Part I Overview Information

Department of Health and Human Services

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

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 Institutional Award (K12)

Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

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

Update: The following update relating to this announcement has been issued:

• January 4, 2012 - See Notice NOT-HS-12-005. This Notice is to inform the scientific community that AHRQ is clarifying the following criteria regarding scholar eligibility, salary support, recruitment/placement, and research development support justification.

Request for Applications (RFA) Number: RFA-HS-12-001

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.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: December 1, 2011
Opening Date: December 30, 2011
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).
Letter of Intent Date(s): December 30, 2011
Application Due Date(s): January 30, 2012
Peer Review Date(s): approximately March, 2012
Earliest Anticipated Start Date(s): approximately July, 2012
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: January 31, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Section 6301(b)) of the Patient Protection and Affordable Care Act , Public Law 111-148 (the Affordable Care Act ), enacted Section 937(e) of the Public Health 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. AHRQ is also authorized to sponsor post-doctoral health services research career development programs under section 902(b) of the Public Health Service Act. This FOA addresses the Affordable Care Act’s provision authorizing AHRQ to support the career development of researchers in comparative clinical effectiveness research. AHRQ encourages submission of applications from minority serving institutions.

• Purpose. The purpose of this solicitation is to support the career development of post-doctoral scholars in methods to conduct comparative effectiveness research. Under this award, these scholars can be selected and appointed to this program by the K12 Program Director and grantee institution.

For purposes of this solicitation, patient centered outcomes research (PCOR) is defined as the conduct and synthesis of research that compares the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in clinical practice settings to inform decision making. Attention should be directed towards individual and system differences that may influence strategies and outcomes. The research should have a strong patient-centered orientation and involvement.

• Mechanism of Support. This Funding Opportunity Announcement (FOA) will utilize the Institutional Research Career Development Mechanism (K12).
• Funds Available and Anticipated Number of Awards. It is anticipated that AHRQ will make 4 to 6 two-year awards, for a total of approximately $2 million total costs annually. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed career development program will vary from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, and costs of the applications received.
• Budget and Project Period. Total annual costs (combined direct and indirect) for an individual grant awarded under this FOA will not exceed $600,000. An application with a budget request that exceeds either $600,000 total costs in any given year, or two years in duration for the program, will not be reviewed.
• Research Training Program Plan Component: Applicants must follow the Supplemental Instructions to the SF424 (R&R) in Section 8.7 for preparing the Research Training Program Plan Component, substituting all references to trainees with scholars and to training with career development. The Research Training Program Plan component is limited to 25 pages including tables, graphs, figures and diagrams (other than the required data tables). This does NOT include the Plan for Instruction in the Responsible Conduct of Research, which may not exceed three pages.
• 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, scientific expertise, and resources necessary to develop and implement the proposed institutional research career development program are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply. See Section III.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Eligible Scholars: Once appointed to the program, post-doctoral candidates will be known as scholars. Scholars appointed under the K12 program must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence at the time of their appointment. They must hold a clinical or health professional doctoral degree or its equivalent. AHRQ encourages scholars from racial and ethnic minority groups. Scholars must commit full-time professional effort in CER career development with the goal of conducting PCOR research in areas noted below in the section on Research Career Development Objectives. A candidate for appointment as a scholar on this award may not simultaneously submit or have an application pending for any other AHRQ or NIH career development award or any PHS award that duplicates any of the provisions of the this award.
• Number of Applications: AHRQ will accept multiple applications from the same institution and/or its affiliate organizations so long as they are scientifically distinct. It is anticipated that no more than one application from a degree-granting institution and/or its affiliate organizations will be funded.
• Resubmissions: Resubmission applications are not permitted in response to this FOA.
• Renewals: Awards are not renewable.
• 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide especially the Specific Instructions for Institutional Training Grant Applications Using the SF424 (R&R) Application (beginning in Part I., Section 8.4). Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted below in Section IV of this announcement. If program-specific instructions in Section IV deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may 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

Section II. Award Information
1. Mechanism of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. 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

1. Research Objectives

Purpose

Section 6301(b) of the Affordable Care Act enacted Section 937(e) of the Public Health Service Act, which authorizes AHRQ to build capacity for comparative effectiveness research by establishing grant programs that provide training for researchers in methods used to conduct research.

