Agency for Healthcare Research and Quality (AHRQ)
NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the
application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.
Agency for Healthcare Research and Quality, Center for Outcomes and Evidence
Funding Opportunity Title
Researcher Training and Workforce Development in Methods and Standards for Conducting Patient-Centered Outcomes Research Studies (R25)
R25 Education Projects
PA-20-072: Competitive Revision Supplements to Existing AHRQ Patient Centered Outcomes Research (PCOR) Grants and Cooperative Agreements to Evaluate Health System and Healthcare Professional Responsiveness to COVID-19 (Supplement - Clinical Trial Optional)
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This funding opportunity announcement (FOA) invites applications for grants to develop, implement, and evaluate an education program for researchers on methodologies and methodological standards used to conduct comparative clinical effectiveness and/or patient-centered outcomes research (CER/PCOR). The purpose of this initiative is to build capacity in the national scientific workforce to conduct high quality CER/PCOR studies. Applicants will develop innovative programs that accommodate the educational needs of a respective professional field, employment setting, and/or researcher community. An education program must have multiple components and include basic, advanced, and experiential training opportunities. Programs may focus on the design and analysis of systematic reviews, technology assessments, observational studies, registries, clinical trials, and/or other approaches to CER/PCOR. Research methods guides produced by AHRQ and methodology standards adopted by the Patient-Centered Outcomes Research Institute are among the content materials that may be used to develop education program components.
July 10, 2013
Open Date (Earliest Submission Date)
August 27, 2013
Letter of Intent Due Date(s)
August 20, 2013
Application Due Date(s)
September 27, 2013, by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)
Scientific Merit Review
Generally, four months after receipt date
Advisory Council Review
Earliest Start Date
Generally, four months after peer review date.
September 28, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This FOA encourages R25 applications for innovative education programs designed for researchers to learn CER/PCOR methodologies and methodological standards. The purpose of this initiative is to build national capacity in the scientific workforce to meet the demand for high quality scientific evidence on the effects of health care interventions on patient health outcomes. Programs may focus on training researchers in methodologies for synthesizing and/or generating scientific evidence. However, applicants are required to incorporate published CER/PCOR methods guides, methodology standards, and peer-reviewed publications into the educational content that is used in program implementation.
Each successful applicant will produce a multi-component education program in CER/PCOR methodologies and methodological standards that is specifically designed for one or more communities of researchers. Researcher community may be defined by an applicant but examples include communities categorized by health profession type, career specialization, geography, or employment setting. Program components must include basic, advanced, and experiential learning opportunities in order to accommodate researchers with diverse educational needs and with different levels of baseline proficiencies in CER/PCOR methodologies. Traditional pedagogic approaches may be employed, but creative programs are encouraged, particularly to expand capacity for conducting CER/PCOR studies into new fields, to address health disparities between patient populations, or in subject areas where knowledge about health outcomes lacks a strong evidence base. Accordingly, applicants are encouraged to form meaningful partnerships with organizations that are committed to supporting, conducting, or using CER/PCOR studies to inform health care decisions. Partners may include, but are not limited to public, private, large corporate, small business, and nonprofit organizations.
Each education program is expected to:
1) develop and implement a series of innovative courses for researchers to learn fundamental methodologies and methodological standards for conducting CER/PCOR systematic reviews, technology assessments, observational studies, registries, and/or clinical trials;
2) create a peer learning network for methodologists, statisticians, and other researchers to exchange knowledge on advanced CER/PCOR analytic techniques and research methods;
3) develop and implement an experiential learning or fellowship program designed for researchers to receive direct experience and mentoring on using CER/PCOR methods for conducting a research project or a systematic review; and
4) evaluate outcomes of the education program, including its effects on CER/PCOR systematic reviews or original research, the scientific workforce, and the competencies acquired by program participants.
AHRQ Effective Health Care Program. Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), 42 U.S.C. 299b-7, and 42 U.S.C. 299a(a) authorizes AHRQ to conduct research on health outcomes and comparative clinical effectiveness. AHRQ established the Effective Health Care (EHC) Program in 2005 (see effectivehealthcare.ahrq.gov/). The EHC Program conducts CER/PCOR research, including research that examines methods for improving the validity of CER/PCOR studies and systematic reviews. The EHC program also sponsors symposia for learning new CER/PCOR methods and publishes the proceedings of these symposia as journal supplements for dissemination to the scientific community. Similarly, investigators affiliated with the EHC Program develop other tools and resources to improve understanding of the wide range of research methods that are applied in EHC research and systematic reviews. These resources include User's Guides on the design of CER/PCOR studies, registries, and systematic reviews (see http://effectivehealthcare.ahrq.gov/tools-and-resources/researcher-resources). Likewise, AHRQ's Electronic Data Methods (EDM) Forum provides opportunities for collaborative learning on the use electronic clinical data for CER/PCOR (see http://www.edm-forum.org). Taken together, AHRQ produces a large collection of informational resources for researchers to learn basic and advanced research methods for conducting CER/PCOR. In addition, AHRQ also supports pre-doctoral and postdoctoral CER/PCOR training through career development grants (K-Awards) and institutional research training grants (T-Awards) at universities and other institutions in the U.S.
