and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
CENTERS FOR AIDS RESEARCH: D-CFAR, CFAR
RELEASE DATE: March 27, 2003
PA NUMBER: PAR-03-089
Receipt Date: June 16, 2003, June 16, 2004, and June 16, 2005
EXPIRATION DATE: June 17, 2005, unless reissued.
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
Fogarty International Center (FIC)
(http://www.fic.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.213, Research and Training in Complementary and Alternative Medicine
No. 93.242, Mental Health Research Grants
No. 93.279, Drug Abuse Research Programs
No. 93.393, Cancer Cause and Prevention Research
No. 93.394, Cancer Detection and Diagnosis Research
No. 93.396, Cancer Biology Research
No. 93.839, Blood Diseases and Resources Research
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.864, Population Research
No. 93.865, Center for Research for Mothers and Children
No. 93.989, Senior International Fellowships
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Terms and Conditions of Award
o Required Federal Citations
PURPOSE OF THIS PA
This program announcement replaces PAR-00-054 published in the NIH Guide,
February 9, 2000.
Participating Institutes of the National Institutes of Health (NIH) invite
applications for center core grants (P30) to support Centers for AIDS
Research: standard CFARs (CFAR) and Developmental CFARs (D-CFAR). CFAR cores
provide infrastructure and promote basic, clinical, behavioral and
translational AIDS research activities at institutions that receive
significant AIDS funding from multiple NIH Institutes or Centers. CFARs
foster synergy and improve coordination of research, support emerging research
opportunities, and promote economy of scale through resources shared by
multiple independent laboratories. CFARs and D-CFARs are intended to promote
all AIDS research efforts at CFAR institutions. D-CFARs provide modest
support for a limited period to assist investigators in the development of a
competitive CFAR. Additionally, this announcement defines a process for CFAR
competitive supplements. Before preparing an application to support a CFAR,
investigators are urged to consult with the program staff listed under
"Inquiries."
NIH Support of Research on this Topic
While this Program Announcement is being issued by FIC, NCI, NCCAM, NHLBI,
NIAID, NICHD, NIDA, and NIMH, the other components of NIH listed below also
have an interest in and support research on the topics covered. Applicants
may wish to contact each of these NIH components listed in INQUIRIES to find
out about other funding opportunities. Institutes and Centers at NIH use
different grant mechanisms to support their portfolios of research; the
components listed here may not use all of the mechanisms specified for this
Program Announcement.
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Applications submitted in response to Program Announcements are assigned
according to established PHS referral guidelines. When the subject of an
application is of interest to more than one component of NIH, dual
assignments are made.
DEFINITIONS
Throughout this program announcement P30 applications to support CFARs are
abbreviated as "CFAR applications" and the corresponding P30 awards to support
CFARs are abbreviated as "CFAR awards." "Core" or "core facilities" are
defined as entities providing services or expertise to be shared by multiple
independent laboratories. NIH CFAR awards support administrative,
developmental, basic science and clinical science cores for AIDS research.
AIDS research and AIDS-related research are abbreviated as "AIDS research."
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal government. Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as principal investigators.
A. Comparison of the two CFAR awards
This program announcement describes two types of CFAR awards. The first is
for a Developmental CFAR (D-CFAR) for AIDS investigators at an institution
that is eligible, but does not yet have a CFAR. The D-CFAR will provide the
support necessary to develop a collaborative network that may permit the
institution to be more competitive for a standard CFAR award. The second type
of award is for a standard CFAR (CFAR). Both the D-CFAR and the CFAR are
funded through the P30 mechanism for infrastructure development. This PA
describes requirements for both types of CFARs. Sections for the D-CFAR
describe characteristics unique to this award.
B. NIH AIDS Funded Research Base
To be eligible for a CFAR award, an institution must have a significant
research base. A significant NIH AIDS funded research base (FRB) is defined
as: the funding level, in annual total cost for the NIH fiscal year (October
1 to September 30), preceding receipt of CFAR applications. The research base
includes peer-reviewed AIDS grants, cooperative agreements, and research
contracts utilizing only the following mechanisms: P01, R01, R03, R18, R21,
R24, R29, R33, R35, R37, U01, U10, U19, U24, U54, and K series awards, and N01
(excluding contracts that primarily fund the production of materials or
services for support of research). Excluded from the NIH AIDS Funded Research
Base are all funds from any source other than NIH.
For the D-CFAR and CFAR awards, a FRB in excess of $6 million is required.
Below is a comparison table of the D-CFAR and CFAR awards.
D-CFAR CFAR
FRB/BASE FUNDING >6M/$750K Total Cost $6-40M/$1.5M Total Cost
$40-80M/$2.25M
>$80M/$3M
FUNDING PERIOD 3 years 5 years
COMPETITIVE RENEWAL Not allowed Allowed
FOCUS Become competitive Support all NIH AIDS
for a standard CFAR investigators at institution
C. Funds available
D-CFAR: Maximum funding level, or base funding of a D-CFAR is limited to
requests for 10% of the FRB as reported by the OAR spreadsheet for the NIH
fiscal year preceding receipt of the application, up to $750,000 total cost.
CFAR: For institutions with a FRB of $6M to $40M, a CFAR award (Total Cost)
will be limited to 10% of the FRB, up to $1.5M, total cost. For institutions
with a FRB of $40M to $80M, a CFAR award will be a base of $2.25M, total cost.
For institutions with a FRB that is greater than $80M, a CFAR award will be a
base of $3M total cost.
Recompeting CFARs will be limited to an inflationary increase beyond the total
cost funding level of the current grant, unless the FRB decreases, in which
case the following conditions apply: If the FRB of a recompeting CFAR is
below $15 million, the applicant is limited to requesting 10% of the FRB. If
the FRB of a recompeting CFAR is $15-40M, the applicant is limited to
requesting $1.5M. If the FRB of a recompeting CFAR is $40-80M, the applicant
is limited to requesting a funding level of $2.25M.
CFARs that successfully recompeted for renewal in 2003, and that have a funded
research base that is greater than $40M or greater than $80M, will be eligible
to submit a complete revised proposal and budget request to increase the CFAR
base funding to $2.25M total funds, and $3M total funds, respectively, for
years 2 through 5 of the award. This will be a one-time allowance in the
first year of this program announcement. Reviewers will evaluate the revised
request as it relates to the recently funded program, but will not
specifically review the recently funded program. Should the new proposal not
receive a fundable score, the CFAR will retain the existing budget until the
entire CFAR submits a competitive renewal application.
D. One CFAR award per institution
No institution will receive more than one CFAR award. Institutions that have
significant overlap in faculty, resources or administration should submit only
one application. Independent campuses that are part of a large, multiple city
university are considered to be separate institutions. Applicants are
encouraged to contact program staff listed under "Inquiries" for additional
guidance.
