Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.
ALCOHOL RESEARCH CENTER GRANTS
Release Date: July 17, 2002
RFA: AA-03-001
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
Letter of Intent Receipt Date: November 12, 2002
Application Receipt Date: December 10, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
1. Purpose of this RFA
2. Research Objectives
3. Mechanism(s)of Support
4. Funds Available
5. Eligible Institutions
6. Individuals Eligible to Become Principal Investigators
7. Special Requirements
8. Where to Send Inquiries
9. Letter of Intent
10. Submitting an Application
11. Supplemental Instructions
12. Peer Review Process
13. Review Criteria
14. Receipt and Review Schedule
15. Award Criteria
16. Required Federal Citations
1. PURPOSE OF THIS RFA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides
grant support for Alcohol Research Centers to conduct and foster
interdisciplinary research on alcoholism and alcohol abuse. The Center
program is interrelated with and complementary to all other research support
mechanisms and scientific activities that comprise the programs of research
on the nature, causes, and consequences of alcohol abuse and alcoholism,
including diagnosis, treatment, prevention, and health services research
related to prevention and treatment of alcoholism. Centers are designed to
stimulate and encourage application of multiple perspectives and approaches
to alcohol related problems.
Support for four of the current 5-year Center grant awards will expire in
late 2003. Research within each of these Centers is organized around a
central theme: alcohol in host defense and infection with focus on HIV and
AIDS; identification of mechanisms to explain stimulus effects of alcohol on
central nervous system and brain response; gene and environment interaction
studies to clarify the respective influence of biological and social factors
on transmission of heritability in polygenic disease; development of
alcoholic liver disease and pancreatitis and the relative role of alcohol
during manipulation of secondary factors known to influence ethanol induced
tissue and organ damage. Applications for new Centers in these and other
research areas will be accepted with applications from currently funded
Centers seeking renewal support.
2. RESEARCH OBJECTIVES
All proposed research to be conducted within a Center must be clearly
directed toward one or more of the following goals: prevalence,
etiology, diagnosis, prediction, clinical course, management or
treatment of alcohol abuse, alcoholism, or alcohol-related health
problems; health services research; consequences of alcoholism or
alcohol abuse; and factors that relate to prevention of alcohol abuse,
alcoholism, or other problems associated with alcohol consumption. Some
examples are research to improve knowledge of the impact of alcohol use
on related health issues, such as human development and aging,
cardiovascular integrity; disease pathogenesis and progression; liver
and gastrointestinal functioning; nicotine and other drug use;
performance ability; neurological impairment; and mental disorders that
co-occur with alcohol abuse disorders.
The Alcohol Research Center grant provides a mechanism for fostering
interdisciplinary cooperation in a group of established investigators
conducting high-quality alcohol research. Therefore, existence of a
strong research capability is fundamental to the establishment of a new
Center or the continuation of an existing Center. A Center should be
an identifiable organizational unit within an institutional or
organizational structure such as a university, medical center, or a
consortium of affiliated cooperating institutions. Unique scientific
opportunities warrant collaboration with investigators in other centers
and/or with scientists in institutions outside the United States. In
such cases the director of the components in which collaborative
activity with a foreign organization is proposed must be affiliated
with a domestic institution.
Center Components
The following paragraphs describe the specific components of a Center
application:
Administrative Core Component
A Center should promote synergistic interaction of broad and diverse
elements that require clearly specified lines of authority and
accountability by appropriate institutional officials. The purpose of
the administrative core component is to provide the organizational
framework for the management, direction, and coordination of the
Center. The administrative core component must be managed by the
Center Director or Scientific Director and may include funds for
scientific enrichment activities such as special lectures, symposia,
seminars, and workshops for research faculty and staff.
