RFA-HS-08-001: AHRQ National Research Service Award Institutional Research Training Grant (T32)

Department of Health
and Human Services (HHS)

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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP)

Title: AHRQ National Research Service Award Institutional Research Training Grant (T32)

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

Announcement Type
New

Request for Applications (RFA) Number: RFA-HS-08-001

Catalog of Federal Domestic Assistance Number(s)
93.225

Key Dates
Release/Posted Date: June 22, 2007
Letters of Intent Receipt Date: September 10, 2007
Application Receipt Date: October 19, 2007
Peer Review Date: January 2008
Earliest Anticipated Start Date: July, 2008
Expiration Date: October 20, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) will award Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) to eligible institutions as the primary means of supporting predoctoral and postdoctoral health services research training to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s health services research agenda.
The primary objective is to prepare qualified individuals for careers in health services research who will focus their careers on producing research that will be implemented to improve the health care of all Americans.
Because of the nature and scope of the proposed research, training needs will vary from application to application and it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, and costs of the applications received. AHRQ plans to fund a mix of new training programs and competing continuation programs, assuming a sufficient number of meritorious applications.
Only domestic, non-profit, private or public institutions that have strong and high-quality research programs in the area(s) proposed for research training and have requisite staff and facilities may apply for grants to support NRSA Institutional Research Training Grants (T32 mechanism).
Eligible Training Program Directors (TPD) include any individual with the skills, knowledge, successful past training records, and available resources necessary to carry out the proposed research training program. Program Directors should have a strong and active track record in research, training, and administration that are essential to conduct and manage the proposed program.
Awards for T32 institutional NRSA research training grants may be for project periods up to five years in duration.
Trainees are required to pursue full-time research training.
Institutional NRSA training grants may not be transferred from one institution to another.
AHRQ will generally support no more than one meritorious application per academic-degree granting institution and its affiliate organizations. Support for two applications per applicant organization and/or its affiliates will be considered when this arrangement is fully justified and achieves programmatic balance across AHRQ priorities.
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Training Objectives

Purpose and Background Information

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans. AHRQ achieves this mission by supporting a broad program of health services research and by working with partners to promote improvements in clinical and health systems practices. AHRQ s programs are designed to (1) improve clinical practice, (2) improve the health care system's ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost, and use of health care services.

Current pressing health care issues are increasingly viewed as being influenced by complex systems that call for a new approach that integrates advances in behavioral sciences, clinical sciences, and health services research. In order to address these challenges, it is important to ensure that a diverse and highly trained interdisciplinary research workforce is prepared with the skills and knowledge necessary to conduct and implement research that can be put into practice by health care providers, policy makers and health care delivery system administrators. The goal is that their research will be implemented to improve the health care of all Americans.

In order to accomplish the above, AHRQ announces its intent to award Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training grants (T32). AHRQ plans to fund a mix of new training programs and competing continuation programs. These programs will recruit and train predoctoral and/or postdoctoral students interested in pursuing careers in health services research. Generally, it is expected that students will be appointed for a minimum of two consecutive years on the AHRQ T32 grant in order to benefit fully from the health services research training program. Planned exceptions to this expectation should be justified in the T32 application.

The requirements of this announcement are intended to be sufficiently flexible to allow applicant institutions to tailor their proposed training program to take advantage of the resources available to them and their institutional strengths. The intent is to develop researchers in each program who will work in a variety of settings and institutions. However, it is emphasized that the content of the training experience supported by AHRQ must be consistent with AHRQ’s mission, addressing areas noted below, and be focused on developing individuals interested in producing and disseminating research useful to issues facing the U.S. health care system. Applicants are further encouraged to consult the report titled, Advancing the Nation s Health Needs: NIH Research Training Programs, which was produced by The National Research Council (NRC) of the National Academies in 2005. This is the twelfth and latest report produced by the NRC in its periodic evaluation of the entire NRSA program. The report was funded by AHRQ and NIH and is available from the National Academies. Further information on it and its contents can be obtained at http://www.nap.edu/catalog.php?record_id=11275.

