RELEASE DATE:  November 20, 2003

RFA Number:  RFA-HS-04-010

Department of Health and Human Services (DHHS)

Agency for Healthcare Research and Quality (AHRQ)
National Institutes of Health
National Library of Medicine (NLM)

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




o   Purpose of the RFA
o   Program Objectives
o   Mechanism(s) of Support
o   Funds Available
o   Eligible Institutions
o   Individuals Eligible to Become Principal Investigators
o   Special Requirements
o   Where to Send Inquiries
o   Letter of Intent
o   Submitting an Application
o   Peer Review Process
o   Review Criteria
o   Receipt and Review Schedule
o   Award Criteria
o   Required Federal Citations 
o   References


The Agency for Healthcare Research and Quality (AHRQ) announces the 
availability of planning grants to assist healthcare systems and their 
partners in planning for activities that will lead to successful 
implementation of health information technology (HIT) to promote and improve 
patient safety and the quality of healthcare. The objective of this Request 
for Applications (RFA) is to support community-wide planning processes across 
multiple healthcare organizations within a local or regional area that will 
enable them to develop HIT infrastructure that provides for effective 
exchange of health information within the community. Successful planning 
efforts should also allow them to compete for future funding for 
implementation activities.  Applicants may use these funds for planning 
development of important infrastructure components including, but not limited 
to, computer networks, hardware, software, personnel, project management, and 
quality improvement and research capacity.  

AHRQ is particularly interested in supporting community-wide collaborative 
partnerships that include acute care hospitals, clinics, health care 
providers, and other health delivery organization (e.g., public health) that 
will also help to provide effective HIT tools for immediate access to 
complete and timely health care information in diverse health care settings 
(e.g., ambulatory care, long-term care - including home health) that involve 
all AHRQ identified priority populations.  Through this initiative, AHRQ 
seeks to support collaborative planning processes that will result in 
standards-based data sharing across multiple care sites and lead to 
measurable and sustainable improvements in patient safety and quality of 

Projects presented for consideration under this RFA should comply with the 
Agency’s policy regarding the inclusion of priority populations 
(  Further 
information on the requirements is listed in the special requirements section 
of this RFA.

It is anticipated that after completion of these planning grants, recipients 
will be in a position to compete for subsequent AHRQ funding in Fiscal Year 
(FY) 2005 (contingent upon funding availability) that will assist them to 
implement HIT successfully in their organizations and measure its impact on 
patient safety and both the quality and costs of care.

This RFA includes an area of special emphasis with a portion of the total 
funding specifically set aside for projects involving rural and small 
hospitals and communities. 

This RFA is one in a series of solicitations to be issued by AHRQ in FY ‘04 
on the use of HIT to improve patient safety and quality of care.  The 
solicitations form an integrated set of activities designed to explore 
strategies for successful planning and implementation of HIT solutions in 
communities and to demonstrate the value of HIT in patient safety and both 
quality and costs of care.  The FY ’04 HIT initiative will place particular 
emphasis on the challenges facing rural and small communities in integrating 
HIT into their healthcare delivery systems.  In addition to this RFA, other 
grants and contracts to be released as part of this program include:

1. Transforming Healthcare Quality Through Information Technology (THQIT) 
Implementation Grants - a series of implementation grants to evaluate the 
effects of HIT on improving patient safety and both quality and cost of 
healthcare.  The objective of this RFA is to support implementation and 
diffusion of HIT information exchange and sharing and to assess the extent to 
which HIT contributes to measurable and sustainable improvements in patient 
safety and both quality and costs of care.  Research resulting from this RFA 
should inform AHRQ, providers, patients, payers, policy makers, and the 
public about how community-wide HIT can be successfully implemented in 
diverse health care settings and lead to safer and better health for all 

2. Demonstrating the Value of Health Information Technology Grants - This RFA 
will focus on the value derived from the adoption and utilization of HIT to 
improve patient safety and quality of care.  This RFA will solicit proposals 
to elucidate and quantify the value of HIT to providers, patients, 
purchasers, payers, policymakers, and other important stakeholders.  Research 
resulting from this RFA should provide important information on the direct 
and indirect costs and benefits of HIT and inform decision makers about 
facilitators and barriers to HIT adoption, including various forms of 
incentives and disincentives.

3. Health Information Technology Resource Center - The center will provide 
technical assistance to grantees; serve as a repository for best practice 
assimilation and diffusion; help develop, maintain and export executable 
knowledge for clinicians and patients; offer expert HIT support for providers 
and communities; perform and sponsor educational activities; and develop and 
disseminate tools to help providers and organizations utilize HIT to improve 
patient safety and quality of care in their communities.  



In the Institute of Medicine’s report, Crossing the Quality Chasm (Institute 
of Medicine 2001), the members of the institute, among other things, 
recommend:  “Congress, the executive branch, leaders of health care 
organizations, public and private sector purchasers, and health informatics 
associations and vendors should make a renewed national commitment to 
building an information infrastructure to support health care delivery, 
consumer health, quality measurement and improvement, public accountability, 
clinical and health services research, and clinical education. This 
commitment should lead to the elimination of most handwritten clinical data 
by the end of the decade.”  In particular, HIT was identified as a critical 
environmental force that could significantly improve healthcare quality.

Further the IOM, the National Committee on Vital and Health Statistics, and 
the President’s Information Technology Advisory Committee have also 
recommended the development of a National Health Information Infrastructure 
to assist other efforts in improving safety, reducing cost and enhancing the 
quality of healthcare.

