PRIMARY CARE PBRNS: COMPETITIVE CONTINUATIONS
Release Date: February 22, 2001
RFA: RFA-HS-01-004
Agency for Healthcare Research and Quality
Application Receipt Date: April 13, 2001
PURPOSE
The Agency for Healthcare Research and Quality (AHRQ) announces the
availability of one-year cooperative agreement research grants to
provide continuing support of primary care practice-based research
networks (PBRNs) and to assist PBRNs in addressing data-related issues.
Although grants will be awarded competitively, applicants are limited to
recipients of planning grants awarded by AHRQ in September, 2000, under
RFA-HS-00-004, Primary Care Practice-Based Research Networks. RFA-HS-
00-004 supported PBRN planning efforts to establish or augment
electronic collection and aggregation of practice-derived data, increase
network capacity to study the health care of racial and ethnic minority
and/or underserved populations, create systems to facilitate the
implementation of research findings by network clinicians, and identify
potential sources of ongoing network support. The current solicitation
builds upon this effort by helping PBRNs address specific data-related
issues identified through planning activities.
Funds are available to support PBRN surveys of network clinicians and
practices, using standardized instruments. These network-defining
surveys will provide baseline data on the clinicians enrolled in the
network, the services provided, and the characteristics of patients
receiving those services. Potential uses of the data include practice
benchmarking and guiding the selection and design of specific PBRN
research projects. PBRNs can also apply for additional funds to pilot
test and evaluate electronic methods of collecting and aggregating
practice-derived research data or to assess clinician and patient
knowledge and attitudes about protecting the privacy and confidentiality
of research data collected in primary care settings. AHRQ’s overall
goal is to improve the capacity of PBRNs to expand the primary care
knowledge base and to establish mechanisms to assure that new knowledge
is incorporated into actual practice and that its impact is assessed.
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.
ELIGIBILITY REQUIREMENTS
In September, 2000, AHRQ awarded planning grants (P20s) to nineteen
PBRNs under RFA-HS-00-004. Funded activities have included the planning
and development of network infrastructure needed to enhance methods of
PBRN data collection. This solicitation is a competitive continuation
that extends the data-related activities, and only current recipients of
PBRN planning grants are eligible to apply. For-profit organizations
may participate in the grant projects as members of consortia or as
subcontractors. Organizations described in section 501(c)4 of the
Internal Revenue Code that engage in lobbying are not eligible.
AHRQ encourages women, members of racial and ethnic minority groups, and
persons with disabilities to apply as Principal Investigators.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an "assistance" mechanism in
which substantial AHRQ scientific and/or programmatic involvement with
the awardee is anticipated during performance of the activity. The
dominant role and prime responsibility for the activity resides with the
awardee(s) for the project as a whole, although specific tasks and
activities in carrying out the studies will be shared among the awardees
and the AHRQ Program Official(s). Details of the responsibilities,
relationships and governance of the study to be funded under cooperative
agreement(s) are discussed later in this document under the section
“Terms and Conditions of Award.”
The total project period for applications submitted in response to the
present RFA may not exceed one year. The anticipated award date is
September 28, 2001.
This RFA is a one-time solicitation. AHRQ has not determined whether or
how this solicitation will be continued beyond the present RFA.
FUNDS AVAILABLE
AHRQ expects to award up to $1.5 million total costs (direct costs plus
facilities and administrative costs) in fiscal year 2001 to support
projects under this RFA. It is anticipated that up to 19 awards to
conduct network-defining surveys will be made for up to $50,000 total
costs (including direct plus facilities and administrative costs) for
one year. In addition, up to 5 of these awards will compete for an
additional $100,000 total costs (including direct and facilities and
administrative costs) to pilot test electronic data collection methods
or to conduct projects related to data safety and confidentiality.
Although this program is provided for in the financial plans of AHRQ,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.
Definition of PBRN
For the purposes of this RFA, a PBRN is defined as a group of ambulatory
practices devoted principally to the primary care of patients,
affiliated with each other (and often with an academic or professional
organization) in order to investigate questions related to community-
based practice. This definition includes a sense of ongoing commitment
to the research endeavor, and an organizational structure that
transcends a single study.
