Expired RFA-HS-10-011: AHRQ ARRA Recovery Act 2009 Limited Competition: AHRQ Institutional National Research Service Award (NRSA) Postdoctoral Comparative Effectiveness Development Training Award (T32)

Department of Health
and Human Services (HHS)

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Part I Overview Information

Department of Health and Human Services

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

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

Title: AHRQ ARRA Recovery Act 2009 Limited Competition: AHRQ Institutional National Research Service Award (NRSA) Postdoctoral Comparative Effectiveness Development Training Award (T32)

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 (RFA).

Request For Applications (RFA) Number: RFA-HS-10-011

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release Date: December 11, 2009
Letters of Intent Receipt Date(s): December 15, 2009
Application Receipt Dates(s): January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date
Additional Information To Be Available Date: Not applicable
Expiration Date: January 21 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

The overall goal of AHRQ institutional NRSA postdoctoral training programs is to help ensure that a diverse pool of highly trained health services and clinical researchers are available in adequate numbers and in appropriate research areas to advance the scientific disciplines and to address the mission of AHRQ to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

Purpose: This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5, invites applications from institutions that have received new five-year NRSA institutional training awards from AHRQ in FY 2008 to compete for the AHRQ institutional NRSA Postdoctoral Comparative Effectiveness Development Training Award (T32). The purpose of this program is to support the postdoctoral training of health services and clinical researchers who have made a commitment to focus their research on the generation, translation, and dissemination of new scientific evidence and analytical tools in comparative effectiveness. The award will provide two years of supervised study and research for two cohorts of clinical and research doctorates, with one cohort initiating training in the first year of the grant and the second initiating training in the second year of the grant.
Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the NRSA Institutional award (T32) mechanism.
Funds Available and Anticipated Number of Awards: It is anticipated that AHRQ will make approximately 5-7 awards for a total of $5 million. 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 training program will vary from application to application, it is anticipated that the size of each award may 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: The total costs for the three year project/budget period for individual grants awarded under this FOA will not exceed $900,000. An application with a total award request that exceeds $900,000 will not undergo peer review.
Research Plan Component Length: The Research Training Program Plan component of the PHS398 (Items 2-5) may not exceed 20 pages, including tables, graphs, figures, diagrams and charts.
Eligible Institutions/Organizations: This is a limited competition. Only institutions/organizations listed in Section III 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 training 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. The proposed PD/PI does not have to be the same individual as the current AHRQ T32 program director at the institution (see Section III).
Number of PDs/PIs: Only one PD/PI may be designated on the application.
Eligible Trainee Candidates: Trainee candidates selected for support in the T32 program must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence at the time of their appointment, who hold a clinical or health professional doctoral degree or its equivalent, and who can commit to a full-time professional effort in training to conduct clinical research and training activities related to comparative effectiveness research and the mission of AHRQ. A candidate for appointment as a trainee on this award may not simultaneously submit or have an application pending for any other AHRQ or NIH training award or any PHS award that duplicates any of the provisions of the T32 award.
Number of Applications: 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. Only one application from each of the twenty-eight NRSA institutional training program grants (T32s) funded under RFA-HS-08-001 may be submitted. This announcement is a competitive opportunity that expands these activities.
Resubmission(s): Resubmission applications are not permitted in response to this FOA.
Renewals: Awards are not renewable and are not transferable from one institution to another.
Special Date(s): N/A.
Application Materials: See Section IV for application materials.
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.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of the AHRQ Institutional NRSA Postdoctoral Comparative Effectiveness Development Award (T32) is to support intensive supervised research training and career development experiences for clinical and research doctorates in the area of comparative effectiveness research. Under this award, clinical and/or research doctorates (referred to as “trainees” in this program announcement) will be selected and appointed to this program by the T32 Program Director and grantee institution. Trainees with different levels of prior research training and at different stages in their training and career development may be appointed. For example, a research doctorate trainee 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 trainee with a clinical research doctorate may require extensive didactic preparation leading perhaps to a Masters degree, followed by a period of closely supervised research experience. With respect to varying levels of prior research training and career development, trainee candidates should resemble those trainees supported by the individual NRSA postdoctoral award (F32). http://grants.nih.gov/grants/guide/pa-files/PA-09-229.html.

