PRACTICE-BASED RESEARCH NETWORKS (PBRNs) AND THE TRANSLATION OF RESEARCH INTO 
PRACTICE

RELEASE DATE:  December 18, 2003

PA Number:  PAR-04-041  

EXPIRATION DATE:  January 12, 2005, unless reissued.

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATIONS:
Agency for Healthcare Research and Quality (AHRQ)
 (http://www.ahrq.gov)
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
Center for Primary Care, Prevention and Clinical Partnerships, CP3, 
 (http://www.ahrq.gov)
National Cancer Institute (NCI) 
 (http://www.cancer.gov) 

CFDA NUMBER: 93.226 for AHRQ and 93.399 for NCI

APPLICATION RECEIPT DATE(S):  April 13, 2004 and January 11, 2005  

THIS PAR CONTAINS THE FOLLOWING INFORMATION: 

o   Purpose of the PAR
o   Research Objectives
o   Mechanism(s) of Support
o   Eligible Institutions
o   Individuals Eligible to Become Principal Investigators
o   Special Requirements 
o   Where to Send Inquiries
o   Submitting an Application
o   Supplementary Instructions
o   Peer Review Process
o   Review Criteria
o   Award Criteria
o   Required Federal Citations 
o   References

PURPOSE OF THIS PAR  

The Agency for Healthcare Research and Quality (AHRQ) and the National Cancer 
Institute (NCI) seek research proposals from new or established primary care 
practice-based research networks (PBRNs) to (1) evaluate scientifically-based 
strategies for translating evidence into sustainable improvements in clinical 
practice and outcomes, and/or (2) develop, improve, and/or validate research 
dissemination methods applicable to cancer control in primary care practice.  
A PBRN is defined as a group of ambulatory practices devoted principally to 
the primary care of patients, affiliated with each other 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.

This program announcement builds on earlier RFAs from AHRQ (Translating 
Research Into Practice I and II; Quality Improvement Strategies in Health 
Care; Partnerships for Quality) and NCI (Research Dissemination & Diffusion 
Supplement to R01, P01, U01 & U19 NCI cancer control research grants) by 
focusing on approaches for promoting the translation of research evidence 
into practice that are effective specifically in community-based primary care 
settings.  In the context of this announcement, research translation 
encompasses the use of “evidence-informed” approaches to primary care 
practice change (e.g., the systematic but as yet untested application of 
recommendations from the Guide to Clinical Preventive Services; 
http://www.preventiveservices.ahrq.gov/), testing the impact of primary care 
practice tools developed by AHRQ (e.g., Put Prevention Into Practice; 
http://www.ahrq.gov/clinic/ppipix.htm), and evaluating the dissemination and 
implementation of “evidence-based” primary care practice tools previously 
tested and found to be effective and/or efficacious in peer-reviewed 
research.

PBRNs are invited to apply for funds to modify or adapt “evidence-based” 
and/or “evidence-informed” tools and strategies for implementing sound 
research evidence and to test their use, sustainability and replicability in 
diverse primary care practices and among various patient populations.  
Evidence-based tool refers to a tool whose use has been shown to impact 
practice through systematic testing and/or evaluation in research.  Evidence-
informed tool refers to a tool where the content is based on science but the 
use (and therefore the impact) of the tool has never been systematically 
tested or evaluated in research.  Applicants will be required to develop 
projects that use rigorous scientific methods to determine the impact of the 
translational effort and to assess the influence of contextual factors on 
their findings.  Project evaluations should include an assessment of 
appropriate outcomes related to quality of care.  A particular interest of 
AHRQ is the use of information technology (e.g., hand-held devices, 
electronic medical records, internet applications) in translating research 
findings into policy and care.  NCI is interested specifically in supporting 
exploratory/developmental dissemination and diffusion research applications 
that focus on the adoption of evidence-based cancer control interventions 
within primary care practices.  An additional interest of NCI is to explore 
the applicability of different theories on the dissemination and diffusion of 
innovation [e.g., Rogers, 2003; Glasgow, 2003] to primary care cancer control 
practice, using tools developed in controlled trials (e.g., smoking cessation 
approaches, reminders, motivational telephone calls, etc.).  

AHRQ and NCI are strongly committed to supporting research in priority 
populations, which include women, children, elderly, minority, rural, urban, 
and low-income populations, as well as patients with special health care 
needs and disabilities.  It is expected that results generated from these 
projects will serve as a basis for planning future, larger-scale (R01) 
research.  The long-term goal of this initiative is to improve the capacity 
of primary care practices in the U.S. to establish mechanisms to assure that 
new knowledge is incorporated into actual practice and that its impact is 
assessed.  
 
