Part I Overview Information

Department of Health and Human Services

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

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

Title: Exploratory and Developmental Grant to Improve Health Care Quality through Health Information Technology (IT) (R21)

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

Announcement Type
This is a new Funding Opportunity Announcement (FOA).

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

• November 13, 2013 - This PAR has been reissued as PA-14-001.
• May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
• August 9, 2012 - See Notice NOT-HS-12-011. Change in Scientific Contact Information.
• August 7, 2012 - See Notice NOT-HS-12-010. This Notice extends the expiration date.
• October 6, 2011 - See Notice NOT-HS-12-001. This Notice extends the expiration date as indicated below by one year.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.
• February 1, 2010 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.
• December 4, 2008 - See Notice (NOT-HS-09-002) Technical Assistance Conference Call for Applications to AHRQ’s Health Information Technology Funding Opportunity Announcements.

Program Announcement (PA) Number: PAR-08-269

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: September 25, 2008
Opening Date: January 16, 2009 (Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Expiration Date: Now expiring November 19, 2013, (Previous Expiration November 14, 2013 per issuance of PA-14-001) (Extended to November 17, 2013 per NOT-HS-12-010), Previously (New Date November 17, 2012 per NOT-HS-12-001), Originally November 17, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to support short-term preparatory, pilot or feasibility studies that will inform larger scale real world health IT implementation and use or the conduct of more comprehensive health IT implementation research.
• Research Areas. This FOA is focused on three research areas of interest:
  1. Health IT to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies;
  2. Health IT to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care; and,
  3. Health IT to improve health care decision making through the use of integrated data and knowledge management.

Each application must clearly identify one of these research areas as the primary research area to be addressed. These three research areas are more fully discussed in Section I.1 below.

• Settings. Applications responsive to this FOA must focus on implementation of health IT in one or more of the following care settings: ambulatory setting(s); transitions in care between ambulatory settings; or transitions in care between an ambulatory setting and non-ambulatory setting. For the purposes of this FOA, ambulatory care settings include: health care clinician offices; outpatient clinics; outpatient mental health centers; outpatient substance abuse centers; urgent care centers; ambulatory surgery centers; community-based, school, or occupational health centers; safety-net clinics; pharmacies; homes; independent living centers; and, long-term residential care facilities.

Applications that feature health IT implementation in a non-ambulatory setting, such as a hospital, skilled nursing facility, or inpatient mental health facility for purposes other than facilitating transitions in care to and from an ambulatory setting will be considered non-responsive to this FOA and will not be reviewed.

• Mechanism of Support. This FOA will use the AHRQ Exploratory/Developmental Research Project (R21) grant mechanism.
• Other AHRQ-Sponsored Health IT FOAs: This FOA runs in parallel with a continuum of AHRQ-sponsored health IT FOAs: Small Research Grant to Improve Healthcare Quality through Health IT (R03) (PAR-08-268); Utilizing Health IT to Improve Healthcare Quality (R18) (PAR-08-270); and, Special Emphasis Notice articulating AHRQ’s support of health IT-oriented career development and dissertation research grants (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-014.html). For further information, please see below in Section I Overview of Current AHRQ Health IT FOAs.
• Funds Available and Anticipated Number of Awards. The total amount awarded and the number of awards will depend upon the mechanism, number, quality, duration, and costs of the applications received.
• Budget and Project Period: Total costs (direct costs and associated indirect costs) are limited to $300,000 for a project period that may be up to two years. A maximum of $200,000 in total costs may be budgeted in a given year. An application with a budget that exceeds any of these limits will not be reviewed.
• Application Research Strategy Length: The R21 Research Strategy section may not exceed 20 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Organizations: Institutions/organizations listed below in Section III, 1.A are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for AHRQ support.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions: Applicants may submit up to two revised applications, known as a resubmission. See Section III.3 (Other-Special Eligibility Criteria) for further information.
• Renewals: Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background: Use of Health IT

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. AHRQ achieves this mission by supporting a program of health services research and by working with partners to promote improvements in clinical and health systems practice that benefit patients.