Scientific Core Components
Core components for this RFA are defined as shared research resources
that enhance productivity or in other ways benefit a group of
investigators working in alcohol-related research to accomplish the
common goals of the Center. A core component is a laboratory,
facility, service, or other resource that interacts synergistically
with research projects of the Center. Cores should primarily be used
to support projects which are part of the Center Grant award, but they
may also be used for other support mechanisms such as Research Project
Grants, Program Projects, or a combination thereof, that have relevance
to the NIAAA mission. Core components should provide investigators with
some technique, instrumentation, service, or resource in a way that
will enhance research progress and contribute to efficiency and
effectiveness. Each core component is directed by an investigator with
established expertise relative to the support or service to be
provided, usually a faculty-level individual. Some examples of research
support that core components typically provide are: (1) technology that
implements automation or large batch preparation; (2) tissue and/or
cell culture facilities; (3) complex instrumentation, e.g., electron
microscopy, mass spectrometry, electrophysiology; (4) animal care and
preparation; (5) service and training; (6) patient coordination; and
(7) information processing, data management, and statistical services.
Research Components
Research components are individual scientific research projects,
interrelated within the overall Center program so that the components
contribute collectively to the goals of the Center program to a greater
extent than if each project were pursued separately. Each research
component must be a highly focused project under the direction of a
component director. The component director should be an established
researcher of independent and scientifically recognized standing who is
responsible for the scientific direction and conduct of the individual
research component. A Center Director or Scientific Director may also
serve as a component director.
Education Component (for P60 applications)
Comprehensive centers (P60) must include at least one component which
supports activities designed to translate research findings into health
care practice or public information dissemination. Such activities may
require a substantial portion of the first year for planning and
development with actual implementation beginning near the second and
continuing in subsequent years. These projects shall in a meaningful way
reflect the Center's program of research. The following examples are types of
projects that may be undertaken but are not limiting:
Translational Research: The development of collaborative partnerships to
advance the alcohol research field through translation of insights and
findings from basic and pre-clinical research to test hypotheses regarding
treatment and prevention of alcohol disorders; to improve interventions with
alcohol affected individuals in clinical practices, health care or community
settings; or the development of innovative interventions to study the effects
of services for diverse populations in disparate social, cultural and
environmental contexts.
Dissemination of Scientific Information and Research Progress: Dissemination
of scientific knowledge through educational efforts directed to the public,
patient populations, professionals and para-professionals; providing
information to educational institutions, the media and other appropriate
organizations/groups; and educational programs for specific audiences, e.g.,
children, women, elderly etc. Dissemination of scientific knowledge through
the establishment of research and research training collaborations for the
purpose of expanding the capacity of and other institution , including
minority serving institutions, in developing rigorous alcohol research
programs.
All translational and educational projects should have specific objectives
and include a method of assuring the effectiveness of the effort.
Pilot Project Component
The purpose of pilot projects is to provide the Center with a flexible
means to develop and explore new research activities or directions, and
unique scientific opportunities that could evolve into independently
funded research projects. These funds are not intended to supplement
ongoing research projects. Pilot projects must be in a separate pilot
project component that incorporates all of the pilot studies of the
proposed Center grant.
3. MECHANISMS OF SUPPORT
The Alcohol Research Centers Grant program is designed to complement
the regular research project grants program of the NIAAA by providing
long-term (typically for 5 years) support for interdisciplinary
research programs with a distinct focus on a particular theme relating
to alcoholism, alcohol abuse, and other alcohol-related problems. The
program is intended to encourage outstanding scientists from
biomedical, behavioral, social science, and other relevant disciplines
to bring a full range of expertise, approaches, technologies and
creativity to the study of problems related to alcohol abuse and
alcoholism. Center grants help to provide a stable environment for
investigators to engage in alcohol research in a coordinated,
integrated and synergistic effort. Centers are expected to be sources
of scientific excellence, provide leadership to the field, and, through
sustained excellence, to become significant regional or national
research resources. In addition, they are expected to attract
promising and established investigators and to provide training, career
development and mentoring opportunities to persons from various
disciplines and professions.
A specialized center (P50) is an integrated, broad-based
multidisciplinary, multi-investigator, long-term program of combined
research and research support activity planned around a specific major
research objective or research theme. In addition to providing support
for shared resources, this type of Center supports a full range of
basic, developmental, clinical, and/or applied research components;
allows for growth and development through pilot projects; and is
intended to provide state-of-the-art leadership in the alcohol field.
A comprehensive center (P60) expands the specialized center program of
research and research training by inclusion of additional components or
elements developed in conjunction with available community based
agencies, institutions, facilities and resources. Projects could
include community education and alcohol information dissemination to
the public and education for medical and allied health care
professionals concerning the problems of detection, diagnosis,
treatment and prevention of alcohol dependence and alcohol abuse.
