Source: http://grants1.nih.gov/grants/guide/pa-files/PAR-08-270.html
Timestamp: 2015-04-26 13:29:28
Document Index: 269181750

Matched Legal Cases: ['arts 160', 'art 46', 'art_2', 'art 67', 'arts 2', 'art 67', 'art 67', 'arts 74']

PAR-08-270: Utilizing Health Information Technology (IT) to Improve Health Care Quality (R18)
of Health and Human Services Participating Organizations Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Title: Utilizing Health Information Technology (IT)
to Improve Health Care Quality (R18)
Note: The policies, guidelines terms and conditions stated in this announcement may
Type This is a new Funding Opportunity
Announcement (FOA). Update: The following update relating to this announcement has been issued: 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.
January 12, 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.
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-08-270 NOTICE: Applications submitted in response to this Funding Opportunity
Catalog of Federal Domestic Assistance Number(s) 93.226 Key Dates
Release/Posted Date: September 25, 2008 Opening Date: December 26, 2008 (Earliest date an application may be submitted to Grants.gov)
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
Dates for E.O. 12372 Not Applicable Additional Overview Content Executive
Summary Purpose. The purpose of this Funding Opportunity
Announcement (FOA) is to support health information technology (IT)
demonstration projects that evaluate factors associated with successful
implementation and utilization of health IT in order to improve the
quality, safety, effectiveness and efficiency of health care in ambulatory
settings and in the transitions between care settings. The use of
health IT has been demonstrated to improve health care in various large
health care delivery systems. Yet, there has been limited diffusion
and evaluation of the implementation and utility of health IT in
ambulatory care settings and in transitions between care settings. This FOA supports real world demonstration projects that evaluate factors
(facilitators and barriers) associated with successful health IT
implementation and use and ultimately improve health care outcomes. As appropriate, facilitators and barriers to health IT implementation may
include adequacy of engagement and training of health care staff,
patients, and family in the use of health IT; characteristics of the health
care setting; organizational processes and practices; workflow; adequacy
of health IT implementation plan; nature of technical support of health
IT; integration of new health IT with pre-existing health IT, and other
factors. Applications responding to this FOA must seek to evaluate
and demonstrate how to optimize functionality of existing health IT;
implement health IT in new settings or with new providers and patient
populations; or, demonstrate sustainability of health IT. Research Areas. This FOA is focused on
three research areas of interest: Health IT to improve the quality and safety of medication
management via the integration and utilization of medication management
systems and technologies; 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, 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 Research Demonstration and Dissemination Projects (R18) grant
mechanism. Other AHRQ-Sponsored Health IT FOAs. This FOA runs in parallel with a continuum of AHRQ-sponsored health
IT FOAs: AHRQ’s Exploratory and Developmental Research Grant to Improve
Healthcare Quality through Health IT (R21) (PAR-08-269); AHRQ’s Small Research Grant
to Improve Healthcare Quality through Health IT (R03) (PAR-08-268); and, its 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).
Applicants to this R18 may wish to submit a companion Small Research
Grant to Improve Healthcare Quality through Health IT R03 proposal that
features a prospective economic analysis. For further information,
please see below 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: The total
project period for an application submitted in response to this FOA must
not exceed three years. The total amount requested need not be the
same in each year of a multi-year budget. Total costs (direct costs
and associated indirect costs) are limited to $1.2 million over three
years and no more than $500,000 total costs in a given year. An
application with a budget that exceeds any of these limits will not be
reviewed. Application Research Strategy Length: The R18 Research Strategy section may not exceed 25 pages,
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
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: Applicants may submit a renewal application. 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
3. Other-Special Eligibility Criteria Section IV. Application and Submission Information
1. Request Application Information 2. Content and Form of Application Submission
Anticipated Start Dates 1. Letter of Intent B. Submitting an
Application Electronically to the NIH C. Application
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
Section I. Funding Opportunity Description 1. Research Objectives Background:
Use of Health IT
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’ ability 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
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.