E. Guidelines for multi-institutional CFARs
In some cases, two or more institutions that can demonstrate a credible plan
for collaborative research networks using CFAR cores may wish to submit an
application for a single CFAR award. Reviewers will look critically at the
request for multi-institutional applications for the following indicators: a
demonstration of exceptional need to establish a collaboration between
investigators at separate institutions; evidence of unique plans, such as the
development of organized communications systems, to overcome the scientific
and management challenges that are naturally a part of multi-institutional
collaborations; specific plans to address anticipated budgetary problems in
the transfer of funds and resources from one institution to another; and
evidence for centralized authority of the CFAR Director for the purpose of
management of the CFAR facilities at other sites.
Multi-institutional CFAR applications may combine the NIH AIDS funded research
of all the investigators at the institutions participating in the proposed
CFAR to meet the NIH AIDS Funded Research Base requirement. CFARs that use a
distant institution for a core facility, but are not including all of the NIH
AIDS investigators at that institution as part of the CFAR may not use the
Funded Research Base of any single investigator at that institution.
A CFAR cannot use the FRB of an institution that is already part of another
CFAR.
A multi-institutional CFAR application must designate a lead institution that
will receive the award and provide details of agreements regarding
coordination and support of cores and activities at other participating
institutions.
F. Cores outside of the CFAR institution
With appropriate justification, CFAR awards may support a core at an
institution that is not part of the CFAR, including a foreign institution that
provides a unique resource such as a clinical site, or a primate facility.
NIH AIDS funding of the investigators at this core facility is not included as
part of the FRB of the CFAR (see Funded Research Base).
G. Funding for CFARs from multiple NIH Institutes
CFARs will be awarded and administered by NIAID. However, a CFAR award will
consist of funds from multiple NIH Institutes. Management oversight of the
CFAR grants will be provided through an NIH CFAR Steering Committee composed
of representatives from the co-funding NIH Institutes and Centers, and from
the Office of AIDS Research (OAR). It is therefore suggested that the
applicant contact the program representatives listed under 'Inquires' to
discuss general CFAR issues, and how CFARs can enhance the AIDS research
mission of the NIH Institutes.
H. CFAR support for all NIH AIDS investigators
NIH will provide applicants with a spreadsheet (Excel) prepared by the Office
of AIDS Research (OAR) indicating all investigators receiving NIH AIDS funding
at an applicant(s) institution, arranged by NIH funding Institute. Applicants
should indicate, in the spreadsheet, those investigators who have formally
agreed to participate in the CFAR, and the primary type of participation
expected (e.g., attendance at seminars, use of virology core, Developmental
Core director, etc.) and include this spreadsheet in their application. See
section E, Administrative Core, for more detail on CFAR support of all
investigators.
It is important that the CFAR be inclusive of the full range of AIDS science
funded at a given institution. Therefore, review committees will be
interested in why some investigators listed in the spreadsheet chose not to be
part of the CFAR. Applicants may also indicate investigators at their
institution(s) who will become part of the CFAR but who were not included in
the spreadsheet. The reason for inclusion, or exclusion, of a given
investigator should be addressed.
RESEARCH OBJECTIVES - ALL CFAR AWARDS
Note that the following applies to all types of CFAR awards. Following this
section is information concerning research objectives that are specific for
the D-CFAR.
Background
The CFAR program was established in 1988 and was renewed in 1993, 1997, and
2000. In May 1999, an ad hoc external review committee convened by the Office
of AIDS Research reviewed the CFAR program. Suggestions of the review
committee remain incorporated into this program announcement. The mission of
the CFAR program and mechanisms for achieving this mission were developed by
the CFAR directors in 1995 and revised in 1996, 1998, and in the 2002 Position
Statement of the NIH CFAR Directors.
The mission of the CFARs is to support a multi-disciplinary environment that
promotes basic, clinical, epidemiological, behavioral, and translational
research in the prevention, detection, and treatment of HIV infection and
AIDS. The CFARs accomplish this mission by:
a. Providing scientific leadership and institutional infrastructure dedicated
to AIDS research
b. Stimulating scientific collaboration in interdisciplinary and
translational research
c. Strengthening capacity for HIV/AIDS research in developing countries
d. Fostering scientific communication
e. Sponsoring training and education
f. Promoting knowledge of CFAR research findings and the importance of AIDS
research through community outreach
g. Promoting and supporting innovative NIH HIV/AIDS research initiatives
h. Establishing collaborative research between CFARs, and supporting HIV/AIDS
research networks
i. Facilitating technology transfer and development through promotion of
scientific interactions between CFARs and industry
j. Supporting research on prevention and treatment of HIV infection in hard-
to-reach populations, especially in inner city, rural poor, and disadvantaged
minorities
A. CFAR added value
CFARs should provide added value to the institution's AIDS research efforts
through support of activities that cannot easily be provided by standard
research grants. For example, CFARs promote and encourage activities that
enhance collaboration and coordination of AIDS research. CFARs promote
translational research activities, i.e., studies bringing findings of the
laboratory to the clinic, and vice versa.
Measures of added value include, but are not limited to: Developmental Core
awards resulting in collaborations, publications, or funding of R01-type
applications; interdisciplinary publications; evidence of CFAR enhancement of
existing programs at the institution; the number of clinical protocols started
within the institution; patent applications filed or issued; and institutional
support for activities previously supported by the CFAR. For recompeting
CFARs, Table (2) is provided on the CFAR web site
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm), and should be used by the
applicant to demonstrate various translational research activities. The
activities shown as examples are not meant to be all-inclusive.
B. CFARs should serve the requirements of all NIH-funded AIDS investigators
at the applicant institutions
Cores should address the needs of AIDS investigators at the applicant
institution(s). Successful CFARs have accomplished this goal. Applicants
should describe in detail the operation of each core (quality control,
procedures, safety, training, etc.) and how the proposed policies and
procedures protect and incorporate the divergent needs of CFAR investigators.
Please see additional details concerning policies and procedures under
"Administrative Core". Applicants are encouraged to contact program staff
listed under "Inquiries" to discuss strategies being planned for how the CFAR
will foster collaboration among AIDS investigators from divergent disciplines.
Applicants for recompeting CFARs should describe how different NIH-funded AIDS
programs, if funded at the institution, participate in the CFAR. Specific
programs funded by the co-funding institutes are listed under "Administrative
Core".
C. CFARs have scientific and fiscal flexibility
A CFAR has the responsibility to use its resources in the best manner to meet
the needs of its investigators. A CFAR has the authority to change allocation
of resources according to the guidelines of CFAR operating policies and
procedures. Applicants should describe how proposed policies and procedures
provide structure for decision-making on several levels, and how each of the
following individuals or groups would participate in the decision process:
core director, CFAR director, internal advisory board, CFAR investigators, and
external advisory board. Applicants should also state the process for
informing NIH of major changes in the CFAR.
A CFAR has considerable flexibility and authority to alter funding of a basic
or Clinical Core, to delete a core, or to initiate a new core. Applicants
should state what policies and procedures will be used as the basis for
reallocation of initial core funding to permit the establishment of new cores,
as needed, without additional funding.
The extent to which CFAR funding may leverage other resources in support of
AIDS research is an important measure of a CFAR's value to AIDS investigators.
Basic and Clinical Cores may be supported totally, or in part by CFAR funds.