RESEARCH OBJECTIVES
 
Background

While there is widespread interest in the translation of valid research 
findings into practice, the most effective methods for accomplishing this 
goal remain unclear.  As a result, Congress has encouraged both the Agency 
for Healthcare Research and Quality (AHRQ) and the National Cancer Institute 
(NCI) to develop initiatives that will expand our understanding of the 
translation of research into practice.  In response, AHRQ has since 1999 
issued a series of RFAs that support projects on the translation of research 
findings into sustainable improvement in clinical practice and patient 
outcomes:  the Translating Research Into Practice (TRIP) RFA 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-003.html), published 
January 8, 1999; the Assessment of Quality Improvement Strategies in Health 
Care RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-002.html), 
published January 22, 1999; the Translating Research into Practice II RFA 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-00-008.html), published 
December 16, 1999; and Partnerships for Quality RFA 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-02-010.html) published 
May 10, 2002.  Projects funded under the first TRIP RFA addressed a variety 
of health care problems primarily through randomized controlled trials, while 
projects funded by the TRIP II RFA evaluated strategies for translating 
research into practice through the development of partnerships between 
researchers and health care systems and organizations.  The Assessment of 
Quality Improvement Strategies in Health Care RFA funded projects that 
evaluated strategies in widespread use by organized quality improvement 
systems, and the Partnerships for Quality RFA promotes collaborations among 
diverse organizations to translate, disseminate and implement research 
findings.  

In 2002, the NCI articulated as a key part of its mission the rapid movement 
of research discoveries through program development into service delivery, to 
ensure that the considerable investment in cancer research would translate 
into improved program services to benefit the health and well being of the 
American public.  In that regard, NCI initiated its Translating Research into 
Improved Outcomes (TRIO) program to: (1) use behavioral risk factor and 
cancer surveillance data to identify needs, track progress and motivate 
action; (2) work collaboratively with public and private sector 
organizations, agencies and healthcare systems to identify, disseminate and 
promote the adoption of evidence-based (i.e., tested in peer-reviewed 
research and published in peer-reviewed journals) interventions for cancer 
prevention and control; and (3) identify and overcome infrastructure barriers 
to the adoption of evidence-based interventions in clinical and public health 
systems that serve the American public, with a particular emphasis on 
reaching those who bear the greatest burden of cancer.  NCI has also issued a 
series of administrative supplement RFAs for NCI grantees to begin the 
process of exploring how best to disseminate and diffuse cancer control 
interventions that have been tested within NCI-funded efficacy and 
effectiveness trials, to the populations and/or settings from which the 
original study sample was drawn:  Disseminate Promising Cancer Control 
Intervention Tested in Effective Research Projects 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-01-010.html); Notice 
of Limited Competition Disseminating Evidence-Based Intervention Research 
Products, published December 31, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-007.html); and 
Notice of Availability of Administrative Supplements for Disseminating 
Evidence-Based Intervention Research Products, published May 12, 2003 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-03-031.html).  While 
a total of 32 applications were submitted and 10 funded in the first three 
rounds, only one application focused on disseminating an evidence-based 
intervention (tobacco cessation for teens) in primary care settings.  In 2000 
and 2001, 54 NCI-funded cancer control intervention research grants, directed 
towards patients at risk for developing cancer, their health care providers, 
or both, in primary care or other clinical settings, completed their study.  
A listing of the research report references from this portfolio of cancer 
control research in clinical practice settings can be found at 
http://cancercontrol.cancer.gov/d4d/info.html.   

While few of the projects funded to date through AHRQ initiatives have 
focused specifically on translational activities conducted in primary care 
settings, AHRQ has contributed considerable resources to the support of 
primary care practice-based research networks (PBRNs), as mandated by 
Congress.  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.  
Since 2000, AHRQ has responded by providing 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 PAR, co-sponsored by AHRQ and 
NCI, is directed to new or existing primary care PBRNs, including (but not 
limited to) those previously or currently funded by AHRQ.  It is intended to 
solicit applications that assess the use of interventions to translate 
research into practice in primary care settings and measure the impact of 
those interventions.

Objectives and Scope

While there is broad agreement about the urgent need to accelerate the rate 
of uptake of evidence-based findings and tools into practice, considerable 
uncertainty persists about the best strategies for doing this and the 
setting(s) in which each strategy is most effective.  The majority of 
strategies that have been studied focus on changing clinician behavior.  From 
these trials, it is known that passive diffusion of information (e.g., 
distribution of educational materials or didactic lectures) is generally 
ineffective as a method of promoting behavioral change while most of the 
interactive implementation strategies tested to date (from audit and feedback 
to computerized decision support systems) have been shown to generate at 
least modest improvement in practices.  However, no single strategy has 
proven superior.  Recent research indicates that multifaceted interventions 
seem to be more effective in changing clinician behavior than single 
interventions. [Bero, 1998]  Other interventions have been proposed which 
directly target patient populations or organizational behaviors.  Much of the 
research to date, however, has been conducted in hospitals or academic 
medical centers.  The generalizability of many of the findings to community-
based primary care settings is uncertain.  It is even less certain whether 
the successes demonstrated using these methods in a given setting are 
achievable with different patient populations and are sustainable over time.  

