications
AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using the detailed budget format. Applications submitted in the Modular format will not be reviewed.
An overall ( composite ) budget must be provided, in addition to separate budgets for the Infrastructure Development Core Plan and each individual research project. Budget justifications for the infrastructure support and for each individual research project must also be included.
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Priority Populations
The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
HCUP & MEPS
Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
Health Literacy
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
Consumer Products
All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.effectivehealthcare.ahrq.gov/options/start-conversation/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Section V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria: Merit Review Criteria described below will
be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
Reviewers will provide one overall impact score and one set of scored review criteria for the entire application. However, reviewers will be asked to provide specific comments on each component of the application (i.e., the infrastructure component and each proposed individual research project) under each category, including the overall impact category. In the overall impact, reviewers will also provide the summary assessment of the application as a whole.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed project will succeed in developing and sustaining infrastructure and partnerships at the emerging institution in order to conduct CER within a patient-centered context.
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. Do the theme and projects address an important problem? If the overall and project-specific aims of the application are achieved, how will scientific knowledge and health care delivery be advanced beyond what is currently exists or populations currently served? How well does the proposed Infrastructure Development Core Plan extend or broaden ongoing research activities and partnerships within and outside of the applicant institution? How will the proposed plans enhance the institution’s ability to conduct PCOR?
Investigators. Are the PD/PI and other key 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 other researchers? Does the PD/PI and investigative team bring complementary, multidisciplinary, and integrated expertise to the program and projects? Are the key personnel adequately trained in the responsible conduct of research?
Innovation. Are the theme, proposed projects, and/or infrastructure original and innovative? Do the proposed project(s) employ novel partnerships, approaches, or technologies? Do the projects offer a novel mechanism for translating research into practice, for example, ways to penetrate difficult-to-reach audiences and populations and thereby inform clinical decision making?
Approach. Are the overall strategy, methodology, and conceptual framework, adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the proposed theme? Are the proposed approaches feasible and do they provide a high probability of successful completion? Does the applicant acknowledge potential problem areas and consider alternative tactics? Have opportunities for meaningful external collaborations and partnerships with key stakeholders and research experts been developed or proposed for development? Have programs to develop and foster meaningful interdisciplinary and cross-sector collaborations within the applicant institution and its affiliate organizations been developed or proposed for development? Are adequate opportunities presented for faculty and staff research development? Are adequate plans in place for insuring future sustainability of the research infrastructure being developed? Are the composition, roles, and responsibilities of the external advisory committee adequate? Are formative and impact evaluation plans appropriate and adequate, including availability of expertise, time and resource allocation?
Environment. Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? What is the level of institutional commitment as evidenced in terms of the amounts and types of resources and support, taking into account the institutional context? Will the proposed infrastructure allow the conduct of other work with additional funding?
2.A. Additional Review Criteria
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Degree of 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?
Budget and Period of Support. Is the proposed budget and its components reasonable and is the requested period of support appropriate in relation to the proposed research?
Inclusion. Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below). In particular, note that technical evaluation groups will:
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 (for details, see the Human Subjects section of the application). For research programs that involve human subjects but do 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:
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.
Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
2.B.
Additional Review Considerations
Not Applicable
2.C. Resource Sharing Plan(s)
Data Confidentiality
The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute, 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/
The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing Research Resources: Rights in Data
Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.
3. Anticipated Announcement and Award Dates
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ grants
management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.
2. Administrative and National Policy Requirements
All AHRQ grant awards are subject to AHRQ s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.
As necessary, Terms and Conditions will be incorporated into the award statement.
2. A.1. Principal Investigator Rights and Responsibilities
The PD/PI will have the primary responsibility for providing strong scientific leadership, for the organization and operation of the grant; mentorship of investigators; liaison with the research community and outside entities such as professional societies, subcontractors, and consumer groups; and communication with AHRQ on scientific and operational matters. The PI must commit substantial time to the oversight of the grant (at a minimum 15% annually).
Grantees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and AHRQ policies.
2. A.2. AHRQ Responsibilities
AHRQ program staff will be responsible for the
normal scientific and programmatic stewardship of the award and will be named
in the award notice.
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. 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.
Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2012, the annual FFR is due 9/30/2012 (90 days after the end of the calendar quarter of 6/30/2012).
A final Progress Report, Federal Financial Report, and Invention Statement are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.
We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may be written or by telephone, and fall into
three areas: scientific/research (program), peer review, and financial or
grants management issues.
1. Scientific/Research Contacts:
Direct your questions about general FOA issues, including information on the inclusion of priority populations to:
Kay Anderson, Ph.D.
Office of Extramural Research, Education, and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555
Fax: (301) 427-1562
E-mail address: [email protected]
2. Peer Review Contacts:
Direct your questions about peer review issues of grant applications made in response to this FOA to:
Kishena Wadhwani, Ph.D.
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- 1362
E-mail address: [email protected]
3. Financial or Grants Management
Contacts:
Direct inquiries regarding fiscal matters to:
Steven Young
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1458
Fax: (301) 427-1462
[email protected]
Section VIII. Other Information
Required Federal Citations
Inclusion of Women and Minorities in Research Study Populations:
Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.
All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).
Human Subjects Protection:
Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).
Standards for Privacy of Individually Identifiable Health Information:
The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.
Access to Research Data through the Freedom of Information Act:
OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm, which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.
Healthy People 2020:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||