Funding Opportunity Announcement (FOA) Guidance

• AHRQ Research Priorities
• AHRQ Grants Policy and Guidance

AHRQ Research Priorities

AHRQ Mission

The AHRQ mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used.

AHRQ's Research Priority Areas

1. Research to improve health care patient safety.
2. Harnessing data and technology to improve health care quality and patient outcomes and to provide a 360-degree view of the patient.
3. Research to increase accessibility and affordability of health care by examining innovative market approaches to care delivery and financing.

Research to Improve Health Care Patient Safety

Patient safety is defined as the freedom from accidental or preventable injury produced by health care as well as the practices that create a safe environment of care. The ultimate goal of AHRQ-supported Patient Safety research is to improve the safety of health care delivery. Patient safety research initiatives that lead to this goal can be considered in three different stages:

• Identification of risks, hazards, and patient harm.
• Design, implementation, dissemination and spread, and evaluation of interventions to improve patient safety.
• Establishment of strategies to sustain patient safety improvements such as just culture, incident/event reporting, measurement, monitoring, and surveillance.

AHRQ's Patient Safety Research Program: (1) identifies specific areas of focus through targeted grant funding announcements (i.e., Program Announcements, Requests for Applications, and Special Emphasis Notices) and (2) encourages investigators to utilize the Agency's general funding announcements to apply this research framework in response to other patient safety threats and opportunities for improvement.

The Patient Safety Portfolio will support research projects to create new knowledge by identifying the risks, hazards, and harm encountered by patients as a result of health care. The Portfolio will also support projects that mitigate those risks, hazards, and harm including the design, implementation and evaluation of strategies (patient safety practices) and the adaptation, refinement, and sustainment of those strategies. These initiatives are part of the Agency's overall mission to improve the quality of health care.

AHRQ encourages an interdisciplinary, systems science patient safety approach. In addition to health services research, perspectives from organizational theory, human factors, industrial engineering, facilities design, education, and other disciplines can be incorporated in research plans.

Projects may address important topics such as: the surveillance, measurement, detection, and reporting of patient safety events; the impact of human performance, work flow, and working conditions on patient safety; the patients' role and contribution to patient safety; health care safety culture, leadership, communication, teamwork, and simulation; prevention and control of healthcare-associated infections (HAIs); diagnostic safety and quality; the safe use of medical devices and medications, including safely prescribing opioids; the role of Patient Safety Organizations; and the challenges inherent in transitions of care in the same setting and between settings and handoffs between health care providers.

Research related to the prevention and control of HAIs is an instructive example of AHRQ’s Patient Safety research interests. AHRQ supports research whose short-term or long-term aim is to develop improved methods for preventing HAIs and to develop effective implementation strategies for HAI prevention in all health care settings. Accordingly, AHRQ’s foci of interest in HAI research are the following broad areas:

• Determination of the clinical efficacy and effectiveness of preventive interventions, including unintended adverse consequences.
• Characterization and assessment of relevant epidemiological aspects of HAIs, including but not limited to patient risk factors, clinical presentation, and sources of antibiotic-resistant organisms involved in the development of HAIs.
• Demonstration, dissemination, and evaluation of strategies and approaches for prevention and reduction of HAIs.
• Research regarding adoption and implementation (including sustainment, spread, and scale-up) of evidence-based approaches for prevention of HAIs.

The HAI research portfolio also encompasses generation of knowledge for combating antibiotic resistant bacteria. AHRQ is interested in studies to promote appropriate antibiotic use, reduce the transmission of resistant bacteria, and prevent HAIs in the first place. The last contributes to antibiotic stewardship by avoiding the need for antibiotic therapy and precludes the possibility of a resistant infection.

Clinical investigations that seek to establish the efficacy or effectiveness of preventive interventions, as noted above, typically involve a comparison of the intervention in question to routine care or, less frequently, to a placebo (when the latter is ethical). Such clinical studies are included in the scope of AHRQ’s HAI research portfolio. The HAI Portfolio does not fund comparisons of two interventions of known efficacy or effectiveness to determine which is more efficacious or effective. Such studies are comparative effectiveness research, which is more appropriately funded by other funding sources.

The Portfolio supports research in all health care settings including the hospital, long-term care, ambulatory care, home health care, pharmacy, and transitions of care between settings.

Patient safety research involves many stakeholder groups including patients, families, clinicians, non-clinical health care staff, policymakers, payers, and health care organizations including providers and accreditors, local and State governments, and the Federal Government, Patient Safety Organizations, and many others.

Projects in this area may also address patient characteristics that might influence the risk of experiencing a patient safety event. For example, attributes of AHRQ's priority populations that can impact patient safety and address strategies to address barriers to safe care.