Purpose of this FOA
supports the conduct of demonstration research grants that
rigorously evaluate health IT implementation to improve the quality,
safety, effectiveness and efficiency of health care in ambulatory settings and
that support transitions in care between ambulatory settings or ambulatory and
non-ambulatory settings. These grants must evaluate the utilization and
implementation of health IT and be designed to provide scientific findings
about the implementation process of health IT and its effects on quality and
safety. AHRQ is interested in supporting health IT demonstration projects
for which the findings regarding the health IT functionality or implementation
approach are demonstrated to be transferable to other settings or
circumstances. Applications responsive to this FOA should also include a
small strategic dissemination plan.
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 R18 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
Settings for this FOA
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
IV.6 (Other Submission Requirements) for instructions on the required and requested
fundamental features of a research proposal.
Current AHRQ Health IT FOAs
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).
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 the health IT R03 FOA 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 Healthcare Quality through Health IT (R21)
FOA: The R21 FOA (PAR-08-269) 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
Health IT to Improve Health Care Quality Grant (R18) FOA: This FOA will support demonstration research grants that
rigorously study health IT implementation and use to improve the
settings and in the transitions between care settings. The total costs of
a health IT R18 FOA project are limited to $1.2 million over three years with
no more than $500,000 in total costs in a given year.
Opportunity Announcement (FOA) will use the AHRQ
Research Demonstration and Dissemination Projects Grant (R18) award mechanism. The
projects. AHRQ is not
using the Modular Grant Application and Award Process. Applications
submitted in modular format will not be reviewed. 2. Funds
financial plans of AHRQ provide support for this program, awards pursuant to
exceed three years. The total amount requested need not be the same in
each year of a multi-year budget. Total costs are limited to $1.2 million
over three years and no more than $500,000 total costs in a given
year. An application with a budget that exceeds any of these
requirements 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 review
and acceptance by Agency staff of the non-competing progress report.
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.
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
Sharing or Matching This program does not require cost sharing for applications in response to this
is no cost sharing requirement included in this FOA, AHRQ welcomes applicant
institutions, including any collaborating institutions, to devote resources to
this effort. An indication of institutional support from the applicant
and its collaborators indicates a greater potential of success and
effort, or other resource investments. Applicant institutions should
indicate institutional support by outlining the specific contributions
to the project and providing assurances that their organization and any
collaborators are committed to providing these funds and resources to the
applications: Applicants may submit more than one
application, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications in response to this
FOA with essentially the same research focus from the same applicant
organization that is currently pending initial merit review (i.e., awaiting a
priority score and Summary Statement) unless the applicant withdraws the
pending application. Resubmissions: If an initial application to this FOA is unfunded after peer review,
it may be revised, regardless of whether or not it received a priority
score. Such revised applications are known as resubmissions; up to one resubmission
can be submitted. Resubmission applications must include an
“Introduction” addressing comments from the most recent Summary Statement; the
Introduction may be up to one page in length. For
additional information on requirements for resubmissions see SF424 (R&R) (http://grants.nih.gov/grants/funding/424/index.htm). Application processing may be delayed or the application will not
be reviewed if it does not comply with all of these
requirements. Renewals: Applicants may submit a renewal application.
registered in the NIH eRA Commons. Several additional
separate actions are required before an applicant can submit an electronic
application, as follows: 1)
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
Email support@grants.gov 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
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. Each PD/PI must hold a PD/PI account in the Commons. Applicants
should not share a Commons account for both an Authorized Organization
both roles should exist under one Commons account. A PD/PI at the applicant organization must be affiliated with that
organization. A PD/PI located at another institution need not be affiliated
with the applicant organization, but must be affiliated with his/her own
organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her
designee who is already registered in the Commons. Both the
PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both
are authorized to view the application image. Note that if
a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR
whether their organization/institution is already registered in both Grants.gov and the Commons. AHRQ will accept electronic
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
(R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm). The SF424
application to AHRQ. Some fields within the SF424 (R&R) application
– Application Guide, Electronic Submission of Grant Applications.” The SF424
others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all
Components: SF424 (R&R) (Cover component)
Research & Related Budget (See Section IV.6., regarding appropriate required
budget component.) Optional
Components: PHS398 Cover Letter File Research & Related Subaward Budget
single institution is involved, follow the instructions contained in the SF424
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424
Submission Dates and Times See Section IV.3.A. for details. 3.A. Submission, Review, and Anticipated Start Dates Opening Date: December 26, 2008 (Earliest date an application may be
Peer Review Date(s): Generally four months after receipt date
Letter of Intent A letter of
Submitting an Application Electronically to AHRQ To submit an application in response to this FOA, applicants should access this
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.