RESEARCH OBJECTIVES
Background
Legislation passed by the one hundred sixth U.S. Congress and signed by
the President in December, 1999, amended Title IX of the Public Health
Service Act (42 U.S.C.299 et seq.) to mandate the establishment within
the newly named AHRQ of a Center for Primary Care Research (CPCR) to
“serve as the principal source of funding for primary care practice
research in the Department of Health and Human Services.” In addition,
AHRQ was directed to employ research strategies and mechanisms that link
research directly with clinical practice in geographically diverse
locations throughout the U.S., including “provider-based research
networks...especially (in) primary care.” In response to these
directives, AHRQ issued in February, 2000, the Request for Applications
RFA-HS-00-004, “Primary Care Practice-Based Research Networks,” which
offered one-year exploratory grants to assist new or established PBRNs
in planning for activities to enhance their capacity to conduct research
in primary care settings and translate research findings into practice.
Awards were made in September, 2000, to 19 PBRNs comprised of over 5,000
primary care clinicians with practices in 49 states serving almost 7
million primary care patients. Each grant supported the development of
a PBRN-specific plan to: (1) establish or augment electronic collection
and aggregation of practice-derived data; (2) increase network capacity
to study the health care of racial and ethnic minority and/or
underserved populations; (3) create systems to facilitate the
implementation of research findings by network clinicians and practices;
and, (4) identify potential sources of ongoing network support. The
current RFA builds upon the earlier solicitation by providing funds to
support PBRN efforts to address specific data-related issues identified
through the planning activities.
Objectives and Scope
Since the first primary care PBRNs were established in the U.S. in the
late 1970s, the major goal of these networks has been to link relevant
clinical questions with rigorous research methods in community settings
to produce scientific information that not only is externally valid but,
in theory, is more easily assimilated into everyday practice (Nutting,
1999). To date, however, the range of research conducted by PBRNs has
been limited. The majority of studies published by PBRNs have been
observational, typically describing the practice patterns of primary
care, with many fewer intervention studies being successfully completed.
The unavailability of adequate funding for large, expensive primary care
research has been a major barrier. However, another factor limiting the
ability of many PBRNs to conduct more sophisticated research has been
the inadequacy of network-defining data needed to determine the
feasibility of, and lay the methodological groundwork for, such studies.
For example, before a PBRN can realistically propose to conduct a
randomized trial or effectiveness study focusing on a specific clinical
condition or patient population, it must have reliable patient
demographic information as well as data on the incidence or prevalence
of the condition among patients served by network clinicians. This is
particularly true for studies involving minority populations or
conditions seen less commonly in primary care settings. Administrative
or billing data routinely collected in primary care practices are often
inadequate for this purpose. Since few if any standards currently
exist for office-based coding of demographic and other research-related
information, the data are often incomplete or incompatible from practice
to practice and cannot be easily aggregated for the purpose of
characterizing the network as a whole. A few networks have been able to
gather data on network demographics by systematically collecting
information on the total number and age-sex distribution of patients in
their practices, as well as the general characteristics of their
providers. However, even this basic level of information is lacking for
the majority of PBRNs (Green, 1999).
Collecting, transferring and analyzing research data is another major
challenge for primary care PBRNs. Since office computers in primary
care are typically used only for billing purposes, the potential to
gather research data electronically is usually not realized. As a
result, most PBRN studies currently involve large volumes of hand-
written information from network practices that often are widely
dispersed geographically. The administrative burden placed on the
research team, as well as the practices, can be considerable. One
obvious solution is the development of a computer-based research
infrastructure that is integrated as much as possible with the computer
system currently in use in the network practices. While the cost of
establishing a comprehensive electronic medical record system across an
entire network can be prohibitive, the use of less expensive
applications, including software upgrades to existing office computers,
may be realistic for many PBRNs. The accuracy and comprehensiveness of
research data collected by various electronic methods in busy office
settings, however, are yet to be tested. Studies are needed that
compare the integrity of information gathered electronically to that
collected by usual collection methods currently employed by PBRNs.
Since clinicians and/or their staff are often involved, if not directly
responsible, for recording the research information, much consideration
also needs to be given to factors that sustain or reduce their
motivation to collect accurate and comprehensive data. Information
systems that interfere with the efficiency of providing patient care are
unlikely to be acceptable to primary care clinicians or their staff
whereas those that save the clinician time or enhance quality of care
are likely to be welcomed (Hogg and Lemelin, 1993). Network clinicians
may be further motivated to use information systems that assist with
prompt and appropriate dissemination of new research evidence and help
measure subsequent changes in practice. Data collected as part of PBRN
research efforts may be useful in developing benchmarks for network
clinician practices and in enhancing collective understanding of
strategies intended to accelerate improvements in the processes and
outcomes of primary care practice (Wasson, 1997).
