SMALL RESEARCH GRANTS FOR PRIMARY CARE PRACTICE-BASED RESEARCH NETWORKS (PBRNs)
RELEASE DATE: April 28, 2003
RFA: HS-03-006
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.226
LETTER OF INTENT RECEIPT DATE: June 23, 2003
APPLICATION RECEIPT DATE: July 24, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
o References
PURPOSE OF THE RFA
The Agency for Healthcare Research and Quality (AHRQ) invites primary care
practice-based research networks (PBRNs) to apply for small research grants to
conduct exploratory/pilot projects or feasibility studies. A PBRN is defined
as a group of ambulatory practices devoted principally to the primary care of
patients, affiliated with each other (and often with an academic or
professional organization) in order to investigate questions related to
community-based practice and to improve the quality of primary care. This
definition includes a sense of ongoing commitment to network activities and an
organizational structure that transcends a single project.
Although a major objective is to encourage creative, investigator-initiated
research within PBRNs, AHRQ is particularly interested in studies that explore
(1) network strategies for assuring that new research evidence is translated
into actual practice and that its impact is assessed; (2) innovative uses of
information technology in primary care practices; (3) the feasibility of
implementing electronic health records in primary care and assessing the
impact on safety, quality, effectiveness and efficiency of care; (4) optimal
methods of delivering preventive services in primary care settings; (5)
methods for improving community-based detection and responses to emerging
public health threats (including acts of bioterrorism); and (6) elucidation of
primary care-based strategies for diminishing disparities in health care
delivery and health outcomes for AHRQ priority populations. This includes
delivery of health care in inner city and rural areas (including frontier
areas); it also includes health care for: low income groups, minority groups,
women; children; the elderly; and individuals with special health care needs,
including individuals with disabilities and individuals who need chronic care
or end-of-life health care. The funds are not intended to supplement ongoing
research or to support large-scale undertakings or analyses of secondary data
sources. It is expected, however, that results generated from these projects
will serve as a basis for planning future, larger scale research.
RESEARCH OBJECTIVES
Background
As part of the December, 1999, legislation (P.L. 106-129) reauthorizing and
renaming the agency, AHRQ was directed, in amended section 911 (42 U.S.C.
299b), to employ research strategies and mechanisms that link research
directly with clinical practice in geographically diverse locations throughout
the country, including the use of "provider-based research
networks...especially (in) primary care." To address issues of disparities in
the health care quality, outcomes, cost and access for various segments of the
U.S. population, amended section 901(b)(2) authorized the agency to implement
research strategies and mechanisms that specifically include PBRNs.
In response to these directives, AHRQ has over the past three years provided
support for primary care PBRN research efforts through the issuance of several
requests for applications. Most recently, RFA-HS-02-003 provided funds in
September, 2002, for infrastructure support and exploratory projects to 36
PBRNs comprised of over 10,000 primary care clinicians with practices in 50
states serving almost 10 million primary care patients. The current RFA is
directed to new or existing primary care PBRNs, including (but not limited to)
those previously or currently funded by AHRQ. It provides awards for
innovative exploratory or pilot projects, or feasibility studies, likely to
lead to larger scale undertakings by the network.
Objectives and Scope
A major goal of primary care PBRNs, some of which have existed in the U.S. for
over twenty years, has been to involve busy community-based clinicians and
their staffs in activities directed by investigators experienced in clinical
and health services research. The best of PBRN investigative efforts have
linked relevant clinical questions with rigorous research methods in community
settings and have produced scientific information that not only is externally
valid, but, in theory, more easily assimilated into everyday practice.
(Nutting, 1999) Leaders of PBRNs in the U.S. and other countries have also
recognized the potential of primary care networks to expand their purposes
beyond traditional research to the nurturing of an evidence-based culture in
primary care practice. (Thomas, 2001). Many PBRNs have begun to envision
their networks as places of learning, where clinicians are continually engaged
in reflective inquiries about practice, and clinicians and their patients in
the community are united with science to search for answers that can provide a
basis for improved delivery of primary care.
