Funding Opportunity Announcement (FOA) 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 at http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.
Healthy People 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" at http://www.health.gov/healthypeople/.
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.
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
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 http://healthdata.gov/. For the conduct of applicable longitudinal analyses, consideration should also be given to use of linked MEPS-NHIS data.
HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids' Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants' use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
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 (http://www.ahrq.gov/funding/grants/policies/informedconsent/index.html) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
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 (https://talkingquality.ahrq.gov/) and AHRQ's guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and 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.
More HELP and Answers to Frequent Questions related to electronic submission of grant applications can be found at: http://grants.nih.gov/grants/ElectronicReceipt/index.htm.
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 of Focus
Within the mission, AHRQ's specific priority areas of focus are:
- Improve health care quality by accelerating implementation of Patient Centered Outcomes Research (PCOR).
- Make health care safer.
- Increase accessibility by evaluating expansions of insurance coverage.
- Improve health care affordability, efficiency and cost transparency.
These areas, relevant to R01, R18, and R03 grant applications submitted to AHRQ, are described in greater detail below.
Priority #1. Improve Health Care Quality by Accelerating Implementation of PCOR
AHRQ seeks research that will to help improve the health and health care of all by accelerating the use of evidence about 'what works, for whom, under what circumstances' into clinical practice and health care policy development. Research should focus on ensuring that patients and their families, health care professionals, and health care policy makers have the information they need in order to make informed health care decisions and are able and empowered to use it.
Specifically, AHRQ areas of research interest include:
- Demonstrating the effectiveness of synthesizing, translating, and communicating complex scientific evidence to facilitate informed care planning and health care decision making by patients, families, and health care professionals at the individual level and informed policy decision making at the health system and population level.
- Discovering, testing, and spreading techniques 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 ambulatory care settings.
- Improving 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 support clinical and organizational improvement.
- Developing the methods underlying the fields of evidence synthesis, stakeholder and patient engagement, decision making, and practice improvement.
Priority #2. Make Health Care Safer
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. Patient safety research initiatives can be considered in three different stages:
- Identification of risks and hazards.
- 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., PAs, RFAs, and SENs) and (2) encourages investigators to utilize the Agency's general funding announcements to apply this research framework in response to other patient safety threats.
The Patient Safety Portfolio will support research projects to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care. The Portfolio will also support projects that mitigate those risks and hazards, 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 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 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; diagnostic error; the safe use of medical devices and medications; the role of Patient Safety Organizations (PSOs); the relationship between medical liability and patient safety; and the challenges inherent in transitions of care and handoffs between health care providers.
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.
Priority #3. Increase Accessibility to Health Care
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 health insurance coverage requires information on the ease with which health insurance transitions are made and how satisfied individuals are with their plans and issues of affordability.
Understanding how policies will affect the evolution of health insurance markets and the health insurance landscape continues to be important issues for study. For example, innovations in health insurance markets, such as the newly created Health Insurance Marketplaces and minimum standards for plans, are important developments to be analyzed. Issues of particular interest include: the relationship between changing health insurance markets and structural changes in the American workplace, especially in light of recent changes in the economy; analyses to assist in the implementation of and improve our understanding of the impact of health care reform on coverage, access and affordability; and the effects of changes in health insurance benefits on consumers' financial burdens and access to care
AHRQ is engaged in efforts to provide evidence on the effects of health insurance coverage expansions on the health and financial security of the uninsured, on labor markets, on health care providers, particularly those in the safety net, and on employer and employee decisions with respect to employer-sponsored insurance. New evidence generated from this initiative will assist federal and state policy makers and private payers with assessments to help them make key decisions in these areas. Attention will be given to improving our understanding of the causes and consequences of lack of insurance, and the effects of health insurance expansions on access to care, utilization of health care, health care spending, affordability and health outcomes.
AHRQ encourages grant applications that propose research that focuses on the topics of health insurance coverage, access to care and health care costs with specific emphasis in the following areas:
- What is the impact of Medicaid and Marketplace coverage expansions on enrollment, access, health care use and expenditures, healthcare disparities, affordability and outcomes?
