DEVELOPMENTAL GRANTS FOR PRIMARY CARE PRACTICE-BASED RESEARCH NETWORKS (PBRNS)

RELEASE DATE:  February 6, 2002

RFA:  RFA-HS-02-003

PARTICIPATING INSTITUTES AND CENTERS (ICs):

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

LETTER OF INTENT RECEIPT DATE:  April 15, 2002

APPLICATION RECEIPT DATE:  May 14, 2002
 
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

PURPOSE OF THE RFA

The Agency for Healthcare Research and Quality (AHRQ) announces the 
availability of developmental/exploratory grants for the purpose of assisting 
new or established primary care practice-based research networks (PBRNs) to 
enhance their capacity to conduct research and translate research findings 
into practice.  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.  This definition includes a 
sense of ongoing commitment to the research endeavor, and an organizational 
structure that transcends a single study (see further detailed Qualifications 
under SPECIAL REQUIREMENTS).

PBRNs are invited to apply for funds to plan, develop or enhance the 
infrastructure supporting network activities.  Potential uses include 
planning and design of information technology to collect/aggregate research 
data, expanding the numbers or types of clinicians or practices enrolled in 
the network, and increasing the range of research expertise available to the 
network. PBRNs can also apply for additional funds to conduct individual 
pilot projects or feasibility studies.  Although the major objective is to 
encourage creative, investigator-initiated research within PBRNs, AHRQ is 
particularly interested in studies that focus on the health care of priority 
populations (especially racial/ethnic minorities), practice-based 
applications of information technology, and the delivery of preventive 
services, including the promotion of healthy behaviors in primary care 
settings.  It is expected that results generated from the exploratory 
projects will serve as a basis for planning future, larger scale research.  
The long-term goal of this initiative is to improve the capacity of PBRNs to 
expand the primary care knowledge base and to establish mechanisms to assure 
that new knowledge is incorporated into actual practice and that its impact 
is assessed.

RESEARCH OBJECTIVES
 
Background
 
In December, 1999, reauthorizing legislation, P.L. 106-129 created a new 
section 915(b) in Title IX of the Public Health Service Act (42 U.S.C.299b-
4(b) mandating the establishment, within the newly renamed AHRQ, of a Center 
for Primary Care Research (CPCR) to "serve as the principal source of funding 
for primary care practice research in the Department of Health and Human 
Services." 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 population in the U.S., 
amended section 901(b)(2) authorized the agency to implement research 
strategies and mechanisms that specifically included PBRNs.

In response to these directives, AHRQ has to date provided support for 
primary care PBRN research efforts through the issuance of several requests 
for applications.  RFA-HS-00-004, "Primary Care Practice-Based Research 
Networks,"offered one-year exploratory grants to assist new or established 
PBRNs in planning for activities to enhance their capacity to conduct 
research in primary care settings and translate research findings into 
practice.  Awards were made in September, 2000, to 19 PBRNs comprised of over 
5,000 primary care clinicians with practices in 49 states serving almost 7 
million primary care patients.  A second solicitation (RFA-HS-01-004, 
"Primary Care PBRNs: Competitive Continuations") provided funds to support 
efforts by the PBRNs to address specific data-related issues identified 
through planning activities.  These awards were made in August, 2001.  
Specific funding set-asides for primary care PBRNs were also included in two 
other RFAs released in 2001 as part of AHRQ"s medical errors and patient 
safety initiative.  The current RFA is directed to new or existing primary 
care PBRNs, including (but not limited to) those previously funded by AHRQ.  
It provides funds for the development or enhancement of the infrastructure 
supporting PBRN research efforts, and for innovative exploratory or pilot 
projects likely to lead to larger scale undertakings by the network.