A critical element to the success of any PBRN effort is an infrastructure that
not only serves research but also coordinates diverse network activities, such
as recruitment and retention of practices, quality improvement efforts, and
the translation of research into practice. Ideally, a network's
infrastructure includes, in addition to leadership and support personnel, an
electronic data system that is capable not only of collecting, transferring
and aggregating primary research data but also of disseminating new
information quickly and measuring subsequent changes in practices and/or
patient outcomes. Such systems have the ability to inform future research
needs, help transform the culture of practice, and support strategies to
accelerate continuous quality improvement within practices. However, numerous
barriers, such as the cost of purchasing, implementing and maintaining
sophisticated information technology and training appropriate staff, have to
date prevented most primary care PBRNs from developing these systems.
Assuring adequate protection of the privacy and confidentiality of patient
data is another critical challenge.
Primary care clinicians have recently participated in the development and
testing of various information technologies, such as decision support systems
and tools for managing medical information, that enhance practice and
potentially improve patient outcomes. (Ebell, 2001) More work is needed,
however, to determine when and how such new technologies can be adopted into
practices that participate in PBRN activities and the extent to which these
technologies improve quality, safety, and efficiency. Certain observers have
argued that the demands of primary care clinicians for the information
necessary for optimal patient care can be satisfied only if clinicians use
electronic medical records (EMRs). EMRs have been praised for their ability
to help solve record movement problems, improve the quality and coherence of
the care process, and assist clinical research, outcomes management, and
process improvement. (McDonald, 1997) Although robust EMR systems are now
available, only about 5% of U.S. primary care providers use them. (Bates,
2003) PBRNs could potentially help define the barriers to adopting EMRs as
well as the benefits realizable through their routine use in primary care
practice.
In light of recent events in the U.S., there is considerable urgency to
develop an infrastructure capable of detecting and responding effectively to
emerging public health threats, including acts of bioterrorism. Early
detection of such threats depends largely on the ability of front line
clinicians to collect, analyze and communicate information. Also critical are
systems for providing bidirectional information flow between these clinicians
and local, state, regional and national public health officials. Most
surveillance systems currently in use within primary care practice were not
designed specifically to detect bioterrorism, but instead were created for
detecting and managing naturally occurring illnesses such as influenza.
(Buffington, 1993) PBRNs can potentially serve as settings to develop and
test "dual function" systems for recognizing and responding to bioterrorism
threats through the adaptation of clinical surveillance systems originally
developed for other purposes. Information technology linkages between PBRN
practices, public health agencies, and emergency response networks would be a
critical element of such systems.
Another major challenge facing PBRNs is identifying and obtaining adequate and
sustained funding for network research. Historically, it has been difficult
for PBRNs to obtain funding through the traditional basic research project
grant (R01) mechanism. Most often, applications are denied either for lack of
preliminary data or for research methods that are adapted to the realities of
practice settings but appear insufficiently rigorous in peer review. At the
same time, few funding opportunities currently exist for PBRNs to generate
preliminary data as evidence of feasibility or to pilot test new projects or
research methods. There is a clear need for a source of funds to support
network efforts to refine innovative research questions and related hypotheses
through pilot testing of original ideas derived from primary care practice.
Such testing could provide important information about the feasibility of data
collection in network practices, data that may be critical to the successful
funding of larger, related projects, and to the design of appropriate methods
for translating study results into actual practice.
Methodological Considerations
Funds available through this RFA provide PBRN investigators the opportunity to
(1) explore the feasibility, as well as the development, of projects
investigating issues important to primary care practice, and (2) generate
preliminary data. The funds are specifically intended to support the study by
PBRNs of original ideas or research approaches where preliminary data as
evidence of feasibility are sparse or do not exist. The funds are not
intended to supplement ongoing research or to support large-scale undertakings
or analyses of secondary data sources. Rather, proposed projects are intended
to serve as a basis for planning and strengthening future research grant
applications (R01s) from PBRNs.
Proposed projects can involve descriptive or interventional studies,
qualitative and/or quantitative work, multimethod designs, or simple
hypothesis testing. While the range of questions that PBRNs can propose is
broad and detailed in the AHRQ Small Research Grant Program Announcement (PAR-
01-040), AHRQ has a particular interest in the following areas of
investigation:
o network strategies for assuring that research evidence is translated into
actual practice and that its impact is assessed. In particular, there is a
need for research that explores the application across multiple practices of
promising translational prototypes (e.g., evidence-based approaches for
treating a specific disease or system changes that improve the quality or
efficiency of care) and also assesses resultant changes in the quality and/or
cost-effectiveness of health care delivery or health care outcomes.
