Expired RFA-HS-13-002: AHRQ Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/R00)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title: AHRQ Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/R00)

Announcement Type

This Funding Opportunity Announcement (FOA) is a new Request for Applications.

Request for Applications (RFA) Number: RFA-HS-13-002

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Note regarding Applicability of NIH Grants Policies and Related Guidance: The policies, guidelines, terms and conditions stated in this FOA are not identical to those used by the NIH. This FOA will reference NIH grants policies and guidance where these issuances are applicable or relevant to submissions.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: September 7, 2012
Opening Date: November 17, 2012
Letters of Intent Receipt Date(s): November 19, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): December 17, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: December 18, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The primary purpose of the AHRQ Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented AHRQ-supported independent investigators trained in comparative effectiveness methods to conduct patient care outcomes research. The program is designed to facilitate a timely transition from a junior non-tenure track faculty or a postdoctoral research position (or their equivalents) to a stable independent research career. The program targets investigators early in their careers to support their development in new sophisticated methodological comparative effectiveness research skills, interdisciplinary perspectives, and capabilities in PCOR.
Mechanism of Support. This FOA will utilize the K99/R00 award mechanism.
Funds Available and Anticipated Number of Awards. Approximately $1.5 million will be available to support the K99 phase of the award and $3 million for the R00 phase. It is anticipated that AHRQ will make approximately 10 awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration and costs of the applications received.
Budget and Project Period. The K99 phase will provide support for up to 2 years. The R00 phase will provide support for up to 3 years. The total project period may not exceed 5 years. See Section II for details.
PHS 398 Career Development Award Supplemental Form Component Sections: Specific Aims are limited to one page. Items 2-4 (Candidate's Background, Career Goals and Objectives, and Career Development/Training Activities During Award Period) and Item 11 (Research Strategy) are limited to a combined total of 25 pages, including tables, graphs, figures, diagrams, and charts. Training in the Responsible Conduct of Research is a separate attachment and limited to an additional one page.
Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Director/Principal Investigator (PD/PI): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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. The PD/PI must commit a minimum of 75% of full-time professional effort conducting research and relevant career development activities specified in the application.
Number of PDs/PIs: Only one PD/PI may be designated on the application.
Number of Applications: Applicants may have only one individual Career Development Award application pending peer review at any time.
Resubmissions: Resubmission applications are not permitted in response to this FOA.
Renewals: Awards are not renewable and are not transferable from one PD/PI to another.
Application Materials. See Section IV.1 for application materials.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially 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 be accepted for review.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
    B. Submitting an Application Electronically to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The overall goal of the AHRQ Research Career Development program is to help ensure that a diverse pool of highly trained scientists are available in appropriate scientific disciplines to address the Nation's health services research needs. More information about AHRQ Career programs may be found at http://www.ahrq.gov/fund/training/trainix.htm.

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.

One of the most challenging times in a research career is the transition from postdoctoral trainee to independent scientist. The objective of the AHRQ Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/R00) initiative is to facilitate a timely transition from a non-tenure track faculty or a postdoctoral research position (or their equivalents) to a stable independent research career. The program targets junior investigators early in their careers to support their development in new sophisticated methodological comparative effectiveness research skills, interdisciplinary perspectives, and capabilities in PCOR. Applications for this award must propose a career development plan that will:

have intrinsic research importance in the area of PCOR (as described below),
serve as a suitable vehicle for learning sophisticated comparative effectiveness research methodology(ies), as well as theories and concepts needed for undertaking a research career in PCOR,
ensure high research productivity; and
sufficiently prepare candidates for PCOR research that is responsive to and involves stakeholders in the development of the research and in the dissemination and implementation of research findings. Research projects conducted by candidates must be designed to provide a strong foundation for conducting PCOR.

Nature of the Career / Research Transition Opportunity

The K99/R00 award will provide up to 5 years of support consisting of two phases. The initial mentored phase will provide support for up to 2 years for very promising and talented eligible emerging junior investigators who have no more than 5 years of postdoctoral research training experience at the time of application submission, and do not have a full-time tenure track assistant professor position (or equivalent). This initial phase of mentored support will allow the candidate time to obtain additional training, complete research, publish results, and bridge to an independent research position. The candidate must propose a research project that will be pursued during the K99 phase and transition into an independent project during the R00 phase of the award. The candidate and mentor(s) together will be responsible for all aspects of the application. An individual may submit an application from an extramural sponsoring institution/organization that has a rich and extensive research program in the area of interest as well as the faculty, facilities and resources to support the proposed research endeavor. The individual must select an appropriate mentor with a track record of funded research related to the selected research topic and experience as a supervisor and mentor. The sponsoring institution must ensure that the candidate has the protected time needed to conduct the proposed research. Candidates are required to commit a minimum of 75% of full time professional effort annually during the mentored phase.

