PATIENT SAFETY RESEARCH DISSEMINATION AND EDUCATION
 
Release Date:  April 23, 2001

RFA:  RFA-HS-01-008
 
Agency for Healthcare Research and Quality (formerly AHCPR)
 
Letter of Intent Receipt Date:  May 10, 2001
Application Receipt Date:       May 24, 2001

PURPOSE
 
The Agency for Healthcare Research and Quality (AHRQ) announces the 
availability of approximately four to seven Cooperative Agreements (U18) for 
up to three years of support for professional associations, educational 
leadership organizations and provider organizations to demonstrate and 
evaluate innovative approaches to provider education; to disseminate patient 
safety research results and best practices; and to promote positive safety 
culture.  These projects are intended to enable these organizations to 
develop, demonstrate, and evaluate new approaches to improving provider 
education and practice in order to reduce medical errors and create a culture 
to improve patient safety.  AHRQ seeks to support projects that can be 
replicated by others on a larger scale which develop, implement, and evaluate 
effective educational strategies to improve patient safety and reduce medical 
errors.  These cooperative agreements are intended to capitalize on advances 
in knowledge about medical errors and translate established strategies to 
reduce medical errors into widespread use through provider education.  AHRQ 
is interested in programs that make maximum use of active learning through 
the use of simulation, team training, and web-based instruction as well as 
traditional educational approaches to disseminate, implement, and evaluate 
provider education to improve patient safety. 

This Request for Applications (RFA) is the last in a series of patient safety 
research solicitations  to be issued by AHRQ in FY01.  The series of 
solicitations form an integrated set of activities to design and test best 
practices for reducing errors in various settings of care, develop the 
science base to inform these efforts, improve provider education to reduce 
errors, capitalize on the advances in information technology to translate 
proven effective strategies into widespread practice, and build the capacity 
to further reduce errors.  At the heart of this competitive demonstration 
program is a portfolio of projects to test the effectiveness, costs, and 
cost-effectiveness of diverse reporting strategies and information technology 
innovation on the identification, management, and reduction of medical 
errors.  These activities are supported and amplified by: 1)  the 
establishment of multidisciplinary centers of excellence in patient safety; 
2)  targeted efforts to understand the impact of provider education, skills, 
staffing, and organization on error rates; 3) partnerships with health 
systems, professional organizations, states, and other groups to build 
capacity for error reduction activities, disseminate effective strategies, 
and coordinate public and private efforts; and 4) cross-cutting activities 
that capitalize on data already collected which can be enhanced to support 
research and action in patient safety.

RFAs released as part of this program include:

1) Health System Error Reporting, Analysis, and Safety Improvement 
Demonstrations -- to support large demonstrations in States, health care 
systems, and networks of providers (both integrated delivery systems and 
primary care networks) to test reporting strategies and patient safety 
interventions.
  
2) Clinical Informatics to Promote Patient Safety (CLIPS) -- to develop and 
test the use of appropriate technologies to reduce medical errors, such as 
hand-held electronic medication and specimen management systems and 
prescription pads, training simulators for medical education, bar-coding of 
prescription drugs, patient bracelets, and automated dispensing of medication 
in a hospital setting. 

3) Centers of Excellence for Patient Safety Research and Practice -- to 
support established cross-
cutting teams of researchers and health care facilities and organizations in 
geographically diverse locations (including rural and urban areas) that will 
determine the causes of medical errors and develop new knowledge to support 
the work of the demonstrations.

4) Developmental Centers for Evaluation and Research in Patient Safety 
(DCERPS) -- to develop new multidisciplinary research teams to improve the 
nation’s capacity in patient safety research, to expand the patient safety 
knowledge base, and to establish mechanisms to assure that new knowledge is 
incorporated into actual practice and that its impact is assessed.

5) Effect of Working Conditions on Patient Safety -- to develop an 
understanding of how the environment of care impacts the ability of providers 
to improve safety (e.g., the effect of fatigue, stress, sleep deprivation, 
and shift work on cognitive ability and the relationship to patient safety) 
and how interactions with the physical healthcare environment (facility 
design, aesthetics, etc.) impacts the provision of safe high quality care. 
 