o innovative uses of information technology in primary care practices. Of
particular interest are projects that test the end user value of wireless
handheld devices or desktop workstations that automate common clinician
practices, such as prescribing, note-taking, clinical decision-making, and
providing patient education.
o feasibility of implementing electronic medical records (EMRs) in primary
care and assessing their impact on safety, quality, effectiveness and
efficiency of care. PBRNs are encouraged to partner with public and private
EMR developers in pilot testing the benefits and barriers to adoption of EMRs
in primary care settings. Projects that focus on the interfaces between new
primary care EMR systems and existing electronic data sources (e.g.,
laboratory systems, pharmacy systems) are strongly encouraged.
o optimal methods of delivering preventive services in primary care settings,
especially those aimed at promoting healthy patient behaviors.
o methods for improving community-based detection and responses to emerging
public health threats, including acts of bioterrorism. Of special interest
are projects that pilot test (through exercises or demonstrations) adaptations
of primary care surveillance systems to respond to a bioterrorist event and
also link primary care practices to local, state, regional or national public
health departments.
MECHANISM OF SUPPORT
This RFA will use the R03 award mechanism. As an applicant, you will be
solely responsibility for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. The anticipated award date is
September 30, 2003.
AHRQ is not using the Modular Grant Application and Award Process.
FUNDS AVAILABLE
AHRQ intends to commit approximately $500,000 in FY03 to fund five new grants
in response to this RFA. The budget limit on small project grant applications
is $100,000 total costs (i.e., direct costs plus facilities and administrative
costs) for the entire project period. Grant support should not exceed 24
months, and budget requests for the full period of support may not exceed
$100,000 in total costs. Applicants responding to this RFA will not be
required to match or share in project costs if an award is made.
Although the financial plans of AHRQ provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications. At this time, it
is not known if this RFA will be reissued.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution is domestic and
included in any one of the following categories:
o Domestic
o Public and private non-profit organizations, such as universities, hospitals
or clinics, and professional associations.
o Units of State and local government
o Eligible components of agencies of the Federal Government
o Eligible faith-based or community-based organizations
While foreign organizations are not eligible, the research network supported
by the applicant may include individual clinical practices located outside the
United States. For the purpose of this RFA, AHRQ will make grants only to
non-profit organizations. For-profit organizations may participate in
projects as member of consortia or as subcontractors. Organizations described
in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are
not eligible.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with a primary care PBRN to
develop an application for support. AHRQ encourages new investigators (as
defined in the PHS 398 application instructions) to apply as Principal
Investigators. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are also encouraged to apply for AHRQ
programs.
SPECIAL REQUIREMENTS
Applications are encouraged from newly formed PBRNs as well as existing
networks, including (but not limited to) those that are currently receiving,
or have in the past received, funds from AHRQ, other Governmental agencies, or
private sources. The application must provide a description of the PBRN's
current state of development as well as its size, patient population served,
leadership/management staff, and affiliations (if any). Applications must
comply with the above special requirements in order to be considered
responsive to this RFA.
PBRN Resource Center
Recognizing the diverse needs of individual networks and the importance of
regular communication with and among funded PBRNs, AHRQ has established a PBRN
Resource Center through Indiana University and the National Opinion Research
Center. The Resource Center will conduct an assessment of each PBRN funded
through this RFA in order to define and prioritize the specific resource needs
of the network. Funded networks will be expected to cooperate fully in this
process with the Resource Center, which will later provide consultative
services and technical expertise, as appropriate, to each PBRN. In addition,
the Resource Center will assist AHRQ in convening two annual meetings of
representatives of recipient PBRNs during the period of funding.
Required Elements
The applicant is expected to provide a concise, clearly stated research
question and to describe the process that was used to generate and develop the
original idea with the network. While originality of the research question or
approach and the potential significance of the proposed project will be major
considerations in the evaluation for funding, the applicant is responsible for
developing a rigorous plan for research and data analysis. Background
literature and a rationale for the research question must be provided.
Applicants must also describe the steps taken to optimize levels of study
participation and the potential implementation of research results by network
membership.
The responsibility for directing the exploratory or pilot project should be
assigned to a senior level person with appropriate research training and
experience. This person may be the network director or another investigator.
He/she must be directly affiliated with the applicant organization and should
devote not less than 10% of his/her time to the project over the period of
funding, although salary support for the principal investigator's effort may
be cost-shared by the applicant organization. Appropriate research
assistant(s) or coordinator(s) may be hired to oversee the daily research
activities. Support should also be requested, as appropriate, for statistical
and other assistance.
