and Human Services (HHS)
EXPIRED
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) 710-0267, 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.
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