Additional components of the Agency’s patient safety initiative will build on 
existing Agency programs.  AHRQ will also support a contract for a 
coordinating center to provide guidance and facilitate interaction among the 
entities funded under the Agency’s patient safety programs.  The coordinating 
center will assure translation of the new knowledge from the research 
projects to the demonstration sites.  The coordinating center will also 
provide general guidance to the grantees supported under this RFA and 
organize meetings of these grantees and other components supported under the 
Agency’s patient safety research initiative.  

Research themes under this RFA and others to be released by the Agency have 
been generated by a variety of activities including public and private sector 
national summits and research agenda-
setting activities on quality, medical errors and patient safety, as well as 
key stakeholder meetings.  Research themes are the outgrowth of ongoing 
activities of the Quality Interagency Coordination Task Force (QuIC) and its 
report (See Ref. # 1) -- “Doing What Counts for Patient Safety - Federal 
Actions to Reduce Medical Errors and Their Impact” (http://www.quic.gov).  
Furthermore, the Agency sponsored a National Summit on Medical Errors and 
Patient Safety Research on September 11, 2000.  Findings from the Summit also 
contribute to the research themes and define a set of focus areas for 
provider education efforts supported under this RFA.  A research summary of 
the summit is available at http://www.quic.gov/summit/resagenda.htm.

For the purpose of this RFA, medical errors are defined as the failure of a 
planned action to be completed as intended or the use of a wrong plan to 
achieve an aim.  Errors can include problems in practice, products, 
procedures, and systems.  The term patient safety, as used here, applies to 
initiatives designed to prevent adverse outcomes from medical error.  The 
enhancement of patient safety encompasses three complementary activities:  
preventing errors, making errors visible, and mitigating the effects of 
errors:  (See Ref. # 1)  Provider education refers to planned learning 
experiences for individuals who provide care to patients.  Providers include 
all health professionals and health care workers engaged in care to patients, 
including but not limited to physicians, nurses, pharmacists, allied health 
professionals, aides and others engaged in the care of patients directly or 
indirectly. 

Provider education can span the continuum of the educational process from 
basic entry level training, through advanced training, to continuous learning 
experiences for individuals in practice. The continuum is often referred to 
as undergraduate, graduate, and continuing education.   For purposes of this 
RFA undergraduate education is the formal entry-level professional training 
of an individual provider leading to entry level degree or certification.  
Graduate education is advanced professional education such as formal graduate 
school leading to an advance degree or certification, including residency and 
fellowship education of physicians or advanced practitioner status for nurses 
and allied health professionals.  Continuing education is organized learning 
experiences for providers to maintain or enhance their competency to provide 
optimal care.  Continuing education activities are not normally associated 
with either degrees or formal certifications. Continuing education that is 
directed to the health professional teachers and faculty designed to improve 
their skills as faculty is generally referred to as faculty development.  
Faculty development is often considered an essential first step in bringing 
about changes in curriculum, instruction and the development of new 
attitudes.  Because of this vital role of faculty development in patient 
safety, projects which address the needs of health care provider faculty can 
be included as a potential target audience under this RFA.

HEALTHY PEOPLE 2010

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

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, public and private non-profit 
organizations, including professional societies, professional associations, 
educational leadership organizations, provider organizations, health care 
delivery organizations, health plans, units of State and local governments, 
and eligible agencies of the Federal government. Given the substantial impact 
of professional associations, educational leadership organizations, and 
provider organizations on the education of healthcare providers, AHRQ is 
particularly interested in applications from professional associations, 
educational leadership organizations, and provider organizations or entities 
which have a direct partnerships with them.  Applications may include foreign 
components, but foreign organizations are not eligible to apply.  Under 
recently enacted reauthorization legislation, AHRQ is authorized to enter 
into cooperative agreements with for-
profit organizations as well as with public and not-for-profit entities.  
Thus, for-profits organizations are invited to respond to this solicitation 
for cooperative agreements. Applications will be administered in accordance 
with 45 CFR Part 74 and 42 CFR Part 67 Subpart A.  The latter regulation was 
amended on December 6, 1999, and reflects changes in Agency name and 
authority. (See AHRQ reauthorization at (http://www.ahrq.gov/hrqa99a.htm). 
Organizations described in section 501(c)4 of the Internal Revenue Code as 
engaging in lobbying are not eligible. 