Qualifications
Applicants should document in their proposals that the PBRN involved in this
project meets, at minimum, the following qualifications:
o The PBRN organizational structure includes a core of at least 15 ambulatory
practices and/or 15 clinicians devoted to the primary care of patients. The
majority of the practices should be located in the U.S. Applicants should
refer to the Institute of Medicine report on primary care (Donaldson, 1996)
for definitions of primary care and primary care clinician.
o The network has an accepted statement of its purpose and research mission
that includes an ongoing commitment to the research endeavor.
o A director has been identified who is responsible for most administrative,
financial and planning functions.
o The director is, or will be, supported by a staff of at least one person.
o A mechanism (such as a community advisory board) is in place to solicit
advice/feedback from the communities of patients served by the PBRN
clinicians.
o An organizational structure exists that transcends a single study, including
multiple systems of communication with and among participating practices in
the form of regularly produced newsletters, e-mail or list-serves, conference
calls, and/or face-to-face meetings of various combinations of network
members.
Priority Populations
The Agency's authorizing legislation (refer to
http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs
to populations of inner-city areas and rural areas (including frontier areas);
low income groups; minority groups; women; children; the elderly; and
individuals with special health care needs, including individuals with
disabilities and individuals who need chronic care or end-of-life health care.
Applications under this RFA should address attention to and potential benefits
for these priority populations.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded
research into practice and policy, grantees and/or contractors are to inform
the Office of Health Care Information (OHCI) when articles from their studies
are accepted for publication in the professional literature. Grantees and
contractors should also discuss any ideas about other dissemination and
marketing efforts with OHCI staff. The goal is to ensure that efforts to
disseminate research findings are coordinated with other Agency activities to
maximize awareness and application of the research by potential users,
including clinicians, patients, health care systems and purchasers and
policymakers. This is critical when outreach to the general and trade press
is involved. Contact with the media will take place in close coordination
with OHCI and the press offices of the grantee's or contractor's institutions.
In cases when products are created (such as annual or final reports, Web-based
tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a
brief plan describing how the product will be publicized. An OHCI staff
person will be assigned to each product and will coordinate the implementation
of the plan, especially issues related to printing and electronic
dissemination, and outreach to the media.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions regarding programmatic issues, including information
on the inclusion of women, minorities, and children in study populations to:
David Lanier, M.D.
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-1489
FAX: (301) 594-3721
Email: dlanier@ahrq.gov
o Direct your questions about peer review issues to:
Carl Ohata, Ph.D.
Health Scientist Administrator
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301) 594-6040
FAX: (301) 594-0154
Email: cohata@ahrq.gov
Direct your questions about financial or grant management matters to:
George Gardner
Division of Grants Management
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-6826
FAX: (301) 594-3210
Email: ggardner@ahrq.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows AHRQ staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by June 23, 2003. The letter of intent
should be sent to:
Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-7180
FAX: (301) 594-3721
Email: nalter@ahrq.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and form (rev. 5/2001). The PHS 398 is available at
https://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.
State and local government applicants may use PHS 5161-1, Application for
Federal Assistance (rev. 5/96), and follow those requirements for copy
submission. To ensure equity among applicants, however, applicants using this
form must observe page number and font size requirements specified in the Form
PHS 398. AHRQ encourages use of Form PHS 398 in preference to Form 5161-1.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/labels.pdf.
SUPPLEMENTAL INSTRUCTIONS: The following supplemental instructions to the form
PHS 398 should be used to guide the preparation of the R03 application:
1) Under "Performance Sites" (page 2), list only the official name of the PBRN
and the address of the PBRN office. A complete list of the clinicians and
practice sites to be involved in the project should be attached to the
application as an appendix. If the proposed activities will involve human
subjects (including surveys or interviews of network clinicians), the
application should include documentation of Multiple Project Assurance (MPA)
or Federalwide Assurance (FWA), if known. Applicants not having a Human
Subjects Assurance should refer to the OHRP website
http://www.hhs.gov/ohrp/assurances/assurances_index.html for information regarding Human
Subject Assurances.
2) Detailed Budget. Budget requests may not exceed $100,000 total costs
(direct plus facilities and administrative costs) for the entire project
period. All budget items must be justified in terms of their support of the
exploratory/pilot project or feasibility study. Requests for computer-related
or other equipment must be well justified and within the scope of work
proposed for the project.