Harnessing Data and Technology To Improve Health Care Quality and Patient Outcomes and To Provide a 360-Degree View of the Patient

AHRQ is interested in research to: advance the methods of evidence synthesis to ensure scientific rigor and unbiased reviews, make evidence-based recommendations on clinical preventive services, conduct research on how health information technology can improve the quality of health care, advance the science of clinical practice improvement, evaluate and support innovative models of practice transformation in primary care and other ambulatory settings, and facilitate communities of learning to promote the implementation of evidence for practice improvement. Further, AHRQ is interested in studying and improving upon the process by which health systems and ambulatory care practices select evidence to implement and how to determine what strategies are used to implement the evidence into everyday practice. The study of implementation strategies and processes is critical because interventions developed in the context of publically funded efficacy and effectiveness trials are rarely scalable without adaptations to specific settings and additional tools and guidance to support uptake and implementation. AHRQ is also interested in research that advances whole-person, 360-degree care especially those with multiple chronic conditions and/or socioeconomic disadvantage. Whole person, 360-degree care is defined as the coordination of health, behavioral health, intellectual/developmental disabilities, and social services in a person-centered manner with the goals of improved health outcomes and more efficient and effective use of resources in the context of people’s lives and the communities they live in. Emphasis is on the orientation of the health care team to consider all domains of a person’s life when assessing and addressing needs. The following lists examples of AHRQ research priorities:

Improving health care quality outcomes by providing integrated, coordinated whole-person, 360-degree care to optimize individual and population health outcomes:

• Generation of knowledge about how clinical teams can most effectively elicit and use a patient’s values; preferences; and personal, social, and clinical context to formulate and use plans of care in partnership with patients, caregivers, and families. Preferences, values, and context may be specific to the situation and also can change over time. Therefore, proposals that address how the process of care planning and the care plans themselves will identify and respond to the specific and dynamic nature of patients’ circumstances are of interest.
• Development of information and data to create/foster/support partnerships and linkages between health care and human service systems (community-based organizations and public health) to improve whole-person care. These could be focused on improving care coordination and strengthening care transitions ensuring that care is fully integrated to support the whole person and family.
• Improvement of health care quality through the use of information systems and data resources that both provide meaningful clinical decision support to health care professionals and patients and families at the point of care and that capture important actions and outcomes of health care to increase evidence on effective practices and support clinical and organizational improvement.
• Implementation of clinical prevention guidelines into learning health systems with innovative ways to include patients’ preferences and values in order to empower whole person-centered care.
• Development and study of models of shared decisionmaking that are tailored to the needs of disadvantaged populations.
• Development of whole-person care research to improve health and health services efforts in persons with multiple chronic conditions.
• Development, implementation, and evaluation of models of primary care for individuals with complexity including multiple chronic conditions, disability, and socioeconomic disadvantage that improve individual and population health while reducing disparities.

 Implement research findings in order to accelerate the spread of evidence-based practices by:

• Implementation of evidence-based approaches to identify, understand, and overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines.
• Research on de-implementation of the use of health system procedures and clinical practices that are ineffective, have been prematurely widely adopted, or are harmful or wasteful.
• Development of a parsimonious set of meaningful measures to evaluate implementation and impact of whole-person care.
• Development of innovative ways to use data and health information technology (IT) in primary care practices in order to increase uptake and implementation of preventive services, especially those involving behavioral change (e.g. obesity prevention, substance use prevention).
• Development of methods underlying the fields of evidence synthesis, stakeholder and patient engagement, decisionmaking, and practice improvement.

Accelerating the ability of health care organizations to evolve as learning health systems that effectively apply data and evidence to improve patient outcomes by:

• Synthesizing, translating, and communicating complex scientific evidence to facilitate informed care planning and health care decisionmaking by patients, families, and health care professionals at the individual level and informed policy decisionmaking at the health system and population level.
• Discovering, testing, and spreading methods and strategies for health care practice improvement to improve health care quality, including accelerating the sustainable implementation of evidence-based practice. AHRQ has particular interest in practice improvement in primary care and ambulatory settings.
• Demonstrating the effectiveness of synthesizing, translating, and communicating complex scientific evidence to facilitate informed care planning and health care decisionmaking by patients, families, and health care professionals at the individual level and informed policy decisionmaking at the health system and population level.

Research to Increase Accessibility and Affordability of Health Care by Examining Innovative Market Approaches to Care Delivery and Financing

Producing evidence that can be used to increase the affordability and efficiency of health care for all Americans is a major AHRQ priority. Potential research areas and questions include but are not limited to the following:

Reducing Cost Growth: In order to make health care more affordable, we must understand the drivers of those costs and their growth, as well as the relationship between cost and quality.

Comparing Performance of Systems and Providers: AHRQ is interested in research that will allow comparison of delivery system and provider performance by health care stakeholders such as consumers, providers, payers, insurers, and policymakers.

Incentives for Improving Performance: Public and private payers have provided a variety of financial and nonfinancial incentives to improve the performance of health care providers and systems. AHRQ is interested in research on the impacts of these changes—both intended and otherwise—as well as how to improve incentive programs.