Access to personal health information is often critical to studies
conducted by primary care PBRNs. At the same time, the use of this
information raises concerns about privacy (whether participants should
provide the data) and confidentiality (how the data may be used later).
In recent years, these concerns have intensified as a result of public
reports of the disclosure of sensitive, personal information without the
knowledge or consent of the individual involved (Institute of Medicine,
2000). Although the large majority of such reports involve non-health
related information, numerous policies have been proposed to grant
patients significant new rights to understand and control how their
health information is used. The federal cornerstone of such policies
is the Health Insurance Portability and Accountability Act of 1996
(HIPAA) which provided the U.S. Department of Health and Human Services
with the authority to craft regulations to control the flow of sensitive
patient information and protect patients’ privacy and confidentiality.
The final regulations, which will come into full effect in two years,
have the goal of protecting all medical records and other individually
identifiable health information held or disclosed by health plans or
health care providers. These regulations are likely to have a
significant effect on procedures used by anyone to collect, analyze and
report research data, especially patient-level data. The impact may be
even more acute, however, on research conducted by PBRNs, since many
network studies involve the collection of patient-level data from a
variety of practices and a very large number of patients. Often it is
not feasible to obtain consent from every patient in a large,
geographically dispersed primary care population for every study being
conducted, particularly when the data being analyzed were previously
collected for some other purpose. At the same time, it is critical that
the privacy and confidentiality of research subjects be adequately
protected. While institutional review boards (IRBs) will play a key
role in dealing with these difficult issues, much is yet to be learned
about the knowledge and attitudes of patients and clinicians with regard
to appropriate and inappropriate uses of patient-level health
information for research purposes.
Methodological Considerations
All applications must include a plan for the PBRN to administer
standardized, network-defining surveys. Guidance on applying to conduct
network-defining surveys is provided in the section entitled SPECIAL
REQUIREMENTS. In addition, applicants may request funds to conduct
special data-related research projects. The special project should
focus EITHER on pilot testing of information technology OR an
investigation of data privacy and confidentiality issues within PBRNs.
Applicants proposing to pilot test methods of electronic data collection
in PBRN settings are strongly encouraged to focus on a single
information technology. Examples of appropriate technologies include
hand-held computerized devices, internet applications, electronic
medical record systems, or special modifications of computer-based
systems currently being used in practices for billing or administrative
purposes. Since limited funding is available for purchasing equipment
or software, applicants are strongly encouraged to partner with vendors
or other companies that produce or test computer-based technology
designed for use in primary care settings. Priority will be given to
projects that (1) propose a controlled design, comparing the reliability
of an electronic data collection method to the PBRN’s usual method of
research data acquisition, and (2) intend to use the standardized survey
instruments recommended for network-defining activities (see above) in
both experimental and control settings. Evaluative strategies that
focus on data quality, including completeness and accuracy of
information collected, and the efficiency of the collection process are
strongly encouraged.
Methods for special projects assessing issues related to data privacy
and confidentiality can include (but are not limited to) rigorous
qualitative studies or surveys of network patients and clinicians.
Potential research questions include, but are not limited to, the
following:
o To what extent do patients object to the use of their primary care
medical records for research purposes? To what extent are these
concerns mollified if personal identifiers are removed from the
extracted information and only composite results reported?
o Under what circumstances would patients provide general consent
allowing their clinician to share, for research purposes, any anonymized
information from primary care medical records, test results, or data
obtained from personal interviews or observations?
o Should clinicians always be informed, and their consent requested,
when they (the clinicians) are the actual subjects of the research?
o To what extent should the clinician be involved in the process of
informed consent for research focused on patients under his/her care?
SPECIAL REQUIREMENTS FOR NETWORK-DEFINING SURVEYS
PBRNs funded to conduct network-defining surveys will be required to
work closely with CPCR, which will serve as a Coordinating Center.
Grant recipients will be expected to send appropriate representatives to
two (two-day) planning and training meetings, to be held in Rockville,
MD. Travel and lodging expenses for up to two representatives from each
network to attend these meetings will be paid for by AHRQ, and
applicants should not include these expenses in their budget requests.