Objectives and Scope

Since the first primary care PBRNs were established in the U.S. in the late 
1970s, the major goal of these networks has been to involve busy community-
based clinicians and their staffs in studies directed by investigators 
experienced in clinical and health services research.  While much of the 
research conducted to date in PBRNs has consisted of small descriptive or 
observational studies, several networks have been successful over the years 
in competing for major grants to conduct larger, more sophisticated primary 
care research.  The best of these 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)  
Noting the substantial body of important findings from PBRN research now in 
the published literature, one observer has recently described networks as 
research laboratories which are "as essential to advancing the scientific 
understanding of medical care as bench laboratories are to advancing 
knowledge in the basic sciences." (Green, 2001) 

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. (Wasson, 1997, Thomas, 2001) As envisioned, the objectives of 
primary care PBRNs should not be limited to conducting individual studies but 
should consider more broadly the development of places of learning, where 
clinicians and their patients in the community are united with science to 
search for answers that can provide a better basis for daily practice.  Equal 
with the PBRN goal of publishing research results should therefore be the 
goal of engaging network practitioners in reflective inquiries about practice 
(that lead to practice improvement or researchable questions) as well as 
partnerships with other professionals concerned with such issues as education 
in primary care, development of local services/resources, and continuous 
quality improvement.  Thomas notes that the "result could be improved 
community and patient experience of primary health care as well as high 
quality research that is increasingly relevant to primary care."

Producing high quality research, transforming the culture of primary care 
practice, and engaging all clinicians in reflective inquiries about practice 
can, however, sometimes be competing aims within a PBRN.  The organizational 
strategy, leadership and infrastructural system(s) supporting the PBRN are 
often critical in determining the network"s success in achieving any or all 
of these aims.  A network with strong links to an academic institution and a 
"top-down" leadership that uses research experts to develop investigational 
ideas, secure funding and direct individual projects is more likely to 
produce high quality research quickly but less likely to transform the 
culture of practices.  On the other hand, a network adopting a "bottom-up" 
approach is likely to be more successful in sustaining the interest of 
clinicians and facilitating grass roots participation in research efforts.  
Such a PBRNs is most often led by a clinician peer(s) and has established 
processes for soliciting research ideas from network clinicians and engaging 
them and others in the analysis of research findings.  These networks, 
however, often require more time and effort to develop research protocols, 
may have less expertise/experience in conducting research, and may
be less successful in identifying a funding source that fits with locally 
developed research interests.  Both the "top down" and "bottom up" approaches 
to network activities have merit, and the approaches do not appear to be 
mutually exclusive.  Any given PBRN may need aspects of both, sensitively 
adapted to the local circumstance.

Regardless of the network"s organizational strategy, a critical element to 
the success of any PBRN effort is an infrastructure that not only serves 
research but also coordinates diverse primary care activities. Many if not 
most PBRNs struggle to build or sustain an infrastructure capable of 
recruiting and retaining participating practices, supporting network 
activities, and generating fundable projects.  Although there is considerable 
variation in the status of current PBRN infrastructural support, few networks 
receive significant, ongoing funding from any academic institution or other 
organization, support which can be especially important in those periods 
between major funded research efforts.  All PBRNs appear to rely heavily on 
volunteerism for central staff support and the cooperation of participating 
practices and investigators.  

Ideally, a network"s infrastructure will include, in addition to leadership 
and support personnel, an electronic data system that extends to all network 
practices and 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.  Such systems are capable of 
informing future research needs, helping to transform the culture of 
practice, and supporting strategies to accelerate continuous quality 
improvement within practices.  However, numerous barriers, especially the 
costs of purchasing, implementing and maintaining sophisticated information 
technology and training appropriate staff, have to date prevented most 
primary care PBRNs from developing such systems.  Planned privacy regulations 
will likely control the flow of sensitive patient information and may have a 
significant effect on the procedures used by PBRNs to collect, analyze and 
report patient-level data across clinician practices.  Obtaining consent from 
every patient in a sizable, geographically dispersed primary care population 
presents a formidable challenge.  At the same time, it is critical that the 
privacy and confidentiality of research subjects be adequately protected 
by PBRNs.

