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EXPIRED

Part I Overview Information

Department of Health and Human Services

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

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

Title: AHRQ Health Services Research Demonstration and Dissemination Grants (R18)

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

For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport

Announcement Type
This FOA updates PA-00-111, which was previously released June 22, 2000.

Update: The following updates relating to this announcement have been issued:

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Program Announcement (PA) Number: PA-07-247

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: March 9, 2007
Opening Date: March 9, 2007 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): June, October, February annually
Earliest Anticipated Start Date(s): August, December, April annually
Expiration Date: January 8, 2010 (New Expiration Date April 4, 2008 per NOT-HS-08-008)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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 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 Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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 Objectives

AHRQ seeks research on a wide range of topics under the Priority

Program Areas:

1) Supporting Improvements in Health Outcomes, 2) Improving Quality and Patient Safety, and 3) Identifying Strategies To Improve Access and Foster Appropriate Use and Reduce Unnecessary Expenditures.

A continuing goal of health services research demonstration projects is to improve the translation, dissemination, and use of research findings for clinicians, other providers, patients, consumers, policy makers, and other decision makers to effect needed health care changes, and to measure the impact of changes at all levels of health care delivery.

AHRQ is especially interested in projects across its program areas that demonstrate innovative strategies for effecting systemic and sustained behavior changes to improve outcomes, quality, access, cost, and use, and document the impact of changes at systems, state, and community levels.

Priority Program Areas

Research demonstration projects on clinical outcomes examine the effectiveness of different strategies for preventing, diagnosing, treating, or managing conditions that are common, expensive, and for which significant variations in practice or outcomes exist, or opportunities for improvement have been demonstrated. Demonstrations in this area also include improving our understanding of how outcomes data can be incorporated into informed decision-making at the patient, provider, and organizational levels of the health care system. Outcomes of clinical interventions include functional status, quality of life, patient satisfaction, and costs, in addition to morbidity and mortality. A particular emphasis is on the outcomes of care provided to the elderly and those with chronic illnesses, including studies that assess when in the course of illness intervention is most effective. Research demonstrations may focus on the type of delivery system or financial arrangements by which care is provided and the effects of these on clinical outcomes. Interests include:

1. Effectiveness and cost effectiveness of clinical and organizational interventions, including trials of interventions across the spectrum of health care settings and those used for multiple conditions, or innovative approaches to health care delivery to improve outcomes.

2. Assessing the impact of diagnostic and other health care technologies on cost and patient outcomes, and how to prioritize such assessments.

3. Developing and testing practical, ready-to-use outcomes measures addressing functional status, quality of life, and severity and risk adjustment, as well as general measurement issues, and strategies for improving outcome measures for patients with multiple comorbid conditions, including incorporation of an individual patient’s values and preferences. In particular, increased use of patient-reported outcome measures as dependent variables in clinical trials offers new opportunities for ancillary studies that can enhance our understanding of the characteristics and use of these measures.

4. Developing and evaluating strategies for informed decision-making, including evaluation of alternative strategies for implementing an infrastructure for collection, analysis and presentation of data, and real-time incorporation of outcomes and evidence into decision-making for patients, providers, and policy-makers.

5. Developing and evaluating strategies for the use of outcome measures including patient-oriented measures in practice (e.g., shared decisionmaking), or development, validation and use of measures that incorporate patient values and preferences.

6. The relationship between processes and outcomes of care, including timing of services.

7. Developing and evaluating measures for outcomes, effectiveness, and cost effectiveness of clinical preventive services for all ages.

8. Analysis of the causes of variations in clinical practice and the use of health care technologies, including the clinical behaviors of primary care and specialty providers, provider training, patient characteristics and preferences, or other factors.

9. Observational studies using Medicare, Medicaid, or managed care data to answer discrete questions related to the outcomes, effectiveness, cost, cost-effectiveness or quality of medical care.

10. The impact of models of undergraduate, graduate, and continuing education on the knowledge, skills, and attitudes of providers and associated patient outcomes.

