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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 Mentored Clinical Scientists Comparative Effectiveness Development Award (K12)

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

Announcement Type

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

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

Request For Applications (RFA) Number: RFA-HS-10-007

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release Date: December 11, 2009
Letters of Intent Receipt Date: December 24, 2009
Application Receipt Date: 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

Executive Summary

The overall goal of AHRQ career development 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 address the mission of AHRQ. The mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

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 Mentored Clinical Scientists Comparative Effectiveness Development Award (K12) 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 scholars in this program announcement) will be selected and appointed to this program by the Program Director/Principal Investigator and grantee institution. Scholars with different levels of prior research training and at different stages in their career development may be appointed. For example, a scholar with limited experience in health services and clinical research may be appointed to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A scholar with previous health services and clinical research and training may not require extensive additional didactic preparation, and may be appointed to support a career development experience that focuses on an intensive, supervised research experience with some limited didactic work. With respect to varying levels of prior research training and career development, candidates should resemble those candidates supported by the individual Mentored Clinical Scientist Development Award (K08) or the Mentored Research Scientist Development Award (K01), described at http://www.ahrq.gov/fund/training/rsrchtng.htm#MRSDA.

Applications for this award should propose a career development and research 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 scholars to conduct comparative effectiveness research that is responsive to and involves stakeholders in the development of the research and/or in the dissemination and use/implementation of research findings. Each scholar appointed must conduct at least one research project during his/her appointment. These projects must be designed to provide a strong foundation for conducting comparative effectiveness research that is responsive to stakeholder (e.g., policy-makers, providers, and patients) needs. The candidate, mentors and sponsoring institution must develop a career development and training program that maximizes the use of available research, educational and partnership resources, 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 mentored scholars.

This institutional career development award program provides for 3 years of support, which is not renewable. The award is intended to support one cohort of scholars for a three-year period of consecutive 12-month appointments. These scholars must be committed 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 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 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 Report to Congress to guide the HHS operational plan with regard to OS 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.

Priority-Setting Process and Inputs for use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS 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:

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 career development grants focusing on preparing emerging researchers to conduct comparative effectiveness research as related to different treatment and practices. The intent of these grants is to support the career development of clinical and research doctorates focusing their research on the generation and translation of new scientific evidence and analytic tools in an accelerated format. 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 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 (PBRNs), and the John M. Eisenberg Clinical Decisions and Communications Science Center. Collaboration in the form of offering two to three month rotational assignments for participants in one of these programs or a similar research environment is strongly encouraged as part of their career development, in order to offer participants the opportunity to develop in and be responsive to real-world practice. 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 grants should include both methodological and clinical components, and the design of the institutional career development grants must demonstrate active involvement of stakeholders to ensure the research is responsive to stakeholder needs and how the stakeholder uses the information in their decision-making. Examples of methodological emphases could include, but are not limited to, the following:

With regard to clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the comparative effectiveness of health care interventions. Applications are also expected to address areas of disparity in traditionally underserved and underrepresented groups. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders and be organized around a set of priority conditions of importance to the Medicare, Medicaid, and CHIP programs as mandated by the MMA section 1013. The current list of priority conditions is described above in this section.

Program Components

1. Program Director/Principal Investigator (PD/PI)

The PD/PI should be an established comparative effectiveness researcher in the areas noted above with a documented record of superior accomplishment, scientific expertise, leadership and administrative skills. (For a detailed description, see Section III.1B)

2. Mentors

A primary mentor must be assigned for each scholar appointed to the program. (For a detailed description, see Section III.1B)

3. Candidates

Once selected, candidates will be referred to as scholars for this program. (For a detailed description, see Section III.1B)

4. Advisory Committee

An Advisory Committee consisting of a chair and up to 3 other members appointed by the PD/PI will be responsible for general oversight and evaluation of the Program. The chair of the Advisory Committee will be appointed by the PD/PI. Advisory Committee members must be: (1) recognized as accomplished investigators in the area of comparative effectiveness research, (2) actively involved in comparative effectiveness research, (3) have a successful record of providing the type of training required under this award, and (4) have a successful record of engendering scholars independence as evidenced by scholars research productivity and their ability to obtain independent research funding; and/or providing a strong foundation for conducting comparative effectiveness research that is responsive to stakeholder needs. Members may be internal to the applicant’s institution or external. Appointment of at least some external members is encouraged. To the extent possible, proposed external Advisory Committee members should be specifically identified in the application. The types of expertise expected for the Advisory Committee must be described. Advisory Committee members may not request compensation. One annual K12 Advisory Committee member meeting is required. Supplemental duties that may be assigned to the Advisory Committee, at the discretion of the PD/PI, include: establishing selection criteria for candidates; reviewing education and career development plans (e.g., formal coursework, mentors, and research experiences) and providing interim monitoring and evaluation of each scholar's progress with recommendations for modifications in the plan.