The purpose of this AHRQ Patient Centered Outcomes Research (PCOR) Institutional Career Development Program (K12) is to support intensive supervised research career development experiences in patient-centered outcomes research (PCOR). The selection and appointment of post-doctoral scholars to funded programs will be made by the K12 Program Director and grantee institution. AHRQ strongly encourages the selection and appointment of scholars from racial and ethnic minority groups. AHRQ encourages submission of applications from minority serving institutions and institutions which provide health care to economically disadvantaged populations and/or have access to unique data on these populations.

Post-doctoral candidates with different levels of prior research training and at different stages in their training and career development may be appointed as scholars. For example, a candidate with extensive research training may be appointed to support a developmental experience that focuses on an intensive, supervised research experience with little or no didactic preparation. A candidate with a clinical doctorate may require extensive didactic preparation, leading perhaps to a Masters degree and including a period of closely supervised research experience.

Applications for this award must propose a research career development plan that has: (1) intrinsic research importance in the area of PCOR (as described below), (2) will serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained PCOR researcher; (3) will ensure high research productivity; and (4) will sufficiently prepare scholars for PCOR research that is responsive to and involves stakeholders in the development of the research and/or in the dissemination and implementation of research findings. Research projects conducted by scholars must be designed to provide a strong foundation for conducting PCOR. The scholar candidate, mentors and sponsoring institution must propose a research career development program that maximizes the use of available research, educational and partnership resources, curriculum, and qualified research faculty as mentors. The entire program should be designed to rigorously monitor and provide well-defined policies and a structure to ensure progress for all scholars.

This institutional career development program is intended to provide for two years of continuous, full-time, 12-month support for one cohort of scholars, and is not renewable. Scholars should be committed to two years of training and to a career in PCOR that also aims at the integration of evidence into practice and decision-making in the United States health care system.

Research Career Development Objectives

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

For purposes of this solicitation, 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 in real world settings. These projects can be approached with the comparison of similar treatments, such as competing drugs, or by analyzing very different approaches, such as devices, surgery, or drug therapy. 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. AHRQ operationalizes the definition to include any potential medical intervention, whether prognostic, preventive, diagnostic, therapeutic, or palliative. PCOR includes assessments of comparative effectiveness and/or safety and the active involvement of stakeholders in defining research questions, thereby establishing a ready audience poised to act upon research findings. PCOR can also include the development and application of methods to assess benefits or harms, or the integration of benefits, or harms in therapeutic decision-making and choices. PCOR can include the synthesis of existing evidence, the generation of new evidence, or educational/translational or systems interventions to apply evidence to clinical practices and behaviors. An emphasis must be placed on the development of population-specific evidence and comparisons related to the above foci. AHRQ is particularly interested in PCOR projects focused on eliminating health care disparities.

Applicants are encouraged to foster partnerships with key stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of their research, and to the extent necessary, the implementation and dissemination of the research. Also, applicants must demonstrate their ability to collaborate with institutions and networks well versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for health care practice and decision-making.

All applicants must demonstrate how the planned career development programs are scientifically and uniquely different from existing programs supported either by AHRQ or NIH.

Special Methodological and Program Objectives for Consideration

Example areas of methodological emphases 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 or randomized 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;
• 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.
• The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as racial and ethnic minorities.

Required Areas of Emphasis

Applicants responding to this FOA must focus their planned career development programs in one or both of the two following areas. All scholars appointed to the grant must also focus their individual training programs in one or both of these areas:

• The reduction of specific and known disparities in health care outcomes and quality among racial and ethnic minority populations and underserved populations.
• Evaluating and comparing health care delivery system designs; developing and evaluating system redesigns; and implementing and disseminating effective, evidence-based design practices. Scholars can focus their research on a wide range of issues within delivery system research, including:
  • the organization and management of health care delivery (e.g., primary care medical home, the development of accountable care organizations, other forms of bundling care);
  • strategies for increasing providers compliance with evidence-based guidelines;
  • transition support for patients with complex health care needs, including ways to reduce unnecessary re-hospitalization;
  • care delivery and coordination for chronic care patients; and
  • payment and reporting strategies for improving access, quality, and/or the value and administration of health care and its delivery.

Applicants 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;

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will utilize the Institutional Research Career Development Mechanism (K12).

