and Human Services (HHS)
EXPIRED
INTEGRATIVE NEUROSCIENCE INITIATIVE ON ALCOHOLISM: EXPANSION RESEARCH PROJECTS
RELEASE DATE: February 11, 2002
RFA: RFA-AA-02-009 (Notice of Limited Competition Request for Applications,
see NOT-AA-06-101)
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute on Alcohol Abuse and Alcoholism
(http://www.niaaa.nih.gov/)
LETTER OF INTENT RECEIPT DATE: March 15, 2002
APPLICATION RECEIPT DATE: April 15, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of This RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites
applications from individual research investigators to join the recently
established consortia under the "Integrative Neuroscience Initiative on
Alcoholism (INIA)". The initial INIA initiative (RFA AA-01-002, see
http://grants.nih.gov/grants/guide/rfa-files/RFA-AA-01-002.html) created two
consortia of highly integrated, multidisciplinary, collaborative research
projects that are focussed on the neurobiological mechanisms underlying
various aspects of neuroadaptation to alcohol. Each of the two INIA consortia
are incorporating neurobiological, behavioral, and molecular genetic
techniques to determine how various aspects of neuroadaptation ultimately
contribute to excessive alcohol intake.
The intention of this Request For Applications (RFA) is to support additional
research projects that can justify the use of the established resources
supported through the consortia, and at the same time, be integrated with the
existing scientific goals of either of the two INIA consortia. The areas of
research appropriate for this announcement should address the neuroadaptive
response to chronic alcohol ingestion and its contribution to excessive
alcohol drinking, and must be relevant to the scientific mission of either
consortium. Of particular importance are applications that propose to use
anatomical (tracer) mapping, multi-unit electrophysiological recording
techniques in behaving animals, and other related methods to identify the
neural circuits and pathways that are involved in the response to chronic
alcohol ingestion. Also of interest are proposals that use neurocomputational
and theoretical approaches to formulate models that can predict the role of
neuroadaptive changes to excessive alcohol consumption.
No further applications are sought from research groups that want to propose
their own consortium or resource core facilities. All proposed research
projects will be expected to fully integrate into either of the two
established consortia, and to work cooperatively towards the research goals
of that consortium.
RESEARCH OBJECTIVES
Purpose of the Consortia
Scientists conducting alcohol research at different levels of analyses, from
molecular to whole organism and behavioral approaches, have made significant
progress towards describing and characterizing the neurobiology of the
neuroadaptive response to alcohol consumption. When the findings from each of
these various levels of analyses are considered together, the overall picture
of the nervous system"s response to alcohol ingestion begins to emerge.
However, there remain limitations in pooling and comparing these data
obtained from multiple analytical approaches. In many instances, it becomes
difficult to completely integrate these data because experimental results are
collected using different animal species and animal models, different
experimental designs and manipulations, and perhaps even differences in the
materials and other resources being used between laboratories. The NIAAA
recognizes the greater enhancement of innovation, synergy, and conceptual
advances that can occur from researchers working collaboratively across
scientific disciplines, methodologies, and levels of analyses. For this
reason, the NIAAA established the INIA consortia to collect and integrate
through a large-scale collaborative arrangement scientific data obtained at
each level of analysis using state-of-the-art techniques.
The incorporation of collaborative groups of scientists into a research
consortium focused on the neuroscience of alcoholism offers many advantages.
Each INIA consortium is addressing selective areas for the study of the
neurobiology of excessive alcohol consumption. The integrative nature of the
consortia thereby allows for multiple research expertise that uses the full
gamut of molecular, cellular, neurochemical techniques, neurocircuitry and
neural network expertise, animal genetics, animal behavior and
psychopharmacology to target and characterize the neuroadaptive response.
Standardizing experimental designs and sharing resources facilitates the
comparison and interpretation of research findings. The information
collected, from the most basic molecular level up to the behavioral level, is
more easily integrated to provide a detailed analysis of the anatomical and
functional changes to neural substrates that occurs in response to excessive
alcohol intake. Lastly, the rapid and detailed exchange of information among
INIA researchers provides immediate opportunities for applying the consortium
expertise to other profitable research arenas.