The research capacities of many primary care PBRNs are restricted by a 
limited ability to involve minority and underserved patient populations in 
network activities.  Most existing PBRNs are composed of practices located 
predominantly in suburban or rural sites, thus making it less feasible for 
them to address (through research, quality improvement, and other activities) 
the persistent, and often increasing, health disparities that have been 
correlated with race, ethnicity, poverty and insurance status.  However, a 
few recently published PBRN studies (e.g., Kelleher,1999) have involved 
meaningful subgroup analyses of minority/underserved patients.  In addition, 
a number of PBRNs are actively enrolling new practices that serve a diverse 
patient population, thereby increasing opportunities to understand the 
etiology of health care disparities and to develop practice-based 
interventions to reduce these disparities.

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

Two categories of funding are available under this RFA.  Eligible applicants 
may apply for one or both categories of funding.  

1)  Category I: Support of the development or enhancement of 
network infrastructure.  

Applicants must describe the current or anticipated resources available to 
the PBRN (including all sources of financial support) and explain how the 
requested funds will be used to plan or further develop the infrastructure 
supporting current or proposed network activities.  Applicants currently 
receiving R01-level federal or other grant funding must thoroughly justify 
the need for additional infrastructure support.  

Priority will be given to applicants whose proposed network infrastructure 
building activities include (1) plans to develop or test computer-based data-
collection or information systems, (2) efforts to improve the translation of 
research into practice and measure its impact within the network, and (3) 
efforts to expand the number or types of practices that are active in network 
research so that the health care of priority populations, especially minority 
and/or underserved patients, can be studied.  Applicants must describe how 
data on patients" race and ethnicity are, or will be, collected in practice 
settings (e.g., clerk-identified designation, patient self-report) and 
identify the race/ethnicity classification system being used.

2)  Category II: Support of exploratory or pilot research projects.

This category of funding provides PBRN researchers the opportunity to (1) 
explore the feasibility, as well as the development, of projects 
investigating community-based primary care and (2) generate preliminary data.  
These 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 previously released AHRQ program announcements, AHRQ 
has a particular interest in the following areas of investigation:

o optimal methods of delivering preventive services in primary care 
settings, especially those aimed at promoting healthy patient behaviors,
o innovative uses of information technology in primary care practices, 
including the measurement and improvement of the quality of primary 
care services,
o methods for improving patient safety and identifying/responding to 
medical errors in primary care practices,
o elucidation of primary care-based strategies for diminishing disparities 
in health care delivery and health outcomes for priority populations, 
including minority, rural and underserved patients (refer to INCLUSION OF 
WOMEN, MINORITIES AND CHILDREN IN RESEARCH STUDY POPULATIONS for a list of 
the groups considered by AHRQ to be priority populations),
o strategies for assessing and improving the primary care delivered to 
individuals with physical and other disabilities,
o methods for improving community-based detection and responses to acts 
of bioterrorism,
o assessments of the interaction between geographical access to primary 
care services and the quality of care received by residents of rural areas,
o strategies for implementing and measuring the effect of patient-centered 
care in primary care settings,
o network strategies for assuring that new research evidence is translated 
into actual practice.

Guidance on applying for each category of funding is provided in the section 
entitled SPECIAL REQUIREMENTS.  Applicants who are applying for both 
categories of funding must provide separate budget requests and budget 
justifications for each category.  The parts of the narrative that apply 
specifically to each category must also be clearly identified in the text of 
the grant application.

MECHANISM OF SUPPORT
 
This RFA will use the Exploratory/Developmental Research ( R21) award 
mechanism.  R21-supported projects are intended to serve as a basis for 
planning and strengthening future research efforts, testing innovative 
research ideas, or generating preliminary data.  These grants are not 
intended for large-scale undertakings or to support or supplement ongoing 
research.  The responsibility for planning, directing, and executing the 
proposed project will be solely that of the applicant. 
 