Applicants are encouraged to develop creative collaborations to improve
utilization of existing resources. Convincing justification will be necessary
for duplication of any basic or Clinical Core that exists in a similar form
elsewhere in the applicant institution(s). Applicants should describe how
cores with partial CFAR funding will be used to enhance the research of CFAR
investigators. For example, a CFAR core supported by other funding (e.g., a
NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may
become more accessible to AIDS investigators through CFAR association and
coordination. Commitments for continued funding in the non-competitive
continuation years of all NIH grants are dependent upon the availability of
funds. Applicants should describe policies and procedures for CFAR "down-
sizing" decisions if there is decreased funding for continuation years.
Responsible management includes annual reporting of progress. The NIH has
developed guidelines that specify the kind of information it needs in order to
answer questions about the program that come from various constituencies,
including Congress. The NIH will assess previous progress reports submitted
by recompeting applicants, as well as additional responses to requests for
information. Results of this assessment will be made available to the
applicant and to reviewers of the competitive renewal. Assessments will
reflect general trends during the funding period, rather than a single
outstanding or insufficient response.
D. Additional CFAR-supported activities
CFARs traditionally use a variety of strategies to achieve the research
objectives of the award. Examples include industry collaborations, community
outreach, development of minority scientists in AIDS research, AIDS research
communications to non-scientists, approach to problems in enrollment and
retention of women and minority groups in AIDS clinical trials, international
collaborations, additional support of ongoing NIH programs not planned in the
initial award, and other activities that meet the AIDS research needs of
applicant institutions.
Applicants are encouraged to explore collaborative, multi-institutional
linkages with international sites and minority institutions. Such linkages
foster international training and collaborative studies and are able to meet
needs that cannot be easily addressed by other funding mechanisms.
Coordination with international programs funded by the Fogarty Center is
strongly encouraged. Contact information for Fogarty programs is provided
under "Inquiries".
Examples of ways in which current CFARs are able to assist in the development
of new investigators, including junior faculty and minority investigators,
both domestic and international, are as follows. These examples are not meant
to be all-inclusive.
1. Specific mentoring programs for junior faculty that may include guidance
in the preparation of developmental core applications, and additional follow-
up counseling if the initial application is not funded.
2. Establishment of collaborations between investigators at institutions in
the developing world that might include mini-sabbaticals to the CFAR to
utilize core facilities, and the mentoring of investigators at the distant
site in person, or via computer linkages.
3. Developing specific collaborations with other NIH programs such as the
AIDS International Training and Research Program (AITRP) with the Fogarty
International Center or the Research Centers in Minority Institutions (RCMI)
program with the National Center for Research Resources (NCRR).
E. CFAR awards support four different types of cores: administrative,
developmental, basic science, and clinical studies:
Each CFAR must have a single administrative and a single Developmental Core,
and a minimum of one basic and one clinical science core to optimally support
the AIDS research at the applicant institution(s). The smallest CFAR would
have a minimum of four cores, that would consist of one of each type of core
(administrative, developmental, basic, and clinical). The terms basic and
Clinical Cores are generic, and the definition of what constitutes a basic or
Clinical Core is sufficiently broad to meet the needs of the applicant
institution(s), and may vary among CFAR applicants. For example,
epidemiology, biostatistics, ethnography, and behavioral cores could be
classified as either basic or Clinical Cores, depending on their focus.
Clinical Cores will have more direct interaction with patients.
An applicant's initial choice of basic and Clinical Cores is an important
measure of the science management process. Applicants should describe the
basic and Clinical Cores to be supported at the time that the CFAR is awarded,
how this choice of cores was selected, other potential cores that were
evaluated but not selected, mechanisms for evaluating utilization of proposed
cores, and criteria for increasing or decreasing funding of these cores during
the course of the award.
1. Administrative Core
The Administrative Core is responsible for the management of all CFAR
activities. The Administrative Core is led by a CFAR director (P30 grant's
Principal Investigator) who should be a recognized leader in the field of AIDS
research. The Administrative Core also may require a senior administrator, a
CFAR office, and a modest staff for support of CFAR activities. The
responsibilities and time allocation of each staff person and the proposed
operational procedures for the Administrative Core should be described in
detail.
The Administrative Core section of the CFAR application should contain
separate sections describing the strategic plan, and policies and procedures.
Both of these sections will be incorporated by reference into the Terms and
Conditions of Award.
a) Strategic plan – Successful applicants will be required to carry out and
report on an ANNUAL strategic planning process to assess current and expected
scientific and fiscal needs and planned adjustments, according to the stated
policies and procedures.
The purpose of the strategic plan is to identify the most significant
opportunities and gaps in science at the applicant institution to be addressed
by the CFAR in the short and long term, and to identify objective milestones
that can measure success or failure. The following process and organization
is suggested for the strategic plan:
1) Strengths - Describe the strengths of the CFAR including a summary of
research of CFAR participants and the current facilities and resources
available. Use Table 4, "Existing Core Facilities at the Institution Applying
for a CFAR Award (all applicants) to list all core facilities and those that
will be used by the CFAR. This table can be found on the CFAR program
announcement web page: (http://www.niaid.nih.gov/research/cfar/cfarpa.htm).
Use the column labeled "Participating" in the Excel table showing the NIH AIDS
Funded Research Base of the institution(s) to indicate investigators who will,
and will not, be participating in the CFAR. Provide a brief explanatory
sentence at the bottom of the table for any non-participating. Recompeting
applicants should describe how any major AIDS programs at the CFAR
institution that are supported by co-funding NIH Institutes are assisted by
CFAR. Specific programs are:
FIC: AITRP, AIDS FIRCA, ICHORTA-AIDS/TB, and GHRIP
NCI: AMC, ACSB
NHLBI: CBR
NICHD: WHIN, Ad health, REACH
NIDA: DARC
NIAID: AACTG, PACTG, HPTN, HVTN, CIPRA, IPCP, MACS, WIHS
NIMH: Brain Bank, EBAN
2) Opportunities - Identify and evaluate all potential opportunities for use
of CFAR funds. This analysis will probably require outreach for suggestions
from all potential CFAR participants. Conduct a cost/benefit analysis to
determine which opportunities both utilize the applicant's unique strengths
and address the missions of NIH funding Institutes.
3) Action Plan - Choose the highest priority opportunities and develop a
detailed plan for the first year of funding. Examples of an action plan
include determining which cores will be established; determining how existing
cohorts will be utilized; identifying the categories of support for
developmental projects, communication and outreach, and identifying the
lectures and meetings the CFAR will sponsor. Some CFARs may find that
specific thematic areas emerge from this strategic planning process.
Development of an action plan that capitalizes on such programmatic themes is
encouraged, but not required.
4) Outcome Measurements - Determine how progress on action plans will be
measured. Include anecdotal and objective measurements of how the CFAR
infrastructure award provides "added value" or the unique contributions of
CFARs that cannot be provided by research awards. Select long-term goals for
the funding period, and annual milestones for the first year.