Health 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 (Shortliffe, 2006). Health IT applications can use a variety of platforms, such as desktop computer applications, cellular phones, personal digital assistants (PDAs), touch screen kiosks, and others. Examples of health IT applications are electronic health records (EHR), electronic medical records (EMR), personal health records (PHR), telemedicine, clinical alerts and reminders, computerized provider order entry, computerized clinical decision support systems, consumer health informatics applications, and electronic exchange of health information.

The use of health IT has been demonstrated to improve health care in large health care delivery systems. Yet there has been limited diffusion of health IT in other care settings, where the majority of health care services are provided, and in transitions between care settings e.g., movement of patients between health care providers and settings (DesRoches, 2008; Bates, 2005; Bodenheiner, 2008; Coleman, 2004).

Even when health IT is available in an ambulatory setting, its usefulness may be limited due to lack of awareness of its functionality, insufficient training of users, inadequate considerations of workflow issues (such as integration to existing workflow and coordination between settings or staff), concerns regarding security of the data on the system, cost considerations, or other challenges. Characteristics of the practice setting, such as number of clinicians, have been shown to influence health IT adoption (DesRoches, 2008; Hing, 2007; Bates, 2005). There also appears to be significant variability in the extent to which individual physicians and practices use, or are even aware of, the range of functions of their EMRs (Hing, 2007; Simon, 2007; Jha, 2006).

Successful implementation of health IT in health care systems is in part dependent on the recognition of the varying roles and perspectives of individuals and organizational culture in the deployment process (Kaplan, 2001). Nurses and other staff often provide critical support in the successful implementation of health IT. The identification of the barriers and facilitators of successful use of health IT at the individual and organizational levels may require the application of both health care and industrial and systems engineering expertise along with other academic disciplines such as sociology, psychology, social psychology, social anthropology, human factors, organizational development, management, administration, and economics (Lorenzi, 1997).

Patients and their caregivers share an increased responsibility for managing their health (Tang, 1997). The field of consumer health informatics focuses on providing consumers, patients and their caregivers, health information directly through computers and other telecommunication systems (Eysenbach, 2000). Meeting patients and caregivers increased need for health information may improve communication between health care providers, patients, and their caregivers. This may enhance patients abilities to self-manage chronic conditions and enhance their ability to follow treatment, medication, and monitoring regimens. Through improved control of disease there may be increased functionality and quality of life and fewer exacerbations of chronic conditions that necessitate emergency room visits and hospitalizations.

The body of literature regarding successful implementation of health IT in non-traditional ambulatory settings, such as in homes, residential settings, and various types of community centers, is underdeveloped. Successful health IT implementation in these ambulatory settings may provide much-needed tools to improve health care for various vulnerable populations including the elderly (Chang, 2004).

AHRQ s Health IT Portfolio

AHRQ s Health Information Technology (IT) Portfolio is part of the Nation’s strategy to put information technology to work in health care. By developing secure and private electronic health records for most Americans, and making health information available electronically when and where it is needed, health IT can improve the quality of care. As of 2008, AHRQ has invested over $260 million in contracts and grants to over 150 communities, hospitals, providers, and health care systems in 44 States to promote access to and encourage the adoption of health IT. These projects constitute a real-world laboratory for examining health IT at work.

One major component of AHRQ’s Health IT Portfolio is the National Resource Center (NRC) for Health IT. The NRC captures the lessons learned in health IT adoption, and documents the progress of the portfolio’s research grants. More information about AHRQ’s Health IT Portfolio can be found at http://healthit.ahrq.gov.

Specific Purpose of this FOA

The purpose of the Agency's Health IT Portfolio is to develop and disseminate evidence on how health IT improves the quality and safety of health care. The program supports the conduct of research that will contribute to health care providers ability to offer high quality health care and/or to support the use of health IT applications that enable patients and/or family members to be better informed and engaged in managing their health and health care.

This FOA supports the conduct of short-term preparatory, pilot or feasibility studies to generate health IT implementation and use strategies that will inform larger scale real world health IT implementation and use or the conduct of more comprehensive health IT implementation research. AHRQ is most interested in applications which, if funded, can lead to future demonstrations of the effects of health IT interventions on quality and safety outcomes of national priority.