In July 2003, AHRQ convened a diverse group of approximately 50 experts who 
helped the Agency to identify gaps in knowledge relating to the use of HIT 
and provided recommendations on important thematic areas for AHRQ’s HIT 
initiatives in FY 2004.  Among the panel’s many recommendations were the need 
for more research on the impact of HIT on important health-related outcomes; 
more research on HIT in diverse healthcare settings; the need to support 
local and regional HIT collaborative projects that would lead to standards-
based data sharing across healthcare delivery sites; the need to demonstrate 
the value of HIT in improving patient safety and quality of care, including 
direct/indirect and tangible/intangible benefits; the need to study 
incentives and disincentives to the adoption and use of HIT; the need for 
technical assistance to providers, organizations, and communities in order to 
implement HIT successfully in their environment; and the need to develop and 
disseminate evidence-based, executable knowledge content and decision-support 
tools to support clinical decision-making.  The panel also encouraged 
collaboration between AHRQ and other Federal agencies, such as the Office for 
Rural Health Policy (OHRP) and the Office for the Advancement of Telehealth 
at the Health Resources and Services Administration (HRSA) and the Center for 
Medicare and Medicaid Services (CMS), to leverage the resources, expertise, 
and experiences of these diverse federal agencies and increase the program’s 
success.  Finally, the panel stressed the need for developing collaborative 
partnerships and HIT programs that are viable and sustainable.  A summary of 
the proceedings is available on the AHRQ website at

As part of the Agency’s FY 2004 patient safety activities, AHRQ is investing 
$50 million to demonstrate HIT’s role in patient safety and quality of care 
in a portfolio of grants, contracts and other activities.  Of this amount, 
$26 million is earmarked for planning and implementing effective technologies 
in rural and small hospitals, where HIT penetration has been low. The 
remaining $24 million is targeted for planning, implementation and evaluation 
of new and innovative technologies in communities and other settings to 
improve patient safety and quality of care in diverse healthcare settings.  
This RFA makes available $7 million of the total $50 million investment.

As healthcare has become increasingly complex, attention has turned to the 
role of information and communication technology as a means to improve 
clinical decision-making, patient safety, and overall quality of care.  Over 
the past 30 years, research has demonstrated that HIT can improve patient 
safety and quality of care.  For example, at LDS Hospital in Salt Lake City, 
a computerized physician order entry (CPOE) system with decision support 
reduced the incidence of adverse drug events related to antibiotic 
administration by 75% [4]. It also significantly reduced orders for drugs for 
which patient’s records reported allergies and adverse effects that were 
caused by antibiotics [5].  At the Regenstrief Institute for Health Care in 
Indianapolis, researchers demonstrated that automated computerized reminders 
increased orders for recommended interventions from 22% to 46% [6]. At the 
Brigham and Women’s Hospital in Boston, use of a CPOE system with decision 
support led to increased use of appropriate medications for high-risk 
clinical situations, such as an increase in the use of subcutaneous heparin 
to prevent venous thromboembolism, from 24% to 47%.  Medication errors were 
also reduced by 19% to 84% [7].  A 1998 systematic review of the literature 
that assessed the effects of 68 computer-based clinical decision support 
systems demonstrated a beneficial, though variable impact on physician 
performance in 43/65 studies (66%) and a beneficial effect on patient 
outcomes in 6/14 studies (43%) [8].

Despite these successes, penetration of HIT has grown at a disappointingly 
low rate, especially in the non-inpatient clinical setting.  Although 
accurate data are not available, it is estimated that less than 10% of 
facilities across the United States have comprehensive HIT systems in place 
and use them regularly to provide clinical care.  

Healthcare organizations, providers and organizations face many challenges in 
adopting HIT, including the lack of financial incentives for HIT investment, 
a reimbursement system that does not reward improved outcomes and safe high-
quality care, multiple competing priorities, effects on clinical workflow, 
medical or organizational traditions and other cultural barriers, lack of 
effective leadership, and lack of HIT standards and interoperable systems. In 
order to successfully implement HIT, organizations will have to address most 
of these barriers.  Other barriers, such as the lack of standards or the lack 
of reimbursement for HIT infrastructure, may be beyond the immediate control 
of the organization or community, but these may change over time as a result 
of ongoing efforts such as the Federal initiatives to develop/adopt national 
standards for the exchange of health information, research and demonstration 
projects on the effects of financial incentives and additional  research that 
demonstrates the beneficial effects of HIT at the provider, organizational, 
and community levels on patient safety and quality of care.  

The objective of this RFA is to support planning grants to assist healthcare 
provider organizations and their partners to plan for activities that will 
lead to successful implementation of HIT to improve patient safety and 
quality of care.  This grant program will support community-wide planning 
processes across multiple healthcare organizations and delivery systems that 
will enable them to develop their HIT infrastructure and data sharing 
capacity with other provider organizations and allow them to compete for 
future Agency HIT implementation funding.

The National Library of Medicine (NLM) provides grant support to health-related 
institutions and organizations for projects to plan, design, test and deploy 
systems and techniques for integrating data, information and knowledge 
resources into a comprehensive networked information management system. NLM 
supports these organizations in their efforts to build integrated advanced 
information managements systems (IAIMS). IAIMS are computer networks that link 
and relate the published biomedical knowledge base with individual and 
institutional databases and information files, within and external to an 
institution. The long-term goal of an IAIMS is a comprehensive and convenient 
information management system, one that brings useful, usable knowledge to 
action settings in health care, education and research, binding knowledge to 
effective action. Particular emphasis is placed on mechanisms that enable the 
easy flow of information between arenas of action, such as between health care 
and education, or between health-related organizations, such as from a 
community clinic to a hospital or public health department. Of particular 
interest to NLM are projects which focus on context-appropriate information to 
guide learning and decisions; standards based information management that 
employs standard vocabularies and information exchange protocols; and digital 


For purposes of this RFA, the following definitions will apply:  

1)   Health Information Technology is broadly defined as the use of 
information and communication technology in healthcare and includes, but is 
not limited to, electronic health records, personal health records, e-mail 
communication, clinical alerts and reminders, computerized provider order 
entry, computerized decision support systems, hand-held computers, 
information resources, and electronic monitoring systems. 