In addition to other items, place information about any advisory committees
under the Administrative Core. Describe the membership of all committees, the
basis for selection of participants, and terms of appointment, authority and
responsibility.
The ability to manage the CFAR award will be judged by the clarity and
thoughtfulness of the scientific management strategies proposed for the
Administrative and Developmental Core sections of the proposal. Reviewers
will also consider how the CFAR uses the annual strategic planning process for
the selection and organization of additional cores through such methods such
as acquisition of information, outside support of cores, and participation of
the AIDS investigators at the applicant institution(s) in core development and
usage.
b) Policies and Procedures
Policies should be considered to be "a set of guiding principles of
operation." There are no "correct" policies and different CFARs may adopt
different polices. Below are several examples of justifiable but not
necessarily compatible policies that might be used to address funding issues.
Funding issues are an example of an area that a CFAR considers in the
development of policies and procedures.
o CFAR funding allocated by discipline in proportion to research performed in
those disciplines
o CFAR funding allocated for projects based on a majority vote of all members
in an individual CFAR
o CFAR funding allocated for projects based on majority vote of an internal
advisory board
Procedures should be considered to be a set of specific actions used to
conduct the affairs of the CFAR. Procedures should specify how various tasks
will be accomplished within the policy guidelines of the CFAR. Policies and
procedures should describe:
o the proposed roles of the CFAR director, core directors, CFAR
investigators, advisory boards, and institutional officials in the decision-
making process.
o the annual strategic planning process. Examples of issues CFAR members
should consider: how funds will be allocated to all types of cores and
activities; procedures for changes in support of any cores; how CFAR-sponsored
conferences, seminars, workshops, and other activities will be identified; how
priorities for communication, outreach and additional CFAR activities will be
established; how cores, core directors, leaders of additional CFAR activities,
internal and external advisory committees will be selected and evaluated; the
authority and responsibility of internal and external advisory committees; how
developmental projects are selected and evaluated; how cores are selected and
reports are developed, including the annual strategic plan and the
noncompetitive renewal.
o other mechanisms used to determine AIDS basic and clinical research core
needs at the applicant institution(s), assign priorities to potential cores,
and select the basic and Clinical Cores to be included in the application.
2. Developmental Core
The intent of a CFAR Developmental Core is to support scientific studies for
short periods of time to develop preliminary data for peer-reviewed research
applications. Four general areas are eligible for support through the
Developmental Core: investigators new to AIDS research who have not previously
received R01-type awards in AIDS research, feasibility studies, emerging
research opportunities, and AIDS research activities of newly recruited
faculty. Applicants are encouraged to explore the use of the Developmental
Core to fund a collaborative study that encompasses two scientific
disciplines, especially two that may not have previously collaborated (e.g.,
basic scientists and scientists studying complementary and alternative
medicine, such as chiropractic or acupuncture; or behavioral scientists and
population geneticists). Examples provided are not meant to be all-inclusive.
Applicants may wish to consult with program staff listed under "Inquiries" to
discuss how Developmental Cores are used at current CFARs.
The CFAR Administrative Core should establish the mechanisms for allocation of
developmental funds and for annual evaluation of supported activities. CFAR
applicants should describe the mechanism to be used for identification, peer-
review selection, and outcome evaluation of projects supported by the
Developmental Core. The Developmental Core director is responsible for
ensuring that all developmental studies involving human or animal subjects
have the appropriate approvals (i.e., domestic and foreign IRB, FWA, IACUC,
human subjects research training, etc.). Applicants must inform the NIH of
any awards made for developmental studies involving foreign sites as soon as
possible. Applicants who have current CFARs should describe outcome
evaluation of previously funded developmental projects. The time period should
include all years for which the CFAR was funded. The applicant should use the
table provided for this purpose on the CFAR program announcement web site
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm) and include with the
application (Table 3).
The Developmental Core section should include a plan for the use of the first
year developmental funds.
3. Basic Science Cores
Basic Science Cores provide equipment, training, services, quality control,
and expertise/advice for research activities that cannot easily be funded
through standard research granting mechanisms. Basic Science Cores should
provide economy of scale through use by multiple laboratories and should
foster collaboration between basic and clinical investigators. Basic science
cores do not substitute for resources that are obtainable commercially, or
replace existing resources normally supported by individual research grants.
Cores should have a clear focus, and contribute to translational research.
Reviewers will look for an emphasis on well managed and efficient core
functions above the overall number and breadth of cores in a given
application. Please use Table 4 to indicate all core facilities at your
institution and whether or not CFAR members will be utilizing them.
CFAR applications should describe the Basic Science Cores to be supported at
the time of the award and any changes anticipated during the course of the
award. A basic science core should be designed to support multiple AIDS
investigators and applicants should indicate the number of anticipated users
and the percent time of use by each. Mechanisms should be described to
prioritize core usage, evaluate use annually, and justify level of continued
CFAR support in the context of evolving scientific priorities at the applicant
institution(s).
4. Clinical Cores
Clinical Cores should have a clear focus and provide the resources for AIDS
translational research between collaborating clinical and basic scientists.
The primary distinction between a Basic and Clinical Core is that a Clinical
Core has direct interaction with patients. This may involve developing a
database for clinical specimens, an intervention for a behavioral study, or
development of INDs. Activities that will not be supported by a CFAR Clinical
Core are normal patient care, including screening of clinical specimens,
diagnosis, treatment or rehabilitation.
Applicants are reminded of the Form 398 requirement to address the
involvement of human subjects and vertebrate animals in the work proposed.
Any new work involving human subjects proposed in the Clinical Core sections
of this application that are not covered by existing IRB approvals will
require such approvals prior to funding. CFAR Cores proposing direct work
with human subjects or vertebrate animals should provide full Human Subjects
Research and Vertebrate Animals Research sections as per Form 398
instructions.
Mechanisms should be described to prioritize core usage, evaluate use
annually, and justify level of continued CFAR support in the context of
evolving scientific priorities at the applicant institution(s).
F. Institutional Commitment
Commitment of the CFAR institution is particularly important for the
coordination of resources across the broad areas and potential boundaries of
research supported by the co-funding Institutes. Examples of the types of
institutional commitment that are demonstrated by current CFARs are: level of
institutional funding, space allocation, co-funding, endowments, designation
of center program status in the institutional bylaws, and provision of a
waiver or partial waiver for indirect costs for certain components of the
CFAR, such as funding of the Developmental Core. These are examples, and are
not exclusive of other possible ways in which an institution may demonstrate
support for the CFAR. The applicant must provide a letter(s) from the
appropriate institutional official(s) (e.g., Dean, President, or Provost)
defining:
1. Position, authority, and reporting responsibility (on institution's
organizational chart) for the CFAR director
2. Financial and other resource support for the CFAR that will be provided by
the applicant institution(s)
3. Authority or influence that the CFAR director has and or will have over
other AIDS projects, facilities and space, as well as decision-making
authority for new faculty and support personnel
G. Scientific Programs and Competitive Supplements
In order to take full advantage of the ability of CFARs to organize AIDS
research at an institution, to encourage collaboration between scientific
disciplines and diverse areas of expertise, and to explore significant
questions and problems in AIDS that are not being addressed, a CFAR is
encouraged, but not required, to identify one, or several, Scientific
Programs. A Scientific Program is defined as an area of scientific activity
for a group of investigators who share common research interests and goals
and participate in competitively funded research. Scientific Programs
function to encourage an existing research direction or a new scientific
focus. Examples of possible Scientific Programs include, but are not limited
to: HIV/AIDS Vaccine Development, HIV/AIDS Prevention, and HIV/AIDS Treatment.