Following the mentored phase, the individual may request up to 3 years of support to apply CER methods to conduct PCOR research as an independent scientist at a sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program in an area which grows out of the mentored phase research and applies skills gained during the mentored phase. However, support for the independent phase is not automatic; it is contingent upon being accepted by an appropriate institution and the successful AHRQ programmatic review of the individual’s mentored phase of the award.

1. Research Career Training Objectives

The purpose of PCOR is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, policy makers, and health care administrators, responding to their expressed needs about which clinical and health system design interventions are most effective for which patients under specific circumstances. Research career training objectives and candidates must focus the content on health care delivery within the United States.

For purposes of this FOA, PCOR 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 purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

As noted above, Section 937(e) of the Public Health Service Act authorizes AHRQ to establish a grant program that provides for the training of researchers in comparative effectiveness methods and states that, [a]t a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act.

The Methodology Committee of PCORI was established to develop and improve the science and methods of comparative clinical effectiveness research. Legislation charges the Committee to develop a translation table that is designed to provide guidance and act as a reference for the Board to determine research methods that are most likely to address each specific comparative clinical effectiveness research question. Grant applicants must be responsive to recommendations made by the Committee in their grant applications if these are released by the application receipt date (i.e., applicants must, at a minimum, meet PCORI methodological standards that are developed.). If these recommendations are released subsequent to the application receipt date and before the scheduled peer review date, AHRQ will issue notification that the PCORI standards have been released and will include any additional submission requirements. A draft report and information on the activity of the Methodology Committee of PCOR can be found at www.pcori.org.

Note, the Methodology Committee has developed a preliminary translation framework that will inform the development of the translation table. Components include:

Determining which research methods are best to address specific clinical effectiveness research questions;
Utilizing a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific research questions; and,
As necessary, utilization of any translational tool adopted by PCORI to assist with the dynamic implementation of the translational framework.

Candidates also need to engage 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. Also, candidates must demonstrate their ability to collaborate with institutions and networks well versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for health care practice and decision-making.

Example areas of 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;
Training in use of registries, combining large-scale longitudinal data sets, and data mining techniques; and
The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as underserved and underrepresented groups.

Candidates are strongly encouraged to emphasize and address the following in their career development programs and applications:

Novel approaches for engaging stakeholder groups (e.g., clinicians, consumers, policymakers, insurers, buyers, and administrators) in the development of research questions, measurement of outcomes, the design of projects, and, as necessary, participation in the research;
Specific plans for disseminating the findings and incorporating them into health care delivery at the onset of developing a research project;
Reduction of disparities involving disadvantaged populations.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the Pathway to Independence (K99/R00) award mechanism. The Project Director/Principal Investigator (PD/PI, also referred to as the Candidate ) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

2. Funds Available

It is anticipated that AHRQ will make approximately 10 awards. Approximately $1.5 million total costs per year will be available to support the K99 phase of the awards (up to 2 years) and $ 3 million total costs per year for the R00 phase (up to 3 years). The total project period may not exceed 5 years. Although the financial plans of the AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Funds may be used only for those expenses that are directly related and necessary to the career development program and must be expended in compliance with applicable OMB Cost Principles (see http://www.whitehouse.gov/omb/circulars_default) and the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).

Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report.

Allowable Costs

The K99/R00 award has two phases: a mentored K99 phase of up to 2 years at an eligible sponsoring institution/organization, followed by an independent investigator phase of up to 3 years sponsored by an eligible institution/organization to which the individual has been recruited.

Mentored Phase of the Pathway to Independence Award Program (K99)

Candidates are required to commit a minimum of 75% of full-time professional effort annually (i.e. minimum of 9 person-months) to the pursuit of their career development and research experience during the mentored phase. This experience may also include activities such as completing research publications and searching for an independent research position. Candidates may engage in teaching and/or clinical duties as part of the remaining 25% of the candidate’s full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

The total salary limit per year for the initial mentored phase must not exceed $90,000 direct costs, plus associated fringe benefits. In addition, research support costs up to $25,000 direct costs for each 12 month mentored budget period may be requested.

