SMALL RESEARCH GRANTS FOR PRIMARY CARE PRACTICE-BASED RESEARCH NETWORKS (PBRNs)

RELEASE DATE:  April 28, 2003

RFA:  HS-03-006

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

CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.226

LETTER OF INTENT RECEIPT DATE:  June 23, 2003

APPLICATION RECEIPT DATE:  July 24, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION:

o   Purpose of the RFA
o   Research 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

PURPOSE OF THE RFA 

The Agency for Healthcare Research and Quality (AHRQ) invites primary care 
practice-based research networks (PBRNs) to apply for small research grants to 
conduct exploratory/pilot projects or feasibility studies.  A PBRN is defined 
as a group of ambulatory practices devoted principally to the primary care of 
patients, affiliated with each other (and often with an academic or 
professional organization) in order to investigate questions related to 
community-based practice and to improve the quality of primary care.  This 
definition includes a sense of ongoing commitment to network activities and an 
organizational structure that transcends a single project.

Although a major objective is to encourage creative, investigator-initiated 
research within PBRNs, AHRQ is particularly interested in studies that explore 
(1) network strategies for assuring that new research evidence is translated 
into actual practice and that its impact is assessed; (2) innovative uses of 
information technology in primary care practices; (3) the feasibility of 
implementing electronic health records in primary care and assessing the 
impact on safety, quality, effectiveness and efficiency of care; (4) optimal 
methods of delivering preventive services in primary care settings; (5) 
methods for improving community-based detection and responses to emerging 
public health threats (including acts of bioterrorism); and (6) elucidation of 
primary care-based strategies for diminishing disparities in health care 
delivery and health outcomes for AHRQ priority populations.  This includes 
delivery of health care in inner city and rural areas (including frontier 
areas); it also includes health care for: 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.  The funds are not intended to supplement ongoing 
research or to support large-scale undertakings or analyses of secondary data 
sources.  It is expected, however, that results generated from these projects 
will serve as a basis for planning future, larger scale research.
 
RESEARCH OBJECTIVES

Background
 
As part of the December, 1999, legislation (P.L. 106-129) reauthorizing and 
renaming the agency, AHRQ was directed, in amended section 911 (42 U.S.C. 
299b), to employ research strategies and mechanisms that link research 
directly with clinical practice in geographically diverse locations throughout 
the country, including the use of "provider-based research 
networks...especially (in) primary care."  To address issues of disparities in 
the health care quality, outcomes, cost and access for various segments of the 
U.S. population, amended section 901(b)(2) authorized the agency to implement 
research strategies and mechanisms that specifically include PBRNs.

In response to these directives, AHRQ has over the past three years provided 
support for primary care PBRN research efforts through the issuance of several 
requests for applications.  Most recently, RFA-HS-02-003 provided funds in 
September, 2002, for infrastructure support and exploratory projects to 36 
PBRNs comprised of over 10,000 primary care clinicians with practices in 50 
states serving almost 10 million primary care patients.  The current RFA is 
directed to new or existing primary care PBRNs, including (but not limited to) 
those previously or currently funded by AHRQ.  It provides awards for 
innovative exploratory or pilot projects, or feasibility studies, likely to 
lead to larger scale undertakings by the network.

Objectives and Scope

A major goal of primary care PBRNs, some of which have existed in the U.S. for 
over twenty years, has been to involve busy community-based clinicians and 
their staffs in activities directed by investigators experienced in clinical 
and health services research.  The best of PBRN investigative efforts have 
linked relevant clinical questions with rigorous research methods in community 
settings and have produced scientific information that not only is externally 
valid, but, in theory, more easily assimilated into everyday practice.  
(Nutting, 1999)  Leaders of PBRNs in the U.S. and other countries have also 
recognized the potential of primary care networks to expand their purposes 
beyond traditional research to the nurturing of an evidence-based culture in 
primary care practice. (Thomas, 2001).  Many PBRNs have begun to envision 
their networks as places of learning, where clinicians are continually engaged 
in reflective inquiries about practice, and clinicians and their patients in 
the community are united with science to search for answers that can provide a 
basis for improved delivery of primary care.

