Participating Organization(s)	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.
Components of Participating Organizations	Agency for Healthcare Research and Quality (AHRQ)
Funding Opportunity Title	AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Investigator Award (K08)
Activity Code	K08 Clinical Investigator Award (CIA)
Announcement Type	New
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-012 - Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications (November 18, 2015) November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014. July 2, 2013 - See Notice NOT-HS-13-010. AHRQ Announces Interest in Patient-Centered Outcomes Research (PCOR) Mentored Career Development Grants focused on Methodologies and Research in Translation, Implementation, and Diffusion of Research into Practice and Policy.
Funding Opportunity Announcement (FOA) Number	PA-13-180
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.226
Funding Opportunity Purpose	The primary purpose of the AHRQ PCOR Mentored Clinical Investigator Award (K08) program is to prepare qualified individuals for careers utilizing complex comparative effectiveness research (CER) methods to clinical and health systems PCOR issues, involving stakeholders, as appropriate, in the design, execution,and dissemination of the research.

Posted Date	April 3, 2013
Open Date (Earliest Submission Date)	May 12, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Generally, four months after receipt date.
Advisory Council Review	Not Applicable
Earliest Start Date	Generally, four months after peer review date.
Expiration Date	July 13, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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

Purpose

The overall goal of the AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Investigator (K08) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's health services research needs. More information about AHRQ Career programs may be found at the AHRQ Training and Education website and at the NIH Extramural Training Mechanisms website.

The objective of the AHRQ PCOR K08 program is to provide salary and research support for a sustained period of protected time (3-5 years) for individuals with clinical doctoral degrees (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines). The K08 provides support for an intensive, mentored research career development experience in comparative effectiveness research (CER) methods as applied to patient-centered outcomes research (PCOR). For purposes of this FOA, CER is defined as 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.

The award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in health services research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous health services research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.

Research Career Training Objectives

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 Service Act, authorizing AHRQ to build capacity for comparative effectiveness research by establishing grant programs that provide training for researchers in methods used to conduct research. It also notes 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.

As noted above, this FOA solicits applications which apply CER methods to PCOR. The purpose of this focus is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which clinical and health system design interventions are most effective for which patients under specific circumstances. Research career training objectives and candidates must focus the content on health care delivery within the United States.

Each proposed career development plan must: (1) have intrinsic research importance in the area of PCOR; (2) serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained PCOR researcher; (3) ensure high research productivity; and (4) sufficiently prepare the candidate for PCOR research using CER methodology that is responsive to and involves stakeholders in the development of the research and/or in the dissemination and implementation of research findings. Research projects conducted must be designed to provide a strong foundation for conducting PCOR.

Example areas of CER methodological emphasis could include, but are not limited to:

Prospective, longitudinal cohort studies of the effectiveness/comparative effectiveness of health care diagnoses, treatment, and services including pharmaceuticals, devices and other types of interventions or combination of interventions;

Cluster-randomized, randomized, or practical clinical trials of the effectiveness/comparative effectiveness of new or existing health care technologies, involving wide inclusion of patients and health systems that adequately reflect health care provision for the general population;

Innovative approaches (clinical, methodological, and statistical) in the design as well as analysis of studies that more adequately identify and account for clinical heterogeneity of treatment effects;

Integration of quantitative and qualitative analytical frameworks and techniques in the screening, synthesis, appraisal, and dissemination/implementation of evidence;

The identification, role, and assessment of observational studies in the systematic review and synthesis of evidence on comparative effectiveness;

Meta-analysis and systematic review methodology;

Decision science modeling and analysis;

The design, analytical tools, and statistical techniques for reducing, confounding and mitigating the impacts of potential bias inherent in the observational studies of comparative effectiveness;

The communication of risk and benefit and contextual information that enhances the use of evidence in decision-making, as well as the comparative effectiveness of different approaches and technologies in accomplishing such objective;

Implementation science methodology, within a comparative effectiveness framework;

Training in use of registries, combining large-scale longitudinal data sets, and data mining techniques (as applied to comparative effectiveness research questions); and

The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as underserved and underrepresented groups with the intent to focus on reduction of disparities.