2)   Electronic Health Record Systems  are defined by the Institute of 
Medicine’s Letter Report on the Key Capabilities of an Electronic Health 
Record System  EHR systems will 
include the ability to collect longitudinal data for and about a person in an 
electronic format; immediate electronic access to person and population level 
information by authorized users; provision of knowledge and decision-support 
tools that enhance the safety, quality and efficiency of health care; and 
support of efficient processes for health care delivery. 

3)   Clinical decision support systems (CDSS) are defined as computer 
applications that assist clinicians in the management of their patients at 
the point-of-care by integrating medical knowledge with patient 
characteristics and generating patient-specific recommendations.  CDSS can 
take the form of computerized reminders, alerts, guidelines, order sets or 
other such tools.

4)   Health Information Technology Value is defined as the sum of financial, 
clinical, and organizational advantages or benefits derived from the 
adoption, diffusion, and utilization of HIT less the costs of achieving these 

o   Financial Benefits include cost reduction, revenue enhancement and 
productivity gains.
o   Clinical Benefits include advances in care processes, improved patient 
outcomes (improvements in safety and quality), and better monitoring of 
diseases and other health risks.
o   Organizational Benefits include improvements in organizational 
effectiveness – as evidenced in work and quality assurance/improvement 
processes, communication among individuals, groups and organizations; 
satisfaction of needs and expectations of patients, providers, and 
stakeholders; capacity to adapt to changing technical and operating 
conditions, such as fluctuations in patient load, acuity, and emergency 
conditions; and organizational risk mitigation. 

1)   Patient Safety refers to the absence of the potential for, or occurrence 
of, healthcare associated injury to patients. Patient safety can result from 
the avoidance of medical errors as well as taking action to prevent errors 
from causing injury.  AHRQ patient safety activities involve four major 
components: identifying threats; identifying and evaluating effective 
practices; education dissemination, and implementation interventions that 
enhance patient safety; and maintaining vigilance.

2)   Medical Errors are defined as mistakes made in the process of care that 
result in, or have the potential to, result in harm to patients.  Mistakes 
include the failure of a planned action to be completed as intended or the 
use of a wrong plan to achieve an aim.  Medical errors can result from an 
action that is taken (error of commission) or an action that is not taken 
(error of omission). 

3)   Medication Error is defined as preventable inappropriate use of 
medication including prescribing, dispensing, and administering.

4)   Adverse Event is defined as an untoward, unintended (usually), and 
unanticipated (usually) outcome that occurs in association with health care.  
Preventable adverse events are a subset of adverse events that are judged to 
have been avoidable if appropriate and reasonable steps had been taken.  For 
example, an anaphylactic reaction to penicillin is an adverse event.  It is a 
preventable adverse event if the patient’s allergy to penicillin is noted in 
his or her chart or if the patient knows of his or her history of penicillin 
reactions and is capable to communicating it to the clinician. 

5)   Preventable Injury is defined as harm that could be avoided through 
reasonable planning or proper execution of an action.

6)   Quality is defined as doing the right thing, at the right time, in the 
right way, for the right person, and having the best possible results.  
Quality of care should strike the right balance in the provision of health 
services by avoiding overuse (e.g., getting unnecessary tests or procedures), 
underuse (e.g., not being screened for high blood pressure or not being 
treated with a beta-blocker when clinically indicated), or misuse (e.g., 
being prescribed drugs that have dangerous interactions or being given the 
wrong dose of a medication). 

7)   Healthcare Environment is defined as the structures and processes 
employed to provide healthcare. They reflect the characteristics of the 
facility (e.g., size, location, specialty, licensure, certification, 
equipment, working conditions); and the organization (e.g., personnel mix and 
experience, lines of authority, leadership, policies and procedures, 
governance, culture).

8)   Rural Hospitals are defined as acute care hospitals physically located 
in a rural or nonmetro area within the borders and confines of any state or 
U.S. territory.  

9)   Rural and/or nonmetro areas are defined as geographic regions that 
Reside within a county or area not designated by the Office of Management and 
Budget as a Metropolitan Statistical Area (MSA) or Metropolitan New England 
City or Town Area (MNECTA).  or 
Reside within a nonmetro region of an MSA or MNECTA designated county or area 
as defined by the Economic Research Service (ERS) of the United States 
Department of Agriculture (USDA) Rural-Urban Commuting Area codes (RUCA).   
Nonmetro areas will be defined by a RUCA code of between 4 and 10.  

1)   Small Hospitals are defined as acute care hospitals containing no more 
than 100 licensed beds or fewer than 6,000 inpatient admissions in the most 
recent 12-month period.

2)   Acute Care Hospitals are defined as short-term hospitals with the 
facilities, medical staff and all necessary personnel to provide diagnosis, 
care and treatment of a wide range of acute conditions, including injuries.

3)  Partnerships are defined as a collaborative working relationship between 
three or more organizations formalized through one or more written agreements 
that contain at a minimum the following elements: a) substantial and 
meaningful contributions of personnel, expertise, money, equipment, 
facilities or other important resources to and from each of the partners; and 
b) sharing of clinical and research data across healthcare delivery sites.

AHRQ is seeking applications from partnerships (as described above) involving 
three or more organizations that are interested in obtaining grant funding to 
help them develop and implement a formal and detailed plan for the adoption 
of HIT in their organizations and the community. AHRQ is specifically 
interested in supporting local or regional collaborative partnerships 
involving multiple organizations (e.g., community hospitals, academic 
hospitals, local public health department, outpatient clinics, community 
health centers) and various healthcare settings (e.g., hospital inpatient, 
ambulatory care, long-term care, home health care).    
The Agency encourages HIT research that incorporates training and educational 
settings. HIT has been implemented in a variety of educational settings such 
as rural residency training sites and many healthcare professional trainees 
are being introduced to HIT in a variety of clinical settings.  This type of 
educational exposure and adoption may have a substantial lasting impact on 
these trainees and may demonstrate even greater value in healthcare quality 

For organizations that qualify as rural or small hospitals or communities, 
the lead partner must be an acute care hospital.  For all other applications, 
an acute care hospital must be included as one of the partners.  The long-
term objective of each partnership should be to develop a viable and 
sustainable plan for HIT implementation within eighteen months of receiving 
the award.  Applicants may use these funds for the planning and prototype 
development of important infrastructure components including, but not limited 
to, community-wide collaborative organizations, information-sharing 
agreements, business and financial plans, information architecture, health 
information access and exchange systems, computer networks, hardware, 
software, personnel dedicated to grant activities, project management, and 
research capacity.  However, no more than 20% (or a maximum of $40,000) of 
the Federal grant funds may be used for purchasing hardware or software.