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

2. Funds Available

The AHRQ Institutional Research Career Development program (K12) awards will be for two years. AHRQ intends to designate approximately $2 million annually to fund approximately 4 to 6 two-year awards for one cohort of scholars, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The annual total cost for each grant will not exceed $600,000. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Facilities and administrative costs based on 8% of modified total direct costs (excluding tuition/fees and expenditures for equipment) may be requested. An application that requests more than $600,000 total costs in any given year or that exceeds two years in duration will not undergo peer review.

Because the nature and scope of the proposed training will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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

Salary. AHRQ will provide salary and fringe benefits for the K12 scholars of up to $90,000 annually plus associated fringe benefits. The K12 requires the appointed scholar to devote 100 percent of effort to the grant. Scholars cannot reduce their level of effort over the course of the award. The total salary requested must be based on a full-time, 12-month staff appointment and on institutional policies for salaries paid to individuals in similar positions, regardless of source of funds. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.

The application should clearly indicate the number of scholar appointments proposed.

Research Development Support. Up to $35,000 per scholar per-year may be requested for research-related costs such as: research mentorship, consultant costs, research supplies, equipment, technical personnel; tuition, fees, and books related to didactic courses or career development; travel for key personnel to attend research meetings or training; health insurance (self-only or family); and statistical services including personnel and computer time. All research-related costs must be justified. Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees. These expenses must not duplicate items generally available at the applicant institution.

Ancillary Personnel Support. Salary for secretarial and administrative assistance, etc., is not allowed.

Indirect Costs. These costs will be reimbursed at eight percent of modified total direct costs (excluding equipment and tuition/fee costs), or at the actual indirect cost rate, whichever is less.

AHRQ Grants Policy: All AHRQ grant awards are subject to the requirements of the applicable requirements in the HHS grants policy statement (see http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc) which will apply to the applications submitted and awards made in response to this FOA.

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;
• Eligible agencies of the Federal government.
• Indian/Native American Tribal Government (Federally Recognized);
• Indian/Native American Tribal Government (Other than Federally Recognized);
• Indian/Native American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the PHS398 Research Training 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

Program Director/Principal Investigator (PD/PI)

Any individual with the skills, knowledge, scientific expertise, and resources necessary to develop and implement the proposed career development program is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. The PD/PI should be an established researcher in the area of PCOR with a documented record of superior accomplishment, scientific expertise, leadership and administrative skills. The PD/PI should have experience in the design, implementation and management of related programs for developing investigators, and must be able to demonstrate a superior record of preparing researchers to conduct patient centered outcomes research. They must also demonstrate a successful record of involving health system stakeholder input and partners in the conduct of research that has influenced health care delivery. The PD/PI must be able to demonstrate access to departmental or other funds for a scholar in the event of a gap in his or her mentor’s research funding. The PD/PI will be responsible for the selection and appointment of eligible scholars to the K12 grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms and reports in a timely manner.

Mentor(s)

• Each scholar must have a primary mentor, who, together with the PD/PI and the scholar, is responsible for the planning, direction, and execution of the program.
• The mentor should be recognized as an accomplished investigator in PCOR and have a track record of success in providing the type of career development and training activities required under this award.
• Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Consultant(s)/Collaborator(s)

Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. A consultant must state his/her daily or hourly consulting rate and specify the number of days or hours to be devoted. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of consulting/collaboration.

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

Career Development Program

The K12 grant must be used to support a program of research career development. Scholars under the K12 program must be appointed for two consecutive, full-time 12-month periods. An appointment or reappointment period may begin any time during a particular budget period but may not begin before the budget period start date of the grant year. An appointment or reappointment may not exceed 12 months. All scholars are required to devote 100 percent professional effort to the program, in accordance with the policies of the sponsoring organization.

Programs which focus on the reduction of disparities, as outlined above, are encouraged to demonstrate they provide health care to economically disadvantaged populations and/or have access to unique data on these populations. They are also expected to demonstrate how scholars in these programs can utilize these opportunities in research projects focusing on the reduction of specific and known disparities.

Degree Requirements

Scholar Eligibility

Post-doctoral research career development is for individuals who have received a Ph.D., M.D., D.D.S., D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. It is the responsibility of the grantee institution, not the AHRQ, to determine if a foreign degree is equivalent. Research career development must emphasize specialized focus on PCOR.

K12 training grants are a desirable mechanism for the career development of physicians and other doctoral-prepared health professionals who may have had extensive clinical training but limited research experience. For such individuals, their career development may be a part of a research degree program. Generally, it is expected that all post-doctoral scholars complete a full two-year appointment on the K12 grant.