Organization and Current Consortium Research
As a result of the previous RFA, the NIAAA presently supports 2 consortia
under INIA. Each INIA consortium consists of a cluster of integrated
cooperative agreement research project applications, and a set of supportive
core resource facilities. An Administrative Coordinating Core provides the
framework for the management, direction, and overall coordination of the
consortium activities. A Consortium Coordinator leads each INIA consortium.
Each highly integrated, multidisciplinary research consortium works
interactively to study the neuroadaptive effects of ethanol and their
contribution to excessive alcohol consumption, from the molecular through the
cellular and neural network levels to well characterized and validated
behavioral models. The approaches used reflect the blend of experience and
creativity of the INIA components and investigators. Through the core
resource facilities within each consortium, the integrated research project
component groups have access to resources, information, technologies, ideas,
and expertise that are beyond the scope of any single research team.
The first consortium, "Neurobiological Basis of Excessive
Drinking" is led by The Scripps Research Institute, (Dr. George Koob,
consortium coordinator). This consortium brings together a large group of
scientists from 6 participating sites: The Scripps Research Institute, The
University of Texas at Austin, the Oregon Health Sciences University, Indiana
University School of Medicine, The University of Colorado Health Sciences
Center, and SRI International. Several Resource Cores are available to
investigators within the consortium. These include an Administrative Core,
Genetic Animal Models Core, Gene Expression Core, Imaging Core, and
Neuroinformatics Core. Several of these cores are located at more than one
participating site.
The research objectives of this INIA consortium are to identify the molecular
and cellular neuroadaptations of the brain reward circuitry within the
amygdala and its associated neural connections. The hypothesis is that
genetic differences and neurobiological neuroadaptive processes within this
circuitry are responsible for individual differences in vulnerability to
excessive alcohol consumption. The specific aims of this consortium include:
establishing animal models to study specific neurobiological targets for
vulnerability that lead to excessive alcohol consumption at the molecular,
cellular and neural circuit levels of analyses, identifying the specific
brain sites involved in the neuroadaptive response within the amygdala
circuitry, and characterizing specific clusters of genes whose expression is
regulated by alcohol and which are responsible for any given model of
excessive alcohol consumption.
The research projects are organized within 3 subgroups, a Neurocircuitry
Subgroup, an Animal Models of Dependence and Neuroadaptation Subgroup, and a
Molecular Basis of Excessive Drinking Subgroup. Research techniques being
used for molecular levels of analyses include brain-specific mRNA
(directional tag PCR subtraction) analysis, gene chip analysis, and molecular
genetic (transgenics, knock-outs, knock-ins) manipulations.
Electrophysiological and neurochemical measures range from single-cell
recording to in vivo microdialysis. These techniques are being used to study
and characterize specific differences or neuroadaptive changes within defined
animal models of the alcohol behavioral response. The animal models being
studied include models of inherent (genetic) excessive drinking, excessive
drinking driven by dependence, by acute abstinence, by protracted abstinence,
by loss of satiety control, and models of vulnerability to relapse. The data
obtained are being applied to generate knowledge regarding the neural
networks and neurocircuitry affected within the amygdala and its connections
in response to alcohol consumption. The derived data will ultimately be used
to understand the determinants of excessive alcohol intake, and applied for
the future development of methods for the prevention and treatment
of alcoholism.
The second INIA consortium, "Stress-Anxiety of Alcohol Abuse" is led by the
Wake Forest University School of Medicine (Dr. Kathleen Grant, consortium
coordinator). This consortium uses a multidisciplinary approach to explore
the neural mechanisms that link stress, anxiety, and excessive alcohol
intake. The common focus of many of the projects within this consortium is to
discover and characterize the complex interactions of genetic and non-genetic
factors that contribute to excessive alcohol intake. This consortium brings
together a large group of scientists from 4 participating sites: the Wake
Forest University School of Medicine, The University of Memphis, Tennessee,
The University of Tennessee Health Sciences Center, and Vanderbilt
University. The Resource Cores contributing to this consortium include an
Administrative Core, Inducible Knockout Mouse Core, Genotyping Core,
Bioanalytical Core, Neurohistology Core and an Informatics Core.