11. Therapeutic outcomes, including:

a. Relative safety, effectiveness, and cost effectiveness of available pharmaceuticals or combinations of therapies, as well as comparison to other treatment options.

b. Relationships among prescribing decisions, pharmaceutical services, use of prescription drugs, and patient outcomes.

Methodological approaches may include quasi-experimental studies using existing data or experimental studies.

A. Quality Measurement and Improvement. Interests include:

1. Innovative approaches to measuring quality, including the perspectives of providers, patients, and consumers.

2. Methods to identify, understand the causes of, and prevent medical errors and improve patient safety.

3. Adapting existing measures as well as developing and validating new measures for use with diseases, conditions, and procedures and in settings where gaps in knowledge exist, including the impact of co-morbidities on measurement of quality of end-of-life care.

4. General quality measurement methods, including risk and severity adjustment, and methods for measuring functional status and quality of life.

5. Evaluating the kinds of quality improvement systems that promote systemic and sustainable changes in clinical practice to improve the quality of care.

6. Evaluating the appropriateness of different data sources for quality measurement, and development and evaluation of methods for using data to improve quality of care.

7. Describing and testing the effects of (1) computerized decision-support systems, (2) integrated information systems, (3) electronic medical records, (4) internet-based information and consultation for use by patients, and (5) other information technology applications on improving quality of care.

8. Developing and validating methods for changing the behavior of clinicians, provider institutions, employers, plans, and patients to improve quality of care and patient safety.

9. Evaluating strategies for integrating quality measurement and improvement and patient safety into office-based, worksite-based, and primary care settings, as well as acute and long-term care settings.

10. Formulating strategies for improving the delivery of clinical preventive services (CPS), including research on quality measurement for CPS and on system changes in primary care that enhance the access to and quality of CPS.

11. Studies of the impact of public policy and other system changes, and organizational and financial arrangements, on health care quality at the national, State, and subpopulation levels.

12. Developing and evaluating typologies and measurement techniques that allow study of the effects of organizational and communication strategies on quality improvement.

13. Research on patient and consumer issues. AHRQ is particularly interested in: (1) the perceptions of care of priority populations, including those cognitively impaired, institutionalized or living with complex care decisions such as people with chronic illness or disability, including HIV/AIDS, (2) innovative ways to present information on quality to patients and consumers that increase salience, usefulness and use, and (3) strategies to assist patient and consumer communication with health professionals and participation in health care decisionmaking.

B. Evidence-based Practice. Integral to improving quality of care is the development, use, and evaluation of evidence-based tools and information. Interests include:

1. Methods for optimal systematic reviews of evidence, including methodological research on meta-analysis, decision analysis, and cost-effectiveness analysis.

2. Evaluating and comparing different methods to implement evidence-based information and tools in diverse health care settings and/or among practitioners or various populations, including:

a. Assessing the role of organizational structure, capacity, and culture in effective use of the tools.

b. Effectiveness of different types of evidence-based information and specific tools in changing behavior of practitioners, patients, and organizations.

3. Evaluating the effects of specific evidence-based guidelines or other tools on access, utilization, quality, outcomes, costs, and/or patient satisfaction.

4. Studies of the cost effectiveness/cost benefit of important new or existing health care technologies.

5. Assessing the extent to which evidence-based information is used in determinations of medical necessity and coverage decisions.

6. The role of informatics in dissemination of evidence-based information, and its impact on patient and clinician behavior.

7. The role of evidence-based information in the development of informatics tools and information sources, the impact of evidence-based decision making and increasing role of just-in-time information systems, and how evidence is incorporated into these systems.

C. Clinical Preventive Services. Interests include:

1. Interventions to address specific patient barriers to preventive care, with specific focus on vulnerable populations, including older women, who may receive fewer or lower quality services.

2. Interventions to improve quality of screening services, including reducing false-positive and false-negative rates, improving follow-up procedures, and improving patient satisfaction.

3. Improving cost-effectiveness of preventive care through interventions to reduce overuse of services, target interventions more effectively to high-risk groups, or reduce adverse effects and costs of screening (including costs and consequences of followup in persons with positive screening results).

