Participating Organization(s)	Agency for Healthcare Research and Quality (AHRQ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.
Components of Participating Organizations	Agency for Healthcare Research and Quality (AHRQ)
Funding Opportunity Title	Exploratory and Developmental Grant to Improve Health Care Quality through Health Information Technology (IT) (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	Reissue of PAR-08-269
Related Notices	May 10, 2017 - New AHRQ "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-HS-17-015. September 29, 2016 - Notice to Extend PA-14-001. See Notice NOT-HS-16-020. May 18, 2016 - Advancing the Collection and Use of Patient-Reported Outcomes and Patient Contextual Data to Improve Quality and Outcomes in Ambulatory Care through Health Information Technology. See Notice NOT-HS-16-015. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number	PA-14-001
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.226
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to fund exploratory and developmental research grants that will contribute to the evidence base of how health IT improves health care quality. This FOA supports the use of a wide variety of research designs in order to generate information regarding the design and development, implementation, use, or impact of health IT on quality. Depending on the research design and intent of the project, applicants may receive support for: (1) pilot and feasibility or self-contained health IT research projects; (2) secondary data analysis of health IT research; or (3) economic (prospective or retrospective) analyses of a health IT project. Each grant application must clearly state which type of the three types of studies is being proposed. This FOA is focused on five research areas of interest that are needed to support health care quality and are considered part of a continuous quality improvement process. The five research areas of interest for this FOA are: 1. Design 2. Implementation 3. Use 4. Impact on outcomes 5. Measurement Each application must clearly state at least one primary research area to be addressed. These five research areas are more fully discussed in Section I below.

Posted Date	November 13, 2013
Open Date (Earliest Submission Date)	November 15, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Generally, four months after receipt date
Advisory Council Review	Not Applicable
Earliest Start Date	Generally, four months after peer review date
Expiration Date	New Date February 17, 2017 per issuance of NOT-HS-16-020. (Original Expiration Date: November 17, 2016 )
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Health information technology (IT) is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management. Health IT can support patient care related activities such as order communications, results reporting, care planning, and clinical or health documentation.1 Health IT applications or systems can use a variety of platforms, such as desktop computers, tablet computers, cellular phones, smart phones, touch screen kiosks, and others. Examples of health IT applications or systems include electronic health records (EHRs),2,3 electronic medical records (EMRs),2,3 telemedicine,4,5 computerized provider order entry (CPOE),6 computerized clinical decision support (CDS) systems,7 consumer health informatics applications (including personal health records [PHRs]),8,9 and electronic exchange of health information.10-12

Health IT applications or systems of interest to AHRQ under this funding opportunity announcement (FOA) must support patient care related activities as outlined above. For the purposes of this FOA, the following types of applications or systems are NOT considered health IT:

• Administrative systems (e.g., billing or scheduling systems), research databases, and non health-related information systems (e.g., geographic information system);
• Health Web sites, videos, or other applications that are not supported by an information system or information processing;
• Devices (e.g., medical devices, radiology or imaging technology, automated or computer assisted surgical equipment or procedures, sensor technology, and video game consoles or systems); and
• Forms, surveys, questionnaires, or data collection instruments converted into electronic format.

Grant applications proposing studies regarding these types of applications or systems will be considered non-responsive and will not be reviewed.

In addition, grant applications that propose to use health IT to conduct other types of health services research (e.g., patient safety or patient-centered outcomes research), but do not propose to conduct health IT research, will be considered non-responsive and will not be reviewed. For example, grant applications proposing to use data from an electronic medical record system as a source for a patient-centered outcomes research project or a project that proposes to conduct a survey on medication-related adverse events and uses a patient portal to recruit study participants, are not considered to be conducting health IT research. Rather, these proposed projects are conducting other health services research, patient-centered outcomes and patient safety research respectively, and not research on the use of health IT to support patient care delivery activities as described above.

The use of health IT has been demonstrated to improve health care quality.13-18 Specifically, several studies and systematic reviews of the literature show that health IT can be used to support chronic disease management, adherence to clinical guidelines, and increased appropriate preventive screening.19 When appropriately integrated into workflow, health IT can improve efficiency and even save time.19,20 Some health IT applications or systems have also resulted in increased patient, caregiver, and provider satisfaction.18 Use of health IT has also been associated with improvement in patient safety,19 by reducing errors, as well as improved cost-effectiveness.18,19

In addition, the evidence base shows that there are certain types of health IT applications or systems, functionality, and attributes that can positively impact use and effectiveness.13,16 There is also evidence of facilitators and best practices in both design and implementation of health IT; and health care setting and patient factors that are associated with increased use and impact on outcomes.13,16,19 For example, integrating new functionality or new health IT applications or systems with existing or related systems (e.g., integrating laboratory and pharmacy systems) can facilitate use.13,19 Health IT that includes features that support health work (both for health care teams, and for patients and/or caregivers), and that is well-integrated to clinical and patient workflow has been associated with positive impact on health care outcomes.13,16,19,21 Effective training can also positively impact adoption and use of health IT.22