Applications for this award should propose a research training plan that has: (1) intrinsic research importance in the area of comparative effectiveness research (as described below), (2) will serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained patient outcomes and effectiveness researcher; (3) will ensure high research productivity; and (4) will sufficiently prepare trainees to conduct comparative effectiveness 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 trainees must be designed to provide a strong foundation for conducting comparative effectiveness research. The trainee candidate, mentors and sponsoring institution must propose a research training 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 trainees.

This institutional training program provides for 3 years of support, which is not renewable. The award is intended to support two cohorts of trainees (one beginning in the initial year and the second starting in the second year) for a two-year period of consecutive 12-month appointments. These trainees must be committed to two years of training and to a career in comparative effectiveness research that also aims at the integration of evidence into practice and decision-making in the health care system.

Research Career Training Objectives

In FY 2009, the Recovery Act provided funds to AHRQ to build on its existing collaborative Effective Health Care program, authorized by Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA), Pub. L. 108-173 (42 U.S.C. 299b-7), in order to provide patients, clinicians, and others with evidence-based information to make informed decisions about health care. The Department of Health and Human Services (HHS) will use the definition of CER used in the Federal Coordinating Council’s (FCC) Report to Congress to guide the HHS operational plan with regard to AHRQ ARRA funds. The definition is as follows:

Comparative effectiveness research is 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. 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.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and sub-groups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.

Priority-Setting Process and Inputs for use of ARRA Funds

There were four main inputs for priorities for ARRA CER funds: public input, an internal Departmental workgroup, the FCC report, and the IOM report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of CER;

2) Potential to inform decision-making by patients, clinicians or other stakeholders;

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4) Feasibility of research topic (including time necessary for research).

The CER-CIT will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

1) Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),

2) Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,

3) Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,

4) Addresses a need or is unlikely to be addressed through other organizations,

5) Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM topic recommendations;

2) An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed; and/or

3) Fall into one of the AHRQ identified evidence gaps.

The current list of priority conditions includes:

Arthritis and non-traumatic joint disorders
Cancer
Cardiovascular disease, including stroke and hypertension
Dementia, including Alzheimer's disease
Depression and other mental health disorders
Developmental delays, attention-deficit hyperactivity disorder and autism
Diabetes mellitus
Functional limitations and disability
Infectious diseases including HIV/AIDS
Obesity
Peptic ulcer disease and dyspepsia
Pregnancy including pre-term birth
Pulmonary disease/asthma
Substance abuse

AHRQ has operationalized the definition of CER with the additional specification that evaluation of treatments includes any potential medical intervention under consideration, whether prognostic, preventive, diagnostic, therapeutic, or palliative.

In response to ARRA and recognizing the importance of enhancing research capacity and infrastructure, in FY2010 AHRQ intends to support institutional research training grants focusing on preparing future researchers to conduct comparative effectiveness research as related to different treatment and practices. The intent of these grants is to support the training of clinical and research doctorates focusing their research on the generation and translation of new scientific evidence and analytic tools. In particular, the emphasis is on developing and enhancing the research and methodological capacities for conducting comparative effectiveness research and for the integration of evidence into practice and decision-making in the health care system. Applicants must demonstrate their ability to collaborate with institutions well versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for health care practice and decision-making. Existing examples of such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), Practice-Based Research Networks (PBRN’s), and the John M. Eisenberg Center Clinical Decisions and Communications Science. Collaboration in the form of offering two to three month rotational assignments/practicum for trainees in one of these programs is strongly encouraged as part of their training and career development, in order to offer participants the opportunity to develop in and be responsive to “real-world setting.” A listing of these research networks under AHRQ’s Effective Health Care program can be found at: http://effectivehealthcare.ahrq.gov/aboutUs/index.cfm.

The design of the T32 institutional training grants must demonstrate active involvement of stakeholders to ensure the research is responsive to stakeholder needs and how stakeholders use the information in their decision-making. 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 trails 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;
The quantitative and qualitative analytical framework and techniques in the screening, synthesis, and appraisal 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 enhance the use of evidence in decision-making, as well as the comparative effectiveness of different approaches and technologies in accomplishing such objective.

Applications are also required to address areas of disparity in traditionally underserved and underrepresented groups. AHRQ 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. (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement will use the Ruth L. Kirschstein National Research Service Award (NRSA) T32 award mechanism. This FOA is a one-time, nonrenewable solicitation. Applicants are solely responsible for planning, directing, and executing the proposed research training program.

AHRQ is not using the Modular Grant Application and Award Process (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Applications submitted in modular format will be returned without review.