This solicitation may be re-issued in fiscal year 2003, contingent upon the 
availability of funds for this purpose.  The anticipated award date is 
September 30, 2002.

FUNDS AVAILABLE

AHRQ expects to award up to $2 million total costs (direct costs plus 
facilities and administrative costs) in fiscal year 2002 to support the first 
year of projects under this RFA.  The total project period for applications 
submitted in response to the present RFA may not exceed two years.  It is 
anticipated that 25 to 30 awards for infrastructure planning/development will 
be made, not to exceed $50,000 annually (direct plus facilities and 
administrative costs) for up to two years of funding.  In addition, 5 to 7 
awards for pilot projects or feasibility testing will be made for up to 
$100,000 annually (direct plus facilities and administrative costs) for up to 
two years of funding.  The actual number of applications funded is dependent 
on the number of high quality applications and their individual budget 
requirements.  Thus, the maximum amount to be awarded under this RFA to any 
single applicant for the support of first year activities is $150,000 (total 
costs).  Representatives of recipient PBRNs will be expected to attend 2-3 
group meetings convened annually by AHRQ during the funding period.  However, 
travel expenses for these meetings will be provided separately by AHRQ (see 
explanation of PBRN Resource Center below) and budget requests should 
therefore not include expenses for this purpose.

Although this program is provided for in the financial plans of AHRQ, awards 
pursuant to this RFA are contingent upon the availability of funds for this 
purpose.  Funding beyond the initial budget period will depend upon an annual 
progress review by AHRQ and the availability of funds.

ELIGIBLE INSTITUTIONS   

You may submit (an) application (s) if your institution is domestic, 
affiliated with a new or existing primary care practice-based research 
network, and included in any one of the following categories:   

o Public and private non-profit organizations, such as universities, 
hospitals or clinics, and professional associations
o Units of State and local governments
o Eligible components of agencies of the Federal Government 
o Faith-based organizations are eligible to apply for R21s

Note:  While foreign organizations are not eligible, the research network  
supported by the applicant may include individual clinical practices located 
outside the United States. AHRQ can make grants only to not-for-profit 
organizations.  However, for-profit organizations may participate in grant 
projects as members of consortia or as a subcontractor.  Organizations 
described in section 501(c)4 of the Internal Revenue Code that engage in 
lobbying are not eligible.
  
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

An individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply (to participate in) for AHRQ support programs.

SPECIAL REQUIREMENTS

Applications are encouraged from newly formed PBRNs as well as existing 
networks, including (but not limited to) those that have received funds from 
AHRQ, other Governmental agencies, or private sources.  The applicant must 
clearly indicate if the request is for (1) network infrastructure 
development/enhancement only, (2) exploratory or pilot research only, or (3) 
both categories of funding.  Emerging networks are especially encouraged to 
apply for Category I funding (network infrastructure 
development/enhancement).

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.  It is expected that the group 
of applicants funded through this RFA will include emerging, developing and 
well-established PBRNs.  Recognizing the diverse needs of such a range of 
networks and the importance of regular communication with and among funded 
PBRNs, AHRQ intends to establish, through a separate funding mechanism, a 
PBRN Resource Center.  In addition to other responsibilities, the Resource 
Center will facilitate the sharing of information, ideas and expertise among 
networks (through, for example, consultations, listserves, sponsored 
conference calls, etc.) and convene up to three annual meetings of 
representatives of recipient PBRNs during the period of funding.