The research objectives of this INIA consortium are to identify the
neurochemistry and neural circuitry of alcohol-stress interactions. The
experimental focus is to gain information about the neural effects of stress,
alcohol, and stress-alcohol interactions on the level of expression and
function of key neuronal molecules, neuronal activities and synaptic
efficacy, the neurophysiology of key systems involved in stress and alcohol
interactions, and the genetic factors that contribute to alcohol-stress
interactions, stress-related conditioning and other behaviors related
to stress.
This consortium is addressing the following hypotheses. One, stress leads to
alcohol intake that provides relief from anxiety, and the effects of ethanol
on the function of neurotransmitter receptors and transporters,
neurotransmitter release and ion channel function contribute to this
anxiolytic action. Two, chronic alcohol exposure and alcohol withdrawal leads
to anxiogenic effects that increase the strength of the stress disequilibrium
and subsequent neuroadaptive processes. This stress disequilibrium
contributes to enhanced ethanol intake by bringing about plastic changes in
inputs to the amygdala, hippocampus and prefrontal cortex, and from these
structures to the nucleus accumbens. Three, alcohol may dampen neuronal
plasticity related to non-stressful information and alcohol might interfere
with proper fear conditioning and related plasticity to alter normal
responses to stressful stimuli. Four, genetic factors that contribute to
increased risk of excessive alcohol intake may involve alterations in
responses to stress, or in alcohol"s effects on such responses. The research
projects of this consortium employ a wide range of technologies including
genetic analysis and the measurement of alterations in gene expression,
neurophysiological measurements of ion channel function, synaptic activity
and the activity of neurons within active circuits in vivo, and the analysis
of stress-related behaviors and alcohol intake. The data obtained should
enable the development of new therapeutic approaches for the treatment of
individuals with excessive drinking problems through the advancement of
better strategies that target stress and alcohol"s effects that
exacerbate drinking.
Proposed Research Project Components
To ensure integration within an INIA consortium, the proposed research
project application must utilize the resources of, and the new technologies
being developed within, one or more of the resource core facilities for that
consortium. However, the research proposed in the application can be
performed at a research site other than the one housing the resource core
facility. Furthermore, the research project is expected to be integrated with
the other current research projects within the INIA consortium. It is
anticipated that several of the research projects within a consortium will
address the same research domain, but will differ in emphasis, approaches and
research questions being addressed.
Applicants should contact the appropriate consortium coordinator to discuss
their interest in joining the consortium as well as to familarize themselves
with the different resource cores and usage policies for that consortium.
NIAAA program staff can also be contacted for additional information
concerning the scientific goals of and resources available within either
INIA consortium.
Furthermore, a description of how the proposed project adds to, and
integrates with, the scientific mission of the INIA consortium that the
applicant seeks to join, and how the proposed research will make use of the
resources within that consortium, should be included as a separate section
within the text of the research application.
Regular investigator-initiated (U01) research project component applications
can request a maximum support period of four years. These applications should
include a detailed budget, but otherwise must follow the traditional PHS 398
application instructions. Exploratory and development projects will also use
the U01 mechanism, but will be limited to up to three years of support and a
maximum budget of up to $100,000 direct costs per year.
Additional Technological Approaches
The focus of the proposed research for any research project application
submitted in response to this RFA is entirely at the discretion of the
applicant. The only requirements are that the proposal utilizes the resources
of the resource core facilities for the consortium the applicant seeks to
join, and that the research project is integrated with the other current
research projects within that INIA consortium. Currently, the following
approaches are of particular interest to the NIAAA.
Anatomical Mapping of Neural Circuits: Identification and characterization of
the neural circuits in the brain that mediate the myriad of neuroadaptive
behavioral effects of chronic ethanol exposure is an important objective of
alcohol research. To understand the mode of operation of a given neural
network, the different neurons that form the circuitry should be identified,
their membrane properties should be defined in terms of their firing
properties, and a description should be made of how these neurons interact
synaptically in both spatial and temporal terms.