Authorization for Researcher Training. Under Section 937 [42 U.S.C. 299b–37] of the Patient Protection and Affordable Care Act of 2010 (ACA), AHRQ is authorized to build capacity for comparative clinical effectiveness research by establishing programs that provide for the training of researchers in the methods used to conduct such research, including systematic reviews of existing research and primary research such as clinical trials. At a minimum, such training is required to be in methods that meet the methodological standards adopted and updated by the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI; see http://www.pcori.org/what-we-do/methodology/).
Definitions. For this FOA, the definition of CER/PCOR is the conduct of systematic reviews or new research that examines the benefits and/or harms of health care interventions and services on patient outcomes. This includes interventions designed to prevent, diagnose, treat and monitor health conditions, or to improve the delivery of health care. CER/PCOR methodologies are defined as scientific techniques used in the design, analysis, and conduct of research that investigates the outcomes and/or effectiveness of health interventions or services on patient outcomes. CER/PCOR methodological standards are derived from guidance documents published by nationally-recognized organizations, institutes, or in peer-reviewed journals; a primary objective of these standards is to strengthen the validity of scientific investigations by assisting investigators with decisions about the design, analysis, and conduct of systematic reviews or new research.
Each successful applicant must develop and implement a multi-component education program that is comprised of basic, advanced, and experiential learning opportunities in CER/PCOR methodologies and methodological standards. Researchers who participate in educational program offerings are expected to acquire new skills in order to conduct high quality CER/PCOR studies. Applicants must focus on CER/PCOR methodologies and standards to conduct (1) systematic research reviews and technology assessments, (2) observational research and registries, (3) clinical trials, or (4) a combination of these aforementioned approaches.
Researcher Community. A program should be designed to meet the educational needs of one or more communities of researchers. Applicants are to select at least one researcher community and explain how the proposed education program will expand the scientific workforce in that community as well as increase the conduct of high quality PCOR/CER studies. A researcher community may be broadly defined by the applicant, but it is recommended that it is comprised of a group of investigators who share common academic, professional, or scientific interests. For instance, a researcher community may be categorized according to health profession type, career specialization, geographic location, or employment setting. Examples of health professions are public health, medicine, dentistry, nursing, pharmacy, physical therapy, epidemiology, health administration, biostatistics, and health economics. Examples of specialization are occupational health, minority health, women's health, geriatric nursing, pediatrics, mental health, rare diseases, surgery and other medical specialties. Geographic location includes rural area, State, region, or health system catchment area. Career settings include medical product development, health data services, public insurance programs, and nonprofit organizations.
Program Participants. Applicants may determine appropriate prerequisite requirements for researchers to participate in an education program's offerings. However, it is recommended that qualified researchers at all career levels be eligible to participate in at least one component or subcomponent of a program. As a result, a program should include training opportunities for early-stage researchers such as graduate students as well as for veteran investigators who seek to develop new competencies in CER/PCOR studies. Preferably, researchers will identify competencies they wish to develop through a program's offerings, and applicants will evaluate and/or certify the mastery of skills that are acquired through successful participation. Notably, this FOA does not require individual researchers to participate in all three program components or in all of its subcomponents.
Program Partners. To accommodate the unique educational needs of a respective researcher community, applicants are encouraged to implement program offerings in partnership with one or more organizations that represent, employ, collaborate, or are professionally affiliated with the selected community. Examples of potential partnership organizations include professional societies, business groups, health care delivery systems, and government institutions. Applicants are encouraged to engage partners in establishing a program's learning objectives, identifying prerequisite requirements, recruiting program participants, and implementing the program to the selected researcher community.
Program Collaboration and Complements. Successful applicants will have the opportunity to collaborate with other awardees to share knowledge, learning, and approaches through quarterly teleconference calls with each other. In addition, applicants are encouraged to consult with AHRQ staff as needed to promote and facilitate educational collaborations.