- What methods are most effective in assisting eligible people to understand coverage options in the Marketplace and to enroll in Medicaid?
- How are the decisions that employers and employees make about employer-sponsored coverage (for both large and small employers), such as those related to plan characteristics, offer and take-up rates, affected by the ACA?
- To what extent does churning of coverage – between Medicaid and the Marketplace, and between being insured and uninsured – create challenges for continuity of care, and what sorts of community-level responses have been most successful in mitigating those challenges?
- How has the ACA affected the overall structure of the insurance market, including the availability of and enrollment in different types of plans and the mix of employment related versus individual coverage?
- What effect has the ACA had on changes in cost-sharing arrangements and the composition of provider networks, and what effects, if any, have these changes had on access to care, patient outcomes, and health care expenditures?
- How do reimbursement and financing mechanisms affect health care expenditures?
- How do tax incentives affect coverage decisions and the level and distribution of health care expenditures and financial burdens?
- What reimbursement and financing mechanisms are effective in controlling health care costs without having adverse effects on quality and access?
- How will changes in the demographics of the population affect health care access, coverage decisions and health care expenditures?
Priority #4. Improve Health Care Affordability, Efficiency, and Cost Transparency
Producing evidence that can be used to increase the affordability, efficiency and cost transparency 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.
- What micro and macro factors have led to the overall changes in national health care cost growth? What is the impact of consolidation and other market changes on the cost and price of health care in particular markets? What is the impact on health care performance, disparities, and safety net facilities?
- How well have Integrated Care Models and their associated reimbursement models (e.g. bundled payments) actually integrated care and reduced costs, readmissions, and post-acute care utilization?
- What is the impact of health IT innovation and health information exchanges on costs?
- What is the extent and cause of geographical variation in costs, quality and utilization?
- How can we improve methods of measuring the cost and outcome of new technologies, procedures, or drugs? What advances can be made in outcome and cost modeling? How can we improve methods of measuring overutilization? How can we best assess the impact of the Choosing Wisely campaign or other provider-based strategies to reduce overutilization? How can we best assess the impact of new malpractice tort reforms on costs and defensive medicine?
Comparing Performance of Systems and Providers: AHRQ is interested in funding research that will allow comparison of delivery system and provider performance by health care stakeholders such as consumers, providers, payers, insurers, and policymakers.
- How do different types of delivery systems compare on performance? Under what circumstances, and with what success, do systems include public health providers or non-medical service providers?
- What structural, functional (including clinical), financial, and operational features are associated with higher performance? What are the factors that most strongly differentiate higher performing from lower performing systems?
- What metrics best measure the performance between and within systems for different audiences such as consumers, payers, and providers, and how can these metrics be improved?
Incentives for Improving Performance: The Affordable Care Act, Federal and state regulations, and public and private payers have provided a variety of financial and nonfinancial incentives to improve the performance of health care providers and systems.
- How do different financial incentives affect health care market structures and system and provider performance? What impact do different types of incentive structures have on disparities in care? How are behavioral economic approaches such as "nudges" or choice architecture being used to affect provider or consumer decisionmaking, and with what effect?
- What non-financial incentives, such as price transparency, public performance reporting for consumers, private performance feedback reports to physicians, and professional norms, work to improve system performance, and under what circumstances?
- When and how do consumer financial incentives, such as provider tiering, reference pricing, and high-deductible health plans affect consumer decisionmaking and the quality or affordability of care?
Interventions to Improve Performance: While alignment with external incentives is very important, it is the provider or system that implements interventions to increase efficiency, while maintaining or improving affordability, quality, equity, and access, and reducing disparities. Interventions may be localized to a lone provider or system, but may also be undertaken on a regional or national scale such as through quality collaboratives or specialty societies.
- What interventions have been most successful in improving performance and why? What conditions are necessary for implementing these interventions? Are there particular factors to consider when designing interventions involving safety net providers?
- How readily can successful interventions be adapted and implemented by systems and providers operating under different conditions?