Given the challenges of achieving successful implementation and use of health IT at various organizational levels, integration of organizational, human factors, systems engineering, and/or behavioral theories in addition to traditional health care and analytical theories and frameworks are encouraged.

Applications in response to this health IT R21 FOA should describe and propose projects that are distinct from those supported through the R03 or R18 health IT FOAs. For example, projects requiring more than two years (R18) or grants featuring economic analyses or secondary data analyses (R03) will not be considered appropriate or responsive to this R21 FOA.

Research Areas

AHRQ has selected three health IT research areas for the focus of this FOA. Each application must clearly identify one of them as the 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 grant is not expected to single-handedly address all elements of a health IT research area. Rather, an applicant must articulate the extent to which a specific grant would generate knowledge regarding elements of that research area and how that knowledge would advance the field of health IT and be transferable to other real world settings. The three health IT research areas are:

1) Health IT to improve the quality and safety of medication management; this includes the utilization of medication management systems and technologies; ambulatory health care providers and out-patient pharmacists use of electronic prescribing systems and/or medication management technologies; integration of evidence-based decision support for priority conditions within electronic prescribing systems; and, providing patients electronic tools to support medication self-management.

2) Health IT to support patient-centered care; this includes, but is not limited to, a focus on the coordination of care across transitions in care settings and the use of electronic exchange of health information to improve quality of care. Patient-centered care is responsive to the needs and preferences of individual patients, provides patients and/or their caregivers with access to their medical information, facilitates communication between patients, caregivers and providers, and empowers patients to be active participants in care decisions and in the daily management of their health and illnesses.

3) Health IT to improve health care decision making; this includes the development, implementation, and integration of health information tools, products or systems through the use of integrated data and knowledge management. AHRQ encourages research projects that propose use of health IT applications that apply principles of evidence based medicine including the use of the best available evidence, health care providers ability to execute their best judgment, and consideration of patients expressed treatment preferences. Ultimately, health IT that supports decision making should possess the capacity for the development and use of aggregate data for ongoing evaluation of quality improvement, organizational improvement, and population management in health care settings. Highly advanced health IT with this functionality should also identify unwarranted variability in practice, accommodate credible variability in recommendations, and identify gaps in the knowledge base that manifest during implementation for feedback to evidence developers and synthesizers.

Research Settings for this FOA

Applications responsive to this FOA must focus on implementation of health IT in one or more of the following care settings: ambulatory setting(s); transitions in care between ambulatory settings; or transitions in care between an ambulatory setting and non-ambulatory setting. For the purposes of this FOA, ambulatory care settings include: health care clinician offices; clinician practices; outpatient clinics; outpatient mental health centers; outpatient substance abuse centers; urgent care centers; ambulatory surgery centers; community-based, school, or occupational health centers; safety-net practices, pharmacies; patients homes; independent living centers; and, residential care.

Applications that feature health IT implementation in a non-ambulatory setting, such as hospital or a skilled nursing facility or inpatient mental health facility for purposes other than facilitating transitions in care to and from an ambulatory setting will be considered non-responsive to this FOA and will not be reviewed.

Elements of a Research Proposal

See Section IV.6 (Other Submission Requirements) for instructions on the required and requested fundamental features of a research proposal.

Overview of Current AHRQ Health IT FOAs

AHRQ provides an integrated continuum of health IT-oriented FOAs to achieve measurable improvements in quality and safety of health care in ambulatory settings and in transitions of care. These FOAs are designed to offer applicants opportunities to receive incremental support for the conduct of progressively more complex health IT research projects: Small Research Grants (R03), Exploratory and Developmental Grants (R21), and Demonstration Grants (R18). The program also includes opportunities for training and the acquisition of individual research skills (R36, K01, K02, K08).

Highlights of this FOA and the others are provided below. Please consult the specific FOA for further information.

Career Development and Dissertation Research Grants: A companion Special Emphasis Notice (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-014.html) has been published to support health IT-oriented career development (K01, K02, K08) and research dissertation (R36) grants. This will support development and enhancement of expertise in health IT and related disciplines, including research and evaluation methods, as well as enhancing the capacity of grantees to participate in multi-disciplinary research teams that apply trans-disciplinary perspectives in health IT research.