However, there are still gaps in the health IT evidence base as these findings cannot be generalized to all types of heath IT applications or systems, all care settings, all user groups, or all care processes. For example, there are issues in systems design that can impact the use and effectiveness of health IT. Newly implemented health IT applications and systems are not always as seamlessly integrated to existing systems, leading to inefficiencies and workarounds.19 Interface design and functionality, when not well-designed, can negatively impact usefulness and may increase workload.19 In addition, overly complex systems can impact use and some systems negatively impact provider workflow and workload by, for example, inefficiently transferring responsibilities among care team members.19,20 Additional limitations of some health IT implementation approaches and other barriers to use are documented in the literature.16,19,23,24

There have been calls for additional user involvement in health IT design and evaluation.25 Health IT research needs to be conducted in health care settings and/or with user groups for which adoption and use lag. Examples include but are not limited to long-term care settings or patients and caregivers. There is also a need for further development of demonstrated best practices in design and implementation of health IT,26 and to better understand which effective health IT designs can lead to higher adoption and use, and improved outcomes. Additional research studies are needed that explicitly include sociotechnical context as part of health IT design and evaluation.20,25,26 Health IT has had inconsistent impact across different process outcomes and it is important to understand why. Finally, additional research is needed to better understand the impact of health IT on workflow and workload, efficiency, economic, and health or clinical outcomes.13,19,20,27,28

References

1. Shortliffe EH, Cimino JJ. Biomedical Informatics: Computer Applications in Health Care and Biomedicine. 3rd ed. New York: Springer; 2006.

2. Garets D, Davis M. Electronic Medical Records vs. Electronic Health Records: Yes, There is a Difference: Healthcare Information and Management Systems Society (HIMSS); 2006.

3. National Alliance for Health Information Technology (NAHIT). Report to the Office of the National Coordinator for Health Information Technology on Defining Key Health Information Technology Terms: Department of Health and Human Services (DHHS); 2008.

4. AHRQ National Resource Center for Health IT. Telehealth. http://healthit.ahrq.gov/telehealth. Accessed June 27, 2013.

5. American Telemedicine Association. What is Telemedicine? http://www.americantelemed.org/learn/what-is-telemedicine. Accessed June 27, 2013.

6. AHRQ National Resource Center for Health IT. Computerized Provider Order Entry. http://healthit.ahrq.gov/cpoe. Accessed June 27, 2013.

7. AHRQ National Resource Center for Health IT. Clinical Decision Support. http://healthit.ahrq.gov/cds. Accessed June 27, 2013.

8. AHRQ National Resource Center for Health IT. Consumer Health IT Applications. http://healthit.ahrq.gov/consumerit. Accessed June 27, 2013.

9. Tang PC, Ash JS, Bates DW, et al. Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. J Am Med Inform Assoc 2006 13:121-6.

10. AHRQ National Resource Center for Health IT. Health Information Exchange. http://healthit.ahrq.gov/hie. Accessed June 27, 2013.

11. Office of the National Coordinator for Health IT. Health Information Exchange (HIE): What is HIE? http://www.healthit.gov/providers-professionals/health-information-exchange/what-hie. Accessed June 27, 2013.

12. American Health Information Management Association. Health Information Exchange. http://www.ahima.org/resources/hie.aspx. Accessed June 27, 2013.

13. Lobach D, Sanders GD, Bright TJ, et al. Enabling Health Care Decisionmaking Through Clinical Decision Support and Knowledge Management. Evidence Report No. 203. AHRQ Publication No. 12-E001-EF. Rockville (MD): Agency for Healthcare Research and Quality; 2012.

14. McKibbon KA, Lokker C, Handler SM, et al. Enabling Medication Management Through Health Information Technology. Evidence Report/Technology Assessment No. 201. AHRQ Publication No. 11-E008-EF. Rockville (MD): Agency for Healthcare Research and Quality; 2011.

15. Gibbons MC, Wilson RF, Samal L, et al. Impact of Consumer Health Informatics Applications. Evidence Report/Technology Assessment No. 188. AHRQ Publication No. 09(10)-E019. Rockville (MD): Agency for Healthcare Research and Quality; 2009.

16. Jimison H, Gorman P, Woods S, et al. Barriers and Drivers of Health Information Technology Use for the Elderly, Chronically Ill, and Underserved. Evidence Report/Technology Assessment No. 175. AHRQ Publication No. 09-E004. Rockville, (MD): Agency for Healthcare Research and Quality; 2008.

17. Chaudhry B, Wang J, Wu SY, et al. Systematic review: impact of health information technology on quality, efficiency, and costs of medical care. Ann Intern Med 2006;144(10):742-52.

18. Marcin, JP. Telemedicine in the Pediatric Intensive Care Unit. Pediatr Clin North Am 2013;60(3):581-92.

19. Karsh, B-T. Clinical practice improvement and redesign: how change in workflow can be

supported by clinical decision support. AHRQ Publication No. 09-0054-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2009.

20. Carayon P, Karsh B-T, Cartmill RS, et al. Incorporating health information technology into workflow redesign--summary report. (Prepared by the Center for Quality and Productivity Improvement, University of Wisconsin Madison, under Contract No. HHSA 290-2008-10036C). AHRQ Publication No. 10-0098-EF. Rockville, MD: Agency for Healthcare Research and Quality. October 2010.