During the planning period, each award recipient will be required to develop 
a plan for HIT implementation that includes the following (at a minimum):
1.   Specification of clinical and organizational needs that can be met through 
2.   Assessment of feasibility of HIT implementation – including identifying 
barriers and ways to address them.
3.   Defining basic project parameters. 
4.   Development of implementation plan, including organizational, governance, 
and financial components.
5.   Specify procedures for ongoing program evaluation and feedback.  

Specific required planning activities to be accomplished with funding through 
this RFA are listed below, by the areas of focus:

1.   Specification of clinical and organizational needs that can be met 
through HIT:

o   Identify partnership organizational goals and needs that can be met by 
o   Explain how HIT will meet these needs and enable the accomplishment of 
objectives (show causal linkages between HIT and desired improvements).
o   Discuss the factors that indicate the partnership organization is 
prepared to take the steps necessary to achieve its HIT implementation goals.

2.   Assessment of feasibility of HIT implementation – including identifying 
barriers and ways to address them:

o   Define resources available to support implementation.
o   Identify potential barriers to implementation and ways to address them. 
-    Financial
-    Technical
-    Organizational
-    Personnel (knowledge, skills, language, readiness and attitudes toward 
-    Procedural (rules, payment procedures, regulations) 

3.   Define basic project parameters:

o   Specify desired outcomes of adopting HIT
o   Specify clinical and organizational practices that will change with 
introduction of HIT; explain how they will change and lead to desired 
o   Indicate how people, units, and organizations will be involved
o   Assign responsibilities and discuss available resources for 
implementation activities
o   Describe anticipated funding of implementation and subsequent operation 
of HIT
o   Identify expertise needed to support HIT implementation and maintain 
long-term sustainability 
o   Specify time frame for main stages of the project (planning, transition, 
full implementation)

4.   Development of implementation plan 

o   Assign tasks, responsibilities, and performance standards for 
implementing and sustaining HIT 
o   Define and establish new organizational entities required, including 
appropriate multi-institutional governance mechanisms
o   Develop detailed budget
o   Set timeline for implementation

5.   Specify procedures for ongoing project evaluation and feedback 
o   Develop a formal plan for  the ongoing  monitoring and evaluation of the 
projects progress throughout the duration of the grant including 
identification of specific timelines and milestones.
o   Designate an individual (or committee) to monitor project progress and 
evaluate its success.

The responsibility for directing the planning and development effort should 
be assigned to an experienced senior level person familiar with managing 
organizational change and program implementation. This person should devote a 
significant proportion (30% or more) of his/her time to this endeavor. The 
collaborative may also choose to have an internal planning committee to 
assist the planning director. The committee will at a minimum be comprised of 
at least one representative from each of participating organizations. The 
director/planning committee should evaluate the current strengths and 
weaknesses in the key areas needed for successful HIT implementation and 
consider all available resources in the planning process. Appropriate 
consultants may be called upon to assist.

The total project period for an application submitted in response to this RFA 
may not exceed 12 months. It is anticipated that after successful completion 
of these planning grants, awardees will be in a position to compete for 
subsequent implementation grants from the Agency, contingent upon the 
availability of funds.  
The application must provide a set of long-term outcome goals and explicitly 
state how the project will support the achievement of these goals.  For 
example, AHRQ’s long-term goals for the overall HIT initiative include the 
o   Successfully deploy or enable the deployment of hospital HIT practices 
that reduce medical errors and improve overall patient safety;
o   Increase the identification and reporting of medical errors and adverse 
o   Decrease in the number of actual errors and adverse events;
o   Increase the number of hospitals utilizing CPOE with CDSS to reduce 
medication errors;
 o   Increase the number of non-hospital providers utilizing CPOE with CDSS 
and EHRs. 
In addition, the application must address how the applicant will monitor 
their progress toward the goal(s) they specify and how those goals further 
the accomplishment of the agency goals.


This RFA will use the P20 award mechanism. As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, competing 
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures. The anticipated award start date is 
September 30, 2004. 

AHRQ is not using the Modular Grant Application and Award Process.

Projects funded under this RFA are considered part of the AHRQ HIT portfolio.  
As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health 
Information Technology Resource Center (HITRC).  The HITRC will provide 
awardees with technical assistance to help them with their planning and 
implementation strategies, including an evaluation of the outcomes resulting 
from the planning process. 


AHRQ intends to commit up to $7 million in FY 04 to fund up to 35 new grants 
in response to this RFA.  It is anticipated that up to $5 million of these 
funds will be used to support applicants from rural and small communities.  
An applicant may request a project period of up to 12 months and a budget of 
up to $200,000 in total costs.  Awards will be made in a single funding cycle 
spanning up to 12 months. Because the nature and scope of the proposed 
project will vary from application to application, it is anticipated that the 
size and duration of each award will vary. 

No more than 20% (or a maximum of $40,000) of the Federal grant funds may be 
used for purchasing hardware or software.