Special Research Training Objectives and Considerations

AHRQ requires all applicants to address at least one of the following research objectives in their T32 institutional training program application. Applications that do not address these AHRQ priorities will be returned without review. Applicants cannot propose areas or use AHRQ funds to support the training of students whose research interests are outside of these AHRQ priorities.

Translating Research into Practice and Policy (TRIPP)

AHRQ's mission includes a commitment to training researchers who are skilled in translating research into practice and policy. Within this area, future investigators are prepared to conduct intervention research and evaluation projects related to the translation of research findings into measurable improvements in quality, patient safety, health care outcomes, cost, use, and access. This research includes clinical interventions for which there is sufficient evidence of effectiveness (e.g. U.S. Preventive Services Task Force (USPSTF) recommended practices, practices found to be effective in Evidence-based Practice Center (EPC) reports or in the Effective Health Care Program http://www.ahrq.gov ). It also includes organizational interventions found to be effective. For example, students are equipped to: 1) test strategies for adoption and implementation of evidence-based interventions; 2) assess the degree to which interventions that have been proven successful in just a few health care settings or outside of health care are appropriate to other health care settings and non-traditional health care settings, and the degree to which practices that worked well with one population fit other populations - especially AHRQ priority populations; 3) identify successful past efforts to adopt and implement evidence-based interventions, and then take these "to scale" by replicating them across a number of organizations and settings; 4) assess the impact of organizational, payment, and market forces on the successful adoption and implementation of evidence-based interventions; and 5) identify barriers to implementation and successful solutions to specific barriers.

Methodological studies focusing on assessments of approaches to translational research are of interest to AHRQ. However, of greater interest, is the assessment of the actual use of these methods to implement and spread evidence from the knowledge domains that follow below.

Patient Safety and Quality

One important element in the AHRQ mission is to support and promote the development of multidisciplinary research to examine the scope and impact of medical errors on the health care system and offer solutions to create a culture of safety and high quality. Training students to conduct research on patient safety and quality improvement involves preparation in examining risks to patient safety, their root causes, and possible effective system approaches to prevent the occurrence of errors among diverse populations and settings of care. In addition, training would include developing expertise in evaluating effectiveness of health care interventions designed to capture information on medical errors, and the use of information technology to reduce errors and increase efficiency. Particular emphasis needs to be placed on the identification of known risks and hazards that threaten patient safety in ambulatory settings, especially among patients with chronic illness. Key areas needing attention are those pertaining to complex information management, coordination of care across multiple settings, health information technology applications, patient-centered care, and medication management in ambulatory settings as well as the impact of organizational, payment, and market forces on the occurrence of adverse events.

Quality Improvement (QI)

Today, policymakers and practitioners are expected to meet growing demands to improve quality. Better ways of generating and sharing evidence in support of improving the quality of health care are needed. A more rigorous and systematic approach to QI research methods and evaluation is needed to ensure that future investments in improving health care are grounded in science and provide value. QI research training initiatives with strong partnerships between multidisciplinary researchers and frontline providers and policymakers in health care who actually implement quality improvement strategies are needed. In addition, contributions to quality improvement theory development and testing of new and promising conceptual frameworks and innovative research designs and methods for quality improvement are of interest to AHRQ. These should focus on improving the validity and generalizability of strategies and findings. QI research training and research at multiple levels of the health care system is encouraged, including: the care delivery sites that provide the care that patients experience (e.g., hospitals, hospital units, ambulatory care settings, home health care, long-term care); and the health care organizations that can foster improved care. Training and research conducted by students should focus on an array of topics, such as: the identification of evidence, best practices policy and their conversion into organizational standards; use of health information technology to improve patient care; development and implementation of effective human resources and team approaches to care; coordination of care across services and settings, including coordination with other organizations; and deployment of measures to foster improvement.

Patient-Centered Care

One critical set of issues facing policymakers is the challenge of designing patient-centered care processes to improve the quality and safety of care delivery. It is important to train future researchers to focus on important issues in patient-centered care. These issues involve focusing on partnerships among practitioners, patients and their families (when appropriate) to ensure that decisions respond to and respect patients' wants, needs and preferences and solicit patients' input on the information, education and support they need to make decisions and to actively participate in their own care.