21. Lau F, Price M, Boyd J, et al. Impact of electronic medical record on physician practice in office settings: a systematic review. BMC Med Inform Decis Mak 2012;12:10.

22. McAlearney AS, Robbins J, Kowalczyk N, et al. The role of cognitive and learning theories in supporting successful EHR system implementation training: a qualitative study. Med Care Res Rev 2012;69(3):294-315.

23. Mair FS, May C, O'Donnell C, et al. Factors that promote or inhibit the implementation of e-health systems: an explanatory systematic review. Bull World Health Organ 2012;90(5):357-64.

24. McGinn CA, Grenier S, Duplantie J, et al. Comparison of user groups' perspectives of barriers and facilitators to implementing electronic health records: a systematic review. BMC Med 2011;9:46.

25. B langer E, Bartlett G, Dawes M, et al. Examining the evidence of the impact of health information technology in primary care: an argument for participatory research with health professionals and patients. Int J Med Inform 2012;81(10):654-661.

26. Black AD, Car J, Pagliari C, et al. The impact of eHealth on the quality and safety of health care: a systematic overview. PLoS Med 2011;8(1):e1000387.

27. Bolton CE, Waters CS, Peirce S, et al. Insufficient evidence of benefit: a systematic review of home telemonitoring for COPD. J Eval Clin Pract 2011;17(6):1216-22.

28. McKibbon KA, Lokker C, Handler SM, et al. The effectiveness of integrated health information technologies across the phases of medication management: a systematic review of randomized controlled trials. J Am Med Inform Assoc 2012;19(1):22-30.

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As one of the agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services.

AHRQ’s Health IT Portfolio develops and disseminates evidence about the effectiveness of health IT on health care quality and evidence-based tools on how to use health IT to improve health care quality. To accomplish this, the Portfolio:

• Anticipates the future needs of the health care system and supports development of innovative health IT solutions;
• Identifies and fills current gaps in knowledge about health IT; and
• Leverages the capability of health IT to improve the quality, safety, efficiency, and effectiveness of health care.

AHRQ’s Health IT Portfolio has invested in research grants and contracts awarded to over 178 distinct institutions in 47 States and the District of Columbia. The AHRQ Health IT Portfolio disseminates findings from these research projects via its Web site, which also documents the progress of the Portfolio’s research grants and contracts. More information about AHRQ s Health IT Portfolio can be found at http://healthit.ahrq.gov.

The purpose of this FOA is to fund exploratory and developmental research grants that will contribute to the evidence base of how health IT improves health care quality.

This FOA supports the use of a wide variety of research designs in order to generate information regarding the design and development, implementation, use, or impact of health IT on quality. These research projects may generate preliminary information and/or results necessary for future health IT research projects. They may involve new, ongoing, or completed (in the case of retrospective data analysis) health IT research activities. These grant applications must demonstrate how findings of the research project will inform the conduct of future health IT research activities.

Depending on the research design and intent of the project, applicants may receive support for: (1) pilot and feasibility or self-contained health IT research projects; (2) secondary data analysis of health IT research; or (3) economic (prospective or retrospective) analyses of a health IT project. Each grant application must clearly state which type of the three types of studies is being proposed.

• Pilot and feasibility or self-contained health IT research projects: These types of projects should be designed to inform development of future health IT applications or systems, improvement on existing health IT applications or systems, strategies for health IT implementation in actual care delivery settings, and/or the conduct of future health IT research. Pilot and feasibility projects can include proof of concept studies, testing or evaluation of new health IT applications or systems, or improvements to existing health IT applications or systems. Self-contained health IT research projects should be designed to study a well circumscribed challenge in health IT design, implementation, or use; or the use of health IT to support quality measurement. Self-contained health IT research projects can also include preliminary or preparatory work such as needs assessments as well as development or validation of research methodology.

Grant applications that will be evaluating the effectiveness of a new or revised health IT application or system should consider these utility and process redesign factors as primary outcomes or potential confounders depending on study design:

1. Usefulness of the health IT application or system,

2. The health IT application’s or system s usability,

3. The presence and quality of associated care process redesign, and

4. The effectiveness and efficiency of associated care process management systems in the health IT design process.

Otherwise, justification of why it is not feasible or appropriate to consider these factors as primary outcomes or confounders should be provided.

Applicants should be able to appropriately describe how the research findings will inform future health IT research. Applicants must also address the relevance of their proposed project to AHRQ’s Health IT Portfolio and its research areas of interest, described below under Research Areas of Interest.

For pilot and feasibility or self-contained health IT research projects, the project director/principal investigator (PD/PI) is not expected or required to be extensively published or have prior experience in a leadership capacity in the conduct of a research project.