1) Required Elements of Infrastructure Development/Enhancement Efforts 
(Category I funding)

Each applicant is expected to define both the immediate and long-term aims 
and objectives of the PBRN.  With these aims in mind, the application should 
identify its network"s unique capabilities and opportunities and consider 
carefully any special problems the network is facing (or expects to face) 
that can potentially be resolved through additional infrastructure support.  
Each applicant will be expected to develop, expand or refine at least three 
key components of the infrastructure that supports network activities.  
Examples of infrastructure components include, but are not limited to:

o   information technology shared by the network for collecting/aggregating 
research data from practices, disseminating information to practices, and 
assessing subsequent changes in practice.
o   other communication systems used to exchange ideas and information with 
and among clinicians enrolled in the network.
o   mechanisms or personnel used by the network to recruit and retain greater 
numbers or types of clinicians/practices in the network.
o   mechanisms or personnel for soliciting clinical or other questions from 
network members, refining further those questions that can be addressed by 
the network, and using the questions to develop research proposals.
o   processes used to optimize the level of study participation within the 
network and to increase the likelihood that findings will be implemented by 
PBRN membership.
o   processes or personnel for coordinating and organizing research and other 
activities within the network.
o   mechanisms to assure that an adequate pool of consultants or co-
investigators with appropriate expertise is available to the network on site 
or through telecommunication linkages.

The responsibility for directing the infrastructure development effort should 
be assigned to a senior level person familiar with PBRN activities and 
competent in administration.  It is expected that, in most cases, this person 
will be the network director.  He/she should devote not less than 10% of 
his/her time to this endeavor over the period of funding.  Appropriate 
planning experts or consultants may be called upon to assist the director.  
The applicant must also provide a plan for evaluating the success of the 
infrastructure development activities at the end of the funding period.

2) Required Elements of Exploratory or Pilot Research Projects 
(Category II funding)

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 within 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.  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 being supported 
meets, at minimum, the following qualifications:

o The PBRN organizational structure includes, or will include, 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, or will be, 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 planned or in place 
to solicit advice/feedback from the communities of patients served by the 
PBRN clinicians.
o An organization structure exists, or will exist, 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.

Publication Transmittal: General AHRQ Requirements

To allow the Agency to evaluate its fulfillment of a statutory mandate to 
translate the results of AHRQ-funded research into practice and policy, 
grantees and/or contractors are expected 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 AHRQ information dissemination 
activities with the grantee"s or contractor"s 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:

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]

Direct your questions about peer review issues to:

Michele Alexander, Ph.D.
Health Scientist Administrator
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD  20852
Telephone:  (301) 594-6057
FAX:  (301) 594-0154

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 Name 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 consideration of any subsequent applications, the information 
allows AHRQ staff to estimate the potential review workload and to avoid 
conflict of interest in the review.  AHRQ will not provide responses to 
letters of intent.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The Letter of Intent should be sent to David Lanier, M.D. 
(see address under SENDING AN APPLICATION TO THE NIH AND AHRQ).

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (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].

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.

Institutional Review Board (IRB) approval of human subjects is not required 
prior to peer review of an AHRQ application.  However, no grant award can be 
made without IRB approval.  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).

SUPPLEMENTAL INSTRUCTIONS:  The following supplemental instructions to the 
form PHS 398 should be used to guide the preparation of the R21 application:

1)  In the Abstract ("Description," page 2), indicate the Category (or 
Categories) of funding being requested: Category I (infrastructure support), 
Category II (exploratory/pilot project) or Both Categories.  

2)  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 network activities 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 Multiple Project Assurance (MPA) or Federalwide 
Assurances (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.

3)  Detailed Budget.  A separate budget request on a separate budget sheet 
(and separate budget justifications) should be included for each category of 
funding requested.

Budget requests for Category I (infrastructure support) funding may not 
exceed $50,000 total costs (direct plus facilities and administrative costs) 
per year.  In general, allowable budget items for Category I activities 
include a portion of the salaries of the network director and key 
administrative and clerical personnel, consultation fees, travel and per diem 
expenses for outside consultants, costs of any required staff travel to and 
from network practices, telephone costs, copying, mailing, and other 
justifiable operating expenses.  If the applicant proposes to pilot test 
information technology for possible incorporation into the PBRN 
infrastructure, modest requests for the purchase of software or computer 
hardware are allowable, although these costs should not supplant funds 
required for evaluation activities.  Due to the limit of Category I level 
funding, any request for equipment should be thoroughly and completely 
justified.  In-kind contributions of the applicant organization or its 
partners (including technology vendors or other commercial groups) should be 
noted.  Overlapping support between the R21 and other grants/contracts to the 
PBRN will be administratively reviewed and, if appropriate, adjustments will 
be made to avoid duplication of funding.