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications cannot include foreign components. AHRQ institutional NRSA postdoctoral training (T32) awards under the Recovery Act will be for three years.

AHRQ has designated approximately $5 million to fund approximately 5-7 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total costs across the three years of individual grants awarded under this FOA will not exceed $900,000. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. An application with a total award request that exceeds three years or a total of $900,000 will not undergo peer review.

Because the nature and scope of the proposed research 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

AHRQ grants policies as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm will apply to the applications submitted and awards made in response to this FOA.

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines. Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the HHS Grants Policy Statement and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Allowable Costs

A. Stipends:

Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual stipend levels at the time of award. For postdoctoral trainees, the annual stipend is based on the number of full years of prior relevant postdoctoral experience at the time of the trainee’s appointment. The FY 2009 range of annual postdoctoral stipend levels is $37,368 to $51,552. Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The Ruth L. Kirschstein National Research Service Award (NRSA) stipend and other budgetary levels effective for fiscal year 2009 can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-075.html. Applicants should estimate stipend levels based on justifiable projections and needs.

B. Tuition and Fees:

AHRQ will provide funds for tuition and fees for eligible NRSA trainees. At present, the formulas for postdoctoral trainees are listed below:

The amount per postdoctoral trainee equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year. The budget justification must explicitly state which trainee(s) will be in a degree-granting program if applicable.

Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. At the current time, AHRQ follows the NIH guidelines for funding of tuition, fees, and health insurance on Ruth L. Kirschstein National Service Awards. A description of the NIH policies can be found on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html

C. Trainee Travel:

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. Applications may request up to $1,500 per trainee annually for travel to annual meeting(s) and conferences. AHRQ supports an annual trainee conference and trainees are encouraged to attend this conference. Priority should be given to using travel funds for this purpose. Additionally, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent organization must be justified considering the type of opportunities available for training, and how the opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed training experience to the trainee’s career stage and goals. This type of travel and research training requires prior approval from the AHRQ, and, if not known at the time of application, may be submitted for approval at any time during the award period.

D. Training Related Expenses (TRE):

The Training Related Expenses (TRE) category includes health insurance as an allowable expense. This category will continue to be referred to as training related expenses but will now include health insurance as an allowable cost. The applicant institution may request NRSA TRE in the amounts listed below:

Up to $15,000 annually for each postdoctoral trainee.

Given the developmental nature of comparative effectiveness research and the need to focus on curriculum development, intense mentoring, short-term rotational assignments/practicum, and partnerships with stakeholders, TRE for up to $15,000 may be requested. These costs are intended to help defray other research training expenses, such as staff salaries, consultant costs, equipment, research-related costs, and faculty/staff travel directly related to the research training program. Funds are provided as a lump sum on the basis of the predetermined amount per postdoctoral trainee approved for support. Applicants must include information in the budget justification regarding how they anticipate using these funds each year; annual details on the actual use of these additional funds must be included and justified in non-competing continuation progress reports.

E. Facilities and Administrative Allowance:

Facilities and administrative costs based on 8% of modified total direct costs (excluding tuition/fees and expenditures for equipment) may be requested.

F. Stipend Supplementation, Compensation, and Other Income:

Policies relevant to stipend supplementation and additional compensation are the same as those pertaining to existing institutional training programs supported by AHRQ.

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program. Information about this program is available at: http://www.lrp.nih.gov/.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. In 2008, AHRQ awarded twenty-eight NRSA institutional training program grants (T32s) under RFA-HS-08-001. This announcement is a competitive opportunity that expands these activities. Only the grantees funded under the above referenced FOA are eligible to apply, given:

limited time between grant submission, award, and required commencement and completion of training activities;
limited time frame for funding (3 years);
demonstrated existence of capacity of existing programs to support more trainees than previous funding allowed;
competency of current programs as demonstrated in the original competition; and
demonstrated ability of current programs to train students in HSR, each possessing an existing cadre of AHRQ-supported students with whom the new two-year limited appointment trainees can interact and jointly engage in complementary training activities.