• Secondary data analysis of health IT research: These types of projects should be designed to generate insight regarding facilitators and barriers to the effectiveness of health IT applications or systems related to the design, implementation, or use of health IT to improve health care quality. The proposed project should focus on the evaluation of factors (e.g., setting characteristics, workflow, integration with previously implemented health IT systems) that enhance or limit effectiveness and impact of health IT on outcomes. Grant applications featuring secondary data analysis may be related to, but must be distinct from, the specific aims of the original data collection and analytical plan. A proposed study may test new hypotheses or synthesize existing data derived through AHRQ-funded studies or collected elsewhere. Grant applications must identify the source of the data; discuss the completeness, reliability and accuracy of the data; and demonstrate that the proposed analysis is distinct from previously funded activities.

Additional information may be collected through the R21 project to supplement the dataset being used for the secondary analysis. Such data collection must be well-described and justified. For example, the duration of the initial research project may have been too brief to collect all relevant data for the evaluation of the health IT application or system. An applicant may wish to collect limited additional data on the outcome measures of interest.

Applicants must address the relevance of their proposed secondary analysis to AHRQ’s Health IT Portfolio and its research areas of interest, described below under Research Areas of Interest.

• Prospective or retrospective economic analyses of a health IT project: These types of projects should be designed to conduct sound economic evaluations of health IT projects. Health IT prospective or retrospective economic analyses should feature an evaluation of financial and non-financial costs and benefits of a health IT project.

The costs and benefits of designing, implementing, and using health IT can be both qualitative and quantitative. Health IT-related costs may include, but are not limited to: initial hardware and/or software investments; incremental costs in hardware and/or software upgrades to support health IT functionality; initial and ongoing technical support of health IT implementation and use; maintenance costs; costs for training users; workflow redesign; lost work time while transitioning to an electronic system; and unintended workflow or health care consequences due to implementation and use of health IT. Benefits may encompass different aspects of health care delivery that can be impacted by a particular health IT implementation such as job satisfaction, quality of health care provided, or measurable impact on productivity or quality improvement indicators. Grant applications must clearly state which benefits and costs will be included in the proposed economic analysis.

Economic analyses should consider to whom the benefits accrue and address to the extent possible both the direct and indirect costs and benefits of implementation and use of health IT. Economic analyses may emphasize any of the following: 1) factors that influence the quality and efficiency of health IT implementation and optimization of functionality; 2) cost-benefit, cost-effectiveness, or cost-utility analyses; or 3) assessments of health IT implementation costs and organizational productivity and efficiency.

Given the potential lag time in accrual of benefits and/or costs attributable to the implementation of health IT, applicants proposing to conduct retrospective economic analyses are encouraged to consider conducting their evaluation based on data obtained for an appropriate period of time to reflect overall costs and benefits of health IT use.

Prospective or retrospective economic analysis projects must focus on a specific health IT project. The specific health IT project need not have been funded by AHRQ and can be an ongoing or a concluded health IT project.

Applicants must address the relevance of their proposed economic analysis to AHRQ’s Health IT Portfolio and its research areas of interest, described below under Research Areas of Interest.

Effective health IT applications or systems should support delivery of high quality care and their design and implementation should be part of quality improvement processes. Ideally, health IT applications or systems should be implemented as part of a planned quality improvement effort in which careful consideration has been given to the goals of the quality improvement effort and how health IT will help support it. Health care requires complex information management. As such, successful health IT applications or systems will need to support a diversity of tasks conducted both by care teams in clinical settings and by patients and caregivers outside of formal health care settings. In addition, health IT applications or systems may be used to enable new models of care and redesign care processes that support both care delivery to individual patients as well as population health management.

Accordingly, this FOA is focused on five research areas of interest that are needed to support health care quality and are considered part of a continuous quality improvement process. Each grant application must clearly state at least one primary research area to be addressed. Given the breadth of each of these research areas and the limitation on time and financial resources of a single R21 grant, one project is not expected to single-handedly address all elements of each research area; and given the potential overlap across research areas, grant applications may want to address multiple areas in one project. Each applicant must, therefore, articulate 1) the extent to which a specific project would generate knowledge regarding elements of a particular research area(s); 2) how that knowledge would advance the field of health IT; and 3) how that knowledge would inform future health IT research. Health IT applications and systems should be designed and implemented with consideration to user needs to promote effective use and positive impacts on outcomes and measurement. If focusing on research areas of interest 2 through 5, applicants must demonstrate they have conducted the necessary preliminary research in each of the previous areas of interest listed below as appropriate.

The five research areas of interest for this FOA are:

1. Design: System design includes understanding current information needs and related processes; user needs, goals, and motivations; and the environments and context in which the health IT application or system will be used. Understanding of these issues can then be used to establish functional requirements, as well as developing and testing system specifications and designs. AHRQ is interested in research projects that address issues with the design of health IT identified in the literature. This may include incorporating innovative or successful approaches from other fields to the design of health IT. In addition, there is a need to identify health IT design factors that may lead to less than optimal use and which may limit the effectiveness of health IT and impact on outcomes.

2. Implementation: Implementation includes the steps needed to make the health IT application or system operational, including conducting training and testing before go-live. Research is needed regarding best practices in health IT implementation and their relationship to health IT adoption and use, and outcomes, including barriers and facilitators to implementation. It is also important to identify how implementation processes may need to vary based on the care process, care setting, end users, and/or type of health IT application or system being implemented.