Scholar Citizenship. At the time of appointment to the career development program, each scholar selected for research training supported by K12 career development grants must be a citizen or non-citizen national of the United States, or must have been lawfully admitted to the United States for permanent residence, i.e., in possession of a currently valid Permanent Resident Card (USCIS Form I-551), or some other legal verification of legal admission as a permanent resident. Non-citizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are born in outlying possessions of the United States (e.g., American Samoa and Swains Island).

It is the grantee institution’s responsibility to ensure that a scholar’s citizenship status at the time of appointment meets these criteria, and to assure that the individual remains eligible for K12 support for the duration of the appointment.

Individuals on temporary or student visas are not eligible for K12 support.

Other Scholar Eligibility Criteria. Individuals are eligible for placement as a scholar if they have been, or currently are the PD/PI of an NIH or AHRQ R36, F31, or F32 grant or a Federal or non-Federal award that duplicates the provisions or research goals of these grants. The scholar will have to terminate the existing award before being appointed to the K12.

Individuals are NOT eligible for appointment as scholars if they are current or former PIs on any research project (R01, R03), program project (P01), center grants, FIRST Awards (R29), sub-projects of program projects (P01) or center grants, other career development Awards (K- awards), or the equivalent types of awards from any other source of funding.

Number of Applications. All applications need to be scientifically distinct from, but can be complementary to, currently supported institutional career development programs, particularly those related to comparative effectiveness research and funded by AHRQ or NIH (e.g., through its Clinical and Translational Science Awards program). Applicants are encouraged to partner with multiple components at their degree-granting institution and its affiliate organizations (e.g., hospitals and health plans). Applicants are also encouraged to partner with external, non-affiliated stakeholders. AHRQ will accept multiple applications from the same institution and/or its affiliate organizations so long as they are scientifically distinct. However, it is anticipated that no more than one application from a degree-granting institution and/or its affiliate organizations will be funded.

Resubmissions. Resubmission applications are not permitted 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). Applicants must also follow the Supplemental Instructions to the SF424 (R&R) in Section 8.7 for preparing the Research Training Program Plan Component, substituting all references to trainees with scholars and to training with career development. Applicants must also follow program-specific instructions noted in Section IV of the FOA. If program-specific instructions in Section IV deviate from those in the Application Guide, the program-specific instructions must be followed.

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
SF 424 (R&R) Budget Component
PHS398 Cover Page Supplement
PHS 398 Research Training Program Plan (for Institutional Research Career Development Program)
PHS398 Checklist
(See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter Component

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 third party agreement 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
Release/Posted Date: December 1, 2011
Opening Date: December 30, 2011
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).
Letter of Intent Date(s): December 30, 2011
Application Due Date(s): January 30, 2012
Peer Review Date(s): approximately March, 2012
Earliest Anticipated Start Date(s): approximately July, 2012
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: January 31, 2012

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 career development program, 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 can be sent electronically, and should be sent to:

Mitra Ahadpour, M.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
Telephone: (301) 427-1012
FAX: (301) 427-1562
Email: [email protected]

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

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants must 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

3.C.1 Submitting On-Time

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.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

Use of CMS Data

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are not allowable. No funds may be provided in support of a scholar until a Statement of Appointment form is submitted to and accepted by AHRQ.

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 Training Program Plan Sections

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts.

Special Application Requirements for this FOA

Research Training Program Plan -- SF 424 (R&R), under Section 8.7 - Research Training Program Plan Component: combined components 2.2 (Background), 2.3 (Program Plan), and 2.4 (Recruitment and Retention Plan to Enhance Diversity) is limited to 25 pages. Any discussion of specific aims must be included within the 25-page limit.

Note that the required plans for instruction in the Responsible Conduct of Research (RCR) will have page limits separate from the page limits for the Research Training Program Plan Component. Applications without plans for instruction in responsible conduct of research will be considered incomplete and will not be reviewed. Specifically, the plan for instruction in RCR (Item 2.5) will have its own separate page limit (3 pages).