The research support costs allowed for this program must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career activities.

Salary must be consistent with the established salary structure at the institution using its own funds to support other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits should be requested based on the sponsoring institution’s rate. Research support costs for the mentored phase may include (a) tuition and fees related to career development; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

The sponsoring institution may supplement AHRQ’s 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 additional PHS funds beyond those provided in the K99 award be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. However, the total salary paid from AHRQ funds may not exceed the legislatively mandated salary cap. For details, see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-12-007.html

Independent Investigator Phase of the Pathway to Independence Award Program (R00)

Total costs for the independent investigator R00 phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support and applicable indirect costs.

The candidate is required to devote a minimum of 75% of their full-time, 12 month professional effort annually to research (i.e., a full-time 9 person-months). However, this effort does not have to be entirely obtained from the R00 project alone. Recipients of the R00 phase awards may devote effort to, and receive appropriate salary from, other research projects so that combined research effort is at least 75% but does not exceed 100%. If a recipient receives additional independent research support that would cause his/her other support to exceed 100%, effort on the R00 may be reduced, provided the total effort devoted to research is at least 75%. Note that a reduction of effort by 25% or more of the approved level of effort devoted to the R00 project will require AHRQ prior approval.

Applicable to both Mentored and Independent Phases

For information regarding AHRQ policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested 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 with equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. In the K99 phase, salary may not exceed $90,000 direct costs for the effort devoted to the project (minimum 75% annual effort). Fringe benefits are based on the sponsoring institution s rate and the percent of effort and are provided in addition to the salary. (see also Eligible Individuals below).

Indirect Costs: For the extramural K99 phase, these costs, also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institution’s Federally-negotiated indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.

Transition from K99 Phase to R00 Phase Award

Transition from the mentored phase to the independent scientist phase is NOT automatic and is subject to review of the awardee’s research training/career development accomplishments and an evaluation of the materials (including progress report) submitted in support of the R00 phase application. The candidate must have accepted an offer by an eligible institution in a tenure-track, full-time assistant professor (or equivalent) position in order to activate the extramural support phase. Information on materials to be submitted is located in Section VI.2., Activating the Extramural Independent Investigator Phase of the Pathway to Independence Award (R00) .

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
Units of local or State government;
Indian/Native American Tribal Government (Federally Recognized);
Indian/Native American Tribal Government (Other than Federally Recognized);
Indian/Native American Tribally Designated Organizations.

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.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

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). Individuals on temporary or student visas are not eligible for support. It is the grantee institution’s responsibility to ensure the applicants citizenship status.

Candidates must have a clinical or research doctorate (including Ph.D., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.V.M., Sc.D., D.N.S., Pharm.D. or equivalent doctoral degrees) and have no more than 5 years of postdoctoral research training at the time of application.

All candidates must be at a stage where they require research mentoring and do not have sufficient research experience or institutional authority to lead an independent research program. This award is intended for and limited to those individuals who are in mentored training positions and who do not have sufficient research experience or institutional authority to lead an independent research program.

Both clinical (e.g., M.D., D.D.S, Pharm.D., D.O.) and research (e.g., Ph.D. or equivalent) doctorate holders are eligible if they are: either in a junior non-tenure track faculty (e.g., Instructor, Assistant Professor) or postdoctoral position; and are not independent in research. Also, it is recognized that some institutions appoint postdoctoral fellows in positions with other titles, although they are still in non-independent training positions. It is incumbent upon the candidate to provide evidence that the position he/she occupies complies with the intent of this eligibility requirement.

Evidence for non-independence may include:

The candidate’s research is entirely funded by other investigator’s grants.
The candidate’s research is conducted entirely in another investigator’s assigned space.
According to institutional policy, the candidate cannot hire postdoctoral fellows or be the responsible supervisor of graduate students.
According to institutional policy, the candidate is not allowed to submit an application as the principal investigator of an AHRQ or NIH research grant application (e.g., R01 or other equivalent research grant).
The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes:

The candidate has a full-time tenure track assistant professor position (or equivalent).
The candidate received a startup package for support of his/her independent research.
The candidate has research space dedicated to his/her own research.
The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire postdoctoral fellows.
The candidate is eligible to apply for independent research funding as the principal investigator of an independent PD/PI on AHRQ or NIH research grants (e.g., R01, R18, R03, R21), or other peer reviewed NIH or Non-NIH research grants or research contracts over $100,000 direct costs per year, or project leaders on sub-projects of program project (e.g. P01) or center (e.g. P30, P50) grants.