PCOR components include:

Utilization of a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific PCOR research questions;

As necessary, utilization of any translational tool adopted by PCORI to assist with the dynamic implementation of the translational framework;

Engagement of stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of their research (in the development of research questions, measurement of outcomes, the design of projects, and as necessary, participation in the research), and to the extent necessary, the implementation and dissemination of the research;

Demonstrated 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;

Assessment of the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; and

Inclusion of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health related quality of life.

Special Note: To ensure that applications are responsive to AHRQ priorites as well as FOA requirements, consultation with AHRQ staff prior to application submission is encouraged.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period may not exceed 5 years.

Salary	AHRQ will provide salary for the award recipient for a requested portion of the candidate's institutional salary, of up to $90,000 annually plus associated fringe benefits. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the AHRQ salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Other Program-Related Expenses	AHRQ will contribute a maximum of $25,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Only the following types of expenses are allowable: a) tuition and fees related to career development; b) research expenses such as supplies, equipment, and technical personnel working with research data; c) travel to research meetings or training; and d) statistical services including personnel and computer time. All expenses must be directly related to the proposed research career development and must be individually justified. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

These projects are being funded pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

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):

• Public or non-profit private institution, such as a university, colleage, or a faith-based or community-based organization;
• Unit of local or State government;
• Eligible agency of the Federal government.
• Indian/Native American Tribal Government (Federally recognized)
• Indian/Native American Tribal Government (Other than Federally recognized);
• Indian/Native American Tribally Designated Organization.

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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

The Program Director/Principal Investigator (PD/PI) must also work with his/her 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 candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI), and who meets the eligibility criteria stated below, is invited to work with his/her mentor and 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. Multiple PD/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status.

Candidates for this award must have a clinical doctoral degree. Such degrees include, but are not limited to, the MD, DDS, DO, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), DVM. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the appropriate AHRQ Program official concerning their eligibility for a K08 award.

Individuals who apply for the PCOR K08 award can also apply or possess an AHRQ or NIH Small Grant (R03) or Exploratory/Developmental Grant (R21) but may not receive salary support from that award if the K08 is awarded.

Individuals are not eligible if they have simultaneously submitted or have an application which is pending peer review for any Federal or non-Federal research grant, contract, or cooperative agreement on which they are named PD/PI which exceeds $100,000 direct costs per year; or are proposed subproject leader on Program Projects (P01) or Center Grants (P50) or cooperative aggreements. Lastly, individuals cannot have been or currently be a PD/PI on peer-reviewed Federal or non-Federal research grants, contracts or cooperative agreements over $100,000 direct costs per year; or be or have been a subproject leader on Program Projects (P01) or Center Grants (P50) or cooperative aggreements. Individuals who have been or are currently a PD/PI on any other individual Federal mentored career development awards are not eligible to apply.

All candidates for AHRQ individual mentored career development grants are limited to a total of five years of mentored career development support. If the candidate has been a scholar appointed to any Federally-funded institutional mentored career development program (from mechanisms including, but not limited to the K12 and KL2), the time appointments on these grants count toward the total five year AHRQ time limitation. For example, an individual who has been appointed to an NIH or AHRQ K12 or KL2 institutional mentored career development grant for three years can request only two years of individual career development support on an AHRQ K08 grant. The minimum allowable time requested for all other applicants to AHRQ’s individual mentored career development grants remains at three years per instructions in this announcement.

This FOA does not require cost sharing.

Applicants may only have one Federal Individual Career Development Award application pending peer review at any time.

At the time of award, the candidate must have a full-time appointment at the applicant institution. A full-time appointment is generally considered to be 40 hours per week, unless otherwise specified and consistently-applied by the applicant instution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with a full-time VA appointment are not eligible to apply.

Candidates (with one exception noted below) must be able to commit a minimum of nine person-months (75% of full-time professional effort) annually conducting research career development activities associated with this awardfor up to five years. The remaining three months (25% effort) annual effort can be divided among other research, clinical, and teaching activities but only if these activities are consistent with the goals of the Award, i.e., the candidate’s development into an independent investigator.