Institutions are eligible to submit applications if they are domestic, non-
profit and included in any one of the following categories:

o  Domestic institutions 
o  Public and private non-profit institutions
o  Units of State and local governments
o  Tribes and Tribal governments 
o  Foreign institutions are not eligible to apply
o  Faith-based organizations

For the purpose of this RFA, AHRQ will award grants only to non-profit 
organizations.  For-profit organizations may participate in projects as 
members of consortia or as subcontractors.  Organizations described in 
sections 501(c)4 of the Internal Revenue Code that engage in lobbying are not 

Practice-based research networks, such as Integrated Delivery Systems 
Research Networks (IDSRNs) and Primary Care Practice-Based Research Networks 
(PBRNs) are eligible and encouraged to apply. The ISDRNs are a model of 
field-based research that links the health care researchers with large health 
care systems to conduct research on cutting-edge issues in health care on an 
accelerated timetable. A PBRN is a group of practices devoted to the primary 
care of patients to investigate questions related to community-based 

Institutions and partnerships which provide a substantial amount of safety 
net care to uninsured and Medicaid patients are encouraged to apply.


Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed planning activities is invited to work with their 
institution to develop and submit an application.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for AHRQ programs.


AHRQ is committed to supporting public-private partnerships that will result 
in interoperable, standards-based data sharing across multiple care sites and 
lead to measurable, generalizable and sustainable improvements in patient 
safety and quality of care.  Where applicable, Planning Directors are 
encouraged to use federal health information interoperability standards that 
have been proposed by the Federal Government’s Consolidated Health 
Informatics (CHI) Initiative and the National Committee on Vital and Health 
Statistics (NCVHS), and adopted by the Secretary of the U.S. Department of 
Health and Human Services (HHS).  NCVHS is a federal advisory committee to 
the Secretary on health data and information policy.  CHI is a collaborative 
effort between the HHS, the Veterans Affairs/Veterans Health Administration, 
the Department of Defense, and other Federal agencies to adopt government-
wide health information standards for implementation into the Federal IT 
architecture.  The first set of CHI standards were adopted by the HHS 
Secretary on March 21, 2003 and include: Health Level 7 (HL7) messaging 
standards; Logical Observation Identifier Name Codes (LOINC) to standardize 
the electronic exchange of clinical laboratory results; National Council on 
Prescription Drug Programs (NCDCP) standards for retail pharmacy 
transactions; Institute of Electrical and Electronics Engineers 1073 
(IEEE1073) standards that allow for health care providers to plug medical 
devices into information and computer systems; Digital Imaging Communications 
in Medicine (DICOM) standards that enable retrieval and transfer of images 
and associated diagnostic information.  More information on CHI can be found 
Information on NCVHS may be found at 

Projects funded under this RFA are considered part of the AHRQ HIT portfolio.  
As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health 
Information Technology Resource Center (HITRC).  The HITRC will provide 
awardees a variety of services, including coordinating the activities of 
awardees across all of the HIT patient safety RFAs.  All awardees under this 
RFA are expected to participate in the activities of the HITRC, including 
participation in periodic conference calls and an annual meeting of all 
awardees in the Washington, D.C. area.  The Principal Investigator and at 
least one key program staff member from the project are required to attend 
the annual meeting.  Travel to the annual meeting should be included in the 
project’s budget.

When appropriate and feasible, AHRQ expects awardees to work with each other 
to identify collaborative opportunities that can contribute to the overall 
success of their projects and the overall success of AHRQs HIT and patient 
safety initiative. These collaborative relationships can be either self-
initiated by the awardee, in conjunction with the HITRC or via mechanisms 
developed during the life of the project.

RAND is under contract to AHRQ to serve as its Patient Safety Evaluation 
Center.  RAND’s evaluation contract activity is not intended to evaluate the 
specific performance of individual patient safety projects but rather to 
provide an objective, comprehensive, and longitudinal view of AHRQ’s patient 
safety initiative.  This work is being accomplished by characterizing AHRQ’s 
(1) progress in achieving its goals, (2) effects on clinical outcomes of 
patient safety interventions undertaken within the patient safety initiative, 
and (3) diffusion of new knowledge and practices beyond AHRQ patient safety 
initiative participants.  The RAND team will conduct interviews with all 
researchers directing the funded patient safety grants and will conduct site 
visits to a few projects that are field testing new interventions.  Full 
cooperation with the RAND evaluation team is a requirement for receiving AHRQ 
HIT patient safety grant support. 


Any disagreements that may arise on scientific/programmatic matters (within 
the scope of the award) between award recipients and AHRQ may be brought to 
arbitration.  An arbitration panel will be composed of three members: one 
selected by the awardee, a second member selected by AHRQ, and the third 
member selected by the two prior selected members.  This special arbitration 
procedure in no way affects the awardee’s right to appeal an adverse action 
that is otherwise appealable in accordance  with the PHS regulations at 42 
CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.


The Healthcare Research and Quality Act of 1999 (See reauthorized the Agency and 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, which 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.  To implement this directive, 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 
Applicants under this RFA should address the requirements of 
including priority populations as specified in the Notice.  


In keeping with the Agency’s efforts to translate the results of AHRQ-funded 
research into practice and policy, grantees and/or contractors are to inform 
the Office of Communications and Knowledge Transfer (OCKT) when articles from 
their studies are accepted for publication in the professional literature.  
Grantees and contractors 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, 
purchasers and policymakers.  This is critical when outreach to the general 
and trade press is involved.  Contact with the media will take place in close 
coordination with OCKT and the press offices of the grantee’s or contractor’s 
institutions.  In cases when products are created (such as annual or final 
reports, web-based tools, CD-ROMs), grantees and contractors 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.

AHRQ expects grant recipients to keep the Agency informed of publications as 
well as the known uses and impact of their Agency-sponsored work.  Applicants 
are to agree to notify AHRQ immediately when a manuscript based on work 
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.