3. Use: This includes factors that lead to increased adoption and use, and how those factors may vary by care process, care setting, end users, and/or type of health IT application or system being implemented. There is a need to characterize drivers and barriers to use of health IT as well as understanding how health IT is used once implemented and the implications for design and quality improvement. Additional research is also needed regarding optimal levels of use of health IT systems, particularly for consumer health IT applications, and impact on other aspects of care due to use of a health IT application or system.

4. Impact on outcomes: This includes understanding whether the health IT implementation goals were achieved and the impact of the implementation on different types of outcomes. There is a need to also understand what moderates that impact and which outcomes can actually be impacted by the health IT application or system based on its functionality and design. AHRQ is particularly interested in understanding the impact of health IT on the priorities listed below as well as addressing gaps regarding the impact on workflow and workload, efficiency, economic, and health or clinical outcomes:

a. Making care safer by reducing harm caused in the delivery of care;

b. Ensuring that each person and his/her family or caregivers are engaged as partners in their care;

c. Promoting effective communication and coordination of care;

d. Promoting the most effective prevention and treatment practices for the leading causes of mortality;

e. Working with communities to promote wide use of the best practices to enable healthy living; and/or

f. Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.

5. Measurement: Central to the use of health IT to support quality improvement is the ability to enable quality measurement using health IT. Quality measurement can both support health care providers and other members of their care team in providing effective and efficient care, as well as health care organizations to understand overall performance. Further research is needed regarding how to best leverage health IT to support quality measurement activities.

AHRQ’s priority is to fund projects that will fill known gaps in the field. Applicants must demonstrate they are addressing a known gap in health IT research, as evidenced in the health IT literature (as described, for example, in the AHRQ-funded evidence reports available at: http://www.ahrq.gov/research/findings/evidence-based-reports/services/health-it/index.html), with regards to how health IT does or does not improve health care quality. Grant applications submitted in response to this FOA must be designed to elucidate what it is about a given health IT application or system and its design or implementation that may or may not have led to improved quality of care.

While not a primary interest of the AHRQ Health IT Portfolio, grant applications focused on the testing or evaluation of new health IT applications or systems or revisions of an existing health IT application or system must demonstrate a unique need for the proposed new or revised health IT application or system, and must discuss how developing or further revising the health IT application or system will fill a gap in the field of health IT as discussed above. Applicants must present a demonstrated need for a new or revised health IT application or system beyond stating that a health IT application or system has not been developed for a particular population, condition, setting, care process (aspect of care), or provider group; and must discuss how the proposed health IT application or system or significant revision to the health IT application or system will address deficiencies on previously developed or currently existing health IT applications or systems including those previously funded by AHRQ (available at http://healthit.ahrq.gov/portfolio) or described in the literature.

See Section IV.2 (Content and Form of Application Submission) for instructions on the required and requested fundamental features of a research application.

AHRQ’s Health IT Portfolio provides an integrated continuum of health IT-focused FOAs to achieve measurable improvements in quality and safety of health care. These FOAs are designed to offer applicants opportunities to receive incremental support for the conduct of progressively more complex health IT research projects and include: Exploratory and Developmental Grants (R21) and Research Project Grant Programs (R01s). The program also includes opportunities for training and the acquisition of individual research skills (R36, K08).

Highlights of this FOA and the others are available at http://healthit.ahrq.gov/healthitfoas. Information about all AHRQ funding announcements is available at http://www.ahrq.gov/funding/index.html. Health IT-focused applications may also be submitted to apply for research funding under Agency-wide funding opportunities. Please consult the specific FOAs or notices for further information.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications. AHRQ is interested in funding projects of varying sizes and lengths.
Award Budget	The total costs (direct and indirect) for a project awarded under this FOA will not exceed $200,000 in any given year or $300,000 for the entire project period. An application with a budget that exceeds any of these limits will not be reviewed.
Award Project Period	The scope of the proposed project should determine the project period. The project period may not exceed 2 years.

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services and with respect to health care technologies.

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

You may submit an application(s) if your institution/organization is a (an):

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Units of local or State government;
• Eligible agency of the Federal government.
• Indian/Native American Tribal Government (Federally recognized)
• Indian/Native American Tribal Government (Other than Federally recognized);
• Indian/Native American Tribally Designated Organization.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account and should work with his/her organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

Only one PD/PI may be designated on the application.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

A letter of intent is NOT required for this funding opportunity.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

• NOTE: For this specific FOA, the Research Strategy is limited to 12 pages.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Personnel:
  • An eligible project director/principal investigator (PD/PI) may come from a variety of areas including, but not limited to: nurses, pharmacists, medical doctors, health service researchers, economists, health system administrators, health IT experts, industrial and systems engineers, or human factors professionals. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.
  • The PD/PI is expected to contribute a minimum of 20% effort annually throughout the course of the grant. If less time is allocated, an explicit justification of the lower level of effort must be included.
  • The PD/PI for a pilot and feasibility or self-contained research project is not expected or required to be extensively published or have prior experience in a leadership capacity in the conduct of a research project.
  • At least one person on the proposed research team must possess health IT expertise.
  • Multidisciplinary research teams are strongly encouraged as appropriate to conduct a project.
  • Research team members must describe their proposed role and why their experience and qualifications make them well-suited for this role in the Personal Statement section of their biographical sketch. For proposed research team members for whom biographical sketches are not required, grant applications must describe their proposed role and why their experience and qualifications make them well-suited for this role in the in the Budget Justification.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Software, Hardware, and/or Equipment Purchases: Combined purchases for software, hardware, or any other equipment needed to conduct the project are expected to be less than 20% of the total direct costs of the project over the duration of the project. These purchases may include modest incremental software development to enable implementation of existing health IT in a new setting or to improve health IT functionality. If funds for such purchases are in excess of 20% of overall total direct costs budgeted for the duration of the project, an explicit justification must be included.