Several newly developed techniques are being employed to identify and
characterize neural circuits. For example, extracellular, single-unit
recordings of neurons in animals have long been used in neurophysiological
studies to characterize the response of individual neurons within specified
neural pathways to external stimuli. More recently, data collected from
multi-unit electrode recording is clarifying the relationship between
patterns of electrical activity of individual neurons residing in different
brain regions and distinct neural circuits in behaving animals. This method
allows the analysis of changes in spatiotemporal patterns of neuronal
activity in response to the external stimulus - ethanol-associated behaviors
and alcohol consumption. In vivo microdialysis, iontophoresis, fast-scan
cyclic voltammetry, confocal microscopy, semiconductor array imaging, two-
photon laser scanning microscopy, and nonlinear fluorescence imaging
methodologies are being used to characterize the neurochemical and cellular
activities of neural circuits and networks within various brain regions.
Of particular importance to alcohol research is the need to obtain an
anatomical map of the neural circuits and networks of nerve cells involved in
neuroadaptation to ethanol. New methodologies, such as anterograde and
retrograde tracer techniques, can be used to identify and define the
anatomical connections between nerve cells - the synapses involved in
neuronal communication. This research will be crucial in describing the
neuroadaptive changes in electrical communication among neurons that leads to
the development of alcohol-induced neuroadaptive behavior.
Neurocomputational and Theoretical Modeling: Computational neurobiology
integrates the disciplines of neurobiology, mathematics, and physics to study
the functional organization and operation of the brain. Neural networks
mediating alcohol-related phenomena are hypothesized or empirically
established and then modeled to determine, in an iterative process, the
organizational principles and mechanisms underlying the targeted phenomena.
It is anticipated that distributed neural networks are involved and are
organized by coupled dynamic rules. Computational neurobiology has been used
successfully in systems-level models and in integrative approaches that
incorporate data from the subcellular to behavioral levels.
There is a need within the alcohol field for the development of
neurocomputational and theoretical models, recently made possible by
computer-based advances, that can predict neuroadaptive responses to alcohol
consumption. These models should help formulate testable hypotheses of 1) how
the nervous system responds physiologically to excessive alcohol ingestion,
and 2) the brain mechanisms that come into play with chronic alcohol use and
the development of neuroadaptive behavior towards alcohol consumption. This
research will enhance the ability to describe alcohol-induced changes to
brain structure and function, and to analyze these simulations.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) cooperative
agreement (U01) award mechanism. As an applicant you will be solely
responsible for planning, directing, and executing the proposed project. Each
research proposal that is included in either of the two INIA consortia under
this RFA will be awarded as separate individual research project (U01)
awards. The anticipated award date is 28 September 2002.
This RFA is a one-time solicitation. However depending on the availability of
funds, this RFA may be re-issued in 2003 to support additional complementary
research areas for the two Integrative Initiative on Alcoholism consortia.
This RFA uses just-in-time concepts. It also uses the non-modular budgeting
format. Specifically, all applications should include a detailed budget
regardless of the level of direct costs requested in each year. Applicants
should follow the instructions for non-modular research grant applications.
The NIH U01 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award". At present, the plans for the cooperative agreement projects beyond
the initial award period are indefinite. Future plans will be based on NIAAA
program staff evaluation of the scientific progress achieved by the two INIA
consortia during the current funding period.
FUNDS AVAILABLE
The NIAAA intends to commit approximately $4,000,000 in FY 2002 to fund 10-12
additional new cooperative agreement applications in response to this RFA.
Because the nature and scope of the research proposed in response to this RFA
may vary, it is anticipated that the size of the awards will also vary. The
total project period for an application submitted in response to this RFA may
not exceed 4 years. Although this program is provided for in the financial
plan of the NIAAA, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose and the receipt of applications of
outstanding scientific and technical merit.
Funds provided under this program may not be used for the purchase of land,
nor for the purchase, construction, preservation, or repair of any building.
However, costs of alteration and renovation of existing facilities necessary
to accomplish the objectives of the grant may be allowed subject to NIH
grants policy limitations and approval by NIAAA staff.