Essential dimensions of patient-centered care include but are not limited to: 1) accessible and customized information, communication, and education; 2) continuous collaboration, coordination and integration of care among providers, across conditions and settings; 3) shared decision-making of clinicians with patients and their families; 4) self-efficacy and self-management skills for patients; 5) patients' experience of care; 6) provider-patient partnership; 7) enhanced cultural competence of health care providers; and 8) timeliness, efficiency, effectiveness and equity of health care. AHRQ supports patient-centered care research focusing on the redesign and evaluation of care processes that lead to greater patient empowerment, improved patient-provider interaction, easier navigation through healthcare systems, and improved access, quality, and outcomes. Specific strategies could include, but are not limited to, electronic clinical communication, patient self-management, Web-based applications for patients and/or health care providers, and shared decision-making.

Payment, Markets, and Organization

A dilemma currently facing America is how to improve health care quality and access while costs continue to rise. An important step in addressing this dilemma is through innovations in organization and payment structures and strengthening of the health care market place. To understand the impact of changes in organizational structure and processes, new technologies, and management innovations, and to discover ways to create a more efficient and higher‑quality health system, AHRQ encourages the training of researchers, who will focus their research careers on system design and change, and the incentives, market forces, policies and regulatory structures most conductive to facilitating such changes. For example, evaluation of innovations in prescription drug payments, value-based purchasing, improving care processes within a health care organization, pay-for-performance incentives, state malpractice reforms, and response to Health Savings Accounts or consumer directed health options, are of interest. Of additional interest is the effect of cost-sharing on access, efficiency and equity of health care.

Health Care Disparities

There is ample evidence that health care disparities continue to exist. For example, AHRQ’s 2006 National Healthcare Disparities Report found that while some improvements have been made, there is still a gap between the quality of care received by whites and African Americans, and that quality of care for Hispanic Americans is actually declining. Addressing such disparities has become a focus of many health care programs, reports, and initiatives. AHRQ is especially interested in supporting the development of researchers interested in conducting research to reduce and eliminate disparities. The examination of approaches to reduce racial, ethnic, and socioeconomic disparities is encouraged.

Core Competencies

Applicants must identify and describe curricula, training experiences, and past partnerships and work experiences related to developing a specific and comprehensive set of core competencies that training programs require of all students. Details should be presented on which competencies are conveyed didactically and which experientially.

Large-Scale Data Base Methods

Answering clinical and policy questions often involves expertise in both the design and analysis of large-scale survey and administrative data bases, such as the Medical Expenditure Panel Survey (MEPS), Healthcare Cost and Utilization Project (HCUP), Medicare and Medicaid data, and health care records. Users of research such as health plans, think tanks, government, purchasers and payers are in need of individuals with skills to use such data bases to readily address issues related to improving patient care. Applicants are encouraged to specifically address the manner in which students are trained in the use and application of such data bases, as related to clinical or organizational improvement and/or policy needs assessment, development or evaluation. This training can include time spent on site at the organization responsible for the data, such as AHRQ, Centers for Medicare and Medicaid (CMS), or State-level HCUP partners.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement will use the Ruth L. Kirschstein National Research Service Award (NRSA) T32 award mechanism. This FOA is a one-time solicitation. AHRQ has not determined whether this solicitation will be continued beyond the current request.

Institutional NRSA research training grants (T32) may be made for periods of up to five (5) years, but can be renewed on a competitive basis with the submission of a competing continuation grant application submitted and peer-reviewed in response to a subsequent FOA. Awards within an approved competitive segment are normally made in 12 month increments with support for additional years based on satisfactory progress and the continued availability of funds.

Applicants are solely responsible for planning, directing, and executing the proposed research training program.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.

2. Funds Available

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

The total project period requested in response to the present FOA may not exceed five (5) years. The actual number of awards is dependent upon the AHRQ NRSA budget and the number of high quality applications and their individual budget requirements; it is not the intent of AHRQ that the awards are equal in size. An application s budget request must not exceed $500,000 in total costs per year including Facilities and Administrative (F&A) costs. Applications with budget requests exceeding this amount will be returned without review.