5. Short-term rotations [optional, but highly encouraged by AHRQ]

Short-term rotations at other institutions are highly encouraged. Short-term rotations should be designed to take advantage of comparative effectiveness educational or research experiences not available at the applicant institution. The proposed short-term rotations should complement other career development, research training and education occurring at the applicant institution. The proposed activities must be distinct from those otherwise available at the applicant institution. During their appointment, a scholar may undertake one or more supervised short-term rotations at different institutions (including stakeholder organizations) for a minimum of two months to a maximum of three months at a given institution during the specified award budget period. This must be based on the individual research scholar’s level of experience and documented need for the specific research training and career development activities. The short-term rotation options and overall plan proposed by the applicant institution for scholars must be designed to fall within the scope of the goals of the proposed K12 program and must be described. The application should describe the purpose, goals and activities of each type of potential short-term rotation. The application must describe how the rotations will complement other research development activities at the sponsoring institution. If the short-term rotation option is included in the proposed program, a Resource Format page (PHS 398) must be included in the application for each participating site.

6. Evaluation and Tracking

The application must describe a strong evaluation plan that includes a system for tracking each scholar appointee during the K12 award and for a period of 5 years (subject to annual reporting) following each scholar’s termination from this K12 program award. The evaluation component must include information on the career trajectories of the research scholars, including positions obtained, publications, and research grant submissions/awards, and achievements/accomplishments with regard to the impact of their work in terms of responsiveness to needs of stakeholders in the health care system.

7. Recruitment Plan

Applicants must describe a recruitment plan that includes a strategy for recruiting candidates. The plan should address the depth and diversity of the applicant pool, including those underrepresented in health services research. These individuals may include underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. The plan should demonstrate that a sufficient cadre of potential scholars is available to ensure that all requested positions will be filled by July 1, 2010 and that all of the scholars will commit to full, three-year term appointments. To the extent possible the plan should list and briefly describe specific potential candidates, and their research interests.

8. Research Environment/Institutional Commitment

The sponsoring institution should have a well-established record of success in developing clinical investigators, capable of conducting comparative effectiveness research, as described above. The institution also has to assure protected time necessary for the scholars to complete the approved career development program. The applicant should also have a track record of collaborations inside the institution(s) proposed and also with outside stakeholder institutions. The sponsoring institution must be the primary site for the career development program and allow faculty to be mentors and provide the necessary facilities and other educational/training resources essential to carry out the program.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the Mentored Clinical Scientist Development Program Award (Institutional K12) award mechanism. Planning, direction and/or execution of the program will be the responsibility of the PD/PI, with the advice of the Advisory Committee on behalf of the applicant institution.

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

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. AHRQ has designated approximately $15 million to fund 5 to 6 grants to support one cohort of scholars each (with a minimum of two scholars per cohort), contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget proposals are limited to $850,000 in total costs per year for a three year project period. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed three years, or budgets that exceed $850,000 in total costs in any one year, or $2.55 million in total costs over the entire project period, will not be reviewed.

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.

Funding for this program is provided under the Recovery Act. 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 career development awards under the Recovery Act will be for three years.

Allowable Costs

Allowable costs must be consistent with AHRQ policy and be reasonable, allocable, well documented and fully justified for the program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

1. Candidates/Scholars

AHRQ provides a salary for K12 scholars of up to 100% of the individual’s institutional base annual salary, up to a maximum of $90,000 annually. Note that the salary allowance must be commensurate with the actual level of effort up to 100%. Candidates must commit a minimum of 75% of full-time professional effort conducting clinical research and career development activities related to comparative effectiveness and three years to their appointments on this grant over the entire project period.

The total salary requested for each proposed candidate must be based on a full-time, 12-month staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.

For each appointed K12 scholar, AHRQ will allow for funds up to $25,000 annually for research-related costs -- examples include consultants, supplies, equipment, technical personnel, data, travel, and statistical services, and other program-related expenses. These costs must be justified as specifically required by the proposed program and must not duplicate items generally available at or through the grantee institution. Short-term rotation costs are included in the allowed $25,000. However, costs allowed for the short-term rotation may not duplicate any costs/benefits allowed for the salaried scholars in the K12 program. These expenses must be specifically identified, reasonable, and justified. Expenses for foreign travel must be exceptionally well justified.