Studies of the multidimensional challenges of translating research into 
everyday practice are hampered by the current concentration of clinical 
research in academic settings.  To pursue translational studies outside the 
academic setting, clinical researchers must be able to work closely over time 
with community-based providers.  They need to study the full range of patient 
populations cared for in primary care and better understand the realities of 
community practice (e.g., providing care to a heterogeneous population of 
patients in busy office settings).  At the same time, community providers 
appear to be more willing to participate in research if they are involved in 
its design, conduct and analysis. [Nutting, 1999]  Through their active 
participation in the research effort, providers not only develop greater 
ownership of the entire process but also come to understand the tangible 
applications of the research to their practice.  Since practice-based 
research networks allow academic researchers access to primary care patients, 
providers and data while also actively engaging primary care providers in the 
research effort, they offer a unique opportunity to address important issues 
related to the “translational block.” [Genel, 2003]  Through the rigorous 
evaluation of methods of translating research into practice in community 
settings, PBRNs have the potential to identify and objectively assess 
implementation strategies that are most likely to be effective and 
sustainable across the full range of primary care.  This PAR is aimed at PBRN 
efforts to:

1.   apply and assess in primary care settings innovative strategies for 
research translation, dissemination and implementation that are based on 
sound theoretical constructs;  
2.   adapt to primary care practice, and evaluate, dissemination and 
implementation strategies and tools initially developed and tested in non-
primary care settings or in different patient populations than those served 
by the applicant PBRN; and,
3.   rigorously assess dissemination and implementation strategies currently 
being used in primary care practices that are evidence-informed but not as 
yet fully evaluated. 

Projects funded under this initiative are expected to assess the conditions 
under which the strategies being tested can be expected to be sustainable, 
can be rapidly transferred or adapted to other primary care settings, and can 
lead to demonstrable improvements in the quality of care and/or patient 
outcomes.  Sustainable efforts are defined as those maintained well beyond 
the period of investigation and likely to persist despite ongoing changes in 
the organization, delivery and financing of health care in the U.S.   

The potential of information technology to assist in translating research 
findings into clinical practice has long been recognized, but its use for 
this purpose is underdeveloped and has not been carefully assessed. [Sung, 
2003]  A few studies have shown that electronic medical records (EMRs) can 
both increase clinician productivity and improve the quality of care provided 
[Wager, 2000] although the use of EMRs in primary care settings has yet to 
become widespread.  The use of other computerized modalities such as handheld 
devices and internet applications are attractive because the technology is 
affordable and can be implemented rapidly.   In support of internet-based 
approaches to disseminating scientific evidence, NCI and AHRQ have recently 
collaborated with the Centers for Disease Control and Prevention (CDC), the 
American Cancer Society (ACS) and the Substance Abuse and Mental Health 
Services Administration (SAMHSA) to deliver evidence-based and evidence-
informed knowledge and programs/tools for cancer surveillance and evaluation 
through the cancer control PLANET (Plan, Link, Act, Network with Evidence-
based Tools; http://cancercontrolplanet.cancer.gov). Further developmental 
work is needed, however, to make the PLANET more useful in primary care 
settings.  Overall, strategies that incorporate information technology 
systems in practice are likely to be more easily transferable and sustainable 
than implementation strategies that are dependent on individuals and personal 
interactions. [Hunt, 1998]   For these reasons, AHRQ and NCI are particularly 
interested in projects that include the use of information technology in 
implementing research findings in primary care practices.

While more information is needed about the generalizability of effective 
implementation strategies across primary care practices, local contextual 
factors are likely to play an important role in determining the effectiveness 
of interventions in any given practice.  Examples of such factors are the 
clinician’s perception of the clinical importance of the intervention to the 
patients served by the practice, the perceived complexity/costs of the 
intervention, external barriers to change (such as lack of reimbursement), 
and the readiness of individual clinicians to change.  The evaluation of 
projects funded under this initiative should include, when appropriate, a 
systematic assessment of the relative influence of such contextual factors on 
the effectiveness of each dissemination and implementation strategy.