AHRQ encourages women, members of racial and ethnic minority groups and 
persons with disabilities to apply as principal investigators.  Special 
preference will be accorded to applications from investigators who have not 
been funded by AHRQ as a principal investigator within the last two years.  

AHRQ also encourages minority institutions or organizations which focus on 
minority providers or patient populations to apply for funding under this 
RFA.  AHRQ also encourages collaboration on projects between minority 
institutions and organizations with non-minority institutions and 
organizations.  In accordance with AHRQ’s recent reauthorization, the Health 
Care Research and Quality Act of 1999, AHRQ is focusing more extensively on a 
number of priority areas and populations: inner-city areas; rural areas, 
including frontier areas; 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.  AHRQ strongly encourages applicants for these 
cooperative agreements to include a focus on one or more of these priority 
areas and populations by targeted data collection, analysis, or safety 
improvement strategies. 

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U18), an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial AHRQ scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under a cooperative agreement, AHRQ’s goal is to support 
and/or stimulate the recipient's research activity by working jointly with 
the award recipient in a partner role, but AHRQ  is not to assume direction, 
prime responsibility, or a dominant role in the activity. Details of the 
responsibilities, relationships and governance of the study to be funded 
under cooperative agreement(s) are discussed later in this document under the 
section “Terms and Conditions of Award.”  The total project period for 
applications submitted in response to the present RFA may not exceed three 
years.  The anticipated award date is September 28, 2001.  This RFA is a one-
time solicitation.  AHRQ has not determined whether or how this solicitation 
will be continued beyond the present RFA.

FUNDS AVAILABLE
 
AHRQ expects to award up to $1,500,000 in fiscal year 2001 to support the 
first year total costs (direct costs and facilities and administrative costs) 
of four to seven projects under this RFA.  The actual number of applications 
funded is dependent on the number of high quality applications and their 
individual budget requirements.  It is not the intent of AHRQ that the awards 
be equal in size. Although the financial plans of AHRQ provide for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds for this purpose.  Should additional funds become available, however, 
and if AHRQ receives a sufficient number of meritorious applications, AHRQ 
reserves the right to fund additional applications under this RFA.  Funding 
beyond the initial budget period will depend upon annual progress reviews by 
AHRQ and the availability of funds.

RESEARCH OBJECTIVES
 
Background

This RFA is part of the Agency’s coordinated efforts to develop, demonstrate, 
and evaluate strategies for reducing errors and improving patient safety.  It 
provides the opportunity for professional associations, educational 
leadership organizations, and provider organizations to develop, implement, 
disseminate, and evaluate the impact of educational strategies to enhance 
provider education on medical error reduction.  Projects funded under this 
cooperative agreement are to be partnerships between awardees and AHRQ to 
translate evidence from patient safety research into educational programs to 
enhance patient safety. 

In November 1999, the Institute of Medicine (IOM) released a report entitled, 
To Err is Human, (2) which estimated that between 44,000 and 98,000 people 
die each year in hospitals from medical errors.  It called for a  “a 
comprehensive and strong response to this most urgent issue facing the 
American people.”  The IOM called for leadership from the Department of 
Health and Human Services (DHHS) in reducing medical errors and identified 
one of its operating divisions, the Agency for Healthcare Research and 
Quality (AHRQ), as the national focal point for patient safety research.  The 
Quality Interagency Coordination (QuIC) Task Force (www.quic.gov), a 
coordinating body for all health care quality improvement activities in the 
Federal government, developed an action plan detailing how the Federal 
government could respond to the IOM’s report and improve patient safety in 
Federally funded health care programs. As part of its reauthorization, AHRQ 
is required to conduct and support research and build private-public 
partnerships to reduce errors in medicine through the pursuit of the 
following three goals:  (1) identifying the causes of preventable health care 
errors and patient injury in health care delivery; (2) developing, 
demonstrating, and evaluating strategies for reducing errors and improving 
patient safety; and (3) disseminating effective strategies throughout the 
health care industry. 