Since travel and lodging expenses for a network representative to attend up to
two collaborative meetings annually in Rockville, MD will be paid for by AHRQ,
these expenses should not be included in the budget request.
3) Biographical Sketches. A biographical sketch of the network director must
be included, as well as sketches of other key personnel to be involved in the
project. If an individual (other than the network director) will be serving
as the Principal Investigator, his/her biographical sketch must also be
included.
4) Research Plan. This narrative part of the application is limited to
fifteen pages of text. It should be organized into two sections, as follows.
Section I. The Practice-Based Research Network
a) Description of the PBRN. Describe the practices included in the network,
including geographical distribution of practices and types of clinicians. The
applicant should provide any reliable information about the characteristics of
the patient population currently served by network clinicians, including (if
available) the percentages of minority and underserved patients. As noted
above, a complete listing of network clinicians and practice addresses should
be included as an appendix to the application. This description should
document that the PBRN meets, at minimum, the qualifications outlined under
SPECIAL REQUIREMENTS, "Qualifications."
b) Current institutional or other resources available to the PBRN. This
discussion (which may alternatively be included in the Resources section of
the application) should describe the relationships between the network and any
affiliated academic department or other organizational unit. A list of the
consultants, co-investigators and other resources available to the network as
a result of the affiliation should be included. Senior officials in any PBRN-
affiliated organization(s) should provide a letter documenting support for the
network's activities. These and other letters of support should be included
as an appendix and referenced in this section of the application. A brief
description of any computer-based or other information systems currently in
use across the network should be included. The discussion should also include
a description of the mechanism used for obtaining advice/feedback from the
patient communities served by the network practices.
c) Network director and staff. The PBRN director and any network support
staff should be identified, including a description of their qualifications.
d) Evaluation. Include a statement indicating the willingness of the PBRN to
cooperate with the PBRN Resource Center and to participate in an AHRQ-
supported evaluation of the agency's overall PBRN initiative, should the
applicant be funded.
Section II. Proposed Exploratory/Pilot Research or Feasibility Study
a) Research issue/question. Define the research question(s) or issue(s) to be
addressed and describe the mechanism used to generate and develop the study
idea with the PBRN. Present background literature and a conceptual framework
supporting the proposed question or approach. Explain why the question being
explored may be significant to the future research efforts of the network and
to primary care practice.
b) Methods and plan. A rigorous research plan must be presented, even if the
purpose of the project is primarily hypothesis testing. Instruments and
methods for data collection must be specified and a timeline for completing
each phase of the project provided. Describe the steps taken to optimize the
level of study participation within the network and to increase the likelihood
that findings will be implemented by PBRN membership. Discuss any similar or
related work successfully completed in the past within the network.
c) Analytic plan. Describe in detail the plan to aggregate and analyze the
study data. The expected sample size should be discussed, including a
contingency plan in the event study enrollment is less than anticipated.
Indicate if the sample will be sufficient for subgroup analysis of the study
population by race/ethnicity, insurance status, or other patient-specific
variables.
d) Potential problem areas. Discuss any methodological or logistical problems
that could affect the timely completion of the exploratory or pilot project.
Describe any backup plans or methods being proposed to address or resolve
these problems, if needed.
e) Investigators. Describe the training and experience of the principal
investigator (and any co-investigators) that quality him/her to carry out the
proposed project.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:
AHRQ is not using the Modular Grant Application and Award Process. Applicants
for funding from AHRQ should ignore application instructions concerning the
Modular Grant Application and Award Process, and prepare applications
according to instructions provided in form PHS 398 . Applications submitted
in the Modular format will be returned without review.
SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten
original of the application, including the checklist, and three signed
photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for courier service)
At the time of submission, two additional copies of the application must also
be sent to:
Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-7180
FAX: (301) 594-3721
Email: nalter@ahrq.gov
APPLICATION PROCESSING: Applications must be received by the receipt dates
listed in the heading of this RFA. If an application is received after that
date, it will be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The CSR and AHRQ will not accept any application in response to this RFA that
is essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to an RFA, it is to be prepared
as a NEW application. That is the application for the RFA must not include
an Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes. While the investigator may still
benefit from the previous review, the RFA application is not to state
explicitly how.Applicants are encouraged to read all PHS Forms 398 instructions
prior to preparing an application in response to this RFA. The PHS 398 type
size requirements (p.6) will be enforced rigorously and non-compliant
applications will be returned. State and local government applicants may use
PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those
requirements for copy submission, http://forms.psc.gov/forms/FF99/PHS-5161-1/
phs-5161-1.html. It is very important to note that limitations on number
of pages and size of font must be observed; applications violating these
requirements will be returned without review.