Grant recipients will participate, as a group, in Phase I survey
activities in close collaboration with CPCR. These activities, to be
completed during the first grant recipients’ meeting, include agreement
on the survey instruments to be used in the research, methods for
sampling, and procedures for standardized data collection. The survey
instruments chosen for this activity, and to be used uniformly by grant
recipients, are likely to be adaptations of the instruments used for the
National Ambulatory Medical Care Survey (NAMCS), which have the approval
of the Office of Management and Budget (OMB). A copy of the 1999-2000
version of the NAMCS instrument is available at the Website of the
National Center for Health Statistics,
http://www.cdc.gov/nchs/data/ahcd/patrec99.pdf. Two types of subjects will
be surveyed: participating network clinicians and a random sample of the
patients cared for by these clinicians. Prior to applying, applicants
should carefully consider (with the guidance of an appropriate IRB)
whether explicit consent is required of both types of subjects and
should address this issue in their applications.
Phase II survey activities include the actual collection, aggregation,
and transmission of survey data by PBRNs. It is expected that PBRNs
will contact all clinicians currently enrolled in their network and be
able to survey 100% of those willing to participate. Applications
should include, in an appendix to the application, a list of the names
and practice addresses of those clinicians who have agreed to
participate. If the PBRN plans to survey less than 100% of those
network clinicians willing to participate, the rationale for this
approach should be included in the application, along with a detailed
description of the proposed sampling method. Applicants are not
expected, however, to provide a plan for random sampling of the patients
cared for by participating clinicians, since standard methods for this
procedure will be finalized through collaboration during Phase I of the
project. The final patient sampling plan will attempt to take into
account such factors as practice-to-practice variations in patient
volume and seasonal variation in the occurrence of health conditions.
The methods proposed by the PBRN to assure that information collected in
the surveys is complete and as accurate as possible should be described.
While the intent of the survey activities is to provide each PBRN with
data that will inform future activities of the network, AHRQ recognizes
that funds offered under this initiative are likely to be inadequate to
support complete survey data analyses by recipient PBRNs. As the
Coordinating Center, CPCR will perform these functions for the PBRNs as
part of the Phase III survey activities. At the end of the survey
period, each PBRN is to mail one copy of their data, stripped of
personal identifiers, to CPCR. Data submitted by each PBRN will be
aggregated and analyzed, and summary reports will be provided for
individual PBRNs during the second meeting of grant recipients, also to
be organized and paid for by CPCR. Applications should include a
statement indicating the PBRN’s willingness to cooperate with CPCR in
all phases of the survey activities. They should also say what summary
data will be most valuable to them and address how the PBRN proposes to
use the summary data. (See RIGHTS IN DATA).
Data Privacy
All information about identifiable individuals or organizations obtained
for the research purpose of carrying out a demonstration project
supported pursuant to this RFA under AHRQ’s statutory authority is
protected by a federal confidentiality statute, section 924 of the
Public Health Service Act, 42 USC 299c-3(c). Under this law, the only
permissible uses or disclosures of the information are those agreed to
by the subject individuals and organizations or by those who supply the
information to the researchers. There are substantial statutory
penalties (up to $10,000) for improper use or disclosure of this
information. Thus, 42 USC 299c-3(c) provides a Federal statutory basis
for resisting any Federal or state court order or subpoena to the extent
that carrying out the order or subpoena would violate the protective
restrictions of the statute. Upon request, AHRQ will provide legal
assistance in defending adherence to these statutory confidentiality
protections with respect to identifiable data obtained in carrying out
Agency research activities.
Note that identifiable data obtained by AHRQ-supported researchers is
protected by this law when it is obtained to carry out AHRQ-supported
research, but this law would not protect against access to this same
information in medical records if it were gathered and recorded there
for other purposes. If providers collect certain information solely for
purposes of this research, it should be so marked and if necessary to
protect its confidentiality, kept separately. Note also that this law
does not protect or restrict aggregate and nonidentifiable statistical
or data analysis and conclusions developed by the researchers that would
not disclose information about any identifiable individuals or
establishments
Pursuant to section 924(c) of the Public Health Service Act (42 USC
299c-3(c)), information obtained in the course of any AHRQ-study that
identifies an individual or entity must be treated as confidential in
accordance with any promises made or implied regarding the possible uses
and purposes of the data collection. In the Human Subjects section of
the application, applicants must describe procedures for ensuring the
confidentiality of such identifying information. The description of the
procedures should include a discussion of who will be permitted access
to the information, both raw data and machine readable files, and how
personal identifiers and other identifying or identifiable data will be
restricted and safeguarded.