Research Methods

To the extent possible, applicants should submit proposals that build on 
available knowledge about dissemination and implementation methods, will 
generate early results, and are modest in terms of time, scale, and cost.  
Strategies for disseminating and implementing evidence into practice that may 
be studied include those that focus on changing primary care clinician 
behavior (e.g., academic detailing, audit and feedback, provider reminder 
systems, incentives, computer decision support systems), changing patient 
behavior (e.g., patient education, patient reminder systems), or changing the 
organizational behaviors of practices (e.g., continuous quality improvement 
initiatives).  Projects that identify which characteristics of the 
“microsystem” (clinician-patient-practice unit) are associated with a strong 
propensity for improvement are of particular interest.  Methods can include 
rigorous qualitative studies, quantitative research, empirical work or a 
combination of methods.  In designing studies, applicants may target specific 
conditions or diseases (to be treated or prevented), specific patient 
population groups, specific processes of care, specific components of 
practice structure/organization or a combination of these.  AHRQ and NCI have 
a particular interest in studies that evaluate two or more implementation 
strategies (comparing their relative effectiveness) or focus on multifaceted 
interventions.  Applications are encouraged that propose to study methods of 
implementing in primary care practices evidence-based recommendations for the 
care and/or prevention of major causes of morbidity and mortality in the U.S.  
Evidence-based practices that derive from the forthcoming National Healthcare 
Quality Report, National Healthcare Disparities Report, or recommendations 
from the U.S. Preventive Services Task Force are the highest priority for 
this announcement.  

In addition, NCI has a particular interest in programs and practices that 
influence the uptake of: (1) tobacco cessation counseling on a regular basis 
recommended for all persons who use tobacco products; (2) behavioral dietary 
counseling for adult patients with hyperlipidemia and other known risk 
factors for cardiovascular and diet-related chronic diseases (e.g., cancer); 
(3) screening mammography, with or without clinical breast examination (CBE), 
every 1-2 years for women aged 40 and older; (4) screening for cervical 
cancer in women ages 21 or who have been sexually active more than three 
years and have a cervix; (5) screening men and women aged 50 and older for 
colorectal cancer; and (6) discussion of cancer risk, risk reduction (e.g., 
identification and referral of women at high risk for breast cancer to 
genetic counseling, chemoprevention trials, or discussion of surgical 
interventions), or long-term survival with cancer.

Projects that involve the application of information technology to 
implementation efforts are strongly encouraged.  For assessments of the 
dissemination and implementation of clinical interventions, applicants should 
employ, if possible, concurrent comparison groups rather than historical 
controls, especially if secular changes in practice could pose a threat to 
internal validity.  Studies of organizational and structural interventions 
will also be expected to address challenges to internal validity.  Proposals 
to develop and assess new, or as yet untested, dissemination and 
implementation strategies are expected to describe a conceptual framework 
supporting the proposed dissemination/implementation method.  

The ultimate goal of dissemination and implementation efforts is improvement 
in health status and reduction in disease burden through changes in our 
health care system, as called for in a recent report from the Institute of 
Medicine [IOM, 2000].  As much as possible, specific patient outcomes 
directly related to the evidence being implemented in primary care practices 
should be measured.  Applicants may also choose to measure outcomes related 
to other national aims for improving the health care system outlined in the 
IOM report (e.g., patient safety, patient centeredness, closing racial and 
ethnic gaps in health care).   Alternatively, applicants may choose to focus 
on specific processes of care such as provider or patient behavior.  While 
not required, attempts to assess in any way resource utilization or the cost 
effectiveness of different strategies for implementation are strongly 
encouraged.  Plans for intervention studies need to include some attempt to 
disentangle the effects of the intervention from the influence of contextual 
factors.  Examples of such factors include the expertise and attitudes of 
health care providers and the demographics of patient populations.  
Qualitative methods such as case studies, interviews and focus groups may be 
appropriate for this purpose.  

In describing analysis plans, applicants should clearly identify the proposed 
unit of analysis.  Given the expectation of small to moderate effect sizes, 
unit of analysis errors (such as analyzing at the patient level when 
randomization occurred at the level of health care providers) can lead to 
false conclusions about the significance of the effectiveness of 
interventions.  Applicants should be aware of the issues related to cluster 
randomization and should ensure that proposed studies will have adequate 
power and will be analyzed using appropriate methods.  Sub-group analyses may 
be necessary to evaluate the effectiveness of interventions to improve care 
for specific racial and ethnic minorities or patients from specific socio-
economic strata.

MECHANISM OF SUPPORT
 
This PAR will use the R21 (Exploratory/Developmental Research) award 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  The total project period for 
an application submitted in response to this PAR may not exceed two years.  
Though the size of awards may vary with the scope of research proposed, 
direct costs are limited to $150,000 in total direct costs per year.  
Applications that include a request for more than $150,000 in total direct 
costs per year will be returned without review. Two annual receipt dates 
(April 13, 2004 and January 11, 2005) have been established.  The program 
announcement may subsequently be reissued.
 