Interventions to Improve Performance: While alignment with external incentives is very important, it is the provider or system that implements interventions to increase performance. AHRQ is interested in research on how interventions to improve quality or cost are best implemented within and spread across providers and systems.

Access to health insurance coverage remains a critical public policy issue. Health insurance helps people get timely access to medical care and protects them against the risk of expensive and unanticipated medical events. Accurate and informed public policy analysis and policy design require precise estimates of the size and composition of the insured and uninsured populations, as well as information on how demographic characteristics, economic factors and health insurance subsidies affect health plan eligibility, decisions to enroll in health insurance plans and trends in health care expenditures and affordability. Evaluation of the equity and stability of the health insurance market requires information on the ease with which health insurance transitions are made and how satisfied individuals are with their plans, as well as the affordability of coverage.

Understanding how changes in policy affect the evolution of health insurance markets and the health insurance landscape is an important area for study. For example, innovations in health insurance markets, such as the increasing use of high-deductible health plans or changes in the cost-sharing structure of plans, are important developments to be analyzed. Other issues of interest include the relationship between changing health insurance markets and structural changes in the American workplace; analyses to improve our understanding of the impact of health care reform on coverage, access, and affordability; and evaluating the effects of changes in health insurance benefits on consumers' financial burdens and access to care.

AHRQ is engaged in efforts to provide evidence related to topics such as health insurance coverage, access to care and health care costs. Potential research areas and questions include, but are not limited to:

• What is the impact of Medicaid and private health insurance coverage changes on enrollment, access, health care use and expenditures, health care disparities, affordability. and outcomes?
• What methods are most effective in assisting people to understand health insurance coverage options and to enroll in coverage?
• How will changes in the demographics of the population affect health care access, coverage decisions, and health care expenditures?
• What factors affect the decisions that employers and employees make about employer-sponsored coverage, such as those related to plan characteristics, offer, and take-up rates?
• What is the impact of health IT innovation and health information exchanges on costs?

AHRQ's Interests in Comparative Effectiveness Research

AHRQ informs the research community of priorities for comparative effectiveness research (CER). CER is research that compares and evaluates the benefits and risks of two or more health care options. CER projects that seek to compare different ways of organizing and delivering health care are a priority for AHRQ. These studies may consider health outcomes, patient and family experience, staff satisfaction, and health care utilization among other research outcomes. CER proposals that seek to compare the clinical effectiveness of specific medications and treatments, diagnostic tools, technologies, procedures, surgeries and other specific preventive, diagnostic, or therapeutic services are not a priority of AHRQ.

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AHRQ Grants Policy and Guidance

Human Subjects Protection

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

Standards for Privacy of Individually Identifiable Health Information

The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, is administered and enforced by the HHS Office for Civil Rights (OCR). The OCR Web site 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.

Access to Research Data Through the Freedom of Information Act

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance  which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020".

Use of CMS Data

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

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

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

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

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts.

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

Publication Transmittal

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 (OC) 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 OC 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 OC 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 OC a brief plan describing how the product will be publicized. An OC staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

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

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

Use of HCUP, MEPS, and Other Surveys

Applicants are encouraged to use relevant AHRQ, HHS, and federal and non-federal public and private data resources to support these research efforts. Examples of such data may be the MEPS (Medical Expenditure Panel Survey), HCUP (Healthcare Cost and Utilization Project), National Health Interview Survey (NHIS), Medicare and Medicaid data resources, and other Departmental data resources. For the conduct of applicable longitudinal analyses, consideration should also be given to use of linked MEPS-NHIS data.

HCUP

HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes four nationwide databases, the Nationwide Inpatient Sample (NIS), the Kids' Inpatient Database (KID), the Nationwide Emergency Department Sample (NEDS), and the Nationwide Readmissions Database (NRD), as well as three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). Select for more information on HCUP.

MEPS

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample. 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.

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

Health Literacy

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

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

Accessibility Provisions for All Grant Application Packages and Funding Opportunity Announcements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws  or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ's TalkingQuality Web site and AHRQ's guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

E-Submission Basics:  Some Quick Tips and Reminders

• Watch out for form fields required by NIH that are not marked required on federal-wide forms (e.g. Credential for PD/PIs and Organization for all entries on R&R Sr/Key Person Profile form; primary site DUNS on Project/Performance Sites form).
• Use PDF format for all attachments. Follow PDF Guidelines.
• Submit early—days, not minutes—to allow time to correct unforeseen errors.
• Track your submission in eRA Commons. Email can be unreliable.
• Check your entire assembled application image in eRA Commons. If you can't view it, we can't review it!
• If federal system issues threaten your on-time submission you need to notify the help desk and follow the Guidelines for Applicants Experiencing System Issues.

Select for more HELP and Answers to Frequent Questions related to electronic submission of grant applications.

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