The report from the Council on Graduate Medical Education and the National 
Advisory Council on Nursing Education and Practice entitled Collaborative 
Education to Ensure Patient Safety  (3) states that practice approaches have 
their foundation in the education and training system of health care 
providers.  If improvements are to be made in patient safety, there must be 
efforts directed toward introducing patient safety as educational content 
into the provider education system at all levels of the continuum.  The IOM 
also addressed the role of health professional societies and groups and their 
potential role in patient safety as follows:

Professional societies, groups and associations can play an important role in 
improving patient safety by contributing to the creation of a culture that 
encourages the identification and prevention of errors.  Few professional 
societies or groups have demonstrated a visible commitment to reducing errors 
in health care and improving patient safety.  Although it is believed that 
the commitment exists among their members, there has been little collective 
action. (See Ref # 2, p. 144)

As the IOM report suggests, professional associations, educational leadership 
organizations, and provider organizations can play a key role in helping to 
build a positive safety culture.  Safety culture development begins within 
the professional education and orientation of new professionals and is re-
enforced during practice.  In addition to their influence on culture, 
professional associations, educational leadership organizations, and provider 
organizations can also play a role in developing, implementing, 
disseminating, and evaluating educational programs to address errors. 

Objectives and Scope

Projects submitted in response to this RFA should propose innovative 
approaches to provider education.  Projects are expected to contribute to our 
understanding of how to enhance provider education in order to reduce medical 
errors and create a positive safety culture in order to improve patient 
safety.  AHRQ is interested in projects in which the results will be 
applicable and generalizable to situations beyond that of the project and 
contribute to enhancing provider education. Proposed educational strategies 
may encompass a variety of approaches.  AHRQ is particularly interested in 
active modes of learning that can be easily replicated by others and 
demonstrate effective methods to enhance knowledge retention.

Methods

All projects must have clearly specified plans for the design, development, 
implementation, and evaluation of the proposed provider education program. 
The plan must include:

1. The specified target audience i.e., which group or groups of providers 
(physicians, nurses, allied health professionals, etc.) and at which level or 
levels of the educational continuum the program is intended to be delivered.  
Applicants should also describe the setting(s) in which interventions will be 
applied.

2. The curriculum development approach to be used to identify the 
knowledge, skills and attitudes to be addressed.  As a cooperative agreement 
AHRQ will provide successful awardees with information on patient safety 
research and best practices generated from other funded activities and the 
patient safety literature. 

3. The instructional methods to be used to reach the target audience.

4. The program evaluation plan which will outline the approach taken to 
document the program process and impact with the target audience.  The 
evaluation, must, at a minimum, determine whether the educational program and 
materials were distributed to the target audience.  It would be desirable to 
also assess whether provider knowledge was changed by the program, if 
provider behavior was changed, and any impact on patient outcomes. (See Ref. 
# 4)  It is expected that most projects supported under this RFA will have 
difficulty in demonstrating an impact on provider behavior and patient 
outcomes but to the extent that such an impact is demonstrable, it would be 
highly desired.  Applicants should also assess the generalizability of their 
program to other settings, provider groups, and areas.

SPECIAL REQUIREMENTS

The awardees of this RFA will meet annually with AHRQ staff, the coordinating 
center, and each other to discuss their programs, coordinate content focus, 
and set priorities for evaluation and dissemination.  Budgets submitted in 
response to the RFA should include travel costs for the principal 
investigator and one co-investigator to attend these annual meetings in 
Rockville, MD.