AHRQ and NCI do not require cost sharing for applications submitted in 
response to this PAR.

AHRQ and NCI have agreed not to use the Modular Grant Application and Award 
Process.  A detailed budget with full justification is required.  
Applications that included a modular budget will be returned without review. 

ELIGIBLE INSTITUTIONS

Any non-profit institution affiliated with a primary care PBRN may submit an 
application if it is included in any one the following categories:

o   Domestic institutions
o   Public or private non-profit institutions, such as universities, 
colleges, hospitals, clinics and professional associations
o   Units of State and local governments
o   Eligible components of agencies of the Federal government (e.g., VA)
o   Tribes and Tribal Organizations
o   Faith-based or community-based organizations

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

PBRNs interested in dissemination and diffusion research to explore/develop 
better methods to translate evidence-based cancer control interventions 
within primary care practice settings are encouraged to consider 
collaborations with NCI-funded cancer control intervention research 
scientists based within NCI-designated cancer centers 
(http://www3.cancer.gov/cancercenters/centerslist.html) or other academic 
medical centers and universities.

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 and NCI encourage 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 always encouraged to apply for AHRQ 
and NCI grants.  

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, NCI, 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 as well as the 
“Qualifications” requirements (below) in order to be considered responsive to 
this PAR.

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 has performed a needs assessment of 
each PBRN funded to date by AHRQ and intends to conduct a similar assessment 
of all new networks funded through this initiative.  This assessment helps 
define and prioritize the specific resources (consultative services and 
technical expertise) that will be provided by the Resource Center, as 
appropriate, to each PBRN.  In addition, the Resource Center assists AHRQ in 
convening two annual meetings of representatives of recipient PBRNs during 
the period of funding.  Funded networks will be expected to cooperate fully 
with the Resource Center in the assessment process and to assure that at 
least one representative attends the two annual meetings.

Required Elements

The applicant is expected to describe:

1)   the clinicians who have agreed to participate in the proposed 
demonstration/evaluation project and the steps taken to optimize levels of 
study participation among network members; 
2)   the efforts (if any) to determine the types of 
dissemination/implementation methods currently employed by network practices 
and the extent to which each method is being actively used;
3)   the potential for the network membership (including those clinicians not 
active in this project) to adopt and sustain in practice the use of 
dissemination/implementation method(s) shown to be effective through this 
research; and,
4)   evidence of a commitment by network leaders and affiliated institutions 
to ongoing support of this effort and other research activities.

The responsibility for directing the dissemination/implementation 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.  This 
PAR does not require cost sharing in order to be eligible for funding.  
Appropriate research assistant(s) or coordinator(s) may be hired to oversee 
the daily activities of the project.  Support should also be requested, as 
needed and appropriate, for individuals with expertise in a variety of 
disciplines, including clinical medicine, dissemination, social science and 
statistics.  

Qualifications

Applicants should document in their proposals that the PBRN involved in the 
dissemination/implementation 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 
clinicians.
o  The network has a statement of its purpose and mission that has been 
accepted by clinicians enrolled in the PBRN and 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 any single study, 
including multiple systems of communication with and among participating 
practices in the form of regularly produced newsletters, e-mail or listservs, 
conference calls, and/or face-to-face meetings of various combinations of 
network members.

Priority Populations

The Healthcare Research and Quality Act of 1999 (See 
http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, 
in carrying out its mission, to conduct and support research and evaluations, 
and to support demonstration projects, with respect to the delivery of health 
care in inner-city and rural areas (including frontier areas); and health 
care for priority populations, which include low income groups; minority 
groups; women; children; the elderly; and individuals with special health 
care needs, including individuals with disabilities and individuals who need 
chronic care or end-of-life health care.  To implement this directive, AHRQ 
published a notice in the NIH Guide on February 28, 2003, establishing a new 
Agency policy on the Inclusion of Priority Populations in health services 
research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this PAR should address the requirements of 
including priority populations as specified in the Notice.  
  