The examples provided are meant to be broad enough to include diverse
biomedical disciplines, e.g., behavioral change, epidemiology, pathogenesis,
clinical research, etc.
The Scientific Director is expected to encourage new collaborations, the
identification of high risk/high impact studies, and scientific gaps that
cannot be addressed by standard funding mechanisms, as well as the submission
of new proposals for peer reviewed funding. Such studies may be conducted
both within a given scientific program, and between scientific programs
within the CFAR. The success of programs will ultimately be measured by
expansion of NIH-supported funding for the program, and the establishment of
successful collaborations within the program and between programs. Programs
should be of adequate size and scientific quality, should exhibit a high
degree of interaction, are encouraged to be multi-disciplinary, and should be
capably led. To insure adequate size and quality, a Program must have the
equivalent of at least three entire peer-reviewed and funded research
projects from a minimum of three separate, independent principal
investigators in the proposed Program. Peer-reviewed, funded research sub-
projects of larger program grants (e.g., P01s) may be counted as separate
projects. Peer reviewed awards that may be used to comprise a Program will
come from the Funded Research Base of the CFAR. Methods to develop
collaborations will vary at each CFAR, but may include formal or informal
planning meetings, seminars, and retreats, new, shared resources, or key
recruitments.
There are three possible ways to fund new collaborative projects: (1) through
new R01 or P01 applications; (2) with CFAR base funding through the
Developmental Core; (3) through competitive supplements. The first is self-
explanatory, and the second and third are explained in more detail below.
CFARs and the Scientific Director are strongly encouraged to identify
innovative, high-risk/high impact projects as a strategy to increase
collaboration among CFAR investigators. Proposed projects are encouraged to
be multi-disciplinary. Projects may be submitted to the NIH as R01 or P01
applications, or may be funded through the Developmental Core of the CFAR.
Examples of scientific projects are provided to suggest a variety of
collaborations that could be considered, but are not limited to those that are
listed: Pulmonary Complications of HIV Infection, Collaborations to Address
Human Subject Issues in International AIDS Research, Collaborations to
Increase Awareness of Drug-Abuse Complications in AIDS Therapeutic, Vaccine,
and Behavioral Studies, Scientific Collaborations with Minority Investigators,
Collaborations to Initiate or Expand AIDS Studies that Address Gender
Differences, Collaborations to Initiate or Expand Efforts to Develop and
Implement Behavioral Prevention Interventions in Clinical Treatment Settings,
Interdisciplinary Collaborative Studies Investigating the Interplay between
Cancer Pathogenesis, Virus Infections and HIV Induced Immune Suppression,
Well-designed Studies to Characterize and investigate Traditional Medicine or
Complementary and Alternative Medicine Practices Used in the Treatment of
HIV/AIDS, and Sustainable Interventions in Developing Countries.
To provide additional encouragement for new collaborative studies, the NIH
may accept requests on an annual basis for competitive supplements for
scientific projects. An NIH Institute participating in the co-funding of the
Program may solicit requests for competitive supplements to launch scientific
programs in a specific area of AIDS research in line with the mission of that
Institute. In addition, the NIH CFAR Program, and the Office of AIDS
Research, will provide competitive supplements for collaborative projects in
areas identified by the NIH, and NIH Advisory groups, with suggestions from
CFAR investigators. Both of these funding mechanisms are subject to funding
availability each year; and funding opportunities, if available, will be
announced each year in early January on the NIH CFAR web site, or by email
communication to eligible investigators.
Funding of the Scientific Director position(s) can be requested for
development of a scientific program(s) through the Administrative Core.
Funding for collaborative projects will be through the Developmental Core,
either from base CFAR funds, or through a competitive supplement. At the time
of submission of a competitive renewal application, applicants should identify
a scientific director(s), the scientific program(s), and specific plans that
will be used to develop collaborative activities. In addition, procedures for
identifying projects, reviewing project applications, and choosing projects to
be supported, should be clearly identified. Policies for continuing,
terminating/revising, or rebudgeting funds for a project should be clearly
identified in the event that the project director leaves the institution, the
study achieves an earlier endpoint than expected, or other unexpected data or
results becomes available that suggests a change in focus. These policies
will be evaluated by the reviewers to determine the ability of the applicant
to responsibly manage funds for these projects during the CFAR funding period,
and will be incorporated into the terms and conditions of award if the CFAR
application is successful. Only CFARs that have been funded for one year or
longer are eligible to utilize base CFAR funds or receive competitive
supplements for funding of these scientific programs and collaborative
projects.
As described under "Funds Available," CFARs that successfully recompeted for
renewal in 2003, and that have a funded research base that is greater than
$40M or greater than $80M, will be eligible to submit a revised proposal and
budget request to increase the CFAR base funding. If a CFAR chooses to submit
a revised proposal, it may also respond to the scientific collaboration
component of the program at the same time. The CFAR would need to respond to
competitive supplement initiatives separately from the revised proposal.
The CFAR strategic planning process should be used to develop policies and
procedures for identifying and prioritizing projects, and to develop funding
plans for projects to be funded through the Developmental Core using base CFAR
funding. Funding for these projects is expected to be greater than for
standard developmental awards, and must be fully justified. At the Annual
CFAR Directors' Meeting, investigators will be required to present a status
report and to describe future plans for ongoing collaborative projects.
Before developing this part of the application investigators are strongly
encouraged to discuss plans with appropriate NIH representatives identified
under "Inquiries."
CFAR BUDGET ITEMS
A. Percent Effort
The percent effort requested should be limited to time devoted specifically to
managing CFAR activities and not to research. The effort devoted to CFAR
activities should not be that which would normally be supported by research
grants. Information documenting the level of effort on CFAR activities must be
included in the application. All requested personnel costs should be carefully
justified.
The percent effort of the CFAR director should be justified in the context of
the director's other responsibilities. Administrative support (a secretary or
an administrative assistant) should be requested for the CFAR office only for
matters directly pertaining to the CFAR.
Core directors are CFAR members who are responsible for the overall technical
excellence of a core facility. The CFAR-supported percent effort of core
directors involved in research activities should only include core management
time. The CFAR may support technical staff to provide CFAR services in core
facilities.
The use of Developmental Core funds for junior faculty salary support is
allowed. Established investigators with R01-type grants are expected to have
salary support from other sources.
B. Core Budgets
Core budgets may include equipment, supplies, support contracts, and other
necessary expenses. All items should be fully justified for allocation of CFAR
funds.