A critical element to the success of any PBRN effort is an infrastructure that 
not only serves research but also coordinates diverse network activities, such 
as recruitment and retention of practices, quality improvement efforts,  and 
the translation of research into practice.  Ideally, a network's 
infrastructure includes, in addition to leadership and support personnel, an 
electronic data system that is capable not only of collecting, transferring 
and aggregating primary research data but also of disseminating new 
information quickly and measuring subsequent changes in practices and/or 
patient outcomes.  Such systems have the ability to inform future research 
needs, help transform the culture of practice, and support strategies to 
accelerate continuous quality improvement within practices.  However, numerous 
barriers, such as the cost of purchasing, implementing and maintaining 
sophisticated information technology and training appropriate staff, have to 
date prevented most primary care PBRNs from developing these systems.  
Assuring adequate protection of the privacy and confidentiality of patient 
data is another critical challenge.

Primary care clinicians have recently participated in the development and 
testing of various information technologies, such as decision support systems 
and tools for managing medical information, that enhance practice and 
potentially improve patient outcomes. (Ebell, 2001) More work is needed, 
however, to determine when and how such new technologies can be adopted into 
practices that participate in PBRN activities and the extent to which these 
technologies improve quality, safety, and efficiency.  Certain observers have 
argued that the demands of primary care clinicians for the information 
necessary for optimal patient care can be satisfied only if clinicians use 
electronic medical records (EMRs).  EMRs have been praised for their ability 
to help solve record movement problems, improve the quality and coherence of 
the care process, and assist clinical research, outcomes management, and 
process improvement. (McDonald, 1997)  Although robust EMR systems are now 
available, only about 5% of U.S. primary care providers use them.  (Bates, 
2003) PBRNs could potentially help define the barriers to adopting EMRs as 
well as the benefits realizable through their routine use in primary care 
practice.

In light of recent events in the U.S., there is considerable urgency to 
develop an infrastructure capable of detecting and responding effectively to 
emerging public health threats, including acts of bioterrorism.  Early 
detection of such threats depends largely on the ability of front line 
clinicians to collect, analyze and communicate information.  Also critical are 
systems for providing bidirectional information flow between these clinicians 
and local, state, regional and national public health officials.  Most 
surveillance systems currently in use within primary care practice were not 
designed specifically to detect bioterrorism, but instead were created for 
detecting and managing naturally occurring illnesses such as influenza.  
(Buffington, 1993)  PBRNs can potentially serve as settings to develop and 
test "dual function" systems for recognizing and responding to bioterrorism 
threats through the adaptation of clinical surveillance systems originally 
developed for other purposes.  Information technology linkages between PBRN 
practices, public health agencies, and emergency response networks would be a 
critical element of such systems.

Another major challenge facing PBRNs is identifying and obtaining adequate and 
sustained funding for network research.  Historically, it has been difficult 
for PBRNs to obtain funding through the traditional basic research project 
grant (R01) mechanism.  Most often, applications are denied either for lack of 
preliminary data or for research methods that are adapted to the realities of 
practice settings but appear insufficiently rigorous in peer review.  At the 
same time, few funding opportunities currently exist for PBRNs to generate 
preliminary data as evidence of feasibility or to pilot test new projects or 
research methods.  There is a clear need for a source of funds to support 
network efforts to refine innovative research questions and related hypotheses 
through pilot testing of original ideas derived from primary care practice.  
Such testing could provide important information about the feasibility of data 
collection in network practices, data that may be critical to the successful 
funding of larger, related projects, and to the design of appropriate methods 
for translating study results into actual practice.

Methodological Considerations

Funds available through this RFA provide PBRN investigators the opportunity to 
(1) explore the feasibility, as well as the development, of projects 
investigating issues important to primary care practice, and (2) generate 
preliminary data.  The funds are specifically intended to support the study by 
PBRNs of original ideas or research approaches where preliminary data as 
evidence of feasibility are sparse or do not exist.  The funds are not 
intended to supplement ongoing research or to support large-scale undertakings 
or analyses of secondary data sources.  Rather, proposed projects are intended 
to serve as a basis for planning and strengthening future research grant 
applications (R01s) from PBRNs.

Proposed projects can involve descriptive or interventional studies, 
qualitative and/or quantitative work, multimethod designs, or simple 
hypothesis testing.  While the range of questions that PBRNs can propose is 
broad and detailed in the AHRQ Small Research Grant Program Announcement (PAR-
01-040), AHRQ has a particular interest in the following areas of 
investigation:

o network strategies for assuring that research evidence is translated into 
actual practice and that its impact is assessed.  In particular, there is a 
need for research that explores the application across multiple practices of 
promising translational prototypes (e.g., evidence-based approaches for 
treating a specific disease or system changes that improve the quality or 
efficiency of care) and also assesses resultant changes in the quality and/or 
cost-effectiveness of health care delivery or health care outcomes.