The grantee should ensure that computer systems containing confidential
data have a level and scope of security that equals or exceeds those
established by the Office of Management and Budget (OMB) in OMB Circular
No. A-130, Appendix III - Security of Federal Automated Information
Systems. The National Institute of Standards and Technology (NIST) has
published several implementation guides for this circular. They are: An
Introduction to Computer Security: The NIST Handbook; Generally Accepted
Principals and Practices for Securing Information Technology Systems;
and Guide for Developing Security Plans for Information Technology
Systems. The circular and guides are available on the web at
http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf.
The application of these confidentiality and security standards to
subcontractors and vendors should be addressed as necessary.
Rights in Data
AHRQ grantees may copyright or seek patents, as appropriate, for final
and interim products and materials including, but not limited to,
methodological tools, measures, software with documentation, literature
searches, and analyses, which are developed in whole or in part with
AHRQ funds. Such copyrights and patents are subject to a worldwide
irrevocable Federal government license to use and permit others to use
these products and materials for government purposes. In accordance
with its legislative dissemination mandate, AHRQ purposes may include,
subject to statutory confidentiality protections, making research
materials, data bases, results, and algorithms available for
verification or replication by other researchers; and subject to AHRQ
budget constraints, final products may be made available to the health
care community and the public by AHRQ or its agents, if such
distribution would significantly increase access to a product and
thereby produce public health benefits. Ordinarily, to accomplish
distribution, AHRQ publicizes research findings through the media and
other appropriate channels in coordination with AHRQ’s Office of Health
Care Information but relies on grantees to publish research results in
peer-reviewed journals and to market grant-supported products.
Important legal rights and requirements applicable to AHRQ grantees are
set out or referenced in the AHRQ’s grants regulation at 42 CFR Part 67,
Subpart A (Available in libraries and from the GPO’s website
http://www.access.gpo.gov/nara/cfr/index.html).
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 "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 are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
To the extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH
Guide Web site
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.
AHRQ also encourages investigators to consider including children in
study populations, as appropriate.
AHRQ Program staff may also provide additional information concerning
these policies (see INQUIRIES).
Terms and Conditions of Award
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67
Subpart A, and other HHS, PHS grants administration policie statements.
Applicants should be familiar with the Agency’s grant regulations, 42
CFR Part 67 Subpart A, and particularly sections 67.18-67.22.
The cooperative agreement (U01) is an “assistance” mechanism (rather
than an “acquisition” mechanism) in which substantial AHRQ scientific
and/or programmatic involvement with the awardee is anticipated during
performance of the activity. Under the cooperative agreement, the AHRQ
purpose is to support and/or stimulate the recipient’s activity by
involvement in and otherwise working jointly with the award recipient in
a partner role, but it is not to assume direction, prime responsibility,
or a dominant role in the activity.
1. Awardee Rights and Responsibilities
Those organizations awarded grants to conduct network-defining surveys
have the responsibility for assuring that the appropriate
representatives attend both working meetings organized by CPCR,
recruiting network clinicians to participate in the survey, distributing
survey materials to practices, instructing practice staff on the proper
administration of the patient-level surveys, gathering and assuring the
completeness of data recorded on survey instruments, making a copy of
the survey data from which personal identifiers have been removed, and
mailing that data to CPCR. Awardees will be required to accept and
implement the common protocol and procedures agreed upon
collaboratively.
Awardees of grants to pilot test a computer-based technology or to
assess data confidentiality and privacy issues have primary authorities
and responsibilities to define objectives and approaches, and to plan,
conduct, analyze, and publish the results, interpretations, and
conclusions of their studies.
2. AHRQ Staff Responsibilities
In working with awardees who conduct network-defining surveys, AHRQ
Program Official(s) will have substantial scientific and programmatic
involvement in designing the general survey protocol, training network
staff to administer surveys, and analyzing and reporting survey data.
The dominant role and prime responsibility for pilot testing computer-
based technology or assessing data confidentiality and privacy issues
resides with the awardee(s) for the project as a whole, although the
AHRQ Program Official(s) will have substantial scientific involvement
through technical assistance, advice and coordination above and beyond
normal program stewardship for grants.
AHRQ reserves the right to terminate or curtail the study (or an
individual award) in the event of substantial shortfall in participant
recruitment, non-participation in required collaborative meetings,
inadequacies in data reporting, quality control, or other major breach
of the agreed-upon protocol.