C. Other Administrative Costs
This category includes the costs necessary for the central administration and
fiscal management of the CFAR, including relevant and reasonable costs for
reprints, graphics, and publications for Developmental Core users.
D. Travel
CFAR Directors' Meeting(s) — The CFAR Director is required to attend the
Annual Directors' Meeting. The CFAR director, the CFAR administrator, and one
senior scientist per center may be provided support to meet at least once, and
possibly two times per year, at the NIH, at a CFAR site, or at the site of a
scientific conference that most of the directors plan to attend. Applicants
should include travel funds specifically for these meetings in the CFAR
Administrative Core budget request. For budget purposes applicants may assume
a total annual direct cost of $6,500 for the CFAR Directors' Meeting(s).
Other Travel — Applicants may request and justify travel funds in addition to
the funds required for the two directors' meetings. These funds should not be
used for travel to scientific meetings, nor should they be used for
advertising and promotion. They may be used for travel to meet with
collaborators at foreign sites. For example, this travel could be used to
promote collaboration among CFAR investigators and AIDS investigators not in a
CFAR program, or at distant cores, for meetings of core directors of similar
cores to share operational and scientific expertise, and for participation of
junior or developing world investigators at CFAR-sponsored meetings and
workshops. These additional travel funds should not exceed $20,000 annual
direct costs.
DEVELOPMENTAL CFARs (D-CFAR)
The goal of a D-CFAR is to provide support for applicants to develop
collaborations, experiment with core facilities that may be important to
support AIDS investigators at the institution, and to correct any deficiencies
that might adversely effect an application for a standard CFAR award. For
example, applicants may wish to initiate AIDS studies with investigators in
the developing world, or expand collaborations between behavioral science and
basic science investigators at an institution that has traditionally had a
more narrow scientific focus in AIDS and AIDS-related research. Other
examples include expansion of communications technology among investigators
who have begun, or are planning, collaborative studies, using the
Developmental Core to fund a collaborative study that encompasses two
scientific disciplines, especially two that may not have previously
collaborated (behavioral scientists developing AIDS prevention interventions,
and clinicians conducting clinical trials of AIDS therapeutics), or developing
an outreach program that could not be started through institutional or
research grant funding. The D-CFAR mechanism may not be used to obtain a
supplement to an existing CFAR award.
All eligibility requirements and specific descriptions provided in this PA for
the CFAR awards are also required for and relevant to, the D-CFAR awards. The
minimum number and type of cores for a D-CFAR is the same as for a standard
CFAR: one administrative, one developmental, one basic and one clinical.
There are several differences between a D-CFAR and a S-CFAR. The maximum
funding level for the D-CFAR award is $750,000 and it is a one-time award for
3 years. We encourage independent AIDS investigators interested in expanding
collaborative efforts at their institution to consider applying for this
award.
Applicants who have never received a CFAR award are eligible to apply, as are
previous CFAR applicants who have not been successful in recompeting for the
CFAR award. Applicants who have not received a CFAR award may choose to apply
for either a standard or developmental CFAR award. Because the D-CFAR is
designed to assist the applicant in the organization and development of a
competitive CFAR application, reviewers will look very carefully at previous
CFAR applications from the same applicant regarding the feasibility of
overcoming obstacles identified by previous reviewers. Applicants should
clearly indicate in the title of the application and in the abstract that this
is for the D-CFAR award. If no indication is provided it will be assumed that
the application is for a standard CFAR.
Applicants applying for a D-CFAR award should plan on providing as much detail
for the Administrative and Developmental Cores as is required for the standard
CFAR application. Please see the instructions for the administrative and
Developmental Core for CFARs, above. The strategic plan should provide
sufficient detail about procedures that will be used to identify challenges at
the institution and proposed solutions that would lead to development of a
competitive CFAR application within the three-year funding period. Proposed
outcome measurements for strategies, and core facilities selected for year 1
should be clearly explained, as well as procedures for adjusting the plan for
years 2 and 3, should changes be needed.
Like the standard CFAR award, the D-CFAR provides funding to foster synergy
and improve coordination of research, support emerging research opportunities,
and promote economy of scale through resources shared by multiple independent
laboratories. D-CFARs also encourage other activities that serve the
requirements of AIDS research. See 'Additional CFAR supported activities'.
Any of these activities may be fostered through a D-CFAR award.
Because both the funding period and level are less than that for a CFAR award,
the D-CFAR is not expected to propose all core facilities that would be
proposed for a standard CFAR. The emphasis for D-CFAR is on the
identification of gaps or deficiencies that would hinder development of a
competitive CFAR application, and core facilities that will reduce or
eliminate these gaps.
MECHANISM OF SUPPORT
This PA will use the NIH center core grant (P30) award mechanism. The
applicant will be solely responsible for planning, directing, and executing
the proposed project. The total project period for CFAR grants may not exceed
five years, and applicants are encouraged to apply for five years. For
D-CFARs the total requested project period may not exceed three years.
APPLICATIONS IN RESPONSE TO THIS PA MUST BE PREPARED USING A MULTI-PROJECT
GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR PREPARING THE CFAR
APPLICATION CAN BE FOUND AT THE CFAR WEBSITE:
http://www.niaid.nih.gov/research/cfar/cfarpa.htm
ELIGIBLE INSTITUTIONS
Domestic institutions may submit an application if the institution has any of
the following characteristics:
o For-profit or non-profit organization
o Public or private institutions, such a university, college, hospital, and
laboratory
o Units of State or local government
Foreign institutions are not eligible to apply.
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 their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs. The principal investigator should be a
recognized leader in the field of AIDS research.
SPECIAL REQUIREMENTS
When clinical studies or trials are a component of the research proposed,
NIAID policy requires that studies be monitored commensurate with the degree
of potential risk to study subjects and the complexity of the study. Terms
and Conditions of Award will be included with awards. NIAID policy was
announced in the NIH Guide on February 24, 2000 and is available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full
policy, including terms and conditions of award, is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Please check the following
website for any changes in contact information:
http://www.niaid.nih.gov/research/cfar/cfarpa.htm. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct questions about scientific/research issues to:
For questions regarding D-CFAR, or CFAR management issues, scientific issues,
or program interests of NIAID please contact:
Janet M. Young, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4137, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626
Telephone: (301) 496-6714
FAX: (301) 402-3211
Email: jy6r@nih.gov
For questions regarding D-CFAR and CFAR scientific and program interests of
other Institutes and Centers please contact:
FIC
Jeanne McDermott, Ph.D.
Division of International Training and Research
Fogarty International Center
Room B2C39 MSC 2220
31 Center Drive
Bethesda, MD 20892-2220
Telephone: (301)-496-1492
FAX: (301) 402-0779
Email: jm548f@nih.gov
NCI
Jodi B. Black, Ph.D.
AIDS Malignancy Program
National Cancer Institute
Room 3A44, MSC-2440
31 Center Drive
Bethesda, MD 20892-2440
Telephone: (301) 402-6293
FAX : (301) 496-0826
Email: jb377x@nih.gov
NCCAM
Morgan N. Jackson, M.D., M.P.H.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Bethesda, MD 20817 (use for express/courier service)
Telephone: (301) 402-1278
FAX: (301) 480-3621
email: mj145m@nih.gov
NHLBI
Elaine Sloand, M.D.