All candidates are NOT eligible if they:

Have currently or previously held an independent research faculty or any tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
Have more than 5 years of postdoctoral research training (e.g., individual postdoctoral fellowship (F32), postdoctoral appointment on an institutional training grant (T32) at the time of initial application;
Have been or are an independent PD/PI on AHRQ or NIH research grants (e.g., R01, R03, R21), career development awards (e.g., K01, K07, K08, K23, K25), or other peer reviewed AHRQ, NIH or Non-NIH research grants or research contracts over $100,000 direct costs per year, or project leaders on sub-projects of program project (e.g. P01) or center (e.g. P30, P50) grants; or
Have been or are on an institutional mentored career development award (e.g., KL2, K12).

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support 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.

3. Other-Special Eligibility Criteria

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. However, AHRQ reserves the right to support no more than two applications from the same institution (e.g., university) or its affiliate organizations (e.g., hospitals, health plans).

AHRQ will not accept any application that is essentially the same as one already reviewed. An individual may not have more than one competing AHRQ or NIH career development applications pending review concurrently. Also, applicants to this program may not concurrently apply for any other PHS award that duplicates the provisions of this FOA.

Resubmission applications are not permitted in response to this FOA.

Level of Effort

At the time of award, the candidate must have a full-time appointment at the institution that is the applicant institution. Candidates who have full time VA appointments and part-time non-VA appointments are not eligible to apply.

Because of the relatively short duration of the mentored phase of each of these awards, a request for off-site career development or a leave of absence lasting more than 3 months, or any other similar request for a change in status, must receive AHRQ prior approval. Such a request must address the impact of such action on the awardee’s ability to make sufficient progress to meet the goals of the award. For example, a request for leave from a K99 awardee must describe how the leave will affect the awardee’s ability to transition to the R00 phase of the award.

Mentor

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. 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. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. 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.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in patient centered outcomes, health services, behavioral, or clinical research. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the candidate. The candidate, mentor(s), and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four to six weeks. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons.
The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
The PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 17, 2012
Letters of Intent Receipt Date(s): November 19, 2012
Application Due Date(s): December 17, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions. Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent should be sent electronically to Tamara Willis at [email protected].

The letter of intent is to be sent by the date listed in Section IV.3.A.

3.A.2. Technical Assistance

Not Applicable.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

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.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete or non-responsive applications will not be reviewed.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. The applicant should obtain a cost estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

NRSA Support: Ruth L. Kirschstein National Research Service Award (NRSA) recipients who are selected for K99/R00 award funding must terminate their NRSA support prior to receiving support from the K99/R00 award.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

AHRQ requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide (See Supplementary Instructions for Research Career Awards, Part I.7.5) that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Specific Aims is limited to 1 page.
Items 2-4 (Candidate's Background, Career Goals and Objectives and Career Development/Training Activities During Award Period) and Item 11 (Research Strategy) are limited to a combined total of 25 pages, including tables, graphs, figures, diagrams, and charts. Training in the Responsible Conduct of Research is a separate attachment and limited to one additional page.
While each section of the Candidate Information and Research Strategy components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Strategy component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.

The following information must be included in the application:

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.

Candidate’s Background (Component of Candidate Information)

Describe the candidate’s commitment to a career in the application of comparative effective methods to patient centered outcomes research.
Describe the candidate’s potential to develop into a successful independent investigator.
Describe the candidate’s current as well as long-term research and career objectives.
If currently supported by an institutional or individual Ruth L. Kirschstein NRSA or institutional career development award (e.g., K12, Kl2), describe the candidate’s current research training, fellowship, or career development program.
For individuals in postdoctoral positions with other titles although still in non-independent training positions, describe evidence of non-independence.