The research training program plan must include:

• Plans for providing specific didactic training as well as experiential research opportunities (depending on the various skill levels/needs of scholar candidates), noting the competencies to be conveyed, how they will be conveyed and how they will be assessed. Information about planned courses, curricula, seminars, workshops or tutorials that will be incorporated into the training program, as well as mentored research experiences and activities, must be included. These plans should also address training required for professional development, communication of research, and translation of research into practice and/or policy.
• The applicant institution’s existing research program in specific methodological and topical areas related to PCOR, and the existence and availability of requisite staff and facilities to carry out the proposed program.
• The scientifically distinct nature of the program from other existing career development programs funded by AHRQ or NIH, particularly those related to comparative effectiveness research.
• Collaborative environment and infrastructure available for interdisciplinary career development related to PCOR.
• Specific mentoring plans and demonstration of qualifications, availability and commitment of major faculty and external non-academic partners in the specific research objective areas proposed.
• Description of any proposed rotations/practicum in PCOR, which will be made available for each scholar. These are not required, but highly encouraged. They should be designed to take advantage of PCOR career development experiences not available at, but complementary to, those at the applicant institution. Scholars participation in these must be reported annually, in conjunction with the assessment/evaluation of the rotation/practicum. Documentation of commitment on the part of the stakeholder group should be included in the application, but does not count toward the research training plan page limitation.
• Documentation of any institution’s commitment to the proposed research career development program’s goals, and a description of support (financial or otherwise) to be provided to the program, which could include, for example, space, equipment, release time for the PD/PI and participating faculty, support for additional scholars in the program, or any other creative ways to improve and enhance the growth of the research career development program.
• A plan for recruiting and retaining high quality scholars from outside as well as inside applicant institutions. The plan should describe any recruitment and outreach plans to increase the depth and diversity of the applicant pool. The plan should guarantee existence of an adequate group of highly-qualified potential post-doctoral candidates available to embark on a two-year commitment to career development in PCOR that is responsive to stakeholder needs. The recruitment plan must include specific efforts designed to enhance diversity. If an application is received without a plan that specifically addresses efforts to enhance diversity, the application will be considered incomplete and will not be reviewed.
• A succinct description of how the program will be assessed using formative and outcome approaches, focusing on both the career development program and scholars.

No Data Tables are required.

Warning: Please be sure to 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.

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. Applications submitted in the Modular format will not be reviewed.

In Section F.1, Other Direct Costs/Materials and Supplies, the total amount requested for Research Development Support costs (not to exceed $35,000 per scholar) must be entered. A detailed budget and justification must be provided. It must include a detailed list, description and justification for the specific Research Development Support costs requested for each scholar that will be used to help achieve the career development and research objectives of the award. Since different scholars will have different Research Development Support needs, it is anticipated that the support requested for each scholar may vary.

A detailed budget justification must be provided.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) instructions of the Research Training Program Plan Component, Section 8.7

Do not use the appendix to circumvent the page limitations of the Research Training Program Plan. All appendix material must be submitted as PDF attachments. A summary listing all of the items included in the appendix is required, and should be the first PDF file of the Appendix. Applications that do not follow the appendix requirements may be delayed in the review process.

NOTE: All of the above appendix materials must only include information relevant to comparative effectiveness (or Patient-Centered Outcomes) research.

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

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

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

Consumer Products

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information

1. Criteria

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

Merit Review Criteria: Merit Review Criteria, 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. All applications must focus on PCOR.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the proposed program address important PCOR topics and methods development as noted above? Does the applicant substantially distinguish the proposed program from other similar programs supported at the institution, in particular those that may be funded through NIH/AHRQ ARRA funds?

Investigators. Are the PD/PI and mentors appropriately trained and supported in PCOR and well suited to carry out this program? Does the PD/PI have a documented record of superior accomplishment, leadership and administrative skills? Is there evidence that an appropriate level of effort will be devoted by the program leadership and mentors to ensure the program’s objectives? Have the PD/PI and mentors adequately provided for access to research funding for the scholars? Is there evidence that mentors have been adequately prepared to actively work with scholars? Does a viable mentoring plan and or mentor/scholar agreement exist? Is mentoring assessed?

Innovation. Is the career development program original or innovative? For example: Does the program provide novel opportunities in exposing scholars to partnerships with key stakeholders in the formulation of their research and career development? Are unique and appropriate mentoring strategies proposed? Does the program focus on innovative research methodologies and/or teaching methodologies? How different is the proposed program from other existing similar programs at the institution? Are scholars exposed to innovative dissemination methods that focus on the implementation and dissemination of their research by users?