A research education program may complement other, ongoing research training and education occurring at an applicant institution, but the proposed educational experiences must be distinct from any research training and research education programs currently receiving any federal support. A program should be designed to expand the use of CER/PCOR methodologies within a researcher community and should not simply supplement existing courses or educational activities. The R25 is not a substitute for an institutional research training program (T32), cannot be used to support individual research activities, and cannot be used to circumvent or supplement National Research Service Award (NRSA) mechanisms. Individuals supported by AHRQ or other Federally-funded training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.
Applicants must propose a multi-component education program in CER/PCOR methodologies and methodological standards that is required to have a minimum of three educational components and a structure that includes an entity for program evaluation. The three required educational components are broadly categorized as (1) basic, (2) advanced, and (3) experiential learning opportunities so that each program offers a range of educational activities to the targeted researcher community. It is expected that as a result of this structure, programs will be better equipped to compete for funding from AHRQ and other funders. AHRQ may decide to publish future FOAs describing education programs, seminars, or research symposia that will be limited to programs funded under the current FOA because of the cohesive infrastructure required to respond to these opportunities.
It is recommended that learning opportunities are administered by a designated unit (e.g., "Training and Education Unit") and independently assessed through a second designated unit (e.g., "Evaluation Unit)". It is recommended that approximately 80 to 90 percent of a program's resources are dedicated to training and education, with the majority of this unit's resources dedicated to providing several basic learning opportunities. Likewise, it is recommended that the remaining 10 to 20 percent of the program's resources are devoted to evaluation activities to assess programmatic outcomes. Additional details about program components and structure are provided below.
Training and Education. Each application must include training and educational offerings with personnel and other resources to develop and implement a researcher education program, its components (i.e., basic, advanced, and experiential), and its operational subcomponents (e.g., courses, webinars, workshops, fellowships, etc.). Education programs are to develop and implement (1) basic courses on CER/PCOR methods or standards that are offered each year; (2) a learning collaborative on advanced CER/PCOR methods topics; and (3) an experiential or fellowship program for individual to receive between approximately one and twelve months of direct CER/PCOR methods training.
Basic Component. For the basic methods component, this FOA supports the development, implementation, and evaluation of a series of innovative didactic short courses, workshops, online training modules, or other approaches to learning. The basic methods component may be developed using traditional and nontraditional pedagogical approaches such as through classroom teaching or distance education. All courses should include learning objectives, prerequisites, and provide participants with an assessment of their learning. Courses should be updated annually or replaced with new courses based on program evaluations or new developments in the field of CER/PCOR methodologies and standards. Applicants must develop courses based, in part, on written guidance documents and standards that are established or adopted by the AHRQ Effective Health Care Program, the NIH, the PCORI Methodology Committee, the IOM, and other recognized authorities in CER/PCOR. Examples of these guidance documents and standards include, but are not limited to:
Advanced Component. For the advanced methods component, each applicant is expected to support training by implementing a methods learning collaborative. A collaborative is a forum for peer-to-peer education, discussion, and scholarly deliberation by researchers on advanced methods for conducting CER/PCOR studies. Advance training may be operationalized as a series of topical seminars provided by objective experts on state-of-the-art analytic methods, methodologies, and emerging research standards. It is recommended but not required that these advanced seminars are produced in a brief, modular format that allows synchronous and asynchronous learning through web-based instructional technology. Applicants should recruit researchers to participate in the learning collaborative as instructors and as participant-learners.
Experiential or Fellowship Component. Each applicant must establish an experiential learning or fellowship program that supports direct experience with applying CER/PCOR methods or standards to a systematic review or research problem. The experiential program should be designed as a research enrichment program whereby experienced researchers are mentored on CER/PCOR methodologies at the applicant's institution or at a partner's organization. In general, fellows should be researchers who are part of the targeted researcher community, but not directly affiliated with the applicant's institution. Participation of researchers from institutions, organizations, businesses, or nonprofit organizations who have not received CER/PCOR grants or contracts from AHRQ or NIH is strongly encouraged. Under this FOA, programs should plan to host a minimum of three fellows, for one to three months, each year for four or five years. Fellows are expected to complete at least one methods project and may also provide lectures in the basic or advanced training course. Fellows may not receive financial support from the grant award and are generally expected to be supported by their employer or through other sources.
Individuals supported by AHRQ and NIH training and
career development mechanisms (K, T, or F awards) may receive, and indeed are
encouraged to receive, educational experiences supported by this R25 mechanism,
as participants, but may not receive salary or stipend supplementation from a
research education program.
Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
Evaluation. Each training program must include an evaluation unit, which tracks program participation and assesses outcomes of the education program. At minimum, this assessment must include an evaluation of the program's effects on CER/PCOR research or systematic reviews, the scientific workforce, and the competency of researchers. Applicants are to evaluate the educational outcomes associated with educational program components and provide program participants with an assessment of mastery and/or certification of the competencies acquired.
Application Types Allowed
Funds Available and Anticipated Number of Awards
AHRQ intends to fund an estimate of 5 to 7 awards, corresponding to a total of $2,500,000, for fiscal year 2014. Awards issued under this FOA are contingent on the availability of funds and the submission of a sufficient number of meritorious applications.
Because the nature and scope of the proposed research education activities will vary from application to application, it is anticipated that the size and duration of the award will also vary.
Application budgets are limited to total costs (including direct and indirect costs) of $500,000 in any given year.
Award Project Period
The duration of the project period must not exceed 5 years.
All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.
You may submit an application(s) if your institution/organization is a (an):
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. 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.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
Only one PD/PI may be designated on the application.
This FOA does not require cost sharing.
While there is no cost sharing requirement included in this
FOA, AHRQ welcomes applicant institutions, including any collaborating
institutions, to devote resources to this effort. An indication of
institutional support from the applicant and its collaborators indicates a
greater potential of success and sustainability of the project. Examples of
institutional support would include: donated equipment and space, institutional
funded staff time and effort, or other resource investments. Applicant
institutions should indicate institutional support by outlining the specific
contributions to the project and providing assurances that their organization
and any collaborators are committed to providing these funds and resources to
the project. 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.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent can be sent electronically, and should be sent to:
Scott R. Smith, Ph.D.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
Describe the educational environment, including the facilities, databases, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
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.
The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Recruitment Plan, Evaluation Plan.
Applications should include information on: (1) participating faculty members (including their experience in research training and research education) and (2) the potential pool of participants. This information will be used by reviewers during peer review and by AHRQ staff in reaching funding decisions.
Proposed Research Education Program (Component of Research Education Program Plan)
While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization must clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program.
Describe the program’s purpose, goals, and intended outcomes. Explain the community or communities of researchers for which the education program is designed to train and the importance of CER/PCOR to that research community. Describe partnerships with employers, health systems, professional societies and/or research institutes and partners' roles in the proposed education program or Center. The application should also provide a summary of the research education program including its components, objectives, and the types of available activities. Explain the basis and rationale for the program particularly for CER/PCOR and any educational principles or evidence of past success that it may be based on.
The information should include a description of the education and/or career levels of the planned participants. Describe the educational level of the participants to be reached, the time and duration of their participation, and the content to be conveyed. Also, the description should include plans for recruiting and selecting participants for the program, duration of training and months in which training will occur, and a description of a typical program. Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).
Describe how the program will be evaluated and, specifically, the evidence and data to be collected. Where applicable, describe the plans for:
Institutional Environment and Commitment (Component of Research Education Program Plan)
Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program especially as it pertains to CER/PCOR research and systematic reviews. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
Program Director/Principal Investigator (Component of Research Education Program Plan)
Provide evidence that the director has a history of being involved in such educational activities, or has the potential to successfully lead the program. Describe arrangements for administration of the program, and provide evidence that the PD/PI is actively engaged in CER/PCOR studies and/or teaching in an area related to the goals of this program. Describe the director’s credentials as an organizer and administrator.
Program Faculty/Staff (Component of Research Education Program Plan)
Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in CER/PCOR research or other scholarly activities. Provide evidence that the participating faculty have experience in training, mentoring, and/or related educational activities. They should also provide a stimulating research and learning environment for all participants. The applicant should list all faculty members who will participate in this program, including their areas of research where applicable.
Program Participants (Component of Research Education Program Plan)
Provide details about the pool of expected applicants and participants, their educational level or career stage, and their qualifications. Where the proposed program involves participants, provide details about the pool of expected participants, their qualifications, recruitment strategies and sources of applicant pool, etc.
Recruitment Plan (Component of Research Education Program Plan)
Explain how eligible researchers will be identified and recruited to participate in the basic, advanced and experiential components of the education program. In addition, explain plans to encourage or support retention and completion of educational program components. Describe plans to encourage the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
Evaluation Plan (Component of Research Education Program Plan)
Applications must include a plan for evaluating the activities supported by the award. The application may specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.
Resource Sharing Plans
Resource sharing is not required. Plans do not need to be included in the application.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the we portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
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 HHS 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.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH/AHRQ.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
AHRQ supports research, evaluations, and demonstration projects concerning 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. 42 USC 299(c). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available at 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.