2. Personnel

It is expected that the PD/PI will devote not less than 10% and no more than 20% effort annually to this K12 program. Support for the PD/PI may be requested but may not exceed $25,000 annually, including fringe benefits. Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant institution may be direct charges to the grant only when specifically identified, reasonable and justified. Advisory Committee members may not receive compensation; however, the applicant can request up to $1,200 per Advisory Committee member to help defray travel costs for the required annual meeting set by the K12 PD/PI. Salary and fringe benefit support for mentors cannot exceed $5,000 annually per scholar. Salaries requested may not exceed the levels commensurate with the institution’s policy for similar positions.

3. Facilities and Administrative (F&A) Costs

F&A costs for the applicant institution and consortium participants (for short-term rotations) will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. 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 of one of the types listed below. The United States institution/organization must be located in the 50 states, or in the territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.

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

Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Program Director/Principal Investigator (PD/PI)

Any individual with the skills, knowledge, scientific expertise, and resources necessary to develop and implement the proposed institutional research career development 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 clinical-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 scholar in the event of a gap in his or her mentor’s research funding.

Mentors

Each scholar appointed to the program must have a primary mentor. All proposed mentors must: (1) be recognized as accomplished investigators in the area of comparative effectiveness research, and/or clinical epidemiology; (2) be actively involved in comparative effectiveness research; (3) have a successful record of providing the type of career development and training activities required under this award; and (4) have a successful record of engendering his or her scholars research careers as evidenced by scholars research productivity, their ability to obtain/participate in a continuing role in independent research, and their ability to work with health system stakeholders in a responsive fashion that has an impact on health care delivery. Proposed mentors must have an AHRQ, NIH, or other equivalent large research grant or contract (e.g., R01) at the time of the K12 award and commit to mentoring of the scholars throughout their total period of development under the award.

Candidates

Note that once selected to the program, candidates will be referred to as scholars . The research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award (K08), the Mentored Research Scientist Development Award (K01), or the Mentored Patient-Oriented Career Development Award (K23).

Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence (by July 1, 2010), and who have earned a clinical or research doctorate, including Ph.D., Sc.D, Dr.P.H., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.N.S. or equivalent doctoral degree. As noted above, these candidates must demonstrate commitment to conducting translational comparative effectiveness research, responsive and useful to stakeholder needs.

Candidates must be willing to commit at least 75 percent of their full-time professional effort (9 person months) annually to the program for a three-year period, with the remainder of their professional effort devoted to developing activities consonant with the objectives of the award. A candidate for the K12 award may not simultaneously submit or have an application pending for any other AHRQ or NIH career award (e.g., K01, K07, K08, K18, K22, K23, K24, K25, K99) or any PHS award that duplicates any of the provisions of the K12 award. Ineligible individuals include current and former principal investigators on AHRQ or NIH research project grants totaling over $100,000 direct costs per year, comparable individual career development awards (e.g., K01, K07, K08, K22, K23, K24, K25, K99), equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants. Candidates may not have a concomitant NIH Challenge Grants in Health and Science Research (RC1).

K12 Scholars should be strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) by the end of their third year appointment.

Institutional Eligibility and Commitment

The applicant institution must be the primary site for the Institutional Career Development program and should demonstrate a commitment to the Program’s goals, submitting with the application documentation of faculty, facilities and other resources that will be available on site to the program.

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 shown/included in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants are encouraged to partner with multiple components at their degree-granting institution, and/or one of its affiliate organizations (e.g., hospitals and health plans). Applicants are also encouraged to partner with external, non-affiliated stakeholders.

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 an Advisory Committee (see Section I for details), 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 candidates will be considered incomplete and will not be reviewed. Applications proposing short-term rotations must also include a statement of institutional commitment to the program by the other institution where the short-term rotations will take place. A Resource Format page must be included in the PHS 398 application for each proposed short-term rotation site.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the 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 announcement 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 24, 2009
Application Receipt Date: January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

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, MSW
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- 1428
FAX: (301) 427- 1562
Email: [email protected]

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

3.B. 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, MSW
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: [email protected]

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.

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 principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

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

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

6. Other Submission Requirements

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, for this FOA please follow the modified instructions below in preparing an application for an AHRQ Mentored Clinical Scientists Comparative Effectiveness Development Award (K12):

1. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Program Announcement (PA) Number: PA-(Number Here), and check the YES box. The Program Director will be the Program Director/Principal Investigator (PD/PI) of the grant application.

2. Description/Performance Site(s)/Key personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. Information should be provided for the PD/PI, Mentors, and internal Advisory Committee members participating in the Program. To the extent possible, proposed external Advisory Committee members should be specifically identified in the application. The types of expertise expected for the Advisory Committee should be described.