ELIGIBLE INSTITUTIONS
You may submit applications if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
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.
SPECIAL REQUIREMENTS
Cooperative Agreement Terms and Conditions of Award
The following Terms and Conditions, which are the same as those applied to
the two existing consortia, will be incorporated into the new award
statements and will be provided to the principal investigators of the
individual research components and to the appropriate institutional officials
at the time of award. These terms and conditions apply to both consortia. The
following 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 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIAAA programmatic involvement
with the awardees is anticipated during performance of the activities. Under
the cooperative agreement, the NIAAA supports and stimulates the recipients"
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role. The NIAAA is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole.
1. Principal Investigator Rights and Responsibilities
The Principal Investigator of each new research project component will
coordinate project activities both scientifically and administratively with
the INIA consortium they join. The Principal Investigator will be responsible
for the scientific and technical direction of the project within the
guidelines of RFA AA-02-009, and agree to abide by the policies and rules set
up by the consortium. This includes accepting the actions and recommendations
approved by the Steering Committee. In addition, each Principal Investigator
will agree to accept close coordination, cooperation and participation of the
NIAAA in those aspects of management of the project as described below. Each
new U01 research project will receive a separate award, and the Principal
Investigator will have control over the project"s operating budget. Awardees
will be required to attend INIA Committee meetings, participate in the
cooperative nature of the INIA consortium.
Awardees will retain custody of, and have primary rights to, the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies. However, awardees will
implement the approved Data Sharing Plan (see Submitting An Application),
which will be incorporated as an additional term of award, and will be
expected to share (make available) these data both within the consortium and
with the scientific community. Awardees should comply with their
institutional intellectual property policies and practices as approved in
the award.
2. Consortium Coordinator"s Rights and Responsibilities
The consortium coordinator is charged with coordinating the scientific and
administrative activities of the INIA consortium. The consortium coordinator
has the responsibility for the scientific and technical direction of the
research projects, and the administration and overall operation of the
consortium. Therefore, the consortium coordinator is responsible for ensuring
that additional projects awarded under RFA AA-02-009, and relevant to the
respective INIA consortium, are fully integrated within the scientific scope
and mission of that consortium. This includes that all new investigators have
access to the resources within the core resource facilities of the
INIA consortium.
A Steering Committee serves to assist the consortium coordinator with the
governing of the consortium. The consortium coordinator chairs this
Committee. In addition, the consortium coordinator must abide by the
operating rules and guidelines developed by the Steering Committee.
Furthermore, the consortium coordinator has agreed to accept participation of
NIAAA staff in those aspects of management of the project described under
"NIAAA Staff Rights and Responsibilities." Lastly, the consortium coordinator
ensures the timely dissemination of information generated by the consortium
component projects to both the consortium project members and the
scientific public.
3. NIAAA Staff Rights and Responsibilities
As per the terms of the collaborative agreement arrangement, the NIAAA has
appointed a Program Official and two Staff Collaborators to participate in
the conduct of each of the two INIA consortium activities. The NIAAA Staff
Collaborators will have substantial scientific-programmatic involvement with
the consortia through providing technical assistance, advice and coordination
above and beyond normal program stewardship of research grants. Although
NIAAA staff participate, the awardees retain the dominant role and prime
responsibility for the activities within each INIA consortium.
The NIAAA Program Official provides normal program stewardship and reviews
the scientific progress of individual research project components, and the
use of the core resource facilities among the research projects within each
INIA consortium. The Program Official also monitors compliance by the INIA
consortia with the operating policies developed by the Steering Committee.
The NIAAA Program Official may recommend withholding of support, suspension,
or termination of an award for lack of scientific progress or failure to
adhere to policies established by the Steering Committee.
The two NIAAA Staff Collaborators coordinate and facilitate the INIA
Consortium programs. Each NIAAA Staff Collaborator attends the INIA Steering
Committee meetings, and participates as a voting member (one-half vote each)
on the Steering Committee and any subcommittee as determined by the Steering
Committee members. The NIAAA Staff Collaborators assist the Steering
Committee in drafting and developing operating policies, and policies for
dealing with recurring situations that require coordinated action. Finally,
the NIAAA Staff Collaborators provide liaison between the Steering Committee,
the INIA Consortium members, and the NIAAA.