Budget requests for Category II funding to conduct an exploratory/pilot 
project may not exceed $100,000 total costs (direct plus facilities and 
administrative costs) per year.  All budget items must be justified in terms 
of their support of the specific exploratory/pilot project.  Requests for 
computer-related or other equipment must be well justified and within the 
scope of work proposed for the exploratory/pilot project.

The maximum annual budget request allowable from one applicant organization 
under this RFA is $150,000 (direct plus facilities and administrative costs) 
for up to two years of funding.  Since travel and lodging expenses for up to 
two network representatives to attend collaborative meetings annually in 
Rockville, MD will be paid for by AHRQ (through a PBRN Resource Center), 
these expenses should not be included in the budget request.

4)  Biographical Sketches.  A biographical sketch (a short professional bio) 
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 for an 
exploratory/pilot project, his/her biographical sketch must also be included.

5)  Research Plan.  This narrative part of the application is limited to 
twenty-five pages of text, even if the applicant is applying for both 
Categories of funding.  It should be organized into sections, as follows.  
Section I is required of all applicants.  Section II is required only of 
applicants requesting network infrastructure support.  Section III is 
required only of applicants proposing to conduct an exploratory/pilot project. 

Section I.  The Practice-Based Research Network

a)  Description of the existing or planned PBRN.  Describe the practices 
included in the current or developing 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 up-to-date 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 (or planned for use) across the network should be 
included.  The discussion should also include a description of the existing, 
or proposed, mechanism for obtaining advice/feedback from the patient 
communities served by the network practices.

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

d)  Progress to date in conducting research or quality-improvement 
activities.  Include a summary of the research or QI projects undertaken and 
completed to date by the PBRN, including the sources and amounts of any 
financial support received for these activities.  A complete list of 
publications (if any) resulting from PBRN research should be included as an 
appendix and referenced in this section of the application.  Emerging PBRNs 
should describe their research and other goals and objectives and provide 
examples of specific projects their networks are interested in (and capable 
of) pursuing.

e)  Progress to date in translating research into practice.  Describe any 
formal or informal systems or mechanisms within the PBRN, current or planned, 
to disseminate the results of research to network clinicians and evaluate the 
impact of this information on practices.

f)  Evaluation.  Include a statement indicating the willingness of the PBRN 
to participate in an AHRQ-supported evaluation of the agency"s overall PBRN 
initiative, should the applicant be funded.  The evaluation is currently 
scheduled to be conducted in 2003.

Section II.  Proposed Activities to Develop or Enhance the PBRN 
Infrastructure (Category I proposals)

a)  Current or proposed infrastructure supporting the PBRN.  This discussion 
should expand upon (rather than duplicate) the information requested in 
Section I.  The annual financial support currently provided to the network by 
the parent (or affiliated) organization should be itemized, including salary 
support (if any) for key network personnel.  An itemized summary of any 
infrastructure support derived from currently active research grants or 
contracts should also be provided.  Discuss in greater detail the information 
systems the network uses, or the options it has considered using, for network 
communications, electronic collection and aggregation of clinical or research 
data, and diffusion of new knowledge into actual practice.  The 
responsibilities of key network personnel should be described in detail.  The 
applicant should also describe any current or proposed mechanisms used by the 
PBRN to recruit and retain clinicians or practices as well as mechanisms used 
to solicit and refine clinical research questions.  The use of any tools 
developed by the network, AHRQ or others for the purpose of research or 
translating research into practice within the network should be described 
(e.g., evidence reports, quality measures, standardized research 
variables, etc).  