Institutional Review Board (IRB) approval of human subjects is required at the
time of submission of an application in response to this RFA. The "AHRQ
Revised Policy for IRB Review of Human Subjects Protocols in Grant
Applications" was published in the NIH Guide on September 27, 2000.
(https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
However, due to time constraints IRB approval is required at the time of
application submission.
The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under
Funding Opportunities) and through AHRQ InstantFAX at (301) 594-2800. To use
InstantFAX, you must call from a facsimile (FAX) machine with a telephone
handset. Follow the voice prompt to obtain a copy of the table of contents,
which has the document order number (not the same as the RFA number). The RFA
will be sent at the end of the ordering process. AHRQ InstantFAX operates 24
hours a day, 7 days a week. For comments or problems concerning AHRQ
InstantFax, please call (301) 594-6344.
In carrying out its stewardship of research programs, the AHRQ, at some point
in the future, may begin requesting information essential to an assessment of
the effectiveness of Agency research programs. Accordingly, grant recipients
are hereby notified that they may be contacted after the completion of awards
for periodic updates on publications resulting from AHRQ grant awards, and
other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications as
well as the known uses and impact of their Agency-sponsored research.
Applicants are to agree to notify AHRQ immediately when a manuscript based on
research supported by the grant is accepted for publication, and to provide
the expected date of publication as soon as it is known, regardless of whether
or not the grant award is still active.
In addition, to receive an award, applicants must agree to submit an original
and 2 copies of an abstract, executive summary, and full report of the
research results in the format prescribed by AHRQ no later than 90 days after
the end of the project period. The executive summary should be sent at the
same time on a computer disk which specifies on the label the format used
(WP5.1 or WP6.0 is preferable).
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness and
responsiveness to the RFA. Incomplete and/or non-responsive applications or
applications not following instructions given in this RFA will be returned to
the applicant without further consideration. Applications that are complete
and responsive to the RFA will be evaluated for scientific and technical merit
by an appropriate peer review group convened in accordance with standard AHRQ
peer review procedures.
As part of the merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed and assigned a priority score.
REVIEW CRITERIA
In the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the scientific merit of the
proposed project and the potential of the PBRN to complete the proposed
activities successfully.
1. Technical merit of the proposal
a) Approach. How clear are the goals and objectives of the proposed project?
Is the research question or hypothesis clearly stated? Are the proposed
methods and data analyses adequately developed and appropriate to the aims of
the project?
b) Significance. How important is the research question/hypothesis to be
tested? If the aims of the project are achieved, how important will this
preliminary work be to future network endeavors?
c) Innovation. Will the proposed project employ novel and original concepts,
approaches or methods? To what extent does the proposed project take
advantage of unique features of the PBRN or employ innovative collaborative
arrangements?
d) Investigator(s). Is the investigator(s) appropriately trained and well
suited to carry out this work? Is the proposed work appropriate to the
experience level of the P.I. and other researchers (if any)?
2. Potential for success
a) PBRN readiness. To what extent has the P.I. (or network director) involved
network clinicians in the development of the research question? How well has
the applicant considered the steps that will be necessary to implement in
practice any findings that may result from this or related work?
b) Scope of work. Is the proposed work sufficiently ambitious for the PBRN,
given its level of development and prior experience? Will the PBRN
realistically be able to complete the entire project within the proposed
timeline?
c) Environment. Is the administrative, organizational and management
environment of the PBRN well established and stable enough to make the
project's success likely? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
o INCLUSION: The adequacy of plans to address the need of both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
aims of the project. Adequacy of attention to other populations of special
priority to AHRQ (see discussion on Priority Populations in the section on
Special Requirements, above, and Inclusion Criteria included in the section on
Agency policies and Requirements, below.)