Career Goals and Objectives (Component of Candidate Information)

Present a systematic plan that: (1) shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences proposed for the mentored phase of the award (K99) and subsequently to independent investigator status (R00); (2) justifies the need for further mentored career development to become an independent research investigator; and (3) that utilizes the relevant research and educational resources of the institution.
Candidates should consult with the proposed mentor to discuss the proposed research training/career development plan for the mentored phase and the research plan to be presented in the application for the subsequent independent scientist phase.

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

Describe the career development plan and how it fits with the candidate’s goals and prior experience. A systematic plan should be presented for obtaining the necessary comparative effectiveness methods training and expertise to launch an independent research career in PCOR. The career development plan must be specifically tailored to meet the needs of the candidate and the ultimate goal of achieving independence as a researcher.
Describe the current training activities and how they relate to the career development plans and the career goals of the candidate. Candidates must justify the need for the award, both the mentored phase and the independent scientist phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored candidate followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular PCOR problem using CER methods.
The candidate should describe how the career development plan will promote the candidate’s success and scientific independence in the application of CER methods to PCOR. This plan should describe activities such as those that will lead to new and/or enhanced research, grant-writing, and communication skills and knowledge. The candidate should also describe how these skills will contribute to research productivity and facilitate the development of new approaches and directions for investigation. Courses or other activities that might allow the candidate to expand the scope of his/her research in order to improve the potential for success in gaining further independent funding are particularly encouraged.
The candidate must describe the plan for evaluation of his/her progress during the mentored phase and for the transition to the independent phase.
The candidate and K99 phase mentor (see below) must describe plans for the transition to the independent phase.

Training in the Responsible Conduct of Research

Applications must include a plan to obtain instruction in the responsible conduct of research.
This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research.
Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction. This information is outlined and explained in NOT-OD-10-019.
The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or may not be reviewed .
The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

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 K99 phase program. The candidate may also identify co-mentors as appropriate to the goals of the program.
The primary mentor 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 should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
The application must include a statement from the mentor(s) that provides: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research training, including any formal course-work; and 4) a plan for transitioning the candidate from the mentored phase to the independent scientist phase of the award.
Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate.
The mentor must agree to provide annual evaluations of the candidate’s progress for the initial mentored phase as required in the annual progress report.
The mentor must agree to review and comment on the extramural independent scientist (R00) phase application (See Section below on Activating the Independent Phase of the Pathway to Independence Award (R00).
Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.

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.
Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan and progression to the R00 phase.

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 the K99/R00 award.
Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs.
Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

Research Strategy (Component of Research Plan)

The candidate should describe his/her research capability that is relevant to the proposed R00 research plan. Ideally, this would include a brief description of research and research training performed prior to the mentored phase, a description of the research and research training planned during the mentored phase, and a detailed description of the research planned for the independent phase. This narrative should describe what the candidate will accomplish during the mentored phase that will enable him/her to conduct the planned independent research program proposed and launch an independent research career.
The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach of the R00 phase research, as well as the ability of the candidate to carry out the research. Consequently, the research plan should provide a detailed rationale, experimental approach and plan for the independent phase research.
The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. The application should describe how the candidate will gain independence from his/her mentors and achieve separation of his/her scientific research program from that of the mentor(s).
If more than one K99 phase mentor is proposed, the respective areas of expertise and responsibility should be described.
Data and Safety Monitoring (when applicable): see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-015.html)

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted Applications lacking the required reference letters will not be reviewed (this information is described in: NOT-OD-11-036). Please note that the specified format must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Referee Information link and not through Grants.gov.

Budget Component

Special Instructions for Modular Grant applications

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

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on AHRQ policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

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.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice. AHRQ policy also requires that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

Section V. Application Review Information

1. Criteria

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

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.

As part of the initial merit review, all applications will:

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

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.

Review Criteria

The overall goal of AHRQ-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s PCOR needs. The scientific review group will address and consider each of these criteria in assigning the application's overall impact/priority score, weighting them as appropriate for each application.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the individual proposed career development plan to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria

Reviewers will consider each of the five 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. These criteria are listed in logical order and not in order of priority.