4. Identifying elements of preventive counseling interventions that have greatest impact on behavior change, developing more comprehensive quality measures for counseling services and other preventive care that extend beyond utilization rates.

5. Interventions to improve patient involvement in preventive care and to improve communication between clinicians and patients around screening results.

A. Access, Costs, and Use of Health Services. Interests include:

1. Studies using MEPS and other AHRQ data sources to assess the cost and utilization of health resources (See "AHRQ Data").

2. Examining the impacts of the trends in health care prices, costs, and sources of payment for services on access, expenditures, and outcomes.

3. Developing new and more effective ways to measure the range of health care costs and to organize and analyze data on costs by clinical condition, sociodemographic factors, site of care, and payment sources.

4. Studies assessing the impact of different outreach and social marketing strategies to increase enrollment in public insurance (e.g., Medicaid, SCHIP) among persons eligible for coverage.

5. Assessing the determinants of access to care and strategies to improve access, especially for underserved populations.

6. Developing and using policy-relevant models to simulate and understand behavior governing the use, cost, financing, and organization of care.

B. Organization, Financing, and Delivery. Interests include demonstration studies of major changes in health care markets and studies examining how variations in health care organization, structure, and delivery affect the outcomes, quality, access to, cost, and use of care, such as:

1. New purchasing activities by employers, coalitions, and governments, and their impact on managed care organizations, providers, employees, and communities.

2. The aggregate impact of major changes in public programs and health care markets on health care costs and quality, including the impact on providers and beneficiaries.

3. Dynamics and impact of recent major changes in financial and legal arrangements such as consolidations, conversions to for-profit status, development of national ownership links among facilities, new relationships among acute, subacute, and long-term care facilities, and new methods of sharing financial risk and contracting for services on quality, cost, access, and use of services.

4. The impact of the movement of care from inpatient to outpatient settings, and from nursing homes to home care on cost and outcomes.

5. The effects of disease management and "carve-in" and "carve-out" arrangements on health care costs, accessibility, and quality of care, particularly for persons with chronic conditions.

6. Conceptual models, measures, and financial and organizational factors supporting clinical integration of health care services and studies of the impact of clinical integration on access, quality, and cost of care.

7. The implementation and use of new staffing and other clinic-level configurations, and evaluations of the effectiveness of particular models in improving access, quality, and cost of care.

8. The use of information technology applications in providing and supporting the delivery of health care and their effects on cost, quality, and access.

9. The role of nonfinancial incentives and organizational characteristics, such as organizational structure and culture, in affecting the behavior of health care organizations and units and individuals within them.

10. Evolving definitions of medical necessity used by managed care organizations to determine when and under what circumstances services will be covered, and the impact of different methods and processes for medical decisionmaking by health plans.

Methods can include rigorous qualitative studies as well as quantitative research, and conceptual and methodological as well as empirical work. Research partnerships using private sector data sources, such as managed care data, are particularly encouraged.

C. Primary Care Practice. The characteristics of primary care practice play a crucial role in facilitating access to and use of services, influencing health costs, and the resulting outcomes and levels of quality. Interests include:

1. Characteristics of primary care practice that lead to improvements in outcomes and quality of care.

2. Effective models of organizing, financing, and managing primary care services.

3. Factors that influence access to primary care services, including socioeconomic, cultural, and geographic factors.

4. Optimal delivery of health care, including primary care services, in low-income inner-city and rural areas.

5. Access to and availability of clinical preventive services.

6. Effects of information technology applications in primary care practice, such as computerized decision-support systems, remote monitoring of patient conditions, and electronically secure exchange of patient health data, on access to care and the costs and quality of health care.

7. Clinical decision-making in primary care, including an emphasis on facilitating shared patient-clinician decision-making.

8. Strategies for integrating quality measurement and improvement into office-based, worksite-based, and primary care settings.

9. Strategies for reducing medical errors and improving patient safety in office-based, worksite-based, and primary care settings.

10. Strategies for facilitating the integration of research findings into office-based, worksite-based, and community primary care practices.