4. Collaborative Responsibilities
Scientific Advisory Panel: Each INIA consortium includes an external
scientific advisory panel whose purpose is to meet annually with the
consortium coordinator and the Steering Committee to assess progress and
provide feedback to the INIA investigators and NIAAA on proposed goals for
the next year of support. The panel members are designated by the NIAAA in
consultation with the Steering Committee, and embody research scientists not
actively involved with the consortia. The NIAAA staff collaborators attend
the meeting of the scientific advisory panel as members of the steering
committee, but are not members of the scientific advisory panel. The
scientific advisory panel will meet at least once a year immediately prior to
the submission of the INIA consortium annual progress report.
Steering Committee: Each INIA consortium has a Steering Committee, which is
the main governing board of the INIA consortia. This committee develops
collaborative protocols, and functions to set priorities for model
derivation, define the parameters for model validation, identify
technological impediments to success and strategies to overcome them, and
decide when models should be made available to the research community for
individual investigator-initiated projects.
The members of the Steering Committee for each INIA consortium are selected
by the consortium coordinator with input from the NIAAA staff collaborators.
The Steering Committee is primarily composed of the consortium coordinator,
several principal investigators of the research project components and core
resource facilities, and the two NIAAA staff collaborators. The Steering
Committee may, when deemed necessary, invite additional, non-voting
scientific advisors to the meetings at which research priorities and
opportunities are discussed. The NIAAA also reserves the right to augment
the scientific or consumer expertise of the INIA Steering Committee when
necessary, and to appoint additional NIAAA staff as nonvoting members of the
INIA Steering Committee and Subcommittees. Each primary member of the
Steering Committee, with the exception of the two NIAAA Staff Collaborators
as discussed above, has one vote. The chairperson of the Steering Committee
is the consortium coordinator. The Steering Committee may establish
subcommittees as it deems appropriate to facilitate the planning and
operation of the INIA consortia.
The Steering Committee meets annually to discuss and refine the scientific
mission and objectives of the INIA consortia, and to evaluate the scientific
progress being made both within the INIA consortium research components and
by outside laboratories. The Committee discusses the various models and
experimental approaches that were proposed in the individual component and
core applications and any relevant new information, and subsequently sets the
research priorities for the consortium. In the interest of facilitating
research in the alcohol field, the Steering Committee of each consortium
evaluates the progress of any animal model or new technology being developed
and decides when the model or technology is sufficiently validated such that
it should be distributed to the research community. The NIAAA will provide
the means to disseminate the models and the information related to them.
To support the scientific mission of the consortium, the Steering Committee
organizes one or more workshops a year. Initially, workshops from each
consortium will be held separately, but with time workshops from each of the
consortia may be combined and held jointly. These workshops, attended by both
INIA and non-INIA participants, enable the INIA consortium members to explore
current scientific or technologic advances and innovations that occur during
the course of the project. The Steering Committee also plans a symposium to
inform the research community of the progress being made towards the
derivation or refinement of animal models, their characterization and
validated uses, and any technological advances related to the design and
derivation of these models. The NIAAA Program Official and other NIAAA staff
provide the Steering Committee with advice on appropriate topics and
participants for the workshops and symposia, and manage the logistics for
these meetings.
5. Arbitration Process
Any disagreement that may arise on scientific or programmatic matters (within
the scope of the collaborative mechanism award) between U01 awardees and the
NIAAA may be brought to arbitration before an arbitration panel. The
arbitration panel will be composed of three members. One member will be
selected by the Steering Committee without NIAAA staff voting, or chosen by
the awardee in the event of an individual disagreement. A second member will
be selected by the NIAAA. The third member, having expertise in the relevant
scientific area, will be chosen by the two 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.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Antonio Noronha, Ph.D.