Office of the Director
National Heart, Lung and Blood Institute
Room 4A11, MSC 2490
31 Center Drive
Bethesda, MD 20892-2490
Telephone: (301) 496-3245
FAX: (301) 594-1290
E-mail: es38n@nih.gov
NICHD
Pat Reichelderfer, Ph.D.
Contraception and Reproductive Evaluation Branch
National Institute of Child Health and Development
Room 8B13
6100 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 496-1661
FAX: (301) 480-1972
E-mail: pr20f@nih.gov
NIDA
Jag Khalsa, Ph.D.
Center on AIDS & Other Medical Consequences
National Institute on Drug Abuse
Room 5198, MSC 9593
6001 Executive Blvd.
Bethesda, MD 20892-9593
Telephone: (301) 443-1801
FAX: (301) 594-6556 or 443-4100
Email: jk98p@nih.gov
NIMH
Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6209, MSC 9619
6001 Executive Blvd.
Bethesda, MD 20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719
E-mail: dr89b@nih.gov
o Direct questions about peer review issues to:
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: dt15g@nih.gov
o Direct questions about financial or grants management matters to:
Lori Zimand
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2246, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-4580
FAX: (301) 493-0597
Email: lz36k@nih.gov
SUBMITTING AN APPLICATION
Applicants for P30 grants must follow special application guidelines in the
NIAID Brochure entitled SPECIAL INSTRUCTIONS FOR PREPARATION OF THE CFAR
APPLICATION; this brochure is available via the WWW at:
http://www.niaid.nih.gov/research/cfar/cfarpa.htm
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted on the dates indicated on the front page of
this document.
Applications that are not received as a single package on the receipt date or
that do not conform to the instructions contained in PHS 398 (rev. 5/01)
Application Kit (as modified in, and superseded by, the NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be
judged non-responsive and will be returned to the applicant.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as applicant is developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept the application
for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. The 350-page limit also applies to
these applications. Additional information on this policy is available in the
NIH Guide for Grants and Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
For applications in response to this program announcement, the page limitation
is 350 pages for the research plan of the CFAR or D-CFAR application,
excluding appendices, required tables
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm), Bio-sketches, and Other
Support, literature cited sections, and other sections that normally fall
outside of sections A-D of the research plan. Please note that appendices
are provided only to the reviewers assigned to the application, and not to all
reviewers. Appendices should not contain information required for review by
other committee members, and are limited to 10 documents or 100 pages. The
350-page limit is a maximum, and applicants are encouraged to be concise.
Applicants submitting a revised application may include an additional 30 pages
to discuss the response to the reviewers' comments. It is helpful to the
review committee if these are placed at the beginning of the research plan,
with reference to locations in the application where changes can be found.
Other support should not be provided in the initial application submission.
SPREADSHEETS AND TABLES
NIH will provide applicants with a spreadsheet (Excel) indicating all
investigators receiving NIH AIDS funding at an applicant's institution (or
institutions if a multi-institution application), arranged by NIH Institute.
Applicants should indicate in the "Participating" field provided, those
investigators who have formally agreed to participate in the CFAR, and a brief
explanation at the bottom of the table as to why investigators may not be
participating. Indicate the type of participation, i.e., core director, user
of Virology Core, etc.
The NIH will provide tables in MSWord for additional information required of
both new and recompeting applications. These may be found at the CFAR program
announcement website: http://www.niaid.nih.gov/research/cfar/cfarpa.htm
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
Two single-sided copies of the application (text) and five copies of
appendices must be sent to:
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: the receipt dates described on the first page of this
document must be followed. The CSR will not accept any application in
response to this PA that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of a substantial
revision of an application already reviewed, but such application must
include an Introduction addressing the previous critique.
Concurrent submission of an R01 and a Component Project of a Multi-project
Application: Current NIH policy permits a component research project of a
multi-project grant application to be concurrently submitted as a traditional
individual research project (R01) application. If, following review, both
the multi-project application and the R01 application are found to be in the
fundable range, the investigator must relinquish the R01 and will not have
the option to withdraw from the multi-project grant. This is an NIH policy
intended to preserve the scientific integrity of a multi-project grant, which
may be seriously compromised if a strong component project(s) is removed from
the program. Investigators wishing to participate in a multi-project grant
must be aware of this policy before making a commitment to the Principal
Investigator and awarding institution.
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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the NIH
Center for Scientific Review and for responsiveness to the goals of this PA
by NIAID staff in consultation with the other co-funding Institutes.
Incomplete or non-responsive applications will be returned to the applicant
without further consideration.
Applications submitted for this PA will be assigned on the basis of established
PHS referral guidelines. P30 applications that are complete and responsive
to this PA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the NIAID.
As part of the initial merit review, all applications will:
o Receive a written critique
o Be assigned a priority score
o Receive a second level review by the National Allergy and Infectious
Diseases Advisory Council and the appropriate Councils or Boards of the co-
funding Institutes
REVIEW CRITERIA
In addition, the following review criteria specific to this PA will be used
in evaluation of applications. Review criteria are based on the mission of
the CFAR Program and mechanisms for achieving this mission. The initial
review group (IRG) will evaluate D-CFAR, and CFAR applications for
significance, approach, innovation, investigator, and environment. In these
evaluations, the IRG will also look for evidence of successful performance
from applicants that have had CFAR awards or similar programs at their
institutions.
The organizational structure of sections in a CFAR application resembles that
of an R01 application:
CFAR Application -R01 Application
-Strengths -Background
-Opportunities -Significance
-Action Plan and Outcome Measurements -Specific Aims
-Policies and Procedures -Materials & Methods
-Choice of Cores and their -Preliminary Results
Operating Structures for new applications
-Progress Report for -Progress Report for
renewal applications renewal applications
The NIH review criteria have been adapted to ensure that the major components
of a CFAR application are evaluated appropriately. The score should reflect
the overall impact that the project could have on the field based on
consideration of the five criteria, with the emphasis on each criterion
varying from one application to another, depending on the nature of the
application and its relative strengths. Note that an application need not be
strong in all categories to be judged likely to have major scientific impact
and thus deserve an outstanding priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward. Review criteria are listed
separately for the developmental CFAR (D-CFAR), the standard CFAR (CFAR),
awards.