3. Collaborative Responsibilities
In conducting network-defining surveys, awardees will share
responsibility with AHRQ Program Official(s) in selecting and refining
survey instruments and in developing specific survey and sampling
protocols.
Awardees of projects to pilot test computer-based technology or assess
data confidentiality and privacy issues will share with AHRQ Program
Official(s) the responsibility of communicating to other awardees their
intended research design and methods. It is hoped that the sharing of
ideas and methods among awardees will allow for collaboration of
efforts, when appropriate.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award), between award recipients and AHRQ may
be brought to arbitration. An arbitration panel will be composed of
three members -- one selected by the individual awardee, a second member
selected by AHRQ, and the third member selected by the two prior
selected members. This special arbitration procedure in no way affects
the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. State and local government applicants may
use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and
follow those requirements for copy submission. Applicants are
encourage 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.
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.
Beginning with applications submitted for the February1, 2001 receipt
date, 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).
Given the nature of this project and the speed with which successful
applicants will need to begin work, however, AHRQ has determined that
IRB approval is required prior to peer review of applications submitted
in response to this RFA. All investigators/applicants proposing
research involving human subjects should pay particular attention to the
instructions in the form PHS 398 regarding human subject involvement.
Applications kits are available at most institutional offices of
sponsored research. They may also be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 435-0714, E-mail: grantsInfo@nih.gov.
AHRQ applicants are encouraged to obtain application materials from the
AHRQ Publications Clearinghouse (see INQUIRIES).
The RFA label and line 2 of the application form PHS 398 (rev. 4/98)
should both indicate RFA number. The RFA label must be affixed to the
bottom of the face page. 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 also be typed on line 2 of the face page and the YES box
must be marked. The sample RFA label available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
Application Preparation
The following supplemental instructions to the form PHS 398 should be
used to guide the preparation of the cooperative agreement application:
1) In the Abstract (“Description,” page 2), indicate if funds are
requested to conduct a special data-related research project in addition
to the request to administer network-
defining surveys.
2) Under “Performance Sites” (page 2), list only the official name of
the PBRN and the address of the PBRN office. A complete list of the
clinicians and practice sites to be involved in the surveys and research
activities should be attached to the application as an appendix.
Include Multiple Project Assurance (MPA) of Federalwide Assurances (FWA)
if known. Applicants not having a Human Subjects Assurance should refer
to the OHRP website http://www.hhs.gov/ohrp/assurances/assurances_index.html for
information regarding Human Subject Assurances.
3) Detail Budget. If the applicant is proposing to conduct a data-
related research project in addition to administering network-defining
surveys, a separate budget request on a separate budget sheet should be
included for each activity.
Budget requests to administer network-defining surveys should not exceed
$50,000 total costs (direct plus facilities and administrative costs).
In general, allowable budget items for this activity include salary
support for key administrative and clerical personnel, any required
travel to and from network practices, telephone costs, copying, mailing
and other justifiable operating expenses. Since CPCR will provide
expertise in survey methodology to all successful applicants (during
Phase I survey activities), requests for personnel or consultation
services for this purpose will not be considered. Since travel and
lodging expenses for up to two network representatives to attend the
planning and training meetings in Rockville, MD will be paid for by
AHRQ, these expenses should not be included in the budget request.
Requests to cover the travel expenses of additional team member(s) to
attend the meetings are allowable, but the application must justify the
PBRN’s need for more than two representatives at these meetings.
Budget requests to conduct a special data-related research project
should not exceed $100,000 total costs (direct plus facilities and
administrative costs). For applications proposing to pilot test
technology in the PBRN, modest requests for the purchase of software or
computer hardware are allowable, although these costs should not
supplant funds required for evaluation activities. In-kind contributions
of the applicant organization or its partners (including technology
vendors or other commercial groups) should be acknowledged. For
applications proposing to assess data privacy and confidentiality
issues, requests for equipment are discouraged.
The maximum budget request allowable from one applicant organization
under this RFA is $150,000 (direct plus facilities and administrative
costs).
4) Biographical Sketches. If different individuals will be serving as
the Principal Investigator and the director of the PBRN, include a
biographical sketch of each, as well as sketches of other key personnel
to be involved in the project.
5) Research Plan. This narrative part of the application is limited to
twenty-five pages of text which should be organized into sections, as
follows. Sections I and II are required of all applicants. Section III
is required of applicants proposing to conduct a data-related research
project.