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

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187. Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the HHS Grants Policy Statement and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Allowable Costs

A. Stipends:

Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual stipend levels at the time of award. The fiscal year (FY) 2007 annual stipend level for a predoctoral trainee is $20,772. For postdoctoral trainees, the annual stipend is based on the number of full years of prior relevant postdoctoral experience at the time of the trainee’s appointment. The FY 2007 range of annual postdoctoral stipend levels is $36,996 to $51,036. Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period. For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration of the annual amount. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The Ruth L. Kirschstein National Research Service Award (NRSA) stipend and other budgetary levels effective for fiscal year 2007 can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-052.html

B. Tuition and Fees:

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

The amount per predoctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training, the amount provided per trainee will be up to $21,000 per year.
The amount per postdoctoral trainee equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year.

Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. A full description of the August 18, 2006 NIH Notice of New NIH Policy for funding of tuition, fees, and health insurance on Ruth L. Kirschstein National Service Awards can be found on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html

C. Trainee Travel

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

D. Training Related Expenses (TRE)

The Training Related Expenses (TRE) category has recently been modified to include health insurance as an allowable expense. This category will continue to be referred to as training related expenses but will now include health insurance as an allowable cost. The applicant institution may request NRSA TRE; for FY 2007 TRE were allowed in the amounts listed below:

$4,200 annually for each predoctoral trainee and
$7,850 annually for each postdoctoral trainee

These costs are intended to help defray other research training expenses, such as staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html. Funds are provided as a lump sum on the basis of the predetermined amount per predoctoral and postdoctoral trainee approved for support.

Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request training related expenses above the standard level. Requests for additional costs must be explained in detail and justified in the application. Consultation with AHRQ program staff in advance of such requests is strongly advised.

E. Facilities and Administrative Allowance

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

F. Stipend Supplementation, Compensation, and Other Income

The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by AHRQ. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

Supplementation: Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee. An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds. Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. An individual may use Federal educational loan funds or VA benefits when permitted by those programs. Under no circumstances may PHS funds be used for supplementation.

Compensation: Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the HHS Grants Policy Statement. Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application. Training Program Directors must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

A full description of the policy regarding NRSA supplementation and compensation is available at http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. Because the primary objective of this FOA is to increase the number of adequately trained health services researchers in the U.S., foreign institutions are not eligible to apply for grants. Applications submitted by for-profit organizations and foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Applicant organizations are encouraged to collaborate across Departments, Divisions, Schools and affiliated organizations within their larger institution in submitting applications to this announcement. AHRQ will generally support no more than one meritorious grant per academic-degree granting institution and its affiliate organizations. Support for two grants per applicant organization and/or its affiliates will be considered when this arrangement is fully justified and achieves programmatic balance across AHRQ priorities.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

The Program Director, who will be the PD/PI for the grant application, should be an established health services researcher with a successful past training record, and available resources to conduct the proposed research training program at the institution. The Program Director will be responsible for the selection and appointment of eligible trainees to the NRSA grants, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.

2. Cost Sharing or Matching

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 any collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

3. Other-Special Eligibility Criteria

Training Program

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

A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D. /Ph.D. For students in joint clinical programs and research doctorate training, AHRQ will only support the research education component. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA supported full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Trainee Citizenship

At the time of appointment to the training program, individuals selected for research training supported by NRSA institutional training grants must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence, i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of legal admission as a permanent resident. Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support. It is the grantee institution’s responsibility to ensure that a trainee’s citizenship status at the time of appointment meets these criteria. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Predoctoral Trainees

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, must be training at the post-baccalaureate level, and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program.