Data Privacy

All information about identifiable individuals or organizations obtained for 
the research purpose of carrying out a demonstration project supported 
pursuant to this RFA under AHRQ’s statutory authority is protected by a 
federal confidentiality statute, section 924 of the Public Health Service Act 
, 42  USC 299c-3(c).  Under this law, the only permissible uses or 
disclosures of the information are those agreed to by the subject individuals 
and organizations or by those who supply the information to the researchers.  
There are substantial statutory penalties (up to $10,000) for improper use or 
disclosure of this information.  Thus 42 USC 299c-3(c) provides a Federal 
statutory basis for resisting any Federal or state court order or subpoena to 
the extent that carrying out the order or subpoena would violate the 
protective restrictions of the statute.  Upon request, AHRQ will provide 
legal assistance in defending adherence to these statutory confidentiality 
protections with respect to identifiable data obtained in carrying out Agency 
research activities.

Note that identifiable data obtained by AHRQ-supported researchers is 
protected by this law when it is obtained to carry out AHRQ-supported 
research, but this law would not protect against access to this same 
information in medical records  if it were gathered and  recorded there for 
other purposes.  If providers collect certain information solely for purposes 
of this research, it should be so marked and if necessary to protect its 
confidentiality, kept separately.  Note also that this law does not protect 
or restrict aggregate and nonidentifiable statistical or data analysis and 
conclusions developed by the researchers that would not disclose information 
about any identifiable individuals or establishments

Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ-study that identifies 
an individual or entity must be treated as confidential in accordance with 
any promises made or implied regarding the possible uses and purposes of the 
data collection.  In the Human Subjects section of the application, 
applicants must describe procedures for ensuring the confidentiality of such 
identifying information.  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.

The grantee 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 
http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf.

The application of these confidentiality and security standards to 
subcontractors and vendors should be addressed as necessary.

Rights in Data

AHRQ grantees may copyright 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 research 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 through the media and other 
appropriate channels in coordination with AHRQ’s Office of Health Care 
Information but relies on grantees to publish research results in peer-
reviewed journals and to market grant-supported products.  The Agency is 
particularly interested in projects that would make educational and 
dissemination tools available to the Agency for further dissemination.

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 
http://www.access.gpo.gov/nara/cfr/index.html).

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY 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 justification 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 
"NIH Guidelines on the Inclusion of Women and Minorities as Subjects in 
Clinical Research," which have been published in the Federal Register of 
March 28, 1994, and updated August 2, 2000.  A complete copy of the updated 
Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  To the 
extent possible, AHRQ requires adherence to these NIH guidelines.

Investigators may obtain copies from the above sources or from the AHRQ 
contractor, listed under INQUIRIES, or from the NIH Guide Website 
http://grants.nih.gov/grants/guide/index.html.

AHRQ encourages investigators to consider including children in study 
populations, as appropriate.  

AHRQ program staff may also provide additional information concerning these 
policies (see INQUIRIES). 

TERMS AND CONDITIONS OF AWARD

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS grant administration 
regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other 
HHS, PHS grants administration policy statements.  Applicants should be 
familiar with the Agency’s grant regulations, 42 CFR Part 67 Subpart A, and 
particularly sections 67.18-67.22.  Under the cooperative agreement, the AHRQ 
purpose is to support and/or stimulate the recipient's activity by working 
jointly with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee for the project as a whole, although 
specific tasks and activities in carrying out the studies may be shared 
between the awardees and the AHRQ Program Official. 

1. Awardee Rights and Responsibilities 

The Awardee will have primary and lead responsibility for the project as a 
whole, including research design and protocol development, participant 
recruitment and follow-up, data collection, quality control, preparation of 
publications exclusively about the data collection, analysis, information 
dissemination and testing of interventions to improve safety within their 
provider education project.  They will be responsible for cooperating and 
collaborating with other AHRQ awardees working on patient safety improvement 
with assistance from the AHRQ Program Official and the coordinating center 
(described below).  In addition, awardees are required to cooperate with 
AHRQ’s evaluation contractor that will be assessing the relative 
effectiveness of the Agency’s entire patient safety research portfolio.  The 
Awardee retains custody of and have primary rights to the data developed 
under these awards, subject to Government rights of access consistent with 
current Department of Health and Human Services, Public Health Services, and 
AHRQ policies.