o innovative uses of information technology in primary care practices.  Of 
particular interest are projects that test the end user value of wireless 
handheld devices or desktop workstations that automate common clinician 
practices, such as prescribing, note-taking, clinical decision-making, and 
providing patient education.

o feasibility of implementing electronic medical records (EMRs) in primary 
care and assessing their impact on safety, quality, effectiveness and 
efficiency of care.  PBRNs are encouraged to partner with public and private 
EMR developers in pilot testing the benefits and barriers to adoption of EMRs 
in primary care settings.  Projects that focus on the interfaces between new 
primary care EMR systems and existing electronic data sources (e.g., 
laboratory systems, pharmacy systems) are strongly encouraged.

o optimal methods of delivering preventive services in primary care settings, 
especially those aimed at promoting healthy patient behaviors.

o methods for improving community-based detection and responses to emerging 
public health threats, including acts of bioterrorism.  Of special interest 
are projects that pilot test (through exercises or demonstrations) adaptations 
of primary care surveillance systems to respond to a bioterrorist event and 
also link primary care practices to local, state, regional or national public 
health departments.  

MECHANISM OF SUPPORT
 
This RFA will use the R03 award mechanism.  As an applicant, you will be 
solely responsibility for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  The anticipated award date is 
September 30, 2003. 
 
AHRQ is not using the Modular Grant Application and Award Process. 

FUNDS AVAILABLE

AHRQ intends to commit approximately $500,000 in FY03 to fund five new grants 
in response to this RFA.  The budget limit on small project grant applications 
is $100,000 total costs (i.e., direct costs plus facilities and administrative 
costs) for the entire project period.  Grant support should not exceed 24 
months, and budget requests for the full period of support may not exceed 
$100,000 in total costs.  Applicants responding to this RFA will not be 
required to match or share in project costs if an award is made.

Although the financial plans of AHRQ provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and the 
receipt of a sufficient number of meritorious applications.  At this time, it 
is not known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution is domestic and 
included in any one of the following categories:

o Domestic
o Public and private non-profit organizations, such as universities, hospitals 
or clinics, and professional associations.
o Units of State and local government
o Eligible components of agencies of the Federal Government
o Eligible faith-based or community-based organizations 

While foreign organizations are not eligible, the research network supported 
by the applicant may include individual clinical practices located outside the 
United States.  For the purpose of this RFA, AHRQ will make grants only to 
non-profit organizations.  For-profit organizations may participate in 
projects as member of consortia or as subcontractors. Organizations described 
in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are 
not eligible.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with a primary care PBRN to 
develop an application for support.  AHRQ encourages new investigators (as 
defined in the PHS 398 application instructions) to apply as Principal 
Investigators.  Individuals from underrepresented racial and ethnic groups as 
well as individuals with disabilities are also encouraged to apply for AHRQ 
programs. 

SPECIAL REQUIREMENTS

Applications are encouraged from newly formed PBRNs as well as existing 
networks, including (but not limited to) those that are currently receiving, 
or have in the past received, funds from AHRQ, other Governmental agencies, or 
private sources.  The application must provide a description of the PBRN's 
current state of development as well as its size, patient population served, 
leadership/management staff, and affiliations (if any).  Applications must 
comply with the above special requirements in order to be considered 
responsive to this RFA.

PBRN Resource Center

Recognizing the diverse needs of individual networks and the importance of 
regular communication with and among funded PBRNs, AHRQ has established a PBRN 
Resource Center through Indiana University and the National Opinion Research 
Center.  The Resource Center will conduct an assessment of each PBRN funded 
through this RFA in order to define and prioritize the specific resource needs 
of the network.  Funded networks will be expected to cooperate fully in this 
process with the Resource Center, which will later provide consultative 
services and technical expertise, as appropriate, to each PBRN.  In addition, 
the Resource Center will assist AHRQ in convening two annual meetings of 
representatives of recipient PBRNs during the period of funding.

Required Elements

The applicant is expected to provide a concise, clearly stated research 
question and to describe the process that was used to generate and develop the 
original idea with the network.  While originality of the research question or 
approach and the potential significance of the proposed project will be major 
considerations in the evaluation for funding, the applicant is responsible for 
developing a rigorous plan for research and data analysis.  Background 
literature and a rationale for the research question must be provided.  
Applicants must also describe the steps taken to optimize levels of study 
participation and the potential implementation of research results by network 
membership.