Budget Component: Special Instructions for AHRQ 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 not be reviewed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

Specific Aims:

• The proposed project’s specific aims, research design, and analytical plan (including fully detailed power calculation estimate(s) as appropriate) should be well-matched to one another and sufficiently detailed.
• Applicants must clearly state which of the three types of studies they are proposing to conduct and which research area of interest the proposed research will address.

Research Strategy:

• Background and Significance: Grant applications must articulate well the gap in the literature or the field that needs to be addressed through the conduct of this research project and provide a justification regarding the significance of the project. Grant applications must also describe how the research results will inform future health IT research.
• Theoretical Framework:
  • Grant applications must be well-grounded in conceptual or theoretical framework(s) and indicate the appropriateness of the research question and likelihood for the study to generate insight.
  • There are documented challenges to achieving successful implementation and use of health IT; many of these challenges are associated with design, organizational, or behavioral considerations. Therefore, use of organizational, human factors, industrial and systems engineering, and/or behavioral theories in addition to traditional health care and analytical theories and frameworks are encouraged as appropriate.
• Research Design and Methods:
  • There is no intrinsic preference for any one study design. Rather, applicants should consider a wide range of scientific methods, including both quantitative and qualitative methods. The study design and analytical plan should be well-justified and consistent with the specific aims and study type.
  • Grant applications must describe in sufficient detail the process and clinical outcome measures to be used, if any.
  • If the focus of the proposed study is to test or evaluate a new health IT application or system, end users (e.g., health care providers, staff, patients, or caregivers) should be involved in the design, development, and/or selection of the health IT application or system and their involvement should be described in the grant application. Similarly, end users perspective regarding the use and/or utility of the health IT application or system should be sought. Otherwise, justification of why it is not feasible or appropriate to incorporate end users in the design process should be provided.
• Health IT Intervention:
  • If the focus of the proposed study is to test or evaluate a new or revised health IT application or system, the grant application must demonstrate a unique need for the proposed new or revised health IT application or system, and must discuss how developing or further revising the health IT application or system will fill a gap in the field of health IT. Applicants must present a demonstrated need for the new or revised health IT application or system beyond stating that a health IT application or system has not been developed for a particular population, condition, setting, care process (aspect of care), or provider group; and must discuss how the proposed health IT application or system or significant revision to the health IT application or system will address deficiencies on previously developed or currently existing health IT applications or systems including those previously funded by AHRQ (available at http://healthit.ahrq.gov/portfolio) or described in the literature.
  • In addition, the grant application must include detailed descriptions of the specific health IT application(s) or system(s) being developed, tested, implemented, and/or revised and support services for each. To the extent there is a previously implemented health IT application or system in the care setting of interest, such as an EHR system, applicants should describe this, and specify whether or not the new or revised health IT application or system would interface with it during the course of the research period or subsequently.
• Additional Requirements for Secondary Data Analysis of Health IT Research:
  • Identify the institution that received the initial grant or contract; provide the title and number of the grant or contract, if funded by Department of Health and Human Services (DHHS); and, present the original study period and specific aims. Pooling of data from more than one previous health IT research study is allowed, as long as all sources are fully identified. The research project that generated the data need not have been supported by AHRQ. The PD/PI for the R21 application need not be the same as the PD/PI for the project that generated the data to be analyzed.
  • Secondary data analyses must clearly demonstrate that the proposed research is related to, yet distinct from, the previous research project.
  • Describe the completeness, reliability and accuracy of the data; specify the extent to which there are missing data and how they will be handled; indicate the fee associated with purchasing the data, if any; the date by which the data will be available; and demonstrate that the data are in the possession of the PD/PI, and if not, provide letters of support indicating access to the data.
  • It may be appropriate for additional information to be collected through the R21 project to supplement the dataset being used for the secondary analysis. As such, applicants should describe and justify the new data to be collected.
• Additional Requirements for Economic Analysis of a Health IT Project:
  • Identify the institution that received the initial grant or contract or conducted (or is conducting) its own health IT project; provide the title and complete award number of the grant or contract, if it was funded by Department of Health and Human Services (DHHS); and, present the original study period and specific aims. Pooling of data from more than one previous health IT research study is allowed, as long as all sources are fully identified. The project that generated the data need not have been supported by AHRQ. The PD/PI for the R21 application need not be the same as the PD/PI for the initial or ongoing health IT project.
  • Describe the completeness, reliability and accuracy of the data; specify the extent to which there are missing data and how they will be handled; indicate the fee associated with purchasing the data, if any; the date by which the data will be available; and demonstrate that the data are in the possession of the PD/PI, and, if not, provide letters of support indicating access to the data.
• Dissemination:
  • AHRQ does not expect the findings from these exploratory or developmental research grants to be generalizable in a national sense. However, grant applications should specify how findings will inform the conduct of future health IT research activities.
  • Applicants should anticipate that some dissemination activities will be conducted in cooperation with AHRQ contractors responsible for monitoring project progress and/or updating content on the Health IT Web site, http://healthit.ahrq.gov. Awardees are required to cooperate fully with AHRQ staff and contractors, in promoting their work and findings. Activities that awardees may engage in with AHRQ contractors on for the duration of their grant may include:
    • Reviewing a project description or profile that a contractor develops for publication on the Health IT Web site and providing timely feedback;
    • Providing brief, high-level quarterly updates on the progress of the grant; and
    • Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, and so that the contractor(s) can update the project profile on an annual basis.
• Privacy and Security Protections in the Development and Implementation of Health IT Systems:
  • From its earliest investments in health IT research activities, AHRQ has emphasized the importance of the privacy and security of personal health information to engender individual trust in the use of health IT applications and systems. Without this trust in a health IT application or system, patients and other users (e.g., clinicians, caregivers) will not use it fully, and as a result system data may be inaccurate or incomplete. As a result, the potential for quality and safety improvement from investments in health IT will be lost. More importantly, assuring privacy and security are values patients and clinicians should expect and receive from the health care system.
  • Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information. New concerns arise, such as who has access to and use of electronic data, how electronic data are stored and kept secure, patient access to an accounting of certain health information disclosures, patient consent requirements for sharing information electronically, the ability of patients to decline participation in electronic data collection, patient access to audit trails or logs, and informing patients of any security breaches.
  • Stakeholder groups have promulgated policies in order to assure patient awareness of, comfort with, and participation in, electronic data collection, use, and disclosure. While privacy and security solutions are not intended to be the focus of projects under this announcement, health IT interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://www.healthit.gov/sites/default/files/GovernanceFrameworkTrustedEHIE_Final.pdf and http://www.healthit.gov/sites/default/files/nationwide-ps-framework-5.pdf).
  • Distinct from a Plan for Protection of Human Subjects, grant applications must contain a Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems. Near the end of the Research Strategy, applicants must insert the header, Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems. In this section the applicant must identify if it is necessary to have a Privacy and Security Protections Plan in place to conduct the research project. If it is not necessary, a justification must be provided. If a plan is required, the Research Strategy section of the grant application must contain a concise summary of the planned resources and processes to be used to address privacy and security issues in the design, implementation, and/or use of the health IT intervention.
  • A full description of the plan for Privacy and Security Protections must be included in Appendix A, unless a justification for not needing a plan has been included in the grant application. The appendix must describe how, in the design, implementation, and/or use of the health IT intervention, privacy and security concerns related to the exchange of personal health information will be identified and addressed. The appendix should describe the resources and processes the applicant will use to assure that these privacy and security concerns are being met throughout the project period. These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.
  • The adequacy of the Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems will be assessed by the peer review panel. AHRQ reserves the right to request clarification on the Plan for Privacy and Security Protections prior to funding.
• Project Administration:
  • Grant applications must fully address the administration of the project. This is especially crucial for teams necessitating the coordination of multiple team members efforts across disciplines, institutions, and geographic regions.
  • Grant applications must include a detailed project timeline.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following additional instructions:

• Appendix A: Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems

If a "Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems," is required as described under PHS 398 Research Plan Research Strategy instructions above, a full description of the Privacy and Security Protections must be included in Appendix A.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
The PD/PI must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete and/or non-responsive will not be reviewed.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://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.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules, if applicable, 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 applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

Applicants are required to follow our Post Submission Application Materials policy.

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. Only the review criteria described below will be considered in the review process.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on health services research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does this grant application demonstrate that an important challenge or gap in the health IT literature or health IT field will likely be addressed through the conduct of this study or lead to future research activities that would? Does this study address one of the health IT research areas of interest to AHRQ? Does the grant application adequately recognize and describe the limitations in the generalizability of the results? Does the grant application adequately demonstrate how findings will inform the conduct of future health IT research activities?

Investigator(s)

Is this a new PD/PI? Are the PD/PI, collaborators, and other researchers appropriately trained and well-suited to carry out this work? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Is there adequate PD/PI support allocated throughout the research period or a well-justified reallocation of leadership during the course of the research project when the PD/PI’s effort is less than the suggested 20% annual level? Does the research team include at least one team member with health IT expertise? Does the grant application include a multidisciplinary research team drawing from diverse fields? Does the grant application demonstrate the investigators aptitude to identify and address weaknesses encountered during the conduct of the research project? Does the grant application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduct of the proposed study?

Innovation

Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies; or combine common research elements in an innovative fashion? If the research elements are not novel, would the project generate much-needed insight to inform future health IT research activities or inform the field of health IT, as appropriate?