Small Research Grant to Improve Healthcare Quality through Health IT (R03) FOA: The R03 FOA (PAR-08-268) supports different types of small research studies including: 1) small pilot and feasibility or self-contained health IT research projects; 2) secondary data analysis of health IT research; and 3) economic (prospective or retrospective) analyses of health IT implementation. The total costs of a health IT R03 project are limited to $100,000 for up to two years funding. For more detailed information, please see the health IT R03 FOA. Highlights of each type of health IT R03 study are provided below:

• Health IT small pilot and feasibility and self-contained research projects may be either preliminary or preparatory work that will inform future health IT implementation and/or research activities or independent research projects designed to study a well circumscribed challenge in health IT development, implementation or use. The PI/PD for these small research projects is not expected or required to be extensively published or have prior experience in a leadership capacity in the conduct of a research project.
• Health IT secondary data analysis investigates additional research questions that are related to, but distinct from, the specific aims of the original data collection. Applicants must identify the source of the data and demonstrate that the proposed analysis is distinct from previously funded activities.
• Health IT prospective or retrospective economic analyses feature an evaluation of financial and non-financial costs and benefits of a companion health IT implementation project. The health IT implementation project need not have been funded by AHRQ. Economic analyses should consider to whom the benefits accrue and address, to the extent possible, both the direct and indirect benefits of implementation and use of health IT.

Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) FOA: This FOA will support health IT exploratory and developmental research projects. These R21 health IT research grants will support the conduct of short-term preparatory, pilot, or feasibility studies that are needed to inform future health IT implementation which may include but are not limited to the conduct of a health IT research demonstration grant. The R21 grants are more comprehensive and broader in scope that the small, self-contained health IT research projects supported by the health IT R03 FOA. The total costs of a health IT R21 project are limited to $300,000 over two years with no more than $200,000 in total costs in a given year.

Utilizing Health IT to Improve Health Care Quality Grant (R18) FOA: The R18 FOA (PAR-08-270) will support demonstration research grants that rigorously study health IT implementation and use to improve the quality, safety, effectiveness and efficiency of health care in ambulatory settings and in the transitions between care settings. The total costs of a health IT R18 project are limited to $1.2 million over three years with no more than $500,000 in total costs in a given year.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the AHRQ Exploratory/Developmental Research Grant (R21) award mechanism. The individual researcher sponsored by the organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

2. Funds Available

Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total costs awarded under this FOA will not exceed $300,000 over the entire project period. The maximum length of the project period for an application submitted in response to this funding opportunity is two years. Although the size of award may vary with the scope of the research proposed, applications must stay within the budgetary guidelines for an exploratory/developmental project; total costs are limited to $300,000 over an R21 two-year period, with no more than $200,000 in total costs allowed in any single year. An application with a project period that exceeds two years, or budget that exceeds $300,000 in total costs, will not be reviewed. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the non-competing progress report.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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

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

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. The PI/PD is expected to contribute a minimum of 20-percent effort throughout the course of the grant. If less time is allocated an explicit justification of the lower level of effort must be included. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Resubmissions: Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Renewals: Applicants may not submit a renewal application.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with his/her institution/organization to make sure they are registered in the NIH eRA Commons.

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:

Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:

eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

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

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons and be assigned the PI role in the eRA Commons prior to the submission of the application.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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

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

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424(R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

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

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

SPECIAL INSTRUCTIONS

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 16, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

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

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.

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

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

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

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

Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are 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.

6. Other Submission Requirements and Information

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

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

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research strategy, including tables, graphs, figures, diagrams, and charts, is limited to 20 pages
• The total project period for an application submitted in response to this R21 opportunity may not exceed two years. Total costs (i.e., direct costs plus Facilities and Administrative costs) are limited to $300,000 over a two-year period, with no more than $200,000 in total costs budgeted in any single year.
• Preliminary data are not required but may be included if available.