REVIEW CRITERIA FOR D-CFARS
Significance – The effect that a D-CFAR award would have on an applicant's
AIDS research efforts
1. Evidence that the proposal will lead to development of a competitive
standard CFAR application
2. The ability of Cores to support the research base, foster synergy,
enhance AIDS research collaborations and produce an economy of scale
3. The ability of proposed scientific communication, outreach, training
efforts, international collaborations, and collaborations with industry to
assist AIDS investigators and lead to development of a competitive CFAR
application
4. Developmental Core procedures for selection of projects and outcomes
evaluation
Approach – The quality of the CFAR scientific planning and management process
5. Annual strategic planning process
6. Policy and procedures to judge value of Cores and reassign funding
priorities; outcome measurements
7. Methods for selection of Basic and Clinical Core users and for
prioritization of use
8. Policies and procedures to identify gaps and mechanisms for filling them
Innovation – The utilization of D-CFAR resources in unique ways to achieve
the scientific goals of all AIDS investigators at the participating
institution(s)
9. The degree of variety in AIDS research projects and disciplines that
commit to participation in and coordination through the D-CFAR structure
10. The incorporation into the D-CFAR of resources (Cores, projects, cohorts,
trials, etc.) that are supported in part or not at all by D-CFAR funds
11. Resources available to enhance a particular D-CFAR goal in order to
facilitate future collaborative interactions
Investigator – The choice of appropriate leaders to carry out the D-CFAR
mission
12. Choice of D-CFAR director, e.g., managerial experience, commitment,
leadership in AIDS research and at the applicant institution
13. Choice of core directors and key personnel, e.g., qualifications,
competence and commitment
14. Proposed advisory groups: responsibility, methods for their selection,
and contribution to the overall D-CFAR goals
Environment – The likelihood that a D-CFAR will achieve its objectives
15. Evidence for D-CFAR providing value added to the AIDS research at the
institution
16. Institutional commitment including space, institutional financial support
and other institutional resources and oversight provided for D-CFAR activities
17. Appropriateness of budget of the overall D-CFAR and of the individual
cores
18. Proposed strategy for expanding the D-CFAR focus
REVIEW CRITERIA FOR CFARS
Significance – The effect that a CFAR award would have on CFAR investigators'
AIDS research efforts
1. The ability of Cores to support the research base, foster synergy, enhance
AIDS research collaborations and produce an economy of scale
2. Evidence that CFAR will enhance proposed scientific communication,
outreach, training efforts international collaborations, and collaborations
with industry
3. Developmental Core procedures for selection of projects and outcomes
evaluation
Approach – The quality of the CFAR scientific planning and management process
4. Annual strategic planning process
5. Policy and procedures to judge value of cores and reassign funding
priorities; outcome measurements
6. Methods for selection of basic and Clinical Core users and for
prioritization of use
Innovation – The utilization of CFAR resources in unique ways to achieve the
scientific goals of all AIDS investigators at the participating
institution(s)
7. The degree of variety in AIDS research projects and disciplines that
commit to participation in and coordination through the CFAR structure
8. The incorporation into the CFAR of resources (Cores, projects, cohorts,
trials, etc.) that are supported in part or not at all by CFAR funds
Investigator – The choice of appropriate leaders to carry out the CFAR
mission
9. Choice of CFAR Director, e.g., managerial experience, commitment,
leadership in AIDS research and at the applicant institution
10. Choice of Core directors and key personnel, e.g., qualifications,
competence and commitment
11. Proposed advisory groups: their responsibility and methods for membership
selection
Environment – The likelihood that a CFAR will achieve its objectives
12. Evidence for CFAR providing value added to AIDS research at the
institution
13. Institutional commitment including space, institutional financial support
and other institutional resources and oversight provided for CFAR activities
14. Previous history of CFAR support for developmental projects and outcomes
15. Previous history of translational research efforts
16. Appropriateness of budget for the CFAR overall and of the individual
Cores
REVIEW CRITERIA FOR SCIENTIFIC COLLABORATIONS
Significance – The effect that a collaborative project would have on the
overall AIDS effort at the institution
1. Evidence for innovative, high-risk/high-impact project(s) that will
address significant problems or gaps in the AIDS field that cannot be
addressed easily through other funding mechanisms
2. Evidence that the proposed project(s) will enhance new multidisciplinary
collaborations, that may include international collaboration, collaboration
with industry, or collaboration with junior or minority investigators
3. Evidence that the process for selection of projects to be funded will lead
to independent funding of high-risk/high-impact studies
Approach - The quality of the CFAR scientific projects, including planning
and management process
4. Project design and appropriate Core selection
5. Policy and procedures to identify and select scientific projects, reassign
funding priorities, and to measure outcome of projects
Innovation – The identification of a unique project or approach to solve an
significant question or gap in AIDS research
6. The degree of variety in AIDS scientific disciplines that are included in
proposed scientific projects
7. The degree of innovation in project selection and experimental design
Investigator – Choice of appropriate scientists to lead the identification and
development of collaborative projects
8. Choice of Scientific Director for scientific areas proposed: leadership in
the field of AIDS
9. Choice of project leader for individual collaborative projects proposed:
scientific qualifications, commitment
Environment
10. Availability of appropriate scientific expertise
11. Previous history of support for developmental projects and outcomes
12. Appropriateness of budget for the scientific projects and of the
individual Cores
13. Evidence that scientific collaborative areas and projects arise from the
scientific environment at the CFAR institution(s)
ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria items
will be considered in the determination of scientific merit and the priority
score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
CONDITIONS OF AWARD
The Conditions of Award will incorporate the following items proposed by the
applicant with potential modifications based on recommendations of the
Initial Review Committee:
A. CFAR Strategic Plan
B. CFAR Policies and Procedures
C. CFAR Advisory Committee(s) authority and responsibility
D. CFAR Advisory Committee for the identification and selection of research
projects and awards (D-CFAR)
Any changes in these items from the Notice of Award will require concurrence
of NIH.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines
are available at http://grants.nih.gov/grants/funding/women_min/
guidelines_amended_10_2001.htm The amended policy incorporates: the use
of an NIH definition of clinical research; updated racial and ethnic categories
in compliance with the new OMB standards; clarification of language governing
NIH-defined Phase III clinical trials consistent with the new PHS Form 398;
and updated roles and responsibilities of NIH staff and the extramural
community. The policy continues to require for all NIH-defined Phase III
clinical trials that: a) all applications or proposals and/or protocols must
provide a description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including subgroups if
applicable; and b) investigators must report annual accrual and progress in
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: tc
"REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS" NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is in the NIH Guide for Grants and
Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the 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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
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 priority areas. This PA
is related to one or more of the priority areas. 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 Catalogue of Federal Domestic Assistance at
http://www.cfda.gov/ in the following citations; No. 93.213, Research and
Training in Complementary and Alternative Medicine; No. 93.242, Mental Health
Research Grants; No. 93.279, Drug Abuse Research Programs; No. 93.393, Cancer
Cause and Prevention Research; No. 93.394, Cancer Detection and Diagnosis
Research; No. 93.396, Cancer Biology Research; No. 93.839, Blood Diseases and
Resources Research; No. 93.855, Immunology, Allergy, and Transplantation
Research; No. 93.856, Microbiology and Infectious Diseases Research; No.
93.864, Population Research; No. 93.865, Center for Research for Mothers and
Children; and No. 93.989, Senior International Fellowships. Awards are made
under authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and administered under NIH grants policies
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program
is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
The NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes
general information about the grant application and review process;
information on the terms and conditions that apply to NIH Grants and
cooperative agreements; and a listing of pertinent offices and officials at
the NIH. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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