1.B. Eligible Individuals

Program Director/Principal Investigator (PD/PI)

The Principal Investigator/Program Director does not have to be the same individual as the current AHRQ T32 program director at the institution. Any individual with the skills, knowledge, scientific expertise, and resources necessary to develop and implement the proposed institutional research training program is invited to work with their 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 programs. The PD/PI should be an established researcher in the area of comparative effectiveness research 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 research training programs for developing clinical investigators, and must be able to demonstrate a superior record of preparation of post doctoral researchers, who conduct clinical comparative effectiveness research and have demonstrated a successful record of involving health system stakeholder input and partners in the conduct of research that has influenced health care delivery beyond the “bed-side.” The PD/PI must be able to demonstrate access to departmental or other funds for a trainee 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 trainees to the NRSA grants, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner. The proposed training program must be integrated within and be a component of the existing AHRQ institutional training program and be submitted by the organizational entity housing the existing AHRQ institutional training grant.

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 that plan to provide support 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 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

Other-Special Eligibility Criteria

Training Program

Trainees appointed to the research training program must have the opportunity to carry out supervised research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

A NRSA institutional research training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training.

No individual trainee may receive more than 3 years of support at the postdoctoral level, including any combination of support from institutional training or individual fellowship awards. Any exception to the maximum period of support requires a waiver from the AHRQ based on a review of the written justification from the individual trainee, and endorsed by the PD/PI and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the AHRQ since this is extremely rare.

Trainee Citizenship

At the time of appointment to the training program, individuals selected for research training supported by NRSA institutional training grants must be citizens or non-citizen nationals 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 generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible for NRSA support. It is the grantee institution’s responsibility to ensure that a trainee’s citizenship status at the time of appointment meets these criteria. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Requirements for Postdoctoral Trainees

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: 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., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research or practice. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Number of Applications. 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. Only one application from each of the twenty-eight NRSA institutional training program grants (T32s) funded under RFA-HS-08-001 may be submitted. This announcement is a competitive opportunity that expands these activities

Resubmissions. Resubmission applications are not permitted in response to this FOA.

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

Other. Applications lacking a recruitment plan, an evaluation and tracking plan, a plan for training in the responsible conduct or research, or a description of institutional commitment to the program and to the trainee candidates will be considered incomplete and will not be reviewed. Applications proposing short-term rotations/practicum must also include a statement of institutional commitment to the program by the other institution where the short-term rotations/practicum will take place. A Resource Format page must be included in the PHS 398 application for each proposed short-term rotation/practicum site.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A below for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: December 15, 2009
Application Receipt Dates: January 20, 2010
Peer Review Date: Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date

3.A.1. Letter of Intent

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

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

The letter of intent can be sent electronically, and should be sent to:

Shelley Benjamin
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) 427-1528
Fax: (301) 427-1562
E-mail: shelley.benjamin@ahrq.hhs.gov

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

3.B. Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Shelley Benjamin
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) 427-1528
Fax: (301) 427-1562
E-mail address: shelley.benjamin@ahrq.hhs.gov

3.C. Application Processing

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

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

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

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

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

Use of CMS Data

Purchase of Centers for Medicare & 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. In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data. 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 confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, the DUA will include the requirement that the data user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

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 principals, 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: Pre-Award Costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made.

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Concurrent awards: An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. An NRSA stipend is provided by the AHRQ as a subsistence allowance for NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that AHRQ takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Service Payback: As specified in the NIH Revitalization Act of 1993, Public Law 103-32, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training support will serve to pay back a postdoctoral service payback obligation

6. Other Submission Requirements

Special Instructions for Modular Grant applications

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

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.

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.
Special Application Requirements for this FOA

Research Training Program Plan (20 page limitation)

The program should briefly discuss:

Plans for providing specific didactic training as well as experiential research opportunities (depending on the various skill levels/needs of trainee candidates), noting the competencies to be conveyed, how they will be conveyed and how they will be assessed. These plans should also address training required for professional development, communication of research, and translation of research into practice and/or policy. Plans must also include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. Applications without plans for instruction in responsible conduct of research will be considered incomplete and will not be reviewed.
The applicant institution’s existing research program in the area(s) proposed for research training, and the existence and availability of requisite staff and facilities to carry out the proposed program.
Collaborative environment and infrastructure available for interdisciplinary training related to comparative effectiveness research.
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 one or two types of short-term rotations/practicum in comparative effectiveness research, which will be made available for each student (at least one per year). These are not required, but highly encouraged. They should be designed to take advantage of comparative effectiveness educational or research experiences not available at, but complementary to, those at the applicant institution. Students’ 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 training 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 trainees in the program, or any other creative ways to improve and enhance the growth of the research training program.
A plan for recruiting and retaining high quality trainees from both 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 postdoctoral candidates available to embark on a two-year commitment (beginning in the summer/fall of 2010) to training in comparative effectiveness research 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 training program and trainees.