Section I. The PBRN and Progress to Date on Planning Activities
a) Briefly describe the PBRN, including any changes that have occurred
in the leadership or infrastructure of the network, and any practices or
clinicians added to the network since April, 2000.
b) Describe and discuss the PBRN’s progress to date in achieving the
planning goals and objectives proposed in the original (P20) application
to AHRQ for a planning grant. This section should include a summary of
any research begun or completed since April, 2000, including sources and
amounts of funding received for the research. A list of articles (if
any) resulting from PBRN research and published since April, 2000,
should be included either in the text or as an appendix and referenced
in this section of the application.
Section II. Network-Defining Surveys
a) Describe previous network experience (if any) in conducting
clinician-level or patient-level surveys. Discuss potential challenges
to the successful administration of surveys in the network and proposed
methods of overcoming these obstacles.
b) Document the ability to recruit a sufficient number of network
clinicians to participate in the survey activities. The network staff
to be involved in the project should also be identified, including a
description of their qualifications.
c) Describe the potential uses and importance of network-defining survey
data to the PBRN.
d) Describe plans to accommodate all requirements outlined in the
“Special Requirements” section of the RFA. A statement should be
included indicating the PBRN’s willingness to follow the common protocol
that will be agreed upon in Phase I and to cooperate with CPCR staff in
all phases of the survey activities.
Section III. Special Data-Related Research Project (if applicable)
a) Applicants proposing to pilot test computer technology for gathering
PBRN data should discuss the rationale for their choice of the
technology, describe the technology in terms that are easily
understandable to the average practicing clinician, and describe the
office settings in which it will be assessed. Previous experience using
the same or similar information technology, by the applicant or others,
should be described as well as the proposed evaluation strategy. The
team members (or consultants) who will provide the necessary expertise
in computer technology and evaluation should be identified, including a
description of their qualifications. If the effort is to involve a
collaboration with a vendor or other commercial company, that
relationship should be addressed, and a letter from the research partner
included indicating the company’s level of commitment to the research.
b) Applicants proposing projects to assess data privacy and
confidentiality issues in PBRNs should explain how the research
questions to be addressed relate to proposed HIPAA regulations. If the
project also relates to specific concerns that have arisen out of
research activities within the applicant’s PBRN or other ambulatory
health care settings, those concerns should be described. The
application should include a description of how answers to the questions
being posed may impact on future research efforts by the network.
A complete and signed, typewritten original of the application,
including the Checklist, and three signed photocopies, must be submitted
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,
labeled “Advanced Copy (s)” must also be sent to:
David Lanier, M.D.
Center for Primary Care Research
Agency for Healthcare Research and Quality
6010 Executive Blvd., Suite 201
Rockville, MD 20852
Telephone: (301) 594-1489
FAX: (301) 594-3721
E-mail Address: dlanier@ahrq.gov
Applications must be received by April 13, 2001. An application
received after the deadline may be acceptable if it carries a legible
proof-of-mailing date, assigned by the carrier, and the proof-of-mailing
is not later than 1 week prior to the deadline date. If an application
is received after that date, it will be returned to the applicant
without review.
In carrying out its stewardship of assistance 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 sponsored research. AHRQ expects
grant recipients to keep the Agency informed of publications or the
impact from Agency sponsored research.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness and
responsiveness. Incomplete applications will be returned to the
applicant without further consideration. Applications that are complete
but are not responsive to the RFA will be returned to the applicant
without further consideration. Applications that are complete and
responsive to the RFA will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the AHRQ in
accordance with the review criteria stated below.
As part of the merit review, all applications will receive a written
critique, and also may undergo a process in which only those
applications deemed to have the highest scientific merit will be
discussed and assigned a priority score.
All applications will be judged on the basis of the scientific merit of
the proposed project and the documented ability of the investigators to
meet the objectives of the RFA. Although the technical merit of the
proposed project is important, it will not be the sole criterion for
evaluation of a study. Other considerations, such as importance and
timeliness of the proposed study and access to subjects will be part of
the evaluation criteria.
General Review Criteria
Applications will be assessed in two general areas: 1) technical merit
of the proposal; and 2) potential of the PBRN to complete the proposed
activities successfully. Peer reviewers will be asked to offer specific
comments in these two areas, and final priority scores will reflect the
peer reviewer’s overall assessment based on their judgements of the two
review areas.