To receive an award, applicants must agree to submit the original and 2 
copies of an abstract, executive summary, and full report of the results in 
the format prescribed by AHRQ no later tan 90 days after the end of the 
project period.  The executive summary should be sent at the same time on a 
computer disk which specifies on the label the format uses (WP5.1 or WP6.0 is 


We encourage your inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 

o Direct your questions regarding programmatic issues, including information 
on the inclusion of women, minorities, and children in study populations to:

Lisa Dolan-Branton, R.N.
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1588
FAX: 301-427-1595

o Direct your questions about peer review issues to:

Patricia Thompson
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  (301) 427-1556
FAX: (301) 427-1561

o Direct your questions about financial or grant management matters to:

George ‘Skip’ Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1452
FAX: (301) 427-1464

o Direct your questions about NLM scientific/research interests to:

Valerie Florance, PhD
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301 
Bethesda, MD  20892
Telephone:  (301) 594-4882
FAX:  301 402-2952

o Direct your questions about NLM financial or grants management matters to:

Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 496-4221
FAX:  (301) 402-0421


Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed project
o Name, address, and telephone number of the Principal Investigator
o Names of the other key personnel
o Participating institutions
o Number and title of this RFA

Although the letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows AHRQ and IC staff to estimate the potential review workload 
and plan for review. 

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Lisa Dolan-Branton, R.N.
Agency for Healthcare Research and Quality
CP3, Room 6103
540 Gaither Road
Rockville, MD  20850


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

To ensure equity among applicants, however, applicants using this form must 
observe page number and font size requirements specified in the Form PHS 398.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application. Type the RFA number on the label. Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked.  The RFA label is also available at:


Applicants are encouraged to make use of AHRQ’S Healthcare Cost and 
Utilization Program (HCUP).  The HCUP includes databases covering 1988-1997, 
with 1998 and 1999 data available in 2001. These all-payer databases were 
created through a Federal- State-industry partnership to build a multistate 
healthcare data system. The main HCUP databases contain discharge-level 
information for inpatient hospital stays in a uniform format with privacy 
protections. The Nationwide Inpatient Sample (NIS) is a nationwide 
probability sample of about 1000 hospitals. The State Inpatient Databases 
(SID) contains inpatient records for all community hospitals in 22 states. 
Other HCUP databases contain ambulatory surgery data from nine states. These 
databases can be directly linked to county-level data form the Health 
Resources and Services Administration’s Area Resource File and to hospital-
level data from the Annual Survey of the American Hospital Association.

This does not preclude the use of secondary data sources or primary data 


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 according to instructions provided in form PHS 398.  
Applications submitted in the Modular format will be returned without review.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
 (20817 for express/courier service)
At the time of submission, two additional copies of the application, labeled 
"Advanced Copy" must also be sent to:

Lisa Dolan-Branton, R.N.
Agency for Healthcare Research and Quality
CP3, Room 6103
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1588
FAX: 301-427-1597


Application Preparation

Complete information about the proposed planning effort must be submitted 
with the application.  The narrative portions of the application, described 
below under “Research Plan,” should be limited to twenty-five pages of text.  
The application should be a complete document that includes all essential 
information necessary for its evaluation.  While additional explanatory 
material may be submitted as appendices, such appendices should not be used 
to bypass page limitations in the application because only selected reviewers 
will receive copies of the appendices.  

Since the form PHS 398 was developed for research grant applications, the 
following supplemental instructions should be used as a guide in the 
preparation of the application. The following supercede the PHS 398 

1)  Under “Performance Sites” (page 2), list only the official name and 
address of the lead partner.  A complete listing of the other partners should 
be attached to the application as an appendix.

2)  Detailed Budget. In general, allowable budget items for these planning 
and development grants are limited to a portion of the salaries of the 
planning director, consultation fees, key administrative and clerical support 
personnel, as allowed by the appropriate Federal cost principals, travel and 
per diem expenses for outside consultants/advisors, and supplies. The budget 
should include travel and per diem expenses for the planning director and/or 
other key personnel to be attend one meeting in Washington, D.C. with AHRQ 
and HITRC staff. The level of effort of personnel should reflect the 
commitment of the individual to the planning process. The purchase of 
equipment, including computer hardware and software, is limited to 20% of the 
total grant. All budget requests should be well justified. Budget requests 
submitted under this part of the RFA should not exceed $200,000 in total 
costs.   Applications submitted with budget requests that exceed $200,000 in 
total cost will be returned without review.

Cost sharing or matching are not required of applications submitted in 
response to this RFA.

3)  Biographical Sketches. Include in this section a biographical sketch of 
the planning director (equivalent of Principal Investigator) and other key 
personnel to be involved in the planning effort.

4)  Resources available to the partnership should be described once, either 
in a separate section following the biographical sketches or included in the 
narrative text (see below).

Research Plan.  This narrative part of the application should contain the 
following elements:

Section I.  Partnerships

a)  Description of the existing or planned partnership.  Describe the 
organizations and their role in the partnership.  Discuss the contribution of 
resources from each organization in the partnership. Include as an attachment 
any memorandum of understanding or agreement (MOU/A) between the partners.

b)  Current or proposed infrastructure supporting the partnership.   Describe 
and discuss the existing or planned infrastructure that supports the 
implementation effort.  This discussion (which may alternatively be included 
in the Resources section of the application) should include details of any 
computer-based or other information systems currently in use (or planned). 
The current, or proposed, director and any support staff should be 
identified, including a description of their qualifications and source of 
salary support (if any).  Senior officials of participating organizations 
should, in addition to the above mentioned MOU/A, provide a letter 
documenting support for the proposed planning and development process. These 
and other letters of support should be included as an appendix and referenced 
in this section of the application.  

c)  Progress to date in developing HIT infrastructure. Include a summary of 
other HIT planning activities completed to date, including a summary of 
decisions and their underlying rationale. Applicants should also include 
discussions of the partnership’s current status for each of the Areas of 

Section II.  The Proposed Planning Effort

a)  Description of the planning director and his/her responsibilities and 
authority to carry out the proposed planning process. Discuss the selection 
of this individual as planning director (equivalent of principal 
investigator) and his/her future role in the partnership. This section should 
present an adequate description of his/her qualifications and administrative 

b)  Description of the planning committee. If an internal planning committee 
is being proposed, list and discuss the membership. List any external 
consultants to the planning committee.