The following information should be presented in tabular format as noted in the 398 application. These tables do not count toward the 20-page limitation of the Research Training Program Plan. Tables not listed should not be included.

Table 1: Membership of Participating Departments/Programs – include only information on the following columns: participating Department/Program, Number of Faculty Members Participating in this Application, Number of Postdoctoral Trainees With Participating Faculty
Table 2: Participating Faculty Members (limit the list to those with specific background/training/mentoring to be provided with regard to comparative effectiveness research methods or substantive areas of interest)
Table 4: Grant and Contract Support of the Participating Faculty Members (only include information on grants and contracts directly relevant to comparative effectiveness research)
Table 5: Pre- and Postdoctoral Trainees of Participating Faculty Members (only include information on postdoctoral trainees of faculty who are specifically involved in research related to comparative effectiveness, and students who have undertaken research in this area. Only the following columns need to be completed: first, second, third, seventh and eighth
Table 6: Publications of Research Completed by Trainees (only list those of current or former postdoctoral trainees that focus on research related to comparative effectiveness. Mentors’ names and years in program do not have to be included)
Table 7B: Admissions and Completion Records for the Participating Departments and Programs During the Past Five Years (Postdoctoral Applicants (limit information to those focusing their training/research on areas related to comparative effectiveness). In completing this table, applicants should note the following amendment to training grant application instructions -- http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-135.html
Table 8B: Qualifications of Recent Postdoctoral Applicants (limit information to those focusing their training/research on areas related to comparative effectiveness)
Table 9B: Qualifications of the Current Postdoctoral Trainees Clearly Associated with the Training Program (limit information to those focusing their training/research on areas related to comparative effectiveness)
Table 10 Admissions and Completion Records for Underrepresented Minority (URM) Trainees, Trainees with Disabilities, and Trainees from Disadvantaged Backgrounds Clearly Associated with the Training Program (only include information for postdoctoral students)

Alternatively, applicants may opt to update and include all of the above-specified tables from the applications of their current AHRQ-supported institutional training grants. If this option is chosen, applicants should highlight in bold all additions, as well as specific information relevant to training/research/faculty related to comparative effectiveness research. Only information relevant to postdoctoral training should be included.

Section V. Application Review Information

1. Criteria

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

Merit Review Criteria are described below. The review criteria described below will be considered in the review process.

2. Review and Selection Process

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

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

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

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Significance
Approach
Investigators
Applicant Recruitment, Selection and Retention
Tracking and Evaluation
Research Environment/Institutional Commitment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score.

Significance: Does the proposed program address important comparative effectiveness topics and methods development as noted above? Does the applicant substantially distinguish the proposed program from other similar training programs supported at the institution?

Approach: Does the program provide for sufficiently comprehensive comparative effectiveness training in research designs and methodologies, and clinical research experiences that will lead to scientific contributions? Does the plan show good evidence of preparing candidates 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 candidates with varying levels of experience? Have adequate steps been taken to ensure high productivity? Are core competencies assessed 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 trainees in areas that are important to the health care delivery system? Is stakeholder input and partnership integrated into the training experience, as appropriate? Are proposed short-term applied rotations/practicum involving stakeholders well thought out, relevant, and likely to be successfully employed by candidates?

Investigators: Are the PD/PI and mentors appropriately trained and supported in clinical effectiveness research 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 trainees?

Applicant Recruitment, Selection and Retention: What is the quality and size of the applicant pool? Are the recruiting procedures, trainee 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., trainees who have not received their research or clinical doctorates/residencies from the applicant institution)? Are the research aptitude and commitment to comparative effectiveness research of applicants prominent in recruitment and selection? Is there racial and ethnic diversity in the proposed 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?

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 these short-term rotations/practicum?

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 training and particularly to this comparative effectiveness research training program? The sponsoring institution must be the primary site for the overall institutional training program, however, if multiple sites are participating (e.g. for short-term 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?

Additional Review Criteria

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

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

Inclusion: Adequacy of plans to include both genders, racial and ethnic minorities (and subgroups) in the proposal. 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).

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 application form.

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:

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
Planned inclusion of racial and ethnic diversity and/or representation of other underrepresented groups in recruitment
Programmatic balance

Appeals will not be permitted. See Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process (see NOT-HS-09-011, http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).