1. Technical merit of the proposal
a) Clarity of project goals and objectives, and the extent to which they
are consistent with the goals and objectives described in the RFA;
b) Appropriateness of the proposed project to the PBRN’s level of
development and prior research experience;
c) Extent to which the application defines potential problem areas
facing the PBRN in carrying out the proposed activities, and
appropriateness of methods proposed to overcome these barriers;
d) Qualifications and appropriateness of the key personnel designated to
direct and conduct the activities.
2. Potential of the PBRN to complete the proposed activities
successfully.
a) Adequacy of clinicians committed to participate in the activity, or
the adequacy of the patient population served by those clinicians;
b) Adequacy and stability of the PBRN’s administrative, organizational
and management capabilities;
c) Evidence of institutional or other support; and
d) Extent to which a one-year timeline is realistic for the PBRN to
complete the activities being proposed.
Special Review Criteria
1. The following additional special merit criteria are directed to
proposals to administer network-defining surveys:
a) Extent to which the application demonstrates an understanding of the
proposed survey activities outlined in the RFA;
b) Adequacy of PBRN plan to insure integrity of data collected through
surveys; and
c) Applicant’s commitment to participate and collaborate with CPCR in
all phases of the survey activities.
2. The following special merit criteria are added for applicants who
propose to pilot test office-based information technology:
a) Extent to which the PBRN provides an appropriate testing site for the
proposed information technology; and
b) Extent to which the applicant intends to compare the new technology
to usual methods of data collection in the PBRN, using standardized
surveys in both arms of the project.
3. The following special merit criteria are added for applicants who
propose to assess data confidentiality and privacy issues:
a) Significance of the questions to be addressed. Are answers to these
questions likely to advance understanding of best methods for PBRNs to
use in protecting rights of data privacy and confidentiality?
b) Adequacy and appropriateness of proposed research methods and
analytical plan.
The initial review group will also examine: the appropriateness of
proposed project budget; the adequacy of plans to include both genders,
children, and minorities and their subgroups as appropriate for the
scientific goals of the research and plans for the recruitment and
retention of subjects; the provisions for the protection of human
subjects; and the safety of the research environment.
AWARD CRITERIA
No more than one award will be made to each successful applicant PBRN,
and no award will exceed $150,000 total costs (direct plus facilities
and administrative costs). The intent of this RFA is to continue
funding those technically and scientifically meritorious applications
unless these is reason to question the applicant’s willingness to
participate in cooperative activities. Proposals to conduct special
data-related research projects will compete for available funds with all
other applications under this RFA. The following criteria will be
considered in making these funding decisions: 1) quality of the proposed
project as determined by peer review; 2) availability of funds; and 3)
program balance with respect to the types of information technology
being tested, data privacy/confidentiality questions being addressed,
geographical location of PBRN, and study populations being targeted.
INQUIRIES
Copies of the RFA and copies of the grant application form PHS 398 (rev.
4/98) are available from:
AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907-8547
Telephone: 1-800-358-9295
TDD Service: 888-586-6340
The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, 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.
AHRQ welcomes the opportunity to clarify any issues or questions from
potential applicants who have read the RFA. Written and telephone
inquiries concerning this RFA are encouraged. Direct inquiries
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
Direct inquiries regarding fiscal and eligibility matters to:
George “Skip” Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-1842
FAX: (301) 594-3210
Email: smoyer@AHRQ.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance,
Number 93.226. Awards are made under authorization of Title IX of the
Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129
(1999). Awards are administered under the PHS Grants Policy Statement
and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92.
This program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide
a smoke-free workplace and promote the non-use of all tobacco products.
In addition, Public Law 103-
227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
REFERENCES
Nutting PA, Beasley JW, Werner JJ. Practice-based research networks
answer primary care questions. Journal of the American Medical
Association 281:686-8, 1999
Green LA. The history of PBRNs: the establishment of practice-based
primary care research networks in the United States. In: Practice-based
research networks in the 21st century: the pearls of research.
Proceedings from the conference convened by the AAFP Task Force to
Enhance Family Practice Research. Leawood, Ks: American Academy of
Family Physicians, 1999
Hogg WE, Lemelin J. Realizing the research potential of the office
computer. In: Conducting research in the practice setting. Newbury
Park: Sage Publications, 1993
Wasson JH, Jette AM, Johnson DJ et al. A replicable and customizable
approach to improve ambulatory care and research. Journal of Ambulatory
Care Management 20(1):17-27, 1997
Institute of Medicine. Protecting data privacy in health services
research. Washington, D.C.: National Academy Press, 2000
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