Candidate
Career Development Plan/Career Goals and Objectives
Research Plan
Mentor, Co-Mentor(s), Consultant(s) and Collaborator(s)
Environment and Institutional Commitment to the Candidate

Candidate:

What is the candidate’s record of research productivity, including the quality of peer-reviewed scientific publications?
What is the quality of the candidate's pre- and postdoctoral research training experience, including expertise gained?
Based on the candidate’s experience, track record and prior research training, what is the candidate’s potential to become an outstanding, successful independent investigator who will contribute significantly to the application of CER methods to PCOR on topics that are directly applicable to improving health care delivery?
To what extent does the application provide evidence of the candidate’s research creativity, and does this evidence suggest that the candidate has the potential to develop a creative, independent research program?
Given the candidate’s prior training, proposed career development plan, and the referees evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent position within the time period requested for the K99 phase of this award?
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?
Relative to the above review criteria, how do these scientists evaluate the candidate?
Do the letters provide strong evidence that the candidate has a high potential to become an independent investigator?

Career Development Plan/Career Goals & Objectives:

Are the content and duration of the proposed didactic and research components of the career development plan appropriate for the candidate’s current stage of scientific and professional development and proposed research career goals?
Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate including his/her successful transition to independence?
How does the proposed career development plan enhance or augment the applicant’s training and/or career development to date?
Is the additional proposed training needed and appropriate for the proposed research plan and the applicant’s future career plans?
To what extent are the plans for evaluating the K99 awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?
Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the K99 phase of the award?

Research Plan:

Is the proposed K99 phase research significant?
Are the scientific and technical merits of the K99 research question, experimental design and methodology appropriate for the candidate’s level of training, an appropriate vehicle for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program?
Is the proposed R00 phase scientifically sound and a logical extension of the K99 phase? Does the capability of the applicant and experience gained from the K99 phase appropriately equip the candidate to successfully complete the proposed R00 plans? Is there evidence of long-term viability of the proposed R00 phase research plan?
Does the R00 phase project address an existing health care delivery issue, as described in the Research Objectives section?
Is the R00 phase project original and innovative? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies in comparative effectiveness research?
Is the project responsive to and does it involve appropriate stakeholders in the development of the research and in the dissemination and implementation of research findings?
To what extent is the proposed R00 phase research likely to contribute significantly to our understanding of patient centered outcomes research issues?
To what extent is the proposed R00 phase research likely to foster the career of the candidate as an independent investigator in patient centered outcomes?

Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s):

To what extent does the mentor have a strong track record in training future independent researchers?
To what extent are the mentor’s research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant’s career development needs?
Do(es) the mentor(s) adequately address the above review criteria including the candidate’s potential as well as his/her strengths and areas needing improvement?
Is the proposed supervision that will occur during the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant’s continued career development appropriate?
Does the mentor have a comprehensive plan to support the proposed K99 phase career development and research plans as well as the candidate’s efforts to transition to independence? Is this plan adequate and appropriate?
Are the consultants /collaborators research and/or mentoring qualifications appropriate for their roles in the proposed K99 phase of the award?

Environment and Institutional Commitment to the Candidate:

To what extent does the institution provide a high quality environment for the candidate’s development?
To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate’s research and career development goals during the K99 phase of the award? What evidence is provided that the K99 sponsoring institution is strongly committed to fostering the candidate s development and transition to the independent (R00) phase?
Is there adequate assurance that the required minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating:

Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Protection of Human Subjects from Research Risk. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R). 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:

1) Risks to the subjects, likelihood & seriousness:

Are all risks identified?
Are all subject pools identified (e.g., are providers subjects)?

2) Adequate protection from risks:

Is there evidence of adequate data security?
Are there special populations that need protections?

3) Potential benefits to subjects and others:

Has the PD/PI identified all anticipated benefits?

4) Importance of the knowledge to be gained:

Does the project propose to provide social benefit?

5) For research involving interventions with human subjects where there is a greater than minimal risk, reviewers will review and comment on:

Adequacy of the proposed Data and Safety Monitoring plan
Any proposed monitoring function, such as monitoring committees, or boards.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion. Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in Section VIII, Required Federal Citations below.). In particular, note that reviewers will:

evaluate the proposed plan and justification for the inclusion of priority populations or evaluate the proposed justification when priority populations are absent.
evaluate the proposed exclusion of priority populations when a requirement for inclusion would be inappropriate with respect to the purpose of the research.
evaluate the plans for outreach and recruitment of study participants where appropriate.
evaluate the proposed plan for conducting subgroup analyses so that study results will be relevant to one or more priority populations where appropriate.
include these criteria as part of the scientific assessment and assigned score.

Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

2.B. Additional Review Considerations

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

Training in the Responsible Conduct of Research. Taking into account the specific characteristics of the career development program, level of candidate experience, and the particular circumstances of the candidate, 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 how faculty will participate in the 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.

Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2.C. Resource Sharing Plan(s)

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities 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.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review
Availability of funds
Responsiveness to goals and objectives of the FOA
Relevance to program priorities
Programmatic, institutional and geographic balance
Portfolio balance within AHRQ and DHHS

NOTE: AHRQ reserves the right to support no more than two applications from the same institution (e.g., university) or its affiliate organizations (e.g., hospitals, health plans).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NoA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NOA signed by the AHRQ grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, additional Terms and Conditions will be incorporated into the award statement.

Activating the Independent Phase of the Pathway to Independence Award (R00)

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual circumstances, (e.g., candidate is waiting to transition to an offered and accepted, permanent tenure-track or equivalent position), AHRQ will not extend the K99 phase beyond the 2-year limit. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) at an eligible institution with appropriate infrastructure to support the proposed research program and a history of external research funding.

The application for the R00 phase of the award must be submitted by the independent phase (R00) grantee organization no later than 2 months prior to the proposed activation date of the R00 award. However, to avoid potential problems in activation, candidates are strongly encouraged to contact their AHRQ program official as soon as plans to assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award, to discuss plans for transition to, and the application for, the R00 phase.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS398 Application. The R00 application must include:

A new face page signed by the R00 phase institutional representative;
A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);
Detailed budget pages and budget justification;
Biographical sketches;
A new Resources page;
A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase;
An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages); and
A new checklist.

In addition, a letter from the R00 Department or Division Chairman (or equivalent) describing the R00 institution’s commitment to the candidate and plans for his/her career development should be submitted (see below), as well as a final evaluation statement by the K99 phase mentor, if not already provided.

These materials should be sent directly to AHRQ. The original application plus one copy are to be mailed to the Grants Management contact person listed in the Notice of Award. The R00 application will be evaluated by program staff for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section 7 of the SF424 Application Guide. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months (75% of the candidate’s full-time professional effort) annually for the duration of the R00 award.

The start-up package and other institutional support must be described and should be comparable to that given to other faculty (or equivalent research position on other eligible institutions) recently hired into tenure-track or equivalent positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member (or equivalent research position on other eligible institutions) who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track assistant professors (or equivalent in nonacademic settings) who are hired without grant support. The R00 sponsoring institution should describe the candidate’s appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (e.g. R01) support.

The R00 award requires that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) be devoted annually to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. AHRQ staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the AHRQ program official prior to submission of the R00 application. AHRQ will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Applicants are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of AHRQ.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This letter typically will be sent within 60 days of receipt of the R00 application.

Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the K99 award phase

If transition from the K99 phase at an eligible sponsoring institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase will not be permitted.

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. For the K99 phase, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

The annual progress reports must include Sections A through J 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.

Please note: The Research Performance Progress Report (RPPR) is a Federal-wide progress report which will eventually replace the PHS 2950. Grantees will be required to follow the new progress report guidelines when they become available.

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, Invention Statement and Federal Financial Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Other Reporting Requirements

Evaluation: In carrying out its stewardship of human resource-related programs, AHRQ may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they 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 research training program.

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.

Usually, funds budgeted in an AHRQ-supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the AHRQ awarding component.

Leave Policies: Leave to another institution from which the career development is taking place, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval by AHRQ and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Publication and Sharing of Research Results: AHRQ supports the practical application and sharing of outcomes of funded research. Therefore, grantees should make the results and accomplishments of their career development activities available to the research community and to the public at large. The grantee organization should assist grantees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results in a timely manner.

Candidates are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee’s research, AHRQ support must be acknowledged by a footnote in language similar to the following: This investigation was supported by the Agency for Healthcare Research and Quality (AHRQ) under National Research Service Award (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the AHRQ.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

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

Tamara Willis, Ph.D., M.P.H.
Office of Extramural Research Education and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
E-mail address: [email protected]

2. Peer Review Contact(s):

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

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Ms. Galen Gregor
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1457
Fax: (301) 427-1462
E-mail address: [email protected]

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm, which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.