The awardees of this RFA are required to meet annually with AHRQ staff, the 
coordinating center, and each other to discuss their programs, coordinate 
content focus, and set priorities for evaluation and dissemination. 

2. AHRQ Staff Responsibilities

The AHRQ Program Officials for the patient safety program include the project 
officers for the funded cooperative agreements and the patient safety staff 
of the AHRQ Center for Quality Improvement and Patient Safety (CQuIPS).  
Specifically, CQuIPS will promote collaboration and comparison of information 
gathered by the projects, the sharing of analytic methods and results, and 
information on effective instructional approaches and methods which have been 
shown to have an impact on reducing the risk to patients and improved patient 
safety.  The AHRQ supported coordinating center will facilitate communication 
and sharing of ideas between the programs funded under this RFA and the 
Agency’s funded Centers of Excellence in Patient Safety Research, Developing 
Centers of Excellence in Research on Patient Safety, and Health System Error 
Reporting, Analysis, and Safety Improvement Demonstration projects. These 
other grantees supported under the Agency’s earlier patient safety RFAs could 
provide content to the dissemination and education programs supported under 
this RFA. A complete description of the purpose of these Centers can be found 
in the requests for applications for each, which are available at 
http://www.ahrq.gov/fund.  The Agency will also provide the results of an 
Agency sponsored Evidence Based Practice Center report, “Compendium of 
Patient Safety Practices,” due in July 2001 to grantees to provide an 
additional source of potential content for the programs supported under 
this RFA.

3. Arbitration 

Any disagreement 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 Steering Committee (with the AHRQ members not voting), or by 
the individual awardee in the event of an individual disagreement, 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 
regulations at 45 CFR Part 16.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent by May 10, 2001 
that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities 
of other key personnel and participating institutions, and the number and 
title of the RFA to which the application may respond.  
Although a letter of intent is not required, is not binding, and does not 
enter into consideration of any subsequent application, the information 
allows AHRQ staff to estimate the potential review workload and avoid 
conflict of interest in the review.  AHRQ will not provide responses to 
letters of intent.

The Letter of Intent is to be sent to:

Greta Drott
Office of Research Review Education and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400 W
Rockville, MD  20852-4908
Telephone:  (301) 594-3421
FAX:  (301) 594-0154
E-mail Address:  gdrott@ahrq.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these cooperative agreements.  State and local government 
applicants may use PHS 5161-1, Application for Federal Assistance (rev. 
7/00), and follow those requirements for copy submission.  The PHS 398 type 
size requirements (p. 6) will be enforced rigorously, and non-compliant 
applications returned.  In part, the PHS 398 states that the application must 
be clear, readily legible, and conform to all of the following requirements: 
1) the height of the letters must not be smaller than 10 point; 2) type 
density must be no more than 15 characters per inch (cpi); and 3) no more 
than 6 lines of type must be within a vertical inch. Applicants are 
encouraged to read all PHS Forms 398 instructions prior to preparing an 
application in response to this RFA.

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 (rev. 4/98).

Beginning with applications for AHRQ submitted for the February 1, 2001 
receipt date, Institutional Review Board (IRB) approval of human subjects is 
not required prior to peer review of an application unless otherwise 
indicated by the Agency 
(http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html.)  
Given the nature of this project and the speed with which 
successful applicants will need to begin work, the Agency has determined that 
IRB approval is required by July 13, 2001 for all applications submitted in 
response to this RFA.  IRB approval may be submitted to Greta Drott at the 
address listed above.  All investigators/applicants proposing research 
involving human subjects should pay particular attention to the instructions 
in the form PHS 398 regarding human subject involvement. 

Applications kits are available at most institutional offices of sponsored 
research.  They may be downloaded from 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  They may also be 
obtained from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone (301) 435-0714, E-mail: grantsInfo@nih.gov.

AHRQ applicants are encouraged to obtain application materials from the AHRQ 
Publications Clearinghouse  (see INQUIRIES).