The responsibility for directing the exploratory or pilot project should be 
assigned to a senior level person with appropriate research training and 
experience.  This person may be the network director or another investigator.  
He/she must be directly affiliated with the applicant organization and should 
devote not less than 10% of his/her time to the project over the period of 
funding, although salary support for the principal investigator's effort may 
be cost-shared by the applicant organization.  Appropriate research 
assistant(s) or coordinator(s) may be hired to oversee the daily research 
activities.  Support should also be requested, as appropriate, for statistical 
and other assistance.

Qualifications

Applicants should document in their proposals that the PBRN involved in this 
project meets, at minimum, the following qualifications:

o The PBRN organizational structure includes a core of at least 15 ambulatory 
practices and/or 15 clinicians devoted to the primary care of patients.  The 
majority of the practices should be located in the U.S.  Applicants should 
refer to the Institute of Medicine report on primary care (Donaldson, 1996) 
for definitions of primary care and primary care clinician.
o The network has an accepted statement of its purpose and research mission 
that includes an ongoing commitment to the research endeavor.
o A director has been identified who is responsible for most administrative, 
financial and planning functions.
o The director is, or will be, supported by a staff of at least one person.
o A mechanism (such as a community advisory board) is in place to solicit 
advice/feedback from the communities of patients served by the PBRN 
clinicians.
o An organizational structure exists that transcends a single study, including 
multiple systems of communication with and among participating practices in 
the form of regularly produced newsletters, e-mail or list-serves, conference 
calls, and/or face-to-face meetings of various combinations of network 
members.

Priority Populations

The Agency's authorizing legislation (refer to 
http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs 
to populations of inner-city areas and 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.  
Applications under this RFA should address attention to and potential benefits 
for these priority populations.  

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded 
research into practice and policy, grantees and/or contractors are to inform 
the Office of Health Care Information (OHCI) 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 OHCI staff.  The goal is to ensure that efforts to 
disseminate research findings are coordinated with other Agency activities to 
maximize awareness and application of the research by potential users, 
including clinicians, patients, health care systems and purchasers and 
policymakers.  This is critical when outreach to the general and trade press 
is involved.  Contact with the media will take place in close coordination 
with OHCI 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 OHCI a 
brief plan describing how the product will be publicized.  An OHCI 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.

WHERE TO SEND INQUIRIES

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 
issues:

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

David Lanier, M.D.
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852 
Telephone: (301) 594-1489
FAX: (301) 594-3721
Email: [email protected] 

o   Direct your questions about peer review issues to:

Carl Ohata, Ph.D.
Health Scientist Administrator
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301) 594-6040
FAX: (301) 594-0154
Email: [email protected]

Direct your questions about financial or grant management matters to:
 
George Gardner
Division of Grants Management
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-6826
FAX: (301) 594-3210
Email: [email protected]

LETTER OF INTENT

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

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

Although a 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 staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by June 23, 2003.  The letter of intent 
should be sent to:

Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-7180
FAX: (301) 594-3721
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and form (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone 301-710-0267, 
Email: [email protected].

State and local government applicants may use PHS 5161-1, Application for 
Federal Assistance (rev. 5/96), and follow those requirements for copy 
submission.  To ensure equity among applicants, however, applicants using this 
form must observe page number and font size requirements specified in the Form 
PHS 398.  AHRQ encourages use of Form PHS 398 in preference to Form 5161-1.

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:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SUPPLEMENTAL INSTRUCTIONS: The following supplemental instructions to the form 
PHS 398 should be used to guide the preparation of the R03 application:

1) Under "Performance Sites" (page 2), list only the official name of the PBRN 
and the address of the PBRN office.  A complete list of the clinicians and 
practice sites to be involved in the project should be attached to the 
application as an appendix.  If the proposed activities will involve human 
subjects (including surveys or interviews of network clinicians), the 
application should include documentation of Multiple Project Assurance (MPA) 
or Federalwide Assurance (FWA), if known.  Applicants not having a Human 
Subjects Assurance should refer to the OHRP website 
http://www.hhs.gov/ohrp/assurances/assurances_index.html  for information regarding Human 
Subject Assurances.

2) Detailed Budget.  Budget requests may not exceed $100,000 total costs 
(direct plus facilities and administrative costs) for the entire project 
period.  All budget items must be justified in terms of their support of the 
exploratory/pilot project or feasibility study.  Requests for computer-related 
or other equipment must be well justified and within the scope of work 
proposed for the project.

Since travel and lodging expenses for a network representative to attend up to 
two collaborative meetings annually in Rockville, MD will be paid for by AHRQ, 
these expenses should not be included in the budget request.