Publication Transmittal: General AHRQ and NCI 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 Communications and Knowledge Transfer (OCKT) when articles from 
their studies are accepted for publication in the professional literature.  
Grantees and contractors should also discuss any ideas about other 
dissemination and marketing efforts with OCKT staff.  The goal is to ensure 
that efforts to disseminate research findings are coordinated with other 
Agency activities to maximize awareness and application of the research by 
potential users, including clinicians, patients, health care systems 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 OCKT and the press offices of the grantee’s or contractor’s 
institutions.  In cases when products are created (such as annual or final 
reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to 
submit to OCKT a brief plan describing how the product will be publicized.  
An OCKT staff person will be assigned to each product and will coordinate the 
implementation of the plan, especially issues related to printing and 
electronic dissemination, and outreach to the media.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAR 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 about scientific/research issues, including 
information on the inclusion of women, minorities, and children in study 
populations to:
 
David Lanier, MD
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  (301) 427-1567
Fax:  (301) 427-1595
Email:  dlanier@ahrq.gov

Stephen Taplin, MD
Outcomes Research Branch
Applied Research Program
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Blvd.
Bethesda, MD  20892
Telephone: (301) 496-8500
FAX: (301) 435-3710
Email:  taplins@mail.nih.gov 

o  Direct your questions about peer review to:

Carl Ohata, PhD
Agency for Healthcare Research and Quality
540 Gaither Road,       
Rockville, MD  20850            
Telephone:  (301) 427-1549
Email:  cohata@AHRQ.gov

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

George Gardner 
OPART/Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:  (301) 427-1453
FAX: (301) 427-1462
Email:  ggardner@ahrq.gov 

Crystal Wolfrey
Grants Administration Branch 
National Cancer Institute 
6120 Executive Boulevard
EPS 243
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyC@mail.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

Specific application instructions included in this PAR related to the 
organization of the application supercede those included in the form PHS 398.  
To ensure equity, all applicants using this form must observe page number and 
font size requirements specified in the Form PHS 398. 

SUPPLEMENTARY INSTRUCTIONS:

The following supplemental instruction to the form PHS 398 should be used to 
guide the preparation of the R21 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 
demonstration/evaluation project should be attached to the application 
as an appendix.  Not sure why they want to do this.

2)   If the proposed activities will involve human subjects (including 
surveys or interviews of network clinicians), the application should 
include documentation of 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 $150,000 total direct 
costs per year of the project, and the project period cannot exceed two 
years.  Requests for general support of the infrastructure of the PBRN are 
allowable, although these requests must (1) be well justified in terms of the 
specific needs and stage of development of the network, (2) contribute in 
some tangible way to the successful completion of the 
exploratory/developmental project, and (3) not result in yearly direct costs 
for the entire project that exceed the $150,000 limit.  Allowable 
infrastructure requests include support of salaries and travel of 
administrative staff, development or maintenance of network communication 
systems, annual meetings of the network membership, and research-related 
education of key network members (provided such training costs are not 
already included in the Facilities and Administrative costs of the applicant 
organization).  Requests for computer-related or other equipment must be well 
justified and within the scope of work proposed for the 
exploratory/developmental project.

Applications submitted in response to this PAR that include only 
infrastructure support will not be acceptable and will be returned without 
review. 

Since successful applicants will be required to have at least one network 
representative attend up to two collaborative meetings of funded PBRNs 
annually in Rockville, MD, travel and lodging expenses for this 
representative should 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 and consultants 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 
twenty five 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.  This description should document that the PBRN meets, 
at minimum, the qualifications outlined under SPECIAL REQUIREMENTS, 
“Qualifications,” and should include the accepted mission/purpose statement 
of the network.  As noted above, a complete listing of network clinicians and 
practice addresses of those who have agreed to participate in the 
demonstration/evaluation project should be included as an appendix to the 
application.

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 in their assessment of the network’s 
resource needs and to send at least one representative to up to two 
collaborative meetings of PBRNs annually in Rockville, MD, should the 
applicant be funded.

Section II.  Proposed Demonstration/Evaluation Of Methods to Translate 
Research Into Practice

a) Dissemination/implementation strategies to be addressed.  Define the 
specific scientific evidence or the evidence-based tool(s) that the network 
intends to implement and evaluate within primary care practices.  Background 
literature and a conceptual framework supporting the proposed implementation 
strategy should be presented, describing how the proposed project will build 
on current dissemination/implementation research findings.  This information 
is critical for methods that are newly developed or as yet untested in 
primary care settings.  Present any information available to the network 
about dissemination/implementation strategies used currently or in the past 
by member practices and reasons the use of these methods have been sustained 
or abandoned by the clinicians.  Describe the mechanism used to reach 
consensus among participating practices on the dissemination/implementation 
strategies to be addressed in this project.

b) Methods and plan.  A detailed plan for introducing and assessing the 
impact of dissemination/implementation strategies must be presented.  Any 
proposed dissemination/implementation tools or systems must be specified, as 
well as instruments and methods for collecting assessment data.  Applicants 
should provide a timeline for completing each phase of the project.