Specific Aims: The proposed project’s specific aims, research design, and analytical plan (including fully detailed power calculation estimate(s) for each subgroup analysis) should be well matched to one another and sufficiently detailed.

Fundamental features of a research strategy for this FOA include the following:

• Background and Significance:
• Applications must articulate well the gap in the literature or the field that needs to be addressed through the conduct of this exploratory or developmental research project and/or any planned subsequent work.
• Applications must provide a justification regarding the significance of the project; discuss any inherent uncertainty associated with the conduct of the exploratory or development project; and, discuss how the research uncertainties may be offset by the potential value of the information to be generated.
• Applications must also describe how the research results will inform larger scale real world health IT implementation and use or the conduct of more comprehensive health IT implementation research.
• Theoretical Framework: 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.
• Research Design and Methods:
• 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 specific aims.
• Applications must describe the components of the health IT implementation and use plan (e.g., training, incentives, redesign of work practices or work flow, organizational changes, motivation, skills, feedback, behavior change). Applicants are encouraged to address the extent to which unintended consequence(s) of health IT were considered in the health IT implementation plan.
• To the extent that process or outcome measures are proposed to be used, applicants must describe them in sufficient detail. Outcome measures may include: clinical outcome measures, system-level process measures, or measures of efficiency, patient satisfaction, patient safety, or implementation costs. To the extent possible applicants are encouraged to use nationally recognized clinical and process measures. For example, patient satisfaction may be assessed using the AHRQ-funded CAHPS Clinician & Group Survey. However, AHRQ recognizes that new outcome measures may need to be developed in order to provide improved clarity and assessment of processes and outcomes measures.
• AHRQ recognizes that the time limit on the conduct of R21 grants limits opportunities for robust evaluation of clinical outcome measures. Any proposed evaluation using clinical outcome measures should be well-matched to the scope of the application and this grant mechanism.
• Clinician and staff’s perspectives on the use and/or utility of the health IT being implemented should be evaluated, or a justification for why that information will not be evaluated should be provided.
• Research that directly engages patients or caregiver’s use of health IT should solicit their perspective during the design, development, and/or selection of the health IT application and on the use and/or utility of the health IT, or a justification of why it is not feasible or appropriate to evaluate that information should be provided.
• An integral part of any health IT implementation research project is the Plan for Privacy and Security Protections (see below Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems. )
• Health IT Intervention:
• The application must include detailed descriptions of the specific health IT application(s) being implemented and support services for each. The description of the health IT application to be implemented should also identify if it is open source or proprietary and the extent to which available functions of the newly implemented health IT application are/would be used. To the extent there is a pre-existing health IT application in the care setting of interest, such as an electronic health record, applicants should describe this, and specify whether or not the new health IT application would be interfaced with it during the course of the research period or subsequently.
• If possible, the health IT intervention should conform to federal and other interoperability standards and use certified products (see http://www.cchit.org). AHRQ recognizes such conformity is not always feasible and, if conformity is not feasible, applicants should provide an explanation. Applicant s status for conforming to those standards will not impact peer reviewers priority scores.
• 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 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 costs budgeted for the duration of the project an explicit justification must be included.
• 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, 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 PI/PD is expected to contribute a minimum of 20-percent effort throughout the course of the grant. If less time is allocated an explicit justification of the lower level of effort must be included.
• The PI/PD for an exploratory or developmental project is not expected or required to be extensively published or have extensive experience in a leadership capacity in the conduct of a research project as one would expect for the conduct of an R18 or R01 research project.
• Multidisciplinary research teams are encouraged as appropriate to conduct a project. Given the challenges of achieving successful implementation and use of the health IT on the individual and organizational level, expertise from behavioral, industrial and systems engineering, business, and administrative disciplines in addition to health care providers (e.g., nurses, pharmacists, physicians, etc.) and analytical expertise may be needed. Applications should reflect the extent to which the research team possesses adequate awareness of: challenges in health IT implementation and use; importance of workflow analysis; organizational processes; and, recognition of the roles various types of people (e.g., health care providers, patients, family, health administrators) play in the use and implementation of health IT.
• To the extent appropriate, AHRQ encourages partnerships between traditional research and evaluation experts and other interested parties such as community-based organizations and point-of-care providers.
• Project Administration:
• Applications should fully address the administration of the grant. This is especially crucial for teams necessitating the coordination of multiple team members efforts across disciplines, institutions, and time zones.
• The application should include a detailed project timeline.
• Dissemination:
• AHRQ does not expect the findings from these exploratory and developmental projects to be generalizable in a national sense. However, applications should demonstrate that findings will inform larger scale real world health IT implementation and use or the conduct of more comprehensive health IT implementation research.
• Applications must include a description of planned dissemination activities. The small, strategic dissemination component of the grant provides an opportunity to share with the research and health services delivery communities the lessons learned for fully, poorly, or partially successful exploratory and developmental health IT research project. Conventional dissemination forums such as peer-reviewed journals are important, but additional strategies for disseminating results targeting both non-technical and technical audiences should also be considered.
• Applicants should anticipate that some dissemination activities will be conducted in cooperation with AHRQ's National Resource Center on Health IT, http://healthit.ahrq.gov. Awardees are required to cooperate fully with AHRQ staff and contractors, such as AHRQ National Resource Center (NRC) for Health IT, in promoting their work and findings.
• Budget:
• Applications must use the detailed budget format (do NOT use the modular format).
• The budget must include funding to allow the Principal Investigator/Project Director and at least one key program staff member of the project to attend at least three days of an annual AHRQ grantee meeting in the Washington DC area for every year of funding.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified for this FOA. Application processing may be delayed, or the application may not be reviewed, if it does not comply with these requirements.