3. Clinical Research Career Development Program (must not exceed 25 pages, including any tables or charts). The application should be organized as per PHS 398 with specific additional information as detailed below:

(1) Aims

The application should describe the overall theme of the program, the particular career development activities planned for Scholar Candidates, and the expected outcomes for candidates.

(2) Investigators

The application should document the experience of the PD/PI and other faculty as mentors, including information on the career outcomes of former Scholars. It should include a clear commitment of staff time.

(3) Core Curriculum

Details on the training plan proposed for scholars should be included. While participating in the Program, preferably in the first and second years, each scholar should receive didactic or experiential training in clinical comparative effectiveness research, design and methodology at the appropriate level for the scholar, biostatistics, bioethics, and the responsible conduct of research. In addition, scholars training should include multidisciplinary team work, grantsmanship, and dissemination/translation of findings for use by components of the health care delivery system, in addition to researchers. Particular developmental activities mentioned such as seminars, scientific meetings, training in responsible conduct of research, and presentations should be linked to the overall theme and goals of the program. Applicants are encouraged to address the type and level of key core competencies that scholars are expected to gain from their training, the mode of delivery, and assessment techniques for their achievement.

In addition, this section should explicitly identify the advantages to this site of a program-based career development award as opposed to, or in addition to creating environments supportive of individual efforts by junior faculty to obtain career development and similar awards. It should distinguish the uniqueness of this planned program from other similarly-supported training programs at the applicant institution.

(4) Research Activities

The application must demonstrate that the institution has a well-funded comparative effectiveness research base, the infrastructure to support it, and the facilities (e.g., inpatient and outpatient facilities, affiliate hospitals, etc.) and access to patients and/or patient data. If other institutions are involved, each must provide written commitments of resources that they will provide to the Program.

Each individual mentored research project should be designed by the scholar upon appointment, to be completed by the end of the appointment period. The research project must be reviewed and accepted by the PD/PI. These must be designed to provide a strong foundation for conducting translational clinical effectiveness research that is responsive to stakeholder needs. In particular, the project should emphasize the integration of evidence into practice and decision-making in the health care system and result in the scholars being able to 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 and dissemination of evidentiary information for health care decision-making. It is anticipated that the result will prepare the scholar for submission of independent peer-reviewed projects or play a major role in crafting and completing multidisciplinary team projects.

(5) Advisory Committee

For details, see Section I.1.4.

(6) Recruitment and Retention Plan

Applicants must submit a recruitment plan. The application should describe plans to increase the depth and diversity of the applicant pool including those underrepresented in the health services research workforce.

(7) Short-term rotations [optional]

See Section I.1.5 for details.

(8) Tracking and Evaluation

The application must describe a strong evaluation and tracking plan including the review of the effectiveness for all program components for which funding is being requested. The initial application must provide a prospective evaluation plan for process and outcome measures. The plan must include a system for tracking the scholars for a 5-year period following program completion to determine the relative success of the research training program. An evaluation and tracking report must be included annually as part of the Progress Report and the Final Progress Report. The Progress Reports should also describe specific short-term rotations completed or planned for each scholar.

(9) Institutional Commitment

Applicant institutions should demonstrate their commitment to the Program's goals. In addition, where Short-Term Research Rotations or consortia are proposed, applicants should describe how sites would coordinate activities, share resources, communicate and otherwise address logistical issues.

(10) Training in the Responsible Conduct of Research

Applications must include a description of a program that will provide formal or informal instruction in scientific integrity and the ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed. Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, candidate attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

4. Other Materials. Note: these items are in addition to those noted under Section IV.6.3. (Clinical Research Career Development Program) and do not count toward the 25 page limit.

(1) Consortium/Contractual Arrangements

Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and consortium organizations.

(2) Letters of Support

Letters documenting any agreements between PD/PI and senior administration officials detailing commitments to and recognition of training scholars to conduct translational research should be included. The following issues should be addressed: (1) faculty, facilities and other comparative effectiveness-related research and educational resources that will be available to the Program; (2) statements about how the institution will integrate the proposed Program with its other related clinical research activities and programs; (3) statements about how the institution encourages clinical comparative effectiveness research, and in particular, research which involves and is used by stakeholders that may not be disseminated solely in peer-reviewed publications (e.g., promotion and tenure, etc.); (4) assurance of protected time annually for candidates (75%), mentors (as needed) and the PD/PI (up to 20%); (5) plans to build upon the specific strengths of existing programs; and (6) statements assuming responsibility for the continued tracking of the scholars career progression as described in the Evaluation and Tracking Plan.