DATA SHARING:
Data Confidentiality
Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ supported-study that
identifies an individual or entity must be treated as confidential in
accordance with any explicit or implicit promises made regarding the possible
uses and disclosures of such data. There are now civil monetary penalties for
violation of this confidentiality statute. [42 U.S.C.299c-3(d)) In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to the information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will
be restricted and safeguarded. Identifiable patient health information
collected by grantees under this RFA will also be managed in accordance with
42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of
patient-related health information. These privacy regulations, developed by
the Department of Health and Human Services pursuant to the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), are effective April 2003.
These regulations serve to limit the disclosure of personally identifiable
patient information and define when and how such information can be disclosed.
Thus, for example, health care plans and providers will require either patient
authorization of disclosures of identifiable information to be made to
researchers who are not their health care providers or waivers of such
authorizations obtained from an IRB or Privacy Board (defined in the
regulations) upon being satisfied that any identifiable health information
will be appropriately safeguarded by the investigators. Additional information
about the regulations and their implementation can be obtained from:
http://www.aspe.hhs.gov/admnsimp/
The awardee should ensure that computer systems containing confidential data
have a level and scope of security that equals or exceeds those established by
the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix
III - Security of Federal Automated Information Systems. The National
Institute of Standards and Technology (NIST) has published several
implementation guides for this circular. They are: An Introduction to Computer
Security: The NIST Handbook; Generally Accepted Principals and Practices for
Securing Information Technology Systems; and Guide for Developing Security
Plans for Information Technology Systems. The circular and guides are
available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.
Rights in Data
AHRQ grantees may copyright unless otherwise provided in grant awards, or seek
patents, as appropriate, for final and interim products and materials
including, but not limited to, methodological tools, measures, software with
documentation, literature searches, and analyses, which are developed in whole
or in part with AHRQ funds. Such copyrights and patents are subject to a
worldwide irrevocable Federal government license to use and permit others to
use these products and materials for government purposes. In accordance with
its legislative dissemination mandate, AHRQ purposes may include, subject to
statutory confidentiality protections, making project materials, data bases,
results, and algorithms available for verification or replication by other
researchers; and subject to AHRQ budget constraints, final products may be
made available to the health care community and the public by AHRQ or its
agents, if such distribution would significantly increase access to a product
and thereby produce public health benefits. Ordinarily, to accomplish
distribution, AHRQ publicizes research findings but relies on grantees to
publish research results in peer-reviewed journals and to market grant-
supported products. AHRQ's Office of Health Care
Information wishes to be consulted in advance of publication in order to
coordinate these issuances with other AHRQ dissemination activities. Important
legal rights and requirements applicable to AHRQ grantees are set out or
referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A
(Available in libraries and from the GPO's website
http://www.access.gpo.gov/nara/cfr/index.html).
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 23, 2003
Application Receipt Date: July 24, 2003
Peer Review Date: August 2003
Earliest Anticipated Start Date: September 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Program balance among awardees with respect to type and focus of
investigations
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS:
It is the policy of AHRQ that women and members of minority groups be included
in all AHRQ-supported research projects involving human subjects, unless a
clear and compelling rationale and justification are provided that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research.
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD
-00-048.html). A complete copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the
extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web
site https://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may
also provide additional information concerning these policies (see INQUIRIES).
AHRQ also encourages investigators to consider including children in study
populations, as appropriate.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
If no Federal act is taken, having the force and effect of law, in reliance
upon an AHRQ supported research project, the underlying data is not subject to
this disclosure requirement and under FOIA, 5 USC 552(b), disclosure of
identifiable data from such study is exempted from disclosure under "the
(b)(3) exemption." It is important for applicants to understand the scope of
this requirement and its limited potential impact on data collected with AHRQ
support. Proprietary data might also be exempted from FOIA disclosure
requirements under "the (b)(4) exemption", for example, if it constituted
trade secrets or commercial information. However, courts have generally not
regarded a researcher's interest in "his" data as proprietary. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Should applicants wish to place data collected under this RFA in a public
archive, which can provide protections for the data (e.g., as required by the
confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-
3(c)) and manage the distribution of non-identifiable data for an indefinite
period of time, they may. The application should include a description of any
archiving plan in the study design and include information about this in the
budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other
human subjects procedures given the potential for wider use of data collected
under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes
involving the review, funding, and progress monitoring of grants, cooperative
agreements, and research contracts can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance, Number 93.226. Awards are made under Title IX of
the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129
(1999). Awards are administered under the PHS Grants Policy Statement and
Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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