11. Improving the quality, value, and access to health care for American workers and individuals with disabilities.

12. Effective strategies in primary care settings for eliminating racial and ethnic disparities in health-related outcomes.

13. Issues related to the outcomes, costs, and delivery of primary care services to the elderly.

14. Improved care for those at the end of life.

15. Organizational and other factors affecting the cost and quality of transitions between ambulatory and other settings, including home, hospital, and long-term care settings.

16. Health care workforce organization, including communication and coordination of services among primary care clinicians and other members of the health care team.

17. The readiness of the health care system, in particular its entry points such as emergency rooms and primary care, to recognize and respond to the effects of exposure to agents of biological or chemical terrorism.

To enhance generalizable results, primary care research demonstrations may involve large data bases or primary care practice-based research networks.

Priority Populations

A number of populations are particularly vulnerable to impaired access to and suboptimal quality of care and experience poor health care outcomes. These groups, which warrant a special focus for health services research, include low-income groups, racial and ethnic minority groups, women, children, the elderly, individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care, and individuals living in inner-city, rural, and frontier areas. Persistent disparities in health status and access to appropriate health care services continue to be documented for certain groups, particularly racial and ethnic minority populations. Gender-based differences in access, quality, and outcomes are also widespread with little understanding of the reasons for these differences. Health services research demonstration projects must do a better job of bringing science-based information to bear on these variations so that effective solutions may be found for improving health.

AHRQ encourages research demonstrations to address population-specific health issues of outcomes, quality, access to, cost, and use of services in each of the Priority Program Areas. Interests include:

Minority Populations

1. Understanding factors that underlie disparities in utilization and outcomes for racial and ethnic minorities including epidemiology, patient preferences and behavior, education, access, health insurance, environment, interactions with the health care system, provider expertise, preferences, and bias.

2. Evaluating effective service delivery methods for eliminating disparities in treatment between minority and non-minority populations.

3. Examining the effect of cultural competence on improving access to and outcomes of care for racial and ethnic minority patients.

4. Eliminating differences in outcomes and health status for racial and ethnic minority populations in six clinical areas: infant mortality, cancer screening and management, cardiovascular disease, diabetes mellitus, HIV, and immunizations for both children and adults (President’s Initiative to Eliminate Racial and Ethnic Disparities in Health).

5. Enhancing meaningful community participation in health services research projects.

Women

1. Assessing the effectiveness of services and treatment approaches for common, high-cost conditions in women in various age, racial/ethnic, and income groups. Research to understand and eliminate inappropriate disparities in health outcomes associated with race or ethnicity, geography, insurance status, or other non-medical factors is particularly needed.

2. Analysis of the cost, use of, and access to primary and specialty health care services among women, including the impact of changes in health systems on women’s health.

3. Developing and assessing women-specific and culturally-appropriate measures of quality, outcomes, and patient satisfaction.

4. Study of health issues related to older women, including the impact of specific clinical and organizational interventions on functional status and quality of life, with special attention given to mediating factors such as co-morbidity, fragmentation of care, and caregiver stress.

5. Research demonstrations on prevention and health services with relevance to particular populations of women, including victims of family violence, lesbian women, and women with HIV/AIDS.

6. Research demonstrations on women and pharmaceuticals, including gender differences in therapeutic outcomes, prescribing practices, occurrence of adverse events, and medical errors.

Children

Dramatic changes are occurring in the organization and financing of children’s health services, however, the knowledge base for guiding these changes or assessing their impact is not well developed.

Researchers are strongly encouraged to include children in all applications and studies, as scientifically and ethically appropriate.

Children’s health care research demonstrations raise some distinct methodological issues that studies are encouraged to address. These include: the need for a development perspective that takes into account the variation and rapid changes in development that are characteristic of children, especially in the neonatal, infancy, early childhood, and adolescent periods, the need for considering a range of perspectives (e.g., child, family, community, society at large), the fact that children generally are much more resilient physically than are older individuals, the need to identify large sample sizes for research with children with specific conditions and/or specific developmental stages, the need to consider the child-relevant range of health care topics (e.g., preventive services through end of life care) and health care settings (including community health clinics, school and other community-based health care delivery sites, ancillary services, as well as health care settings such as community-based offices and hospital inpatient and emergency departments), the fact that many children live in poverty, the need to consider in more detail long-term outcomes and the need for longitudinal research, and ethical issues surrounding the delivery of health care to children (e.g., to adolescents).