c) Analytic plan.  Identify the intended unit(s) of analysis and discuss the 
expected sample size.  Provide a contingency plan in the event study 
enrollment is less than anticipated.  Describe in detail the plan to analyze 
the study data and any issues related to cluster randomization.  Indicate, 
when appropriate, if the sample will be sufficient for subgroup analysis of 
the study population by race/ethnicity, insurance status, or other subject-
specific variables.

d) Contextual factors and sustainability.  Describe proposed methods for 
assessing the conditions under which the dissemination/implementation 
strategies being evaluated can be expected to be sustainable and how easily 
they can be transferred to other primary care settings.  Provide a plan for 
determining the contextual factors that appear to play a role in determining 
the effectiveness of each dissemination/implementation strategy in practices, 
and for assessing the relative influence of each factor.

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

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

g) Human subjects protections.  Identify the group(s) of human subjects who 
are the focus of the investigation:  clinicians? patients (or 
parents/guardians)? clinical or administrative practice staff?  Describe the 
measures proposed to ensure the protection of all subjects and/or 
individually identifiable data related to subjects.

Other Instruction

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

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

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 

AHRQ and NCI will not use the Modular Grant Application and Award Process for 
this PAR.  Applicants for funding through this PAR 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 (if appropriate):  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:

Natalie Alter
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  (301) 427-1569
FAX: (301) 427-1595
Email:  nalter@ahrq.gov 

APPLICATION PROCESSING:  Applications must be received  on or before the 
receipt dates listed on the first page of this announcement.

The CSR will not accept an application in response to this PAR that is 
essentially the same as one currently pending initial review, unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

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

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

Institutional Review Board (IRB) approval of human subjects is not required 
prior to peer review of an application.  The “AHRQ Revised Policy for IRB 
Review of Human Subjects Protocols in Grant Applications” was published in 
the NIH Guide on September 27, 2000.
(http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

The PAR is also available on AHRQ’s Web site, http://www.AHRQ.gov, and NCI’s 
Web site, http://cancercontrol.cancer.gov (see under Funding Opportunities). 

In carrying out its stewardship of funded programs, the AHRQ and NCI may 
request information essential to an assessment of the effectiveness of agency 
programs.  Accordingly, grant recipients are hereby notified that they will 
be asked for periodic updates on publications resulting from AHRQ or NCI 
grant awards, and other information AHRQ or NCI requires in order to evaluate 
the impact of AHRQ- and NCI-sponsored projects.

AHRQ and NCI expect grant recipients to keep the agency informed of 
publications as well as the known uses and impact of their Agency-sponsored 
work.  Applicants are to agree to notify AHRQ and/or NCI immediately when a 
manuscript based on work supported by the grant is accepted for publication, 
and to provide the expected date of publication as soon as it is known, 
regardless of whether or not the grant award is still active.

To receive an award, applicants must agree to submit an original and 2 copies 
of an abstract, executive summary, and full report of the 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 uses (WP5.1 or WP6.0 is 
preferable).

Projects will ordinarily not use CMS (Medicare or Medicaid) data involving 
individual identifiers.  Purchase of CMS public-use data, if required, should 
be discussed in the application narrative and included in the budget.  
         
PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by AHRQ and NCI. Incomplete and/or non-responsive applications 
or applications not following instructions given in this PAR will be returned 
to the applicant without further consideration.  Applications that are 
complete and responsive to the PAR will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by AHRQ in 
accordance with standard AHRQ and NCI peer review procedures.  

As part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score. 
o Receive a written critique
o If selected by NCI it will receive a second level review by the National 
Cancer Advisory Board.

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 demonstration/evaluation project and the potential of the PBRN to 
complete the proposed activities successfully.

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

1.  Technical merit of the proposal

a) Significance.  If the aims of this dissemination/implementation project 
are achieved, how will knowledge about translating research into practice in 
primary care settings be advanced?  What will be the effect of this study on 
the concepts or methods that drive this field?

 b) Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

c) Innovation.  To what extent does the proposed dissemination/implementation 
project take advantage of unique features/strengths of the PBRN or employ 
innovative evaluative methods?

d) Investigator(s).  Has the PBRN identified individuals with the appropriate 
expertise to assist in each phase of the project?  Is the proposed work 
appropriate to the training and experience level of the P.I. and other 
researchers (if any)?

e) Budget.  Is the proposed budget reasonable for the proposed project and 
for the requested period of support?

2. Potential for success

a) PBRN readiness.  To what extent has the work completed to date by the PBRN 
prepared it to take on this dissemination/implementation project?  To what 
extent has the P.I. involved network clinicians in the design and plan for 
this project?

b) Scope of work.  Is the proposed project sufficiently (or overly) ambitious 
for the PBRN, given its level of development?  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, the following 
items will be considered in the determination of scientific merit and the 
priority score:

o   PROTECTION:  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 and NCI (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:

1)  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 PA 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 
scheduled to be effective and enforceable in 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. 