institution/organization) on the application due date(s). (See Section IV.3.A. for
all dates.) If an application is
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
letters on late applications. The “Reject”
after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
completeness by the Center for Scientific Review, NIH, and AHRQ.
AHRQ will not accept
any application in response to this FOA that is essentially the same as one
pending application. AHRQ will not accept any application that is essentially
the same as one already reviewed. However, AHRQ will accept a resubmission
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
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
Intergovernmental Review This initiative is not subject to intergovernmental review. 5. Funding
costs are allowable. A grantee may, at its own risk and without AHRQ prior
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
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
6. Other Submission Requirements and Information. Fundamental
features of a research proposal for this FOA include the following:
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. 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 research
project and provide a justification regarding the significance of the
project. Applications must also describe how the research results
will inform future research and/or other real world implementation
efforts. Theoretical Framework and Preliminary Studies: Applications must be well grounded in conceptual or theoretical
framework(s) and present pilot data and/or results from the literature to
indicate the appropriateness of the research question and likelihood for
the study to generate insight. Research Design and Methods: This FOA requires the evaluation of health IT implementation and
use in real world settings. While a randomized clinical trial may
be a feasible and appropriate study design for some health IT
demonstration projects, there is no intrinsic preference for that study
design or any other in these health IT demonstration projects. Rather, applicants should consider a wide range of scientific methods,
including both quantitative and qualitative methods. The study
design and analytical plan should be well justified and consistent with
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. Applications must describe in sufficient detail the process and
outcome measures to be used. Outcome measures may include: clinical
outcome measures, system-level process measures, measures of efficiency,
patient satisfaction, patient safety, 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. 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. 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 demonstration
projects to be generalizable in a national sense. However,
applications should demonstrate that findings will be transferable to
other settings and/or populations and to acknowledge limitations, if any,
in interpretation of those findings. Applications should articulate
how information generated from a proposal could be transferable to other
ambulatory settings or transitions in care given the extent to which a
similar health IT application is or could be deployed. 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 health IT research
demonstration projects. 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. 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. 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).
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.” This section 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.
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
Protection of Human Subjects:
E, 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 and http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc#Part_2). 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
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:
PD/PI Credential
registration with Grants.gov. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.” PHS398
to 25 pages
with no spaces or special characters, and a .pdf extension must be used. Warning: Please be sure that you observe the direct cost, project period, and
page number limitations specified above for this FOA. Application
processing may be delayed, or the application may be rejected without review,
if it does not comply with these 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 IMPORTANT
NOTE: AHRQ has published new limitations on grant application appendix
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. Applications
must 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
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
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
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).
As specified in that notice, applicants to this FOA should address the
extent to which priority populations are included in the research design; the
appropriateness of their inclusion with respect to the purpose of the research;
plans for outreach and recruitment of study participants as appropriate; plans
to conduct subgroup analyses relevant to one or more priority populations if
appropriate; or, justification, if such subgroup analyses are not planned. In Section
D, Research Methods, applicants must have a section labeled “AHRQ Priority
Populations.” AHRQ requests that this be the last topic addressed in Section
D. In that section, investigators should discuss inclusion of subjects
from one or more AHRQ priority populations or provide a rationale for exclusion
of priority populations when the requirement for inclusion would be
inappropriate with respect to the purpose of the study. If priority
populations are included in a project, appropriate sub-group analyses should be
presented that focus specifically on those populations. AHRQ Priority
populations include: inner-city and rural areas (including frontier areas); and
health care for priority populations, which include low income groups; minority
care or end-of-life health care.
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
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
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
award is still active. HCUP &
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
use of HCUP and/or MEPS data does not preclude the use of secondary data
sources or primary data collection.