c)  Description of other key personnel and their duties.  Discuss the 
selection and duties of the key personnel supporting the planning director 
and planning committee.

d)  Description of issues that will need to be resolved through the planning 
and development process and strategies to overcome them. Discuss the 
issues/obstacles that must be considered in the planning and development 

e)  Detailed description of the planning proposed. Include discussions of the 
proposed approach to planning activities and basic project parameters for 
each of the Areas of Focus.

f)  Discussion of partnership’s future plans to implement and evaluate HIT 

Applications submitted under this RFA must be received by April 22, 2004. An 
application received after the deadline may be acceptable if it carries a 
legible proof-of-mailing date, assigned by the carrier, and the proof-of-
mailing is not later than one week prior to the deadline date.  If an 
application is received after that date, it will be returned to the applicant 
without review.


Applications must be received on or before the application receipt dates 
listed in the heading of this RFA.  If an application is received after that 
date, it will be returned to the applicant without review.  

The CSR and AHRQ will not accept any application in response to this RFA that 
is essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  However, when a previously 
unfunded application, originally submitted as an investigator-initiated 
application, is to be submitted in response to a RFA, it is to be prepared as 
a NEW application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made and the text must 
not be marked to indicate the changes from the previous unfunded version of 
the application.  

Applicants are encouraged to read all PHS Forms 398 instructions prior to 
preparing an application in response to this RFA.  The PHS 398 type size 
requirements (p.6) will be enforced rigorously and non-compliant applications 
will be returned.  It is very important to note that limitations on number of 
pages and size of font must be observed; applications violating these 
requirements will be returned without review.

Institutional Review Board (IRB) approval of human subjects is not required 
prior to peer review of an AHRQ application.  The "AHRQ Revised Policy for 
IRB Review of Human Subjects Protocols in Grant Applications" was published 
in the NIH Guide on September 27, 2000.  
The RFA is also available on AHRQ's Web site,, (see under 
Funding Opportunities).

Application Preparation (for Using CMS Data)  
Purchase of 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 Center for Medicare and Medicaid Services (CMS), previously 
called Health Care Financing Administration (HCFA), 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 AHRQ’s confidentiality statue, 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 included in the DUA 
is the requirement that the 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 6 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 INQUIRIES.

Assessment of AHRQ Grant Programs 

In carrying out its stewardship of research programs, the 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 are to 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. 

To receive an award, applicants must agree to submit an original and 2 copies 
of an abstract, executive summary, and full report of the research results in 
the format prescribed by AHRQ no later than 90 days after the end of the 
project period.  The executive summary should be sent at the same time on a 
computer disk which specifies on the label the format used (Word Perfect, or 
Word, or ASCII format).
The past cooperation of applicants with regard to the submissions described 
in this section may be considered in the application review to assess 
applicants’ potential for responsible stewardship of awarded funds.

AHRQ encourages applicants to take advantage of a technical assistance 
conference call sponsored by AHRQ program staff.  This two hour conference 
call will provide potential applicants with background information and 
respond to questions about the preparation of an application in response to 
this RFA.  Participants are encouraged to submit questions via email prior to 
the conference call.  Please submit up to five questions with your name and 
the name of your institution to by January 20, 2004.  
Questions of a similar topic and nature may be grouped at the sole discretion 
of AHRQ staff. The conference call is open to any individual or organization 
intending to apply.  Participation is not a prerequisite to applying.  The 
conference call will take place on January 22, 20043 at 1:00 p.m. EST and 
last approximately 2 ½ hrs. The last hour of the call will be reserved 
exclusively for issues relevant to small community and rural applicants.  To 
register to participate in the call, please send your request to by January 20, 2004.

Transcripts of the conference call will be available seven business days 
after the call.  Please send your request for a copy of the transcripts to


Upon receipt, applications will be reviewed for completeness and 
responsiveness by the Agency Referral Officer, program staff, and grants 
management staff.  Incomplete and/or non-responsive applications or 
applications not following instructions given in this RFA will be returned to 
the applicant by the Agency Referral Officer without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened in accordance with standard AHRQ peer review procedures.  

As part of the merit review, all applications will:

o   Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score
o   Receive a written critique


In the written comments, reviewers will be asked to evaluate the application 
in order to judge the likelihood that the proposed project will have a 
substantial impact on the pursuit of the RFA’s goals:

o   Significance
o   Approach
o   Innovation
o   Planning Director
o   Environment
o   Budget

The application does not need to be strong in all categories to be judged 
likely to have  major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 

SIGNIFICANCE: Does your project address an important gap or problem?  If the 
aims of your application are achieved, how do they advance the general 
knowledge with regard to HIT diffusion and adoption?  What will be the effect 
of your project on the concepts or methods that drive this field? To what 
extent will the proposed implementation activity involve populations of 
providers or patients most in need of HIT innovations?

APPROACH: Are the conceptual framework, design, methods, and analysis 
adequately developed, well integrated to the aims of the project?  Do you 
acknowledge potential problem areas and consider alternative tactics? 

INNOVATION: Does your project employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does your project challenge existing 
paradigms or develop new methodologies or technologies?

PLANNING DIRECTOR:  Are you appropriately trained and well suited to carry 
out this work?  Is the work proposed appropriate to your experience level as 
the principal investigator? Does the study team contain appropriate 

ENVIRONMENT: Does the environment in which your work will be done contribute 
to the probability of success?  Do the proposed experiments take advantage of 
unique features of the environment or employ useful collaborative 
arrangements?  Is there evidence of institutional support? 

BUDGET: The proposed project budget and the requested period of support 
should be reasonable in relationship to the project. 