Postdoctoral Trainees

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

Section IV. Application and Submission Information

1. Address to Request Application Information

Applicants must use the currently approved version of the PHS 398. The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A)

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: September 10, 2007
Application Receipt Date: October 19, 2007
Peer Review Date: January 2008
Earliest Anticipated Start Date: July 2008

3.A.1. Letter of Intent

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

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:

Kishena C. Wadhwani, Ph.D., M.P.H.
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2032
Rockville, MD 20850
Phone: (301) 427-1556
Fax: (301) 427-1562
Email: Kishena.Wadhwani@ahrq.hhs.gov

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

3.B. Sending an Application to AHRQ

Applications must be prepared using the research grant applications instructions found in the PHS 398 and the specific NRSA institutional grant application instructions that begin on page 61 of the PHS 398. 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 including copies of the appendix material must be sent to:

Greta Drott
Division of Research Education
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1530
FAX: 301-427-1562
Email: greta.drott@ahrq.hhs.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR) at NIH and AHRQ, and for responsiveness by AHRQ. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

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

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

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

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

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

6. Other Submission Requirements

Technical Assistance Conference Call

AHRQ encourages potential applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with an opportunity to ask questions about the preparation of an application in response to this FOA. The conference call will take place on Tuesday, August 28, 2007 from 1:00 - 3:00 p.m. EDT. To register to participate in the conference call, please send an e-mail request to T32TA@ahrq.hhs.gov by Aug 20, 2007. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB Aug 27, 200 7. Potential applicants are encouraged to contact Ms. Benjamin with any questions (see Where to Send Inquiries, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to T32TA@ahrq.hhs.gov by Aug 20, 2007. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be available on the AHRQ web site. Requests for a copy of the notes may also be sent to T32TA@ahrq.hhs.gov.

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 be returned without review.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also found at 42 USC 299. 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, the 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 are to 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 inpatient 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 databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory care surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. 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, noninstitutionalized population. MEPS is comprised 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.

Special Requirements

Research Training Program-- The program should plan to provide didactic training as well as research experience. This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals. The program should develop trainee skills in understanding research, conducting research, identifying problems in the process of conducting research, raising questions and proposing solutions to resolving problems. Trainees should be prepared to utilize their research findings as they pursue future research. Programs should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support, communication of research to users of research, translation of research into practice and/or policy, and interdisciplinary team work.

Program Director: The Program Director must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The Program Director will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.

Interdisciplinary Training: Applicants should describe the collaborative environment and infrastructure available for interdisciplinary training. Evidence of this infrastructure could include collaborative research projects, co-authored publications, joint service on dissertation committees, collaborative teaching, and regular interactions in journal clubs and seminar series. For successful programs, it is expected that special efforts will be made to integrate the science, and the trainees, into a cohesive program where there is close and constant interchange of ideas, information, mentorship and an array of training experiences.

Mentoring: Applicants must include mentoring plans that succinctly summarize the qualifications of major faculty and external non-academic partners in the specific research objective areas proposed for training and mentors commitment of sufficient time and attention to the student.

Past Training Record: This should describe the past research training record of the program, the Program Director, and designated preceptors/mentors. The information should describe the success of former trainees of the designated preceptors/mentors in seeking further career development and in establishing productive careers. Evidence can include successful completion of programs, further career advancement of former trainees such as receipt of fellowships, careers awards; further training appointments and similar accomplishments. Evidence of a productive heath services career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, promotion to health services research positions, and any other accepted measures of success consistent with the nature and duration of the training period and program emphasis (e.g., academia versus applied research preparation).

Trainee Appointments: All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the AHRQ.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training or individual fellowship awards. Any exception to the maximum period of support requires a waiver from the AHRQ based on a review of the written justification from the individual trainee, and endorsed by the Program Director and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the AHRQ since this is extremely rare.

Research Environment/Resources: The applicant institution must have a strong and high-quality research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program.

Institutional Commitment: The applicant institution should include information that documents a commitment to the proposed research training program’s goals, and provide assurance that the institution intends the program to be an integral part of its research and research training endeavor. The application should include a description of support (financial or otherwise) to be provided to the program, which could include, for example, space, equipment, funds for curriculum development, release time for the Program Director and participating faculty, support for additional trainees in the program, or any other creative ways to improve and enhance the growth of the research training program.