Applications with innovative and efficient research designs that can address these child-relevant issues are encouraged. Specific research interests include:

1. The urgent need for outcomes and effectiveness research in many areas of children’s health care is well documented. Specific areas of interest in outcomes and effectiveness research include: 1) developing valid and useful measures of health, functional status, quality of life, satisfaction with care, processes of care, and costs and cost-effectiveness of care applicable to children of different ages and with different health conditions, 2) assessing interventions that are unique to children, and that may involve the children’s caregivers (e.g., health promotion and disease and disability prevention services such as anticipatory guidance and counseling), 3) assessing treatments that are commonly administered to children but that may have been evaluated for safety and effectiveness only in adult populations, 4) documenting long-term effects (or lack thereof) associated with health interventions in populations of mothers, infants, and children, and 5) evaluating costs, benefits, and cost-effectiveness of care to children.

2. The development of quality measures for children that can be used to enhance accountability, support consumer choice, and develop, test, and implement quality improvement strategies in children’s health care.

3. Evidence-based research translation and quality improvement strategies are needed to form the basis of efforts to improve practice at the policy, health systems, and clinical practice levels.

4. The U.S. health care system provides the occasion for many "natural experiments" in organizational and financial arrangements for care.

In addition to examining the effects of these variations and changes on children’s health outcomes (see above), there is a need to continue to carefully examine their impact on quality, cost, use, and access.

5. Local, federal, and private efforts to increase children’s enrollment in Medicaid and the State Child Health Insurance Program (Titles XIX and XXI of the Social Security Act, respectively) can be enhanced by providing an evidence base for effective strategies. There is a critical need for rigorous research on what works in outreach and other strategies.

6. AHRQ encourages researchers to address the needs of children living in inner-city, rural, and frontier areas, low-income children, minority children, female children, and children with special health care needs.

7. AHRQ encourages researchers to include adolescents and the health care settings that are used by adolescents in research about children and children’s health care.

Additional guidance on AHRQ’s previous activities and current interests in children as a priority population can be found in AHRQ’s 1999 GPRA report on children as a priority population (http://www.ahrq.gov/about/gpra2001/gpra01app6.htm) and in AHRQ’s strategic plan for children as a priority population (http://www.ahrq.gov/about/stratpln.htm).

Elderly

Providing health care to the aging U.S. population is one of the most pressing health care challenges confronting the nation. Although the scientific knowledge base exists to extend the years of active life and prevent the onset of disability with age, current clinical practice falls far short in delivering these interventions to older people. The underuse of effective interventions, the overuse of interventions shown to be ineffective, and the misuse of others (especially polypharmacy) have all been well documented in the elderly. There is a need for studies that focus on interventions aimed at reducing well-documented disparities in health status, access, use of services, and health outcomes by gender, race/ethnicity, and socioeconomic status among the elderly. Interests include:

1. Developing cost-effective models of acute, preventive, chronic, rehabilitative, and long-term care delivery (including informal care) that improve the health and functioning of the elderly.

2. Assessing the outcomes and effectiveness of clinical, organizational, and social interventions that improve or delay decline of functional status.

3. Improving our ability to measure change in functioning across the broad range of functional levels for a diverse aging population and developing strategies to incorporate these functional status measures routinely in clinical practice.

4. Understanding the impact of co-morbidities (physical and mental) on disease management, clinical decision-making, preventive care, and health and functional outcomes, and how best to adjust clinical practice to account for them.

5. Assessing models of collaborative care so that patients and their families can be active participants in the decision making process and age bias in clinical decision makings is minimized.

6. Understanding how best to integrate preventive, acute, chronic, and long-term care (formal and informal care), and to coordinate the delivery of care across multiple sites and settings of care, including out-patient, hospital, rehabilitation, sub-acute care, home care, long-term care (institutional and community care), and community-based social services.