In addition, letters of support from all participating consortium members and short-term rotational sites should be included detailing arrangements, coordination of activities, resource/data sharing, and dissemination/publication agreements.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process and may not be reviewed. Letters of support and consortium/contractual arrangements should not be included in appendices.

No supplemental/update information will be accepted.

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 PHS 398. 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.

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 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:

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.

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 clinical 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 career development and 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 mentored candidates in areas that are important to the health care delivery system? Is stakeholder input and partnership integrated into the training experience, as appropriate?

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 to ensure the program’s objectives? Have the PD/PI and mentors adequately provided for access to research funding for the candidates? Is there a plan to access other funding in the event that there is a gap in the mentor’s research funding?

Applicant Recruitment, Selection and Retention: What is the quality and size of the applicant pool? Are the recruiting procedures, candidate selection criteria, and retention strategies appropriate and well defined? Are the research aptitude and commitment to translational comparative effectiveness research of applicants prominent in recruitment and selection? Do recruitment plans address the depth and diversity of the applicant pool, including those underrepresented in health services research?

Advisory Committee: Are the proposed Advisory Committee chair and members appropriately selected and well suited to provide general oversight and evaluation of the program? Is the proposed mix of internal and external members appropriate to the program proposed? If external members have been included, are the types of expertise expected for the Advisory Committee adequately described and appropriate? Given that some members may not be identified, are there adequate assurances of the qualifications, expertise, and availability of proposed members to participate at an appropriate level of effort?

Short-term rotations [optional]: Do proposed types of short-term rotations enhance and complement the career development plan at the applicant institution? Do the short-term rotations proposed present clear purposes, attainable goals, and feasible activity plans? Are they clearly linked to the delivery of care in the health system?

Tracking and Evaluation: Does the application describe a sufficiently strong evaluation plan that meets the evaluation and tracking objectives?

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 clinical research training and particularly to this clinical comparative effectiveness career development/research training program? The sponsoring institution must be the primary site for the overall institutional career development program, however, if multiple sites are participating (e.g. for short-term rotations) is the institutional commitment to the proposed program appropriate in each case, and is this adequately justified in terms of the research educational experiences provided? Are adequate plans provided for coordination and communication between multiple sites? Is there evidence of adequate research support, equipment, and facilities? Is the information provided for each site adequate to determine appropriateness of the site? Is there institutional commitment to the development and recognition of researchers who focus on multidisciplinary teamwork, and the production of translational research centering on improvements in the health system?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be 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 address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below).

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

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:

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).

2.B. Additional Review Considerations

N/A

2.C. 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).

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. Once any/all administrative and programmatic issues have been resolved, a formal notification in the form of a the Notice of Award 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.

The following related administrative policies apply to Research Career ( K ) programs:

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

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

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

B. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the AHRQ funding component is required.

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

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

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

C. Changes of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by AHRQ. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. Programmatic changes will be evaluated to ensure that the program remains within the scope of the original, peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

D. Change of PD/PI: If a change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by AHRQ, provided that: the current PD/PI or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to the program contact listed on the Notice of Grant Award describing the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the intensive supervised research training and career development experiences for clinicians leading to research independence. This request must be submitted in writing and sufficiently in advance of the requested effective date to allow the necessary time for review.

E. Transfer of Program: Neither the integrated career development/training program nor any component of the K12 program may be transferred from one institution to another.

F. Termination: When a grantee institution plans to terminate an award, the AHRQ Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. AHRQ may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, AHRQ shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

G. Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval of AHRQ. When required, such requests must include compelling justification including the status of candidate/scholar appointments to the program.

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5.1.4 of the 2590 instructions. 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.

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 Grant Award and incorporated into AHRQ Terms and Conditions of Award.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

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

Scholar Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until this document is submitted and accepted by the AHRQ.

Progress Reports

An annual Progress Report for the grant is required, to include:

Additional information should be reported in concert with the PHS 2590 Progress Report instructions. Progress reports are submitted using Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/forms.htm

Report 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.

Additional Reporting Requirements:

Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and reviewed.

Final Reports: A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Note that an evaluation and tracking report is required as part of the Final Progress Report.

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

Publication and Sharing of Research Results: Scholars are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a scholar’s research, AHRQ support should be acknowledged by a footnote in language similar to the following: This project was supported by AHRQ grant 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 funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (includes the preliminary application and letter of intent phases of the program), 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:

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:

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: [email protected]

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: [email protected]

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: [email protected]

or

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: [email protected]

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009: 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.

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.

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