3) Biographical Sketches.  A biographical sketch of the network director must 
be included, as well as sketches of other key personnel to be involved in the 
project.  If an individual (other than the network director) will be serving 
as the Principal Investigator, his/her biographical sketch must also be 
included.

4) Research Plan.  This narrative part of the application is limited to 
fifteen pages of text.  It should be organized into two sections, as follows.

Section I.  The Practice-Based Research Network

a) Description of the PBRN.  Describe the practices included in the network, 
including geographical distribution of practices and types of clinicians.  The 
applicant should provide any reliable information about the characteristics of 
the patient population currently served by network clinicians, including (if 
available) the percentages of minority and underserved patients.  As noted 
above, a complete listing of network clinicians and practice addresses should 
be included as an appendix to the application.  This description should 
document that the PBRN meets, at minimum, the qualifications outlined under 
SPECIAL REQUIREMENTS, "Qualifications."

b) Current institutional or other resources available to the PBRN.  This 
discussion (which may alternatively be included in the Resources section of 
the application) should describe the relationships between the network and any 
affiliated academic department or other organizational unit.  A list of the 
consultants, co-investigators and other resources available to the network as 
a result of the affiliation should be included.  Senior officials in any PBRN-
affiliated organization(s) should provide a letter documenting support for the 
network's activities.  These and other letters of support should be included 
as an appendix and referenced in this section of the application.  A brief 
description of any computer-based or other information systems currently in 
use across the network should be included.  The discussion should also include 
a description of the mechanism used for obtaining advice/feedback from the 
patient communities served by the network practices.

c) Network director and staff.  The PBRN director and any network support 
staff should be identified, including a description of their qualifications.

d) Evaluation.  Include a statement indicating the willingness of the PBRN to 
cooperate with the PBRN Resource Center and to participate in an AHRQ-
supported evaluation of the agency's overall PBRN initiative, should the 
applicant be funded.

Section II.  Proposed Exploratory/Pilot Research or Feasibility Study

a) Research issue/question.  Define the research question(s) or issue(s) to be 
addressed and describe the mechanism used to generate and develop the study 
idea with the PBRN.  Present background literature and a conceptual framework 
supporting the proposed question or approach.  Explain why the question being 
explored may be significant to the future research efforts of the network and 
to primary care practice.

b) Methods and plan.  A rigorous research plan must be presented, even if the 
purpose of the project is primarily hypothesis testing.  Instruments and 
methods for data collection must be specified and a timeline for completing 
each phase of the project provided.  Describe the steps taken to optimize the 
level of study participation within the network and to increase the likelihood 
that findings will be implemented by PBRN membership.  Discuss any similar or 
related work successfully completed in the past within the network.

c) Analytic plan.  Describe in detail the plan to aggregate and analyze the 
study data.  The expected sample size should be discussed, including a 
contingency plan in the event study enrollment is less than anticipated.  
Indicate if the sample will be sufficient for subgroup analysis of the study 
population by race/ethnicity, insurance status, or other patient-specific 
variables.

d) Potential problem areas.  Discuss any methodological or logistical problems 
that could affect the timely completion of the exploratory or pilot project.  
Describe any backup plans or methods being proposed to address or resolve 
these problems, if needed.

e) Investigators.  Describe the training and experience of the principal 
investigator (and any co-investigators) that quality him/her to carry out the 
proposed project.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:

AHRQ is not using the Modular Grant Application and Award Process.  Applicants 
for funding from AHRQ should ignore application instructions concerning the 
Modular Grant Application and Award Process, and prepare applications 
according to instructions provided in form PHS 398 .  Applications submitted 
in the Modular format will be returned without review.
 
SENDING AN APPLICATION TO THE NIH and AHRQ:  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 courier service)
 
At the time of submission, two additional copies of the application must also 
be sent to:

Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-7180
FAX: (301) 594-3721
Email: [email protected]

APPLICATION PROCESSING:   Applications must be received by the 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.  

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

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 an 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.  While the investigator may still 
benefit from the previous review, the RFA application is not to state 
explicitly how.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.  State and local government applicants may use 
PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those 
requirements for copy submission, http://forms.psc.gov/forms/FF99/PHS-5161-1/
phs-5161-1.html.  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 required at the 
time of submission of an application in response to this RFA.  The "AHRQ 
Revised Policy for IRB Review of Human Subjects Protocols in Grant 
Applications" was published in the NIH Guide on September 27, 2000.
(http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).  
However, due to time constraints IRB approval is required at the time of 
application submission.