Chief, Neurosciences & Behavioral Research Branch
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 402
6000 Executive Boulevard
Bethesda, MD 20892-7003
301-443-7722 (telephone)
301-594-0673 (fax)
email: [email protected]
Roger Sorensen, Ph.D. MPA
Project Officer, Neurosciences & Behavioral Research Branch
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 402
6000 Executive Boulevard
Bethesda, MD 20892-7003
301-443-2678 (telephone)
301-594-0673 (fax)
email: [email protected]
o Direct your questions about financial or grants management matters to:
Judy Simons
Chief, Grants Management Office
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-0915 (telephone)
(301) 443-3891 (fax)
email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIAAA staff to estimate the potential review workload and
plan the review.
The letter of intent should be sent by March 15, 2002 to:
RFA-AA-01-009
Extramural Project Review Branch
Office of Scientific Affairs, NIAAA
Willco Building, Suite 409, MSC 7003
6000 Executive Boulevard
Bethesda, MD 20892-7003
or Rockville, MD 20852 (for express/courier service)
(301) 443-4375 (telephone)
(301) 443-6077 (fax)
SUBMITTING AN APPLICATION
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) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS: To evaluate the degree of integration of the
project within the INIA consortium, the contributions of the Resource Core
facilities to the proposed project must be summarized in item (h), Form PHS
398, Consortium/Contractual Arrangements of the Research Plan. This should
include an explicit description of which resource core facilities will be
utilized, including any of the services, tests, animals, etc. being provided.
In addition, arrangements made for utilization of these core resources of the
consortium should be discussed. Also include a description of the involvement
and protection of human subjects or vertebrate animals, if appropriate.
Furthermore, this section should describe the collaborative and integrative
interactions of the proposed project with other research projects within the
consortium. Applicants should provide enough detail such that reviewers and
NIAAA staff can understand the full scope of these interactions.
PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY: The NIH requires applicants
who respond to this RFA to develop and propose specific plans for sharing the
data and materials generated through this large-scale collaborative project.
This requirement addresses the interests of the Government in the
availability of, and access to, the results of publicly funded research. The
initial review group will comment on the proposed plans. In addition, as one
of the criteria for award, NIAAA staff will also consider the adequacy of the
plans. Because dissemination is a critical and important aspect of this RFA,
the proposed sharing and data release plans, after negotiation with the
applicant when necessary, will be made a condition of the award. The members
of the consortium should disclose to the Steering Committee their ties to
profit-making organizations to aid the project in avoiding conflict of
interest situations. Applicants are also reminded that the grantee
institution is required to disclose each subject invention to the NIAAA
within two months after the inventor discloses it in writing to grantee
institution personnel responsible for patent matters.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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)
Also at the time of submission, two additional copies of the application plus
five sets of any appendix materials should be sent to:
Chief, Extramural Project Review Branch
ATTN: AA-02-009
Office of Scientific Affairs, NIAAA
Wiilco Building, Suite 409
6000 Executive Boulevard
Bethesda, MD 20892-5452
or Rockville, MD 20852 (for express/courier service:)
(301) 443-4375 (telephone)
(301) 443-6077 (fax)
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAAA.
Incomplete and/or non-responsive applications 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 NIAAA in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Alcohol
Abuse and Alcoholism.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on achieving the goals of the
collaborative projects or consortium? Will the project tie or enhance the
independent work of the participating investigator to the collaborative
project, or will the project add an essential missing aspect to the
collaborative project?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider
alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o RESOURCE FACILITY UTILIZATION: The adequacy of plans by which the resource
core facilities will be utilized and arrangements made for utilization of
these resources.
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 15, 2002
Application Receipt Date: April 15, 2002
Peer Review Date: June-July 2002
Council Review: September 18, 2002
Earliest Anticipated Start Date: September 28, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: (if applicable) 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: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement 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.
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 RFA 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.
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
RFA, Integrative Neuroscience Initiative on Alcoholism, is related to the
priority area of alcohol abuse and alcoholism reduction. Potential applicants
may obtain a copy of "Healthy People 2010" at:
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.273. 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 Public Health Service (PHS) strongly
encourages all award 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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