Approach

Are the theoretical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the grant application reflect an adequate understanding of the factors related to design, implementation, and use of health IT that may impact its effectiveness? If focusing on research areas of interest 2 through 5, does the grant application demonstrate the necessary preliminary research in each of the previous areas of interest has been conducted as appropriate? If proposed, how appropriate are the process and clinical outcome measures to be used?

For grant applications featuring pilot and feasibility or self-contained health IT research projects that focus on the testing or evaluation of new or revised health IT applications or systems, is adequate justification provided for the need to develop or revise the health IT application or system? To what extent are end users (e.g., health care providers, staff, patients, or caregivers) directly involved in the design, development, and/or selection of the health IT application or system, or is adequate justification of why their involvement is not feasible or appropriate provided? Is their involvement adequately described in the grant application and appropriate for the proposed study design? To the extent that health care providers, staff, patients, and/or caregivers are directly involved in the design, implementation, or use of the health IT application or system, is their perspective regarding the use and/or utility of the health IT application or system sought or an adequate justification of why such information is not feasible or appropriate provided? As appropriate, are the 1) usefulness of the health IT application or system, 2) the health IT application’s or system s usability, 3) the presence and quality of associated care process redesign, and/or 4) the effectiveness and efficiency of associated care process management systems in the design process considered as factors in the study or as primary outcomes or confounders, or an adequate justification of why it is not feasible or appropriate to do so provided?

For grant applications featuring secondary data or economic analyses, are the reliability, validity, completeness, and availability of the data adequately discussed? If the applicant is proposing to pool data from more than one previous health IT research study or project, are all sources clearly and fully identified?

For grant applications featuring secondary data analyses, is the proposed project designed to generate insight regarding facilitators and barriers to the effectiveness of health IT applications or systems related to the design, implementation, or use of health IT to improve health care quality? Does the proposed project focus on the evaluation of factors that enhance or limit effectiveness and impact of health IT on outcomes? Has the applicant demonstrated that the proposed project is distinct from the specific aims of the original data collection and analytical plan? If the applicant is proposing to collect additional data to supplement the dataset being used for the secondary analysis, is the proposed data collection well-described and justified?

For grant applications featuring economic analyses, is the proposed project designed to conduct sound economic evaluations of a health IT project? Is the proposed prospective or retrospective economic analysis focusing on a specific health IT project and is this health IT project well-described? Does the grant application adequately consider appropriate financial and non-financial costs and benefits? Does the grant application adequately consider appropriate financial and non-financial costs and benefits? Are the benefits and costs to be included in the proposed economic analysis clearly stated in the grant application and well-justified? Does the economic analyses consider to whom the benefits accrue and address to the extent possible both the direct and indirect costs and benefits of implementation and use of health IT as appropriate?

Environment

Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the grant application adequately demonstrate multiple levels of engagement and support from individual health care providers, staff, and institutions?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Privacy and Security Protections in the Development and Implementation of Health IT Systems

Is a section entitled Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems included in the Research Strategy section of the grant application? Has the applicant identified if it is necessary to have a Privacy and Security Protections Plan in place to conduct the research project? If the applicant states such a plan is not necessary, is adequate justification provided? If a plan is necessary, has the applicant adequately described the privacy and security policies and features of the health IT application or system being designed, implemented, or used in the proposed study? Has the grant application adequately described the process for identifying and addressing privacy and security issues related to the exchange of personal health information and encouraging the involvement of patients to the extent appropriate? Has the grant application adequately considered patient access to an accounting of certain health information disclosures, patient consent process for sharing information electronically, ability for patients to decline participation in electronic data collection, patient access to audit trails or logs, and patient notification of security breaches?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Degree of Responsiveness

Reviewers will assess how well the application addresses 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? How well does the grant application address the purpose and objectives of this FOA? To what extent is the proposed project an exploratory or developmental research study that will contribute to the evidence base of how health IT improves health care quality?

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements ).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research. Is the budget allocation for purchase of health IT hardware, software, and support appropriate and well-justified? Is the budget allocation for purchase of health IT software, hardware, and support less than 20% of the total direct costs of the project over the duration of the project? If not, is appropriate justification provided for exceeding the 20% limit on these costs?

Resubmissions

For Resubmissions (formerly "revised/amended" applications), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Not Applicable

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

- Receive a written critique

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ portfolio priorities, as well as overall programmatic balance.

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

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

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the Notice of Award.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

Not Applicable

AHRQ strongly encourages grantees to submit quarterly reports on project status, lessons learned, and challenges encountered. This will support AHRQ’s mission and enable AHRQ to tailor its interactions with grantees to be most supportive of the individual projects in the Health IT Portfolio and to be able to evaluate the Health IT Portfolio.

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

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

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 does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Amy Lindinha
Health IT Program
Telephone: 301-427-1505
E-mail: HealthITFunding@ahrq.hhs.gov

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

Kishena C. Wadhwani, Ph.D., M.P.H.
Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov

Direct your questions regarding fiscal matters to:

Brian Campbell
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1266
Fax: (301) 427-1462
E-mail address: Brian.Campbell@ahrq.hhs.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.