The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under 
Funding Opportunities)  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.

In carrying out its stewardship of research 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 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. 

In addition, 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 
(WP5.1 or WP6.0 is preferable).
 
PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness and  
responsiveness to the RFA.  Incomplete and/or non-responsive applications or 
applications not following instructions given in this RFA 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 
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   Receive a written critique
o   Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score. 
 
REVIEW CRITERIA

In the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the scientific merit of the 
proposed project and the potential of the PBRN to complete the proposed 
activities successfully.

1.  Technical merit of the proposal

a) Approach.  How clear are the goals and objectives of the proposed project?  
Is the research question or hypothesis clearly stated?  Are the proposed 
methods and data analyses adequately developed and appropriate to the aims of 
the project?

b) Significance.  How important is the research question/hypothesis to be 
tested?  If the aims of the project are achieved, how important will this 
preliminary work be to future network endeavors?

c) Innovation.  Will the proposed project employ novel and original concepts, 
approaches or methods?  To what extent does the proposed project take 
advantage of unique features of the PBRN or employ innovative collaborative 
arrangements?

d) Investigator(s).  Is the investigator(s) appropriately trained and well 
suited to carry out this work?  Is the proposed work appropriate to the 
experience level of the P.I. and other researchers (if any)?

2.  Potential for success

a) PBRN readiness.  To what extent has the P.I. (or network director) involved 
network clinicians in the development of the research question?  How well has 
the applicant considered the steps that will be necessary to implement in 
practice any findings that may result from this or related work?

b) Scope of work.  Is the proposed work sufficiently ambitious for the PBRN, 
given its level of development and prior experience?  Will the PBRN 
realistically be able to complete the entire project within the proposed 
timeline?
c) Environment.  Is the administrative, organizational and management 
environment of the PBRN well established and stable enough to make the 
project's success likely?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

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 on Priority Populations in the section on 
Special Requirements, above, and Inclusion Criteria included in the section on 
Agency policies and Requirements, below.)

DATA SHARING:

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 
patient-related 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), are effective April 2003. 
These regulations serve to limit the disclosure of personally identifiable 
patient information and define when and how such information can be disclosed. 
Thus, for example, health care plans and providers 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. Additional information 
about the regulations and their implementation can be obtained from: 
http://www.aspe.hhs.gov/admnsimp/  

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 http://csrc.nist.gov/publications/nistpubs/800-12/.  
The applicability and intended means of applying these confidentiality and 
security standards to subcontractors and vendors, if any, should be addressed 
in the application. 

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 Health Care 

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:   June 23, 2003
Application Receipt Date:   July 24, 2003
Peer Review Date:   August 2003
Earliest Anticipated Start Date:   September 2003

AWARD CRITERIA

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

o   Scientific merit (as determined by peer review)
o   Availability of funds
o   Program balance among awardees with respect to type and focus of 
investigations

REQUIRED FEDERAL CITATIONS

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

Investigators may obtain copies from the above sources or from the AHRQ 
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web 
site http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may 
also provide additional information concerning these policies (see INQUIRIES).

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

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:

The 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 and under FOIA, 5 USC 552(b), disclosure of 
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. However, courts have generally not 
regarded a researcher's interest in "his" data as proprietary. NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 

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. 

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (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 comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance, 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.

REFERENCES

Bates DW, Ebell M, Gotlieb E, Zapp J, Mullins HC.  A proposal for electronic 
medical records in U.S. primary care.  J Am Med Inform Assoc 2003;10(1):1-10

Buffington J, Chapman LE, Schmeltz LM, Kendal AP.  Do family physicians make 
good sentinels for influenza?  Arch Fam Med 1993;2:858-65

Donaldson MS, Yordy KD, Lohr KN, Vanselow NA, eds.  Primary Care: America's 
Health in a New Era.  National Academy Press, Washington, D.C.  1996

Ebell MH, Frame P.  What can technology do to, and for, family medicine?  Fam 
Med 2001;33(4):311-9

McDonald CJ.  The barriers to electronic medical record systems and how to 
overcome them.  J Am Med Inform Assoc 1997;4(3):213-21

Nutting PA, Beasley JW, Werner JJ.  Practice-based research networks answer 
primary care questions.  JAMA 1999;37:1092-1104

Thomas P, Griffiths F, Kai J, O'Dwyer A.  Networks of research in primary 
health care.  BMJ 2001;322:588-90

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