7. Understanding the impact of financial incentives (including health-based payments) on health care decisions and their subsequent effect on the health and outcomes of elderly.

End-of-Life Health Care

Further research is needed on how to provide appropriate health services for patients living with fatal or serious chronic illness (such as cancer, stroke, dementia, congestive heart failure, lung failure). While increased life span may be desirable, the goals of medical interventions for these patients also include a greater focus on preventing excess disability and assuring symptom reduction (e.g., pain and dyspnea control) or palliative care. Specific research interests include:

1. Optimal processes for advance care planning.

2. Methods of maximizing connectivity and continuity between different providers and systems of health care (e.g., nursing home, hospice, home care, acute care, ambulatory care).

3. Evaluation of the comparative costs and quality of care at different sites of end-of-life care.

4. Methods of using severity data to identify those patients in need of more extensive services.

5. Studies of ways to expand access to appropriate sites of end-of-life care (e.g., hospice, home or community-based).

6. Research on the financial and social burden of family caregivers.

7. Developing methods to improve joint patient/family/provider decision-making at the end of life.

Research priorities are being developed for the additional populations listed including: individuals living in inner-city, rural, and frontier areas, individuals with special health care needs, individuals with disabilities, and low-income groups.

Emerging Research Interests

Two additional areas of health services research that have become increasingly important in today’s rapidly changing market-driven delivery system are research on methodological advances, especially cost-effectiveness analysis (CEA) and research on ethical issues, which may be related to decisions based on cost effectiveness, but which also cut across the spectrum of health care delivery. Interests include:

A. Cost-Effectiveness Analysis (CEA) and Other Methodological Advances that will enhance the capacity of health services research to provide needed information. Interests include:

1. Producing standardized analytical components (e.g., cost components, general population health profiling, national health utility index, and incidence-based illness burdens) to facilitate the comparability of CEA findings.

2. Exploring the use of CEA as a framework for guiding decisions, both clinical and organizational.

3. Systematic reviews, meta-analyses, and other methods that enhance the generalizability of clinical and other research for application to practice.

B. Ethical Issues raised by changes in the health care delivery system that need to be addressed. Interests include:

1. Studies on ethical issues across the spectrum of health care delivery, including equity in access to all levels of care.

2. Studies on the impact of genomics on the organization and delivery of health services.

3. Studies on changing values regarding the provision of care, from the provision of all possible care without cost considerations, to the provision of less costly care.

4. Studies to emphasize and clarify tradeoffs related to resource allocation and the tension between individual and population or societal needs.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Research Demonstration and Dissemination Grants (R18) award mechanism. The individual researcher sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.

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

Research applications requesting total costs of $100,000 or less should follow the application procedures in the "AHRQ Small Research Grant Program (R03)" PA, published on

June 7, 2006 (http://grants.nih.gov/grants/guide/pa-files/PAR-06-448.html). AHRQ also supports conference and dissertation grants (NIH Guide: AHRQ Small Grant Program for Conference Support (R13), November 18, 2005 (http://grants.nih.gov/grants/guide/pa-files/PA-06-074.html); AHRQ Grant Program for Large Conference Support (R13 & U13), April 28, 2006 (http://grants.nih.gov/grants/guide/pa-files/PA-06-378.html); and, AHRQ Grants for Health Services Research Dissertation (R36), January 13, 2006), (http://grants.nih.gov/grants/guide/pa-files/PAR-06-118.html).

2. Funds Available

Because the nature and scope of the proposed research 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. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

The total costs awarded under this FOA will not exceed $300,000 annually for the entire project period. Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation report. An application with a budget that exceeds $300,000 total costs per year will be returned without review.

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:

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Foreign institutions may participate in projects as members of consortia or as subcontractors only. 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.

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.

2. Cost Sharing or Matching

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

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and their 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

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

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

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 9, 2007
Application Submission/Receipt Dates: http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Dates: June, October, February annually
Earliest Anticipated Start Dates: August, December, April annually

3.B. Submitting an Application Electronically to AHRQ

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

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.

Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.

If the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and AHRQ. Incomplete or non-responsive applications will be returned without review.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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

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

Use of CMS Data

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

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

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

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will be returned without review.

APPENDIX MATERIALS

IMPORTANT NOTE: NIH and AHRQ have published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

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

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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, non-institutionalized 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.

This does not preclude the use of secondary data sources or primary data collection.

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:

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

Scientific merit of the proposed project as determined by peer review.

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.

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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does the proposed demonstration project address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the demonstration project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Is the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed demonstration projects benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

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:

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

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Required Federal Citations, below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See item 7 of the Research Plan, component of the SF 424 (R&R)).

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 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 RFA will also be obtained and managed in accordance with 42 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.aspe.hhs.gov/admnsimp/ or 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, for 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 7 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 via email notification from the awarding component to the grantee business official.

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 to you 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 the award statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Public Health Service (PHS) Grants Policy Statement, found at http://grants.nih.gov/grants/policy/gps/index.html.

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 for these progress reports.

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

A final Progress Report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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 Contacts:

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

Direct your questions regarding specific program matters to the offices listed below by specific program areas:

Public Health Preparedness
Sally Phillips, R.N., Ph.D.
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1571
[email protected]

Data Development
Doris Lefkowitz, Ph.D.
Center for Financing, Access, and Cost Trends
301-427-1477
[email protected]

Chronic Care Management
David Atkins, M.D.
Center for Outcomes and Evidence
301-427-1608
[email protected]

Socio-Economics of Health Care
Claudia Steiner, M.D, M.P.H.
Center for Delivery, Organization, and Markets
301-427-1407
[email protected]

Joel Cohen, Ph.D.
Center for Financing, Access, and Cost Trends
301-427-1659
[email protected]

Health Information Technology
Jon White
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1171
[email protected]

OR

Carol Cain
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1622
[email protected]

Quality and Safety of Patient Care
Marge Keyes
Center for Quality Improvement and Patient Safety
301-427-1333
[email protected]v

Long Term Care
D.E.B.Potter, M.S.
Center for Financing, Access, and Cost Trends
301-427-1564
[email protected]

William Spector, Ph.D.
Center for Delivery, Organization, and Markets
301-427-1446
[email protected]

Pharmaceutical Outcomes
Scott R. Smith, R.Ph., Ph.D.
Center for Outcomes and Evidence
301-427-1511
[email protected]

Clinical Prevention
Therese Miller, DrPh.
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1585
[email protected]

Training and Career Development
Karen Rudzinski, Ph.D.
Office of Extramural Research, Education, and Priority Populations
301-427-1529
[email protected]

Questions regarding AHRQ priority populations should be directed as follows:

Minority Health and Health of Inner City and Low Income Populations
Francis Chesley, M.D.
Office of Extramural Research, Education, and Priority Populations
301-427-1449
[email protected]

Children's Health
Denise Dougherty, Ph.D.
Office of Extramural Research, Education and Priority Populations
301-427-1868
[email protected]

Populations with Disabilities
Harvey Schwartz, Ph.D.
Office of Extramural Research, Education, and Priority Populations
301-427-1552
[email protected]

Women's Health

Francis Chesley, M.D.
Office of Extramural Research, Education, and Priority Populations
301-427-1449
[email protected]

Rural Populations Health
Ronda Hughes, Ph.D. R.N.
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1578
[email protected]

Older Adult Health
William Spector, Ph.D.
Center for Delivery, Organization, and Markets
301-427-1446
[email protected]

Populations Needing End of Life Care
Ronda Hughes, Ph.D.
Center for Primary Care, Prevention, and Clinical Partnerships
301-427-1578
[email protected]

2. Peer Review Contact(s):

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education, and Priority Populations/Division of Scientific Review
301-427-1556
[email protected]

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to:

Joan Metcalfe
Director, Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20852
Telephone: 301/427-1450
Fax: 301/427-1462
[email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

Investigators may obtain copies from the above sources or from the NIH Guide Web site 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 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.

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