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 and exchange of health information. Without this trust and faith in an information system, patients and other users (e.g. clinicians, caregivers, etc.) will not use it fully, and system data will 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 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, disclosure to patients regarding the collection and use of the data, patient consent requirements, the ability of patients to decline participation in electronic data collection, patient access to audit records, what happens to data after research is completed, and informing patients of any security breaches.

Developers of electronic health information systems have promulgated policies in order to assure patient awareness of, comfort with, and participation in electronic data collection and use. While privacy and security solutions are not intended to be the focus of projects under this announcement, interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://healthit.ahrq.gov/hiepolicyissues).

Distinct from a Plan for Protection of Human Subjects, applications must contain a Plan for Privacy and Security Protections in the Development and Implementation of Health IT System. Near the end of Section D. Research Methods, applicants must insert the header, Plan for Privacy and Security Protections in the Development and Implementation of Health IT System. 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, section D of the application must contain a concise summary of the planned resources and processes to be used to address privacy and security issues in the development and 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. The appendix must describe how, in the development and implementation, and/or use of the health IT intervention; privacy and security issues related to the exchange of sensitive health information will be identified and addressed. The appendix should describe the resources and processes they 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 System will be assessed by the peer review panel and will be reflected in the priority score. AHRQ reserves the right to request clarification on the Plan for Privacy and Security Protections prior to funding.

Plan for Protection of Human Subjects:

Applicants must declare whether or not human subjects (and their data) are involved. If human subjects are involved, an applicant must present his or her Plan for Protection of Human Subjects (see 45 CFR Part 46) and appropriately address Inclusion of Women and Minorities (See Section VIII). Critical steps for complying with Plans for Protection of Human Subjects include but are not limited to:

• Determine if one or more of the unique studies within an application involve human subjects or their data.
• If no human subjects or their data are involved, make that declaration and provide a justification.
• If all the proposed research meets the criteria for one or more of the six exemption categories, the application must specify the type of exemption requested and provide a justification.
• If research involves human subjects and an exemption is not appropriate the applicant must address the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others; and, the importance of the knowledge gained or to be gained. The designation of Human Subjects Research is not restricted to patients. Health services research may include human subjects who are health care providers, administrative staff, students and others. Whether or not involvement or information for such participants constitutes human subjects research depends on the nature of the study.
• Proposals involving human subjects are to provide appropriate targeted enrollment table(s) for each unique study group (http://grants.nih.gov/grants/funding/424/SF424R-R_enrollment.doc) save for applications in which all the proposed research meets the requirements of exemption 4, Existing data/specimens, publicly available, unlinkable to individuals.
• Projects involving a clinical trial are to have a Data Safety Monitoring Plan.