b)  Issues to be addressed.   Describe and discuss the long-term aims and 
objectives of the network and the issues or obstacles the network faces (or 
is likely to face) in achieving those objectives that can be addressed 
through further support or enhancement of the network infrastructure.  
Examples of such issues include geographically dispersed network practices, 
lack of formal linkages with practices that serve a diverse patient 
population, lack of adequate research expertise, and inadequately developed 
methods for safeguarding individually identifiable data or for coordinating 
the review of network protocols by institutional review boards.

c)  Specific activities proposed and resources requested.  Describe in detail 
proposals for planning activities, hiring or purchasing that will help 
resolve the identified issues/obstacles and lead to a stronger network 
infrastructure.  The proposed activities should relate to at least three 
different components of the infrastructure supporting the network and should 
be compatible with the long-term aims of the network.  The applicant should 
describe how the proposed activities will capitalize on the network"s unique 
capabilities and opportunities.  Contingency plans should also be described.  
The goals and objectives of any network planner or planning committee should 
be clearly stated.   If new support staff or consultants will be hired, 
discuss the specific expertise and responsibilities of the proposed individuals.

d)  Plan for evaluation.  Discuss the method(s) that the PBRN will use at the 
end of the funding period to evaluate the effect or outcome of 
infrastructure-building activities.

Section III: Proposed Exploratory or Pilot Research Project(s) 
(Category II proposals)

a)  Research issue/question.  Define the research question or issue to be 
addressed and describe the mechanism used to generate and develop the study 
idea within 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)  Investigator.  Describe the training and experience of the principal 
investigator that qualify 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.

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/label-bk.pdf.  
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 express/courier service)
 
At the time of submission, two additional copies of the application must also 
be sent 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
E-mail Address:  [email protected]

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.  Note:  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.

The CSR and AHRQ staff 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.  The CSR and AHRQ 
staff will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

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. 
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).

Copies of the RFA are available from www.ahrq.gov (Funding Opportunities) 
and 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, (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. 

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by AHRQ.  

Incomplete applications will be returned to the applicant without further 
consideration.  Applications that are complete but are not responsive to the 
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 by the AHRQ in accordance with the review criteria stated below.  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. 

All applications will be judged on the basis of the scientific merit of the 
proposed project and the documented ability of the investigators to meet the 
objectives of the RFA.  Category-specific criteria for evaluation of each 
application will include a consideration of the proposal"s technical merit 
and the potential of the PBRN to complete the proposed activities successfully.  

REVIEW CRITERIA

In the written comments, peer reviewers will be asked to assess each category 
of funding requested in an application separately, using category-specific 
criteria.  One priority score will be assigned to your application, as 
appropriate, reflecting the peer reviewers" judgement of the application"s 
strength in the category (or categories) of funding requested.

Category I Review Criteria: Proposals to develop or enhance 
network infrastructure

1.  Technical merit of proposal

a)  Approach.  Has the applicant adequately described the current (or 
projected) resources available to the network and justified the need for 
additional infrastructure support?  Is the proposed request appropriate to 
the PBRN"s current level of development?

b)  Goals.  To what extent do the proposed infrastructure 
development/enhancement activities have clearly stated goals consistent with 
AHRQ"s goals of expanding the primary care knowledge base and assuring that 
new knowledge about primary care is incorporated into actual practice?

c)  Problem areas.  Has the applicant adequately defined the potential 
problem areas facing the PBRN?  To what extent will the proposed 
infrastructure support address or resolve the identified problem areas?

d)  Key personnel.  Is the current or proposed network director appropriately 
trained and well suited to direct network activities?  Are the designated or 
proposed personnel appropriate and qualified to assist the director?