The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should 
both indicate RFA number.  The RFA label must be affixed to the bottom of the 
face page.  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 also be typed on line 2 
of the face page and the YES box must be marked.  The sample RFA label 
available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has 
been modified to allow for this change.  Please note this is in pdf format.

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 
“Advance Copy” must also be sent to:

Greta Drott
Office of Research Review Education and Policy  
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400 W
Rockville, MD  20852-4908
Telephone:  (301) 594-3421
FAX:  (301) 594-0154
E-mail Address:  gdrott@ahrq.gov

Applications must be received by May 24, 2001.  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 1 week prior to the deadline date.  If an 
application is received after that date, it will be returned to the applicant 
without review.  In carrying out its stewardship of assistance programs, the 
AHRQ, at some point in the future, may begin requesting 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 sponsored research.  AHRQ expects grant recipients to keep the 
Agency informed of publications or the impact from Agency sponsored research.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and 
responsiveness.  Incomplete and/or non-responsive applications will be 
returned to the applicant without further consideration.  Applications that 
are complete and responsive to the RFA will be evaluated for scientific and 
technical merit in accordance with the review criteria stated below by an 
appropriate peer review group convened by AHRQ.

As part of the merit review, all applications will receive a written 
critique, and also may undergo a process in which only those applications 
deemed to have the highest scientific merit will be discussed and assigned a 
priority score. 

General Review Criteria

The goals of AHRQ-supported research are to enhance the quality, 
appropriateness, and effectiveness of health care services, and access to 
such services.  The reviewers will be asked to discuss the following aspects 
of the application in their written critiques in order to judge the 
likelihood that the proposed projects will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered by the reviewers in assigning the overall score, weighting them as 
appropriate for each application. 
 
1. Significance.  Does the proposed education and dissemination program 
address an important problem?  If the aims of the application are achieved, 
how will scientific knowledge be advanced and patient safety improved?  What 
will be the effect of the education and dissemination program on the concepts 
or methods that drive this field?

2. Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
education and dissemination program?  Are the proposed sources of evidence 
for dissemination appropriate and adequate?  Does the applicant acknowledge 
potential problem areas and consider alternative tactics?

3. Innovation.  Does the education and dissemination program employ novel 
concepts, approaches or methods?  Are the aims original and innovative, 
challenge existing paradigms or develop new methodologies or technologies?

4. Investigators.  Are the investigators appropriately trained and well 
suited to carry out this work?   Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers?  Is the 
project (or work plan) well organized? 

5. Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed education and 
dissemination programs take advantage of unique features of the provider 
environment or employ useful collaborative arrangements?  Is there evidence 
of institutional or organization in kind support?

6. Responsiveness.  Does the application respond closely to the challenges 
and requirements identified in this RFA?  Does the proposed study target the 
priorities outlined in this RFA and the priorities identified at the Patient 
Safety Research Summit held on September 11, 2000?

The initial review group will also examine: dissemination and evaluation 
activities; the appropriateness of proposed project budget and duration; the 
adequacy of plans to include both genders, children, and minorities and their 
subgroups as appropriate for the scientific goals of the research and plans 
for the recruitment and retention of subjects; the provisions for the 
protection of human and animal subjects; and the safety of the research 
environment.

Special Review Criteria 

In addition to the general review criteria above, the following special 
review criteria will also be applied:

1. The extent to which the team which will be conducting the education and 
training program encompasses experience in developing such programs and 
knowledge of patient safety issues.  The qualifications of the project staff 
should include evidence of qualification in health professional education, 
curriculum and instructional design, and educational program evaluation.

2. The extent to which the educational or training program’s target audience 
is described and the degree of evidence the team provides as to their ability 
to get the target audience to participate in the educational or training 
programs.

3. The extent to which the application demonstrates an innovative approach 
to patient safety and education, drawing on prior proven innovations in 
provider education.

4. The extent to which the application can describe the proposed program.  
This description should focus primarily on the processes that will be used 
(e.g., curricula development, CME programs, simulation, etc.).  It is 
anticipated that the actual content of these programs will vary among 
applications depending upon the availability of evidence and will be shaped 
by discussions with Agency program staff.