Approach. Does the program provide for sufficiently comprehensive PCOR training in research designs and methodologies, and research experiences that will lead to applied contributions? Does the plan show good evidence of preparing scholars to address topics and/or methodological development in areas with intrinsic health care delivery importance as noted above? Does the plan include a suitable core curriculum and didactics? Does the program properly accommodate research scholars with varying levels of experience? Have adequate steps been taken to ensure high productivity? Are core competencies discussed in terms of their level of sophistication, delivery and assessment? Is the program well-designed to rigorously monitor, evaluate and provide well-defined policies and a structure to ensure progress towards high research productivity for all scholars in areas that are important to the health care delivery system? Is stakeholder input and partnership integrated into the career development experience, as appropriate? Are proposed rotations/practica involving stakeholders well thought out, relevant, and likely to be successfully employed by scholars?

Research Environment / Institutional Commitment. Does the scientific/educational environment of the sponsoring institution contribute to the probability of success? Does the proposed program benefit from unique features of the scientific environment, employ useful collaborative arrangements, within the institution and external to it? Is there strong, documented evidence of institutional commitment to health services research career development and particularly to this PCOR career development program? The sponsoring institution must be the primary site for the overall institutional career development program, however, if multiple sites are participating (e.g. for rotations/practicum) is the institutional commitment to the proposed program appropriate in each case, and is this adequately justified in terms of the research educational experiences provided? Are adequate plans provided for coordination and communication between multiple sites? Is there evidence of adequate research support, equipment, and facilities? Is the information provided for each site adequate to determine appropriateness of the site? Is there institutional commitment to the development and recognition of researchers who focus on multidisciplinary teamwork, and the production of translational research centering on improvements in the health system?

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?

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

• 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.

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).

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.

Applicant Recruitment, Selection, and Retention. What is the quality and size of the applicant pool? Are the recruiting procedures, scholar candidate selection criteria, and retention strategies appropriate and well defined? Do recruitment and selection plans and historical precedent at the institution include significant external applicants (i.e., scholars who have not received their research or clinical doctorates/residencies from the applicant institution)? Are the research aptitude and commitment to PCOR research of applicants prominent in recruitment and selection? Is there racial and ethnic diversity in the proposed recruitment plan and applicant pool? Are other underrepresented groups such as individuals with disabilities and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds represented in the applicant pool?

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.

Tracking and Evaluation. Does the application describe a sufficiently strong evaluation plan that meets the evaluation and tracking objectives? If short-term rotations/practicum are being proposed, do they appropriately include measures to evaluate the effectiveness of proposed rotations/practicum?

Training in the Responsible Conduct of Research. Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, 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.

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 program as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities
• Programmatic balance
• Portfolio balance within AHRQ and DHHS

2.B. 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 worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. 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).

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.

3. Reporting

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590). This report must demonstrate each scholar s commitment to completing two years of training. The annual progress report must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5.1.4 of the 2590 instructions, and Part 6 of the 2590 instructions entitled, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant. 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 annual Progress Report for the grant should also include:

• Relevant information on rotations and practicums, including: how they were selected; experiences offered; and a list of the scholars and respective mentors involved.

Federal Financial Reports (FFRs; SF 425) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2012, the annual FFR is due 9/30/2012 (90 days after the end of the calendar quarter of 6/30/2012). A hard copy of the report should be submitted to the AHRQ FFR Coordinator.

Scholar Reporting Requirements

Institutions must submit a completed Statement of Appointment (PHS Form 2271) for each post-doctoral scholar appointed or reappointed to the career development grant. This form must be completed at the beginning of the initial appointment and annually thereafter. AHRQ requires the use of xTrain for the electronic submission of Appointment Forms and Termination Notices. More information can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-11-026.html. No funds may be provided in support of the scholar until the Statement of Appointment form submitted to and accepted by AHRQ.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment Form. Individuals with Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7) via xTrain.

Final Progress and Federal Financial Reports

A Final Progress Report and final Federal Financial Report are required when an award ends. Evaluation results should be included as part of the Final Progress Report.

Other Reporting Requirements

Evaluation: In carrying out its stewardship of human resource-related programs, the 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.

Publication and Sharing of Research Results: AHRQ supports the practical application and sharing of outcomes of funded research. Therefore, scholars 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 scholars 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.

Scholars are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a scholar’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 Grant 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 sub-awards 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 Sub-award Reporting System (FSRS) available at www.FSRS.gov on all sub-awards 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:

Mitra Ahadpour, M.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
Telephone: (301) 427-1012
FAX: (301) 427-1562
Email: [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- 1362
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

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

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.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. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

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.