All the application instructions outlined in the SF424 (R&R) guidance are to be followed with the following requirements:

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

Appendix Materials

R21 Appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism.

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

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

Do not use the Appendix to circumvent the page limitations of the Research Plan component.

As appropriate, applicants should also include the Plan for Privacy and Security Protections in the Development and Implementation of Health IT System. This plan should be attached as Appendix A.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. 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. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP include two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

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

Plan for Sharing Research Data

Not applicable

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below. The review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

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

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

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.

The AHRQ R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health services research.

Because the Research Strategy is limited to 20 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. 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.

Overall Impact. Reviewers will provide an overall impact/priority 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 study address one of the three health IT research areas of interest to AHRQ? Does the application focus on a gap in the literature or the field that needs to be addressed? Does the application adequately recognize and describe the limitations in the generalizability of the results of this project and any planned subsequent work and demonstrate the applicability of these research findings to other settings and circumstances?

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Does 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 PD/PI’s support is less than suggested twenty-percent level? Does the application demonstrate the investigators aptitude to identify and address weaknesses found either in the proposal or encountered during the conduct of the research project? Does the application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduction of the proposed study?

Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies; or combine common research elements in an innovative fashion? Does the project extend existing health IT to new settings or with new providers and patient populations? If the research elements are not novel, would the project generate much-needed insight to inform larger scale real world health IT implementation and use or the conduct of more comprehensive health IT implementation research, as appropriate?

Approach: Are the conceptual, design, methods, and analytical plan adequately developed, well-integrated, well-reasoned, and appropriate to the specific aims of the project? If proposed, how appropriate are the process and clinical outcome measures to be used? To what extent are patients and/or families directly involved in the design, development and/or selection of the health IT application or is adequate justification of why their involvement is not feasible or appropriate provided? To the extent that staff, patients and families are directly involved in the health IT implementation, is their perspective on the use and/or utility of the health IT sought or an adequate justification of why such information is not feasible or appropriate provided?

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? Does the application adequately demonstrate multiple levels of engagement and support from individual health care providers, staff, and institutions?

2.A. Additional Review Criteria:

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Strategy of the SF424 (R&R).

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? To what extent is the support of key personnel appropriate across the duration of the study? Is the budget allocation for purchase of health IT hardware, software, and support appropriate and well justified?

Privacy and Security Protections in the Development and Implementation of Health IT System: Has the applicant adequately described the privacy and security policies and features of the health IT system being developed, implemented, or used in the proposed study? Has the application adequately described the process for identifying and addressing privacy and security issues related to the exchange of sensitive health information and encouraging the involvement of patients to the extent appropriate? Has the application adequately considered patients access to audit records, disclosure to patients regarding collection and use of electronic data, patient notification of security breaches, patient consent process, and ability for patients to decline participation in electronic data collection?

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the changes in the resubmission application well justified?

2.B. Additional Review Considerations

Not applicable.

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are 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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The 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 (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. 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).

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended R21 applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities
• Programmatic balance of the Health IT Portfolio within AHRQ and DHHS

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

If funded, a formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official. The NOA signed by the grants management officer is the authorizing document.

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.

2. Administrative and National Policy Requirements

Executive Order 13410, Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs (www.whitehouse.gov/news/releases/2006/08/200060822-2.html) promotes efficient delivery of quality health care through the use of health information technology, transparency regarding health care quality and price, and incentives to promote the widespread adoption of health information technology and quality of care. To support this mission, the awardee shall, at a minimum, implement the following clause/condition and, in doing so, the actions and steps taken to implement the clauses shall not impose additional costs onto the Federal government:

• Use services available at HHS Agency for Healthcare Research and Quality (AHRQ) National Resource Center for Health Information Technology (NRC) at www.healthit.ahrq.gov. The NRC provides technical assistance, identifies challenges to health IT adoption and use, and identifies solutions and best practices that have the potential to transform clinical practice through the best and most effective use of IT.
• A final rule amending the Federal Acquisition Regulations (FAR) to implement Section 508 of the Rehabilitation Act of 1973 became effective on June 25, 2001. See 66 Fed. Reg. 20894 (April 25, 2001) (codified at 48 CFR Parts 2, 7, 10, 11, 12, and 39); 66 Fed. Reg. 20898 (April 25, 2001) (codified at 48 CFR Chap. 1). To the extent that grantees prepare materials for Federal venues, grantees are expected to cooperate with AHRQ staff and the NRC to prepare 508-compliant materials to assure the public’s access and use of information. Additional information will be communicated to the grantee after the grant award.

AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, Terms and Conditions will be incorporated into the award statement.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from ten or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

3. Reporting

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 a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 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 will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.

A final Progress Report, Final Invention Statement, and Financial Status Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm. To promote dissemination of AHRQ-funded research results, these reports will be posted at the National Resource Center (NRC) for Health IT at http://healthit.ahrq.gov.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

Direct your questions about general or programmatic FOA issues to:

Angela Lavanderos
Center for Primary Care, Prevention, and Clinical Partnerships
Health Information Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1505
Fax: (301) 427-1597
E-mail address: [email protected]

Direct your questions about the inclusion of priority populations to:

Linda Franklin
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1904
Fax: (301) 427-1562
E-mail address: [email protected]

2. Peer Review Contact(s):

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

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

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Brian Campbell
Grants Management Specialist
Agency for Healthcare Research and Quality
Office of Performance, Accountability, Resources, and Technology
Grants Management
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1266
Fax: (301) 427-1462
Email address: [email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4), for example, if it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.

References (from Section I.1: Research Objectives):

Bates DW. Physicians and ambulatory electronic health records. 2005. Health Affairs (24)5: 1180-1189.

Berwick DM. The Science of Improvement. JAMA, March 12, 2008, (299)10:1182-1184.

Bodenheimer, T. Coordinating care Perilous journey through the health care system. N Engl J Med. 2008 March 6; 358;10:1064-1071.

Chang BL,’s Bakken, SS Brown, et al. Bridging the Digital Divide: Reaching Vulnerable Populations. 2004. J Am Med Inform Assoc. 11:448-457.

Coleman EA, Berenson RA. Lost in Transition: challenges and opportunities for improving the quality of transitional care. Ann Intern Med. 2004 Oct 5; 141(7):533-536.

DesRoches CM, EG Campbell, K Donelan, et al. Electronic Health Records in Ambulatory Care A National Survey of Physicians. N Engl J Med 359;1:50-60.

Eysenbach G. Clinical review. Recent Advances Consumer Health Informatics. BMJ. June 24 2000; 320.

Hing ES, Burt CW, DA Woodwell. Electronic Medical Record Use by Office Based Physicians and Their Practices: United States, 2006. Advance Data From Vital and Health Statistics/ October 26, 2007; 393:1-6.

Institute of Medicine, Priority Areas for National Action: Transforming Healthcare Quality. Washington, DC: National Academy Press, 2003.

Jha AK, Ferris TG, Donelan K et al. How Common Are Electronic Health Records in the United States? A Summary of the Evidence. Health Affairs (Millwood). November-December 2006. 25(6) w496-507.

Kaplan B, Brennan PF, Dowling, AF, et al. Toward an Informatics Research Agenda: Key People and Organizational Issues. 2001, J AM Med Inform Assoc. 2001. 8:235-241.

Lorenzi NM, RT Riley, JC Andrew, et al. Review Antecedents of People and Organizational Aspects of Medical Informatics: Review of the Literature. Mar/April 1997. J Am Med Inform Assoc. 4:79-93.

Shortliffe EH and JJ Cimino, Biomedical Informatics: Computer Applications in Health Care and Biomedicine. Third Edition. 2006.

Simon SR, R Kaushal, Cleary PD, et al. Physicians and Electronic Health Records. Archives Internal Medicine. March 12, 2007. 167:507-512.

Tang PC, C Newcomb, Informing Patients: A Guide for Providing Patient Health Information. Nov/Dec 1998. JAMIA (5):6:563-570.