5. The extent to which the project results will be applicable and 
generalizable to situations beyond that of the project and contribute to 
enhancing provider education.  Projects can be conducted by professional 
associations and provider organizations and with all types of health care 
providers (physicians, nurses, allied health professionals, pharmacists, 
aides at any level of the educational continuum).  The Agency is particularly 
interested in projects that are  generalizable to other settings and types of 
providers.

6. The extent to which the study will build in an evaluation of the program 
and the products of that evaluation.  In order of preference, evaluations 
should strive to determine how the programs 1) changed patient care; 2) made 
current practice better; 3) improved healthcare provider knowledge; and 4) 
succeeded in dissemination of materials.  It is anticipated that most 
programs will have difficultly delivering on the first 2 of these evaluation 
goals but AHRQ is particularly interested in those applications that can 
address all four evaluation topics.  In addition the Agency is interested in 
applications which will evaluate whether the program resulted in new clinical 
policies or in some way changed the participating professional associations, 
educational leadership organizations, and/or provider organizations.   

7. The extent to which approaches and products are evidence based.

AWARD CRITERIA

Applications will compete for available funds with all other applications 
under this RFA.  The following will be considered in making funding 
decisions: 1) quality of the proposed project as determined by peer review; 
2) availability of funds; 3) responsiveness to the goals and objectives of 
the RFA; 4) portfolio balance, including with respect to the foci of this RFA 
and AHRQ’s other patient safety projects (includes diversity in geographic 
area, professional type, specialty, population served, and educational 
program type); 5) compatibility with other awardees with respect to 
cooperative activities; and 6) relevance to the formulation of public policy. 

Special preference will be accorded to applications from principal 
investigators who are not recent (within 2 years) or current AHRQ funded 
principal investigators of an AHRQ grant for research related to health care 
quality.

Awardees under this RFA will be required 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 (WP5.1 or WP6.0 is 
preferable). 

Awardees must also 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 active or has ended. 

INQUIRIES
 
Copies of the RFA are available from:

AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD  20907-8547
Telephone:  1-800-358-9295 
TDD Service:  888-586-6340

The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, and 
through AHRQ InstantFAX at (301) 594-2800.  To use InstantFAX, you must call 
from a facsimile (FAX) machine with a telephone handset.  Follow the voice 
prompt to obtain a copy of the table of contents, which has the document 
order number (not the same as the RFA number).  The RFA will be sent at the 
end of the ordering process.  AHRQ InstantFAX operates 24 hours a day, 7 days 
a week.  For comments or problems concerning AHRQ InstantFax, please call 
(301) 594-6344.

AHRQ welcomes the opportunity to clarify any issues or questions from 
potential applicants who have read the RFA.  Written and telephone inquiries 
concerning this RFA are encouraged.   Direct inquiries regarding programmatic 
issues, including information on the inclusion of women, minorities, and 
children in study populations to:
 
Francis D. Chesley, M.D.
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400 W
Rockville, MD  20852
Telephone:  (301) 594-6410
FAX:  (301) 594-0154
Email:  training@ahrq.gov

Direct inquiries regarding fiscal and administrative matters to:

Michelle Burr
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 594-1840
Fax:  (301) 594-3210
Email:  mburr@ahrq.gov

AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance No. 
93.226.  Awards are made under authorization of 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 and 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.

REFERENCES

1. QuIC report to the President.  Doing What Counts for Patient Safety:  
Federal Actions to Reduce Medical Errors and Their Impact.  February 21, 1999.

2. Kohn LT, Corrigan JM, Donaldson MS, eds.  To Err is Human; Building a 
Safer Health System.  Washington, D.C.:  National Academy Press.  
November 29, 1999.

3. COGME/NACNEP Collaborative Education to Ensure Patient Safety Rockville, 
MD:  Health Resources and Services Administration.  2001.

4. Stryer D, Tunis S, Hubbard H, Clancy C. The outcomes of outcomes and 
effectiveness research:  impacts and lessons from the first decade.  Health 
Serv Res 2000 35(5 Pt 1):  977-93.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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