Partnership Formation: In order to provide students with applied experiences and promote geographic and demographic diversity, applicants are further encouraged to form partnerships with developers and users of research in applied settings. Oversight of the grant activities must remain with the applicant organization. Partners are not eligible for a sub award. These can include health plans, quality improvement organizations, think tanks, purchasers, insurers, policy offices and/or emerging or developed centers of excellence and translational networks, such as, but not limited to, the following programs supported by AHRQ: the Developing Evidence to Inform Decisions about Effectiveness (DeCIDE) network, Practice-Based Research Networks (PBRN s), Accelerating Change and Transformation in Organizations and Networks (ACTION) programs, Building Research and Infrastructure Capacity (BRIC) and Minority Research and Infrastructure Support (MRISP) programs, Healthcare Cost and Utilization (HCUP) Partners, and Evidence-Based Practice Centers (EPCs) http://www.ahrq.gov.

Evaluation and Tracking Component: The application must describe a strong evaluation and tracking component that will review and determine the effectiveness of all aspects of the program. This should include a system for tracking trainees for a 10-year period following their completion of the program to determine success or failure of the program. The follow up tracking would include information on program publications, grant proposals, awards, and career trajectory of trainees who were supported by the program. This should include information on the impact of trainees research and/ or careers on health care policy or delivery. Applications must include specific methods for ongoing evaluation of the quality of the training program and develop plans to obtain feedback from former trainees to help identify weaknesses in the program and provide suggestions for program improvement. The application should provide a prospective evaluation plan for process and outcome measures. Outcome measures may include relevant positions obtained, current activities related to research, publication record, the success rate of applying for and obtaining Federal and non-Federal research grant support, and other markers of success related to nonacademic employment. This should include information on the impact of trainees research and/or careers on health care policy or delivery. The evaluation and tracking report should be included annually as part of the Progress Report, in future competing continuation applications, and as part of the Final Progress Report.

Recruitment and Retention Plan: Applicants must submit a plan for recruiting and retaining high quality trainees from both outside and inside their institutions. The plan should describe any recruitment and outreach plans to increase the depth and diversity of the applicant pool. The recruitment plan must include specific efforts designed to enhance diversity. If an application is received without a plan that specifically addresses efforts to enhance diversity, the application will be considered incomplete and will not be reviewed.

AHRQ recognizes a unique and compelling need to promote diversity in the behavioral, clinical and social sciences workforce. AHRQ expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. AHRQ is particularly interested in encouraging the recruitment and retention of the following:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/). In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary of Health and Human Services (HHS) for use in all health professions programs. The Secretary HHS periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

Students or post doctorates who applied for admission or positions within the department(s)/programs(s) relative to the training grant,

Students or post doctorates who were offered admission to or a position within the department(s)/program(s),
Students actually enrolled in the academic program relevant to the training grant, and
Students or postdoctorates who were appointed to the research training grant.

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

Peer reviewers will separately evaluate the recruitment and retention plans to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel s evaluation will be included in an administrative note in the summary statement. If the application is selected for funding, but the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. AHRQ will determine whether amended plans and reports submitted after initial review are acceptable.

Training in the Responsible Conduct of Research -- Every NRSA Trainee supported by an institutional training grant must receive instruction in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants1.nih.gov/grants/guide/notice-files/not92-236.html.

Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. Applications without plans for instruction in responsible conduct of research will be considered incomplete and will not be reviewed.

Although AHRQ does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies and regulations regarding human subjects research. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or post doctorates appointed to the program.
Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction.
The rationale for the proposed plan of instruction must be provided.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications. AHRQ encourages institutions to provide instruction in the responsible conduct of research to all graduate students, post doctorates, and research staff regardless of their source of support.

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 in Section V.2 below. The review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration.

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

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

Applications submitted in response to this funding opportunity and recommended for funding will compete for available funds with all other recommended applications.

The following will be considered in making funding decisions:

Scientific merit of the proposed program as determined by peer review.
Availability of funds
Relevance to program priorities
Program balance
Demonstrated unique relevance to AHRQ and relevance to AHRQ’s mission
Partnership formation

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 research 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.