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
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. Overall
additional review criteria (as applicable for the project proposed). Scored Review
Significance: Does this study address one of the three health IT research areas of
interest to AHRQ? Does this application demonstrate that an important challenge or gap in the
literature regarding health IT implementation and use will likely be addressed? Does the application adequately recognize and
describe the limitations in the generalizability of the results and demonstrate the applicability of the 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
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 the field? Approach: Are the conceptual, design, methods, and
analytical plan adequately developed, well-integrated, well-reasoned, and
appropriate to the specific aims of the project? Does the application
reflect an appropriate level of understanding of workflow and factors impacting
successful health IT implementation, use, and sustainability? How appropriate are the proposed
process and clinical outcome measures? 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? Does the small, strategic dissemination plan adequately
consider informing individual, stakeholders, and institutions as
appropriate? Environment: Do(es) the scientific environment(s) in
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
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
Inclusion: Adequacy of plans to address the needs of
both genders, racial and ethnic minorities (and subgroups). Adequacy of
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?
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?
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?
Resource Sharing Plan(s) Data
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,
the disclosure of personally identifiable patient information by covered
entities and define when and how such information can be disclosed e.g., to
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/.
in the application. Sharing
Research Resources: Rights in
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
algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made
CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html). Selection
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,
to access his or her priority score within 3-5 business days via the NIH eRA Commons. Within four to six weeks of the peer review, the Summary Statement (written
critique) will be available via the PC/PI’s NIH eRA Commons account. If the
application is under consideration for funding, AHRQ will request
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
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
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).
necessary, Terms and Conditions will be incorporated into the award statement.
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.
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.
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
Progress Report, Final Invention Statement, and Financial Status Report are
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.
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.
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
Telephone: (301) 427-1505
E-mail address: Angela.Lavanderos@ahrq.hhs.gov
questions about the inclusion of priority populations to:
Office of Extramural Research, Education, and Priority
Telephone: (301) 427-1904
E-mail address: Linda.Franklin@ahrq.hhs.gov
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.
Email: Kishena.Wadhwani@ arhq.hhs.gov
inquiries regarding fiscal matters to: Anna
Caponiti
Phone: (301) 427-1402
Email: anna.caponiti@ahrq.hhs.gov
Federal Citations Inclusion of
Women and Minorities in Research Study Populations:
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
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).
NIH’s Office of Extramural Research supports a comprehensive webpage of updated
Guidelines available at http://grants.nih.gov/grants/policy/hs/. To the extent possible, AHRQ requires adherence to these NIH Guidelines.
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).
regulations require that applications and proposals involving human subjects
research must be evaluated in accordance with those regulations, with reference
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/policy/index.html). Standards
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.
(OCR). The OCR website (http://www.hhs.gov/ocr/) provides information
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.
Research Data through the Freedom of Information Act:
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
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
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
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
activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to
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
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: (Referring to Section I.1 Research Objectives):
Bates DW.
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Chang BL, S Bakken, SS Brown, et al. “Bridging the Digital Divide: Reaching Vulnerable
Populations.” 2004. J Am Med Inform Assoc. 11:448-457.
Berenson RA. “Lost in Transition: challenges and opportunities for improving
the quality of transitional care.” Ann Intern Med. 2004 Oct 5;
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CM, EG Campbell, K Donelan, et al. “Electronic Health Records in Ambulatory
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Eysenbach G.
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Burt CW, DA Woodwell. Electronic Medical Record Use by Office Based
Physicians and Their Practices: United States, 2006. Advance Data From Vital
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Areas for National Action: Transforming Healthcare Quality. Washington, DC: National Academy Press, 2003. Jha AK,
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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.
EH and JJ Cimino, “Biomedical Informatics: Computer Applications in Health Care
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Kaushal, Cleary PD, et al. “Physicians and Electronic Health Records.” Archives Internal Medicine. March 12, 2007. 167:507-512.
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Newcomb, “Informing Patients: A Guide for Providing Patient Health
Information.” Nov/Dec 1998. JAMIA (5):6:563-570. Weekly TOC for this Announcement