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.
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.
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 applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.
Applicants are encouraged to form meaningful partnerships with other institutions, business groups, professional societies, and non-profit research organizations. Anticipated costs associated with these partnerships, if any, should be included in the budget.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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:
Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.
Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.
Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific 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.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? For each component of the proposed education program, does the component address one or more key audiences or important needs in CER/PCOR methods education? Depending on the purpose of the program, is there convincing evidence in the application that the proposed program will significantly augment the training of the CER/PCOR workforce? Will the proposed education program strengthen the conduct of CER/PCOR systematic reviews, original research or both? If the aims of the education program are achieved, will the project (1) lead to the development of highly trained scientists focused on CER/PCOR research studies and with advanced skills in CER/PCOR methodologies and standards, and (2) provide public education and outreach to a variety of audiences? Are the goals clearly stated and achievable? Are CER/PCOR methods topics prominently integrated into planned activities? How does the plan take advantage of the research infrastructure of the applicant institution? What is the value added and how does this program differ from the institution's current ongoing activities? Does the application include a meaningful partnership with other institutions, business groups, professional societies, and/or nonprofit organizations to support training and workforce development in CER/PCOR studies?
Are the PD/PI, collaborators, and other researchers 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? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Is the leadership approach, governance and organizational structure appropriate for the project? Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed Center and its education program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal? Is there evidence that the participating faculty have experience in mentoring students and teaching CER/PCOR methodologies and research standards? Are the faculty good role models to the participants by nature of their scientific accomplishments? Is there evidence that the faculty have sufficient support to create a sound educational environment for the participants? Are individuals with the right expertise in CER/PCOR methods and standards involved in the development and management of the program? Does the PD/PI have sufficient involvement in the program? Does the program leverage ongoing activities designed and managed by others? Do the PD/PI and key personnel maintain an appropriate level of involvement to ensure the substantial and unique added value critical CER/PCOR? Does the Program Coordinator have the scientific expertise to implement activities that are essential for the success of the participants and their anticipated career?
Is the project original and innovative? Does the project develop or employ novel approaches, tools, or technologies for this area? Does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience? Is the proposed research education program characterized by innovation and scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program. If distance learning is proposed, is this approach appropriate for the curriculum delivered by this method to the proposed participants? Does the proposed program provide state-of-the-art educational opportunities? Does the applicant make a strong case for this program reaching participants in need of the program's offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches to improve the knowledge and/or skills of the intended audience?
Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves human subjects research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of AHRQ priority populations? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? Are the recruitment activities adequate to ensure a highly qualified and diverse participant pool? Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome(s)? Are the methods and activities appropriate for the program objectives and the intended audience? Are there strong plans for program administration with any partnering organizations? If applicable, are the nature and extent of the partnerships explained? Where partnerships are proposed, are there plans to monitor their effectiveness and to avoid duplication? Is the proposed plan for evaluation sound and likely to provide data on the effectiveness of the program in achieving its goals and objectives? Does the plan adequately describe how outcomes will be determined and evaluated? Is the proposed Scientific Committee designed adequately to ensure scientific and administrative oversight of the proposed research education program?
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? Is there evidence of institutional support? Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
Are the facilities adequate and appropriate? Are the facilities accessible for persons with disabilities?
Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Degree of Responsiveness
Reviewers will assess how well the application addresses 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? [NOTE: Information may be added here]
Inclusion of Priority Populations
Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements”).
Budget and Period of Support
The committee will evaluate whether the proposed budget is reasonable and the requested period of support is appropriate in relation to the proposed research.
Privacy and Security Protections for Patients
Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention. (Note: use this as appropriate)
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
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 eRA Commons.
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
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 a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
wardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.
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, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.
All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.
As necessary, additional Terms and Conditions will be incorporated into the award statement.
When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.
The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.
The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.
Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).
A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Direct your questions about general FOA issues, including information on the inclusion of priority populations to PCORMethodsFOA@ahrq.hhs.gov. For reasons of equity and consistency, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email. A compilation of frequently asked questions and answers will be posted at: http://www.ahrq.gov/fund/grantix.htm.
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
E-mail address: PCORMethodsFOA@ahrq.hhs.gov
Direct your questions about peer review issues of grant application made in response to this FOA:
Ali Azadegan, DVM, Ph. D.
Agency for Healthcare Research and Quality (AHRQ)
E-mail address: email@example.com
Direct your questions regarding fiscal matters to:
Agency for Healthcare Research and Quality
Telephone: 301-427-1015E-mail a
Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm).
AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.
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.
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