Training Program:

Are the objectives, design and direction of the proposed research training program appropriate and responsive to the goals of this announcement? Does the proposed program provide suitable didactic and experiential training for predoctoral students? Is the quality of proposed course contents and training experiences appropriate?
Does the application include a discussion of core competencies to be conveyed in the training experience and how they will be implemented? Are they suitable?
Are there appropriate mechanisms to monitor and guide trainees (e.g., by the Ph.D. degree departments/programs, training program, mentors, thesis committees)?
Have the applicant institutions made attempts to form viable internal and external partnerships that enhance their program?
Does the application describe how the proposed training grant fits into the institution’s overall graduate training programs and how it is unique from other existing training programs, including those supported by other Federal Agencies, such as NIH and HRSA?
Does the application describe any innovative features or activities that will be provided for trainees, including opportunities for applied internships?

Training Program Director and Administrative Structure:

Does the Program Director have the scientific background, expertise, and experience appropriate to direct, manage, coordinate, and administer the proposed research training? Does the Program Director plan to commit adequate time to the program?
Is the program administration structure adequate and appropriate?

Preceptors/Mentors:

Is the caliber of preceptors/mentors as researchers, including successful competition for research support in areas directly related to the proposed research training program, appropriate for their role in the training program?
Is the nature and breadth of the research conducted by the faculty and preceptors appropriate to the goals of this solicitation? Are there a sufficient number of experienced mentors with appropriate expertise and funding available at the applicant institution to support the number of trainees being proposed in the application?
Is the composition of the faculty by rank and distribution in different fields/departments appropriate?
Is there evidence of collaboration and cooperation among the faculty members?

Past Training Record:

Is the past research training record of the program, the Program Director, and designated preceptors/mentors appropriate and demonstrated?
How successful are former trainees in seeking further career development and in establishing productive careers?
Is there evidence of successful completion of training (e.g., predoctoral students earning Ph.D s, clinical postdoctoral students completing at least two years of research training?) Is there evidence of productive scientific and applied research careers among former students?

Institutional Training Environment, Commitment, and Resources:

Is the quality of the research environment for the proposed research training program appropriate?
Is the level of institutional commitment, quality of available facilities, courses, research and research training support suitable and supportive of the type of training planned (including that for the development of applied researchers)?
Is the proposed program to be an integral component of the applicant institution’s overall research program/mission?

Trainee Recruitment, Selection, and Retention Plan:

Are the quality of the applicant pool and plans for the selection and retention of individuals appointed to the training program appropriate? Specifically, what is the size and quality of the applicant pool?
Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined? Are there advertising plans or other effective strategies to recruit high-quality trainees?
Do plans demonstrate a commitment to recruiting students from outside of the applicant’s academic institution or affiliate organizations? Do the plans demonstrate a commitment to training students for careers outside of the applicant’s academic institution or affiliate organizations?
For competing renewal applications: How successful has the program been in efforts to recruit and retain individuals from diverse underrepresented populations?

Evaluation and Tracking Plan:

Is the evaluation plan adequate and sufficiently detailed to track career outcomes of trainees and determine if the program is successful? Does it include a system for tracking participants for at least a 10-year period following program completion? Does it include such measures as publications, grant proposals, awards, and impact of the research or careers of supported trainees and nonacademic measures for those pursuing applied careers?
For competing renewal applications: Are there plans to make changes that improve program performance and the assessment of outcomes? Competing renewal applications must describe the program accomplishments to date.

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 high priority score.

2.A. Additional Review Criteria

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

Budget: The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels.

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups) in the research conducted by students. Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in section IV.6 above, and Inclusion Criteria in section VIII below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in proposed research to be conducted by students will be assessed.

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

2.B. Additional Review Considerations

Recruitment and Retention Plan to Enhance Diversity: AHRQ recognizes a unique and compelling need to promote diversity in the behavioral, clinical and social sciences workforce. AHRQ expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, AHRQ continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from 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. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel s evaluation will be included in an administrative note in the summary statement. If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. AHRQ will determine whether amended plans and reports submitted after initial review are acceptable.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. AHRQ will judge the acceptability of the revised plan.