2)   Rights in Data 

AHRQ and NCI 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 or NCI 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 legislative dissemination mandates, AHRQ and 
NCI 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 and NCI 
budget constraints, final products may be made available to the health care 
community and the public by AHRQ and/or NCI or their agents, if such 
distribution would significantly increase access to a product and thereby 
produce public health benefits. Ordinarily, to accomplish distribution, AHRQ 
and NCI publicize research findings but rely on grantees to publish research 
results in peer-reviewed journals and to market grant-supported products. 

AHRQ's Office of Communications and Knowledge Transfer 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.gpoaccess.gov/cfr/index.html).  NCI will 
approach its grantees with efficacious dissemination/implementation 
approaches to list their programs and products on the Research-Tested 
Intervention Programs (RTIPs; http://cancercontrol.cancer.gov/rtips/) website 
of the Cancer Control PLANET.  Grantees will be required to submit the 
programs and products for RTIPs review, but will retain the right to refuse 
posting on the RTIPs website after reviewing the content of the RTIPs 
posting.

AWARD CRITERIA

Applications submitted in response to a PAR will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:

o   Scientific merit of the proposed project as determined by peer review
o   Availability of funds
o   Program balance among awardees with respect to nature and type of 
dissemination/implementation strategies/methods
o   The distribution of funded PBRNs by predominant provider types and 
geographical location may be special considerations 

REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS:  
It is the policy of AHRQ and NCI that women and members of minority groups be 
included in all agency-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 and NCI require 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 and NCI 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- or NCI-supported research project, the underlying 
data is not subject to this disclosure requirement.  Furthermore, even if a 
Federal regulation action is taken in reliance on AHRQ- or NCI-supported data 
under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential 
identifiable data from such study is exempted from disclosure under "the 
(b)(3) exemption." It is important for applicants to understand the scope of 
this requirement and its limited potential impact on data collected with AHRQ 
or NCI support.  Proprietary data might also be exempted from FOIA disclosure 
requirements under "the (b)(4) exemption", for example, if it constituted 
trade secrets or commercial information collected. NIH has provided general 
related guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does 
not include discussion of the exception applicable to confidential 
identifiable data collected under AHRQ’s authorities. 

Should applicants wish to place data collected under this PAR 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 consider how to structure informed consent 
statements or other human subject protection procedures to permit or restrict 
disclosures of identifiable data, as warranted.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:   The 
Department of Health and Human Services (DHHS) issued the last modification 
the "Standards for Privacy of Individually Identifiable Health Information", 
was mandated by the "Privacy Rule," on August 14, 2002.  This regulation was 
mandated by the Health Insurance Portability and Accountability Act (HIPAA) 
of 1996 which governs the protection of individually identifiable health 
information.  It is administered and enforced by the DHHS Office for Civil 
Rights (OCR). Mandatory compliance with the Privacy Rule (for those 
classified under the Rule as "covered entities") must do so by April 14, 2003 
(with the exception of small health plans which have an extra year to 
comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with covered entities. 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 that may be used to determine whether a researcher is a 
staff of a covered entity.  Project Officers will assist grantees in 
resolving questions about the applicability of HIPAA requirements.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting health improvement 
priorities for the United States.  AHRQ and NCI encourage 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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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.  
                                 
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

Bero LA, Grilli R, Grimshaw JM, et al.  Closing the gap between research and 
practice: an overview of systematic reviews of interventions to promote the 
implementation of research findings.  BMJ 1998;317:465-468.

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.

Genel M, Dobs S.  Translating clinical research into practice:  practice-
based research networks – a promising solution.  J Invest Med 2003;51(2):64-
71.

Glasgow RE, Lictenstein E, Marcus AC.  Why don’t we see more translation of 
health promotion research to practice?  Rethinking the efficacy to 
effectiveness transition.  AJPH 2003;93(8):1261-67.

Hunt DL, Haynes RB, Hanna SE, Smith K.  Effects of computer-based decision 
support systems on physician performance and patient outcomes.  JAMA 
1998;280:1339-46.

Institute of Medicine, 2000.  Crossing the Quality Chasm: A New Health System 
for the 21st Century.  Washington, DC:  National Academy of Sciences.

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

Rogers EM.  Diffusion of Innovations.  New York, NY: Free Press, 2003.

Wager KA, Lee FW, White AW, Ward DM, Ornstein SM.  Impact of an electronic 
medical record system on community-based primary care practices.  JABFP 
2000;13(5):338-348.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.