Applicants for the AHRQ individual mentored career development award who have had three years of a mentored experience on another Federally-funded career development grant, such as those noted above, can request a minimum of 50% effort for two years. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award.

Salary support for research effort over and above that devoted to the K08 may not be obtained from Federally-funded projects unless authorized by the Federal program from which such funds are derived.

The sponsoring institution may supplement the AHRQ salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.

K08 award recipients are encouraged to obtain funding from AHRQ or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award under certain circumstances. To be eligible for salary support from peer-reviewed research awards from any Federal agency, the following criteria must be met: First, the K08 award recipient must be the PD/PI on a competing AHRQ or NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency). These specified grant mechanisms are for illustrative purposes and not meant to be all-inclusive. If necessary, the recipient should contact AHRQ Staff for clarification or additional information. Second, the K08 award must be active when the competing research grant application is submitted. Third, the K08 award must be in its final two years of a five-year individual award or the final year of a four-year individual award.

At the time the research grant is awarded, the effort required on the K08 award may be reduced, with prior AHRQ approval, to no less than six person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at nine person-months (75% full-time professional effort) or more for the duration of the K08 award. A reduction in effort will result in recalculation of salary provided by the K08 grant.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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.

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 the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Project Summary/Abstract (Component of the Other Project Information Component)

This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to continue in the independent phase.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate’s Background (Component of Candidate Information)

• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator in CER applied to PCOR. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Describe the candidate’s commitment to a career in CER applied to PCOR.

Career Goals and Objectives (Component of Candidate Information)

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development to become an independent investigator; (3) utilizes the relevant research and educational resources of the institution; and (4) is focused on CER methods as applied to PCOR.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The candidate and sponsor may propose a mentoring team (or an Advisory Committee).
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career.
• Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely didactic in nature and is followed by a period of intense, supervised research.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

• The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
• The sponsoring institution must provide a statement of commitment to the candidate’s development into a productive, independent investigator and to meeting the requirements of the award. The sponsoring institution must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.

Research Strategy (Component of Research Plan)

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
• Data and Safety Monitoring (when applicable): Plans for data and safety monitoring must be included as needed.

Budget Component: Special Instructions for AHRQ applications

• AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

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 online 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 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.

Important reminders:
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 AHRQ/NIH.

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 [email protected] 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 should 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 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

For this particular announcement, note the following:

Reviewers will provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below (specific to the application of CER methods to PCOR) 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.

The following criteria are specific to the application of CER methods to PCOR.

Candidate

Does the candidate have the potential to develop as an independent and productive researcher? Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Are the candidate's prior training and research experience appropriate for this award? Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Research Plan

Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan? If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

Environment & Institutional Commitment to the Candidate

Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program?

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 and how responsive the application is to the special eligibility criteria.

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

If applicable, reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan is reasonable.

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.

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:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ portfolio priorities, as well as overall programmatic balance.

After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Generally, applicants should anticipate a minimum of 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.

Awardees 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 A through J as described in the PHS form 2590 instructions (see " Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports"). These instructions supplement those provided on the AHRQ website.. 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.

In carrying out its stewardship of human resource-related programs, AHRQ may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Tamara Willis, PhD, MPH
Agency for Healthcare Research and Quality
Office of Extramural Research, Education, and Priority Populations
Division of Research Education
Telephone: (301) 427-1011
Fax: (301) 427-1562
E-mail address: [email protected]

Direct your questions about peer review issues of grant application made in response to this FOA:

Ali Azadegan, DVM
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1869
Fax: (301) 427-1562
E-mail address: [email protected]

Direct your questions regarding fiscal matters to:

Galen Gregor, CRA
Agency for Healthcare Research and Quality
Office of Performance Accountability, Resources and Technology
Grants Management
Telephone: (301) 427-1457
Fax: (301) 427-1462
E-mail address: [email protected]

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.

AHRQ Grants Policy and guidance 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.