Additional Review Considerations

Not applicable.

Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. 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 funds, 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 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 any/all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA will be generated via email notification from the awarding component to the grantee business official. The NOA signed by the grants management officer is the authorizing document.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions American Recovery and Reinvestment Act of 2009. (see http://www.ahrq.gov/fund/arraterms.htm).

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.”

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.

Special Administrative Requirements associated with NRSA programs:

Policies related to the following administrative requirements remain the same as those pertaining to the 2008 NRSA institutional training grants awarded by AHRQ and the NRSA guidelines which is located at http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

Leave
Carryover of Unobligated Balances
Termination of Award
Trainee Change of Institution
Training Program Director Change
Change of Program
Service Payback Provisions

3. Reporting

Progress Reports

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually. This report must demonstrate the trainee’s commitment towards completing two years of training.

The annual progress reports 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 IV of the 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The annual Progress Report for the grant is required to include:

A brief introductory description reiterating the program objectives, research training component, and overall accomplishments;
A summary table delineating which mentors have left the program and which, if any, new individuals have been added or are taking their places, including for each person his/her degree and department affiliation (or equivalent); biographical sketches of new participating mentors;
An account of efforts made to recruit trainee candidates that enrolled in the program, including efforts to recruit candidates that are described in the Diversity Recruitment and Retention Plan;
A brief paragraph for each funded trainee describing: the research and didactic training experiences completed and ongoing, as well as specific future plans for satisfying the requirements of the program; and information on the progress of each trainee including dissemination activities (publications, presentations, and other dissemination/translational activities relevant to the award (such as the contributions and use of their research to improving health care)); and (optional) independent research grant submissions and awards.
Any recommended changes to improve the program (e.g. new mentors, changes in didactic components or programmatic activities, changes in core requirements, recruitment strategies, short-term rotations/practicum, if applicable, etc.).
If a short-term rotation/practicum is offered as a part of your program: provide information about how they were selected; briefly describe any courses or workshops and research experiences offered; and list the trainees and respective mentors involved. For each trainee, describe each short-term rotation/practicum taken, planned or completed in the past year. This description must include the purpose, goals and activities of the each practicum and an evaluation of its pertinence to the goals of the trainee and its success in meeting these goals. An evaluation of the trainee’s progress provided by the mentor where the short-term rotation/practicum takes place should be incorporated into the annual report.
Information on Training in the Responsible Conduct of Research: Report the type of instruction provided, topics covered, and other relevant information, such as attendance by candidates and faculty participation.

Financial Status Reports (FSRs; SF 269) 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). This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.

Section 1512 of The American Reinvestment and Recovery Act of 2009 (ARRA) requires prime recipients of the ARRA funds submit quarterly report, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10). Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the ARHQ Website at http://www.ahrq.gov/about/arrawebinars.htm.

In addition, AHRQ is currently developing AHRQ-specific reporting requirements. Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Award and incorporated into AHRQ Terms and Conditions of Award.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement Form (PHS 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support. No funds may be provided until such documents are submitted and accepted by the funding Institute.

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

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, trainees should make the results and accomplishments of their NRSA research training activities available to the research community and to the public at large. The grantee organization should assist trainees 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.

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

Section VII. Agency Contacts

This FOA is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (also including submission of a letter of intent) by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

i) the communication is purely logistical;

ii) the communication is made at a widely attended gathering;

iii) the communication is to or from a Federal agency official and another Federal Government employee;

iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

v) the communication is initiated by the Federal agency official.

For additional information see: http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

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

1. Scientific/Research Contacts:

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

2. Peer Review Contacts:

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

Kishena Wadhwani, Ph.D., M.P.H.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to:

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail: George.Gardner@ahrq.hhs.gov

Michelle Burr
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail: Michelle.Burr@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm

Funding under this program is subject to the “Updated Guidance Regarding Communications with Registered Lobbyists About Recovery Act Funds” that was issued by the Office of Management and Budget on July 24, 2009 to implement section 3 of the President’s March 20, 2009 Memorandum entitled “Ensuring Responsible Spending of Recovery Act Funds.” Many of the restrictions described in the guidance also apply to non-lobbyists after the submission of competitive applications for Recovery Act funds and before awards are made. The guidance is available at http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.

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 under FOIA, disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption” in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information. 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 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," 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 2010" 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.