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score: 

o   PROTECTIONS: The adequacy of the proposed protection for humans or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

o   INCLUSION:  The adequacy of plans to address the need of both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the aims of the project.  Adequacy of attention to other populations of 
special priority to AHRQ (see discussion of Priority Populations in the 
section of Special Requirements, and Inclusion Criteria included in the 
section on Agency policies and Requirements, below).

Finally, applications will be assessed in two additional areas: 1) technical 
merit of the proposed planning process; and 2) potential of the new or 
existing organization to implement its HIT plan. Peer reviewers will be asked 
to specifically comment in these two areas. The final priority scores will 
reflect the peer reviewer’s overall assessment based on their judgments of 
the two review areas.

1.  The technical merit of the proposed planning process:

a)  Clarity and appropriateness of planning goals and objectives;
b)  Extent to which the application appropriately defines the problems that 
need to be resolved in the planning process;
c)  Extent to which the proposed detailed planning effort has clear and 
appropriate goals consistent with AHRQ’s stated goals and is of adequate 
scope with regard to the Areas of Focus;
d)  Qualifications of the proposed planning director to lead the planning and 
development effort and his/her leadership experience, administrative skills 
and research background;
e)  Qualifications and appropriateness of the key personnel designated to 
assist the planning director;
f)  Appropriateness of the membership and stated functions, as well as 
potential effectiveness, of the proposed internal planning committee (or 
advisors to the planning director), and,
g)  The adequacy of measuring the success of the planning process.

2.  The potential of the organization to implement its HIT plan:

a)  Adequacy of the commitment of the members of the collaborative to 
implement HIT, as evidenced by previous work in HIT implementation or letters 
of support;
b)  Adequacy of the organization to address the healthcare of priority 
c)  Adequacy and stability of the organization’s administrative, 
organizational and management capabilities; and,
d)  Extent to which the award of grant funds will enhance the ability of the 
organization to plan future activities for implementing HIT.

The reviewers will also examine the adequacy of the budget for the proposed 
project to achieve the projects goals.



Data Confidentiality 

Pursuant to section 924(c) of the Public Health Service Act [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 now civil monetary penalties for 
violation of this confidentiality statute. [42 U.S.C.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 the 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 RFA will also be managed in 
accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to 
the privacy of protected health information. These privacy regulations, 
developed by the Department of Health and Human Services pursuant to the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA), became 
mandatory for covered entities on April 14, 2003. 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. 
Thus, for example, health care plans, clearinghouses, and those providers who 
engage in HIPAA-covered electronic transactions will require either patient 
authorization of disclosures of identifiable information to be made to 
researchers who are not their health care providers or waivers of such 
authorizations obtained from an IRB or Privacy Board (defined in the 
regulations) upon being satisfied that any identifiable health information 
will be appropriately safeguarded by the investigators.   The HHS Office of 
Civil Rights (OCR) is the enforcement body for this regulation.  Additional 
Information about the regulations and their implementation can be obtained 
from: . 

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

Rights in Data 

AHRQ grantees may copyright unless otherwise provided in grant awards, or 
seek patents, as appropriate, for final and interim products and materials 
including, but not limited to, methodological tools, measures, software with 
documentation, literature searches, and analyses, which are developed in 
whole or in part with AHRQ funds. Such copyrights and patents are subject to 
a worldwide irrevocable Federal government 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, 
data bases, results, and algorithms available for verification or replication 
by other researchers; and 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 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 these issuances 
with other AHRQ dissemination activities. Important legal rights and 
requirements applicable to AHRQ grantees are set out or referenced in the 
AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries 
and from the GPO's website 


Technical Assistance Conference Call:  January 22, 2004
Letter of Intent Receipt Date:  February 6, 2004
Application Receipt Dates:  April 22, 2004
Earliest Anticipated Start Date:  September 30, 2004


Award criteria that will be used to make award decisions include:

o   Scientific merit (as determined by peer review)
o   Availability of funds
o   Programmatic priorities


POPULATIONS:   It is the policy of AHRQ that women and members of minority 
groups be included in all AHRQ-supported research projects involving human 
subjects, unless a clear and compelling rationale and justifications are 
provided that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  

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 
A complete copy of the updated Guidelines is available at  
To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the AHRQ 
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web 
site  AHRQ Program staff may 
also provide additional information concerning these policies (see 

Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some 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 act is taken, having the force and effect of law, 
in reliance upon an AHRQ-supported research project, the underlying data is 
not subject to this disclosure requirement.  Furthermore, even if a Federal 
regulation action is taken in reliance on such data under FOIA, 5 USC 552(b), 
disclosure of statutorily protected confidential identifiable data from such 
study is exempted from disclosure under "the (b)(3) exemption." 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", for example, if it constituted trade secrets or commercial 
information collected. NIH has provided general related guidance at 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 RFA in a public 
archive, which can provide protections for the data (e.g., as required by the 
confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 
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 think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award. 

Department of Health and Human Services (DHHS) issued the last modification 
the "Standards for Privacy of Individually Identifiable Health Information", 
was mandated by the "Privacy Rule," on August 14, 2002.  This 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). Mandatory compliance with the Privacy Rule (for those 
classified under the Rule as "covered entities") must do so by April 14, 2003 
(with the exception of small health plans which have an extra year to 

Decisions about applicability and implementation of the Privacy Rule reside 
with covered entities. The OCR website ( 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 of a covered entity.  Project Officers will assist grantees in 
resolving questions about the applicability of HIPAA requirements.

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance, Number 93.226.  Awards are made under Title IX 
of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-
129 (1999).  Awards are administered under the PHS Grants Policy Statement 
and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92.  
This program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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 PHS mission to protect and advance the physical and mental health of 
the American people.


Committee on Quality Health Care in America and Institute of Medicine (2001). 
Crossing the quality chasm: a new health system for the 21st century. 
Washington, DC, National Academy Press.

Harrison, M. and A. Shirom (1999). Organizational Diagnosis and Assessment: 
Bridging Theory and Practice. Thousand Oaks, CA, Sage.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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