2.C. Sharing Research Data

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 now civil monetary penalties for violation of this confidentiality 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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 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 of 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 awardee 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. 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; and 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 the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 10 months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support 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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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 your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, Terms and Conditions will be incorporated into NGA.

Special Administrative Requirements associated with NRSA programs:

Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the AHRQ for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm for further guidance regarding vacations and requested leave.

Carryover of Unobligated Balances: AHRQ does not allow carry over of funds from one budget period to another.

Termination of Award: When a grantee institution plans to terminate an award, the AHRQ must be notified in writing as soon as possible.

Change of Institution: Awards are made to a specific institution for a specific research training program and the training program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment using the Termination Notice (form PHS 416-7, Rev. 10/05), located at http://grants.nih.gov/grants/forms.htm#training.

Change of Training Program Director: If change of a Training Program Director (TPD) is necessary, support of the award is not automatic but may be continued with prior written approval by the AHRQ, provided that the following conditions are met: The grantee institution has submitted a written request for the change, signed by the appropriate institutional business official, to program and grants management staff at the AHRQ describing the reasons for the change. The Biographical Sketch of the proposed TPD, 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 TPD and that the new TPD has the appropriate research training and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of Program: The grantee institution must submit a written request for the change, signed by the appropriate institutional business official. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. Any change requires prior approval by the AHRQ program staff. If the new program does not satisfy this requirement, the award will be terminated.

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

Postdoctoral trainees in the first 12 months of postdoctoral Kirschstein-NRSA support must sign the Payback Agreement Form (PHS 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support.

Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payment agreement form and will not incur a service payback obligation for this period of support. In addition, the 13th and subsequent months of postdoctoral Kirschstein-NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year.

Service payback obligations can also be paid back after termination of Kirschstein-NRSA support by conducting health-related research or teaching averaging at least 20 hours per week of a full work year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research. Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of Kirschstein-NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to AHRQ specifying the need for additional time and the length of the required extension.

Recipients of Kirschstein-NRSA support are responsible for informing the AHRQ of changes in status or address.

For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, DHHS (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. Detailed information on the accrual and repayment of the Kirschstein-NRSA service payback obligation and waivers is available at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.

Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation must be discussed.

If the trainee has a payback obligation, he or she must notify the AHRQ of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied. Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

3. Reporting

When multiple years are approved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement, found at http://www.ahrq.gov/fund/hhspolicy.htm . The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable and additional instructions for these progress reports.

An annual Financial Status Report (SF 269) is required and must be submitted within 90 days of the end of each budget period. A hard copy of the report should be submitted to the AHRQ FSR Coordinator. Continuation support will not be provided until the required form is submitted and accepted.

A final Progress Report and Financial Status Report are required at the end of the grant project period

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement Form (PHS 6031, Rev. 10/05) must be submitted for each postdoctoral trainee in his or her first 12 months of support. No funds may be provided until such documents are submitted and accepted by the funding Institute.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) to AHRQ.

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

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

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

Inventions: Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants.

Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA. Written and telephone inquiries concerning this FOA are encouraged.

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

Shelley Benjamin, M.SW.
Division of Research Education
Office of Extramural Research, Education and Priority Populations (OEREP)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301- 427-1528
FAX: 301-427-1562
Email: Shelley.Benjamin@ahrq.hhs.gov

Brenda Harding, M.A.
Division of Research Education
Office of Extramural Research, Education and Priority Populations (OEREP)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301- 427-1527
FAX: 301-427-1562
Email: Brenda.Harding@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Kishena C. Wadhwani, Ph.D., M.P.H.
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2032
Rockville, MD 20850
Phone: (301) 427-1556
Fax: (301) 427-1562
Email: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Al Deal
Grants Management Specialist
OPART/GM
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1806
Fax: (301) 427-1462 Fax
Email: Al.Deal@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

Investigators may obtain copies from the above sources or from the NIH Guide Web site 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 45 CFR 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption in FOIA. 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", for example, if they constitute trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 U.S.C. 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 authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing 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 PHS mission to protect and advance the physical and mental health of the American people.