2.  Potential for success

a)  Clinician enrollment and commitment.  How adequate is the pool of 
clinicians who have agreed to participate in network activities?  Does the 
application present evidence that network clinicians, as a group, have 
successfully completed prior research or quality improvement activities?  If 
not, does the application include other evidence of commitment (e.g., letters 
of support) from clinicians enrolled in the network?

b)  Patient population.  How adequate is the current or proposed patient 
population served by the PBRN practices to support a wide range of primary 
care research?  To what extent will be network be able to involve 
racial/ethnic minority and underserved patients in network activities? To 
what extent does the applicant demonstrate an awareness of the challenges 
involved in protecting the privacy and confidentiality of patient-related 
data when conducting research and other network activities?

c)  Organization and resources.  How adequate and stable are the PBRN"s 
current or proposed administrative, organizational and management 
capabilities?  To what extent is the network supported by it"s affiliated 
organizations?  To what extent does (or will) the PBRN have access to a full 
range of consultants or co-investigators with expertise in research methods 
and quality assessment/improvement?
Category II Review Criteria: Exploratory or pilot projects

1. Technical merit of 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.  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:  

1. PROTECTIONS:  The adequacy of the proposed protections for humans 
subjects and their privacy or the environment, to the extent they may be 
adversely affected by the project proposed in the application.

2. INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below)

3. DATA SHARING:

Data Privacy

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 explicit or implicit promises made or implied regarding the possible uses 
and disclosures of such data.  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. 

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/handbook.pdf.  The application of these 
confidentiality and security standards to subcontractors and vendors, if any, 
should be addressed.

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 but relies on grantees to 
publish research results in peer-reviewed journals and to market grant-
supported products.

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).
BUDGET:   The reasonableness of the proposed project budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    April 15, 2002
Application Receipt Date:         May 14, 2002
Peer Review Date:                 August 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

All applications requesting infrastructure development/enhancement support 
will compete for available Category I funds.  All applications requesting 
support of an exploratory/pilot project will compete for available Category 
II funds.  Funding decisions for one category will be made independently of 
decisions made for the other category.  Applicants requesting support in both 
categories may be awarded, for example, Category II funding without Category 
I funding, or vice-versa.

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

o  Quality of the proposed project as determined by peer review
o  Program balance among awardees for infrastructure support with respect to 
types and specific disciplines of primary care providers enrolled in the 
networks, patient populations served by network clinicians, and 
geography/regional representation
o  Program balance among awardees for exploratory/pilot projects with respect 
to type and focus of investigations 
o Availability of funds

No first year award for infrastructure support will exceed $50,000 total 
costs (direct plus facilities and administrative costs) and no first year 
award for an exploratory/pilot project will exceed $100,000 total costs 
(direct plus facilities and administrative costs).  Each successful PBRN 
applicant will receive one award, with no first year award exceeding $150,000 
total costs (direct plus facilities and administrative costs).

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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of 
clinical research, updated racial and ethnic categories in compliance with 
the new OMB standards, clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398, and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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 SENDING AN 
APPLICATION TO THE NIH AND AHRQ).

AHRQ also encourages investigators to consider including children and other 
priority groups in study populations, as appropriate.  The priority 
populations specified in AHRQ"s reauthorization legislation include: 
individuals living in inner-city areas or 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.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned 
without review. 

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.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.  It is 
not likely that data gathered under projects supported through this 
initiative will be used as a basis for federal regulation or action having 
the force and effect of law.  However, it might be possible.  Therefore, 
should applicants wish to place data collected under this PA in an archive 
for potential public access to nonidentifiable research data "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-3c) 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.

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

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

Green LA, Dovey SM.  Practice based primary care research networks: they work 
and are ready for full development and support.  BMJ 2001,322:567-8

Kelleher KJ, Moore CD, Childs GE, Angelilli MY, Comer DM.  Patient race and 
ethnicity in primary care management of child behavior problems: a report 
from PROS and ASPN.  Med Care 1999,37:1092-1104

Nutting PA, Beasley JW, Werner JJ.  Practice-based research networks answer 
primary care questions.  JAMA 1999,281:686-8

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

Wasson JH, Jette AM, Johnson DJ, et al.  A replicable and customizable 
approach to improve ambulatory care and research.  J Amb Care Man 
1997,20(1):17-27

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