While not all of these areas must be represented in one center, the
community education or information dissemination project proposed
should be a comprehensive approach and have a clear relationship to the
research theme of the center.
4. FUNDS AVAILABLE
It is estimated that approximately 7.0 million dollars will be available in
FY2004 to fund four or five Centers. The total cost (direct plus Facilities
and Administrative (F&A) costs) for a Center may not exceed $1.8 million per
year for a P50 and $2.0 million per year for a P60. Continuation support in
future years is anticipated.
5. ELIGIBILITY INSTITUTIONS
You may submit (an) application(s) 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
o Faith-based organizations
In addition, the proposed Center must be affiliated with an institution, such
as a university, medical center, or research center that has the resources to
sustain a long-term, coordinated research program. An applicant institution
must demonstrate the ability to attract high-quality scientists from
biomedical, behavioral, clinical and/or social science disciplines who
are willing to make a long-term commitment to research, and must assure that
research-training opportunities will be available. An application
must also have a detailed 5-year plan for a proposed research program.
6. 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 individual named as principal investigator for the Center grant will also
serve as Director of the Center. This individual must demonstrate the
ability to organize, administer, and direct the Center, and have sufficient
authority to allocate space, personnel, and other resources essential to the
Center.
7. SPECIAL REQUIREMENTS
The following paragraphs describe the Special Requirements for a Center
application. Details for preparing the application are provided in the
Supplemental Instructions (see Item 11.) It is essential that applicants
carefully adhere to the Supplemental Instructions.
Center grant applications should be organized into discrete components
that comprise a proposed program of research. Each component is either
a research component or a core component for which a separate detailed
budget is included in the application. The application must include an
administrative core and at least three research components; it may also
include shared scientific resource cores, education on translational research
component for P60s, and/or a pilot project component.
The minimum acceptable combined number of research components and core
components is four (an administrative core and three research
components). The maximum combined number of research components and
core components, including a pilot project component, is 10. An
education component does not count toward this total. More than a total
of 10 components is not acceptable even if some components are in
operation for less than the 5-year period. All proposed research
components need not be ongoing at any one time, but may be phased in at
different time points during the life of the proposed Center grant. At
least three research components must be ongoing at all times, and no
more than 10 research and/or core components may be proposed over the
entire project period. Education components do not count toward the
required three research components. This aspect should receive careful
attention in the application and individual component preparation.
The research plan for each core component, each research component, and
each education component is limited to 25 pages. Pages not used for one
component may not be used to extend the page limit of other
components/cores. These page limits do not apply to pilot projects.
For pilot project requirements, see section entitled "Pilot Project
Component," (below).
Administrative Core Component
The administrative core component plays a key role in the coordination
and operation of the Center. This core should be described in
sufficient detail to assure that all proposed components and related
activities will function optimally and in an interactive synergistic
manner. An important function of this core is the administration of
the budget. Through this component, the Center Director provides
substantive leadership and manages the administrative core component.
This component may also include the costs of scientific enrichment and
education activities for faculty and staff.
Scientific Core Components
Each shared scientific resource component should be clearly described
in terms of the services/resources to be provided to investigators.
The description should include a discussion of the core's contributions
to the research objectives of the Center. Relevant aspects of cost
effectiveness, timesaving, and increased efficiency attributable to the
existence of the cores should also be addressed. A core component
should support Center grant research components and may also support
separately funded research project grants that are related to the
Center's theme. Each separately funded research project associated
with the Center and utilizing core facilities should have a brief
description that includes its research objectives and how the Center's
core facility will impact upon it. The minimum number of research
components/projects supported by a core component is two.
A core component director who has documented experience and scientific
expertise relative to the purpose of the core must be designated for
each core. This person should be an established scientist in his or
her field. The description of the organization and mode of operation
of the shared resource core should include discussion of quality
control for the service or resource, and the procedures for evaluating
and selecting projects eligible for use of the core facility. Training
in complex techniques and methods should be described if they are
functions in proposed cores. Core components are intended to enhance
opportunities for investigators at the Center to include new
technologies that broaden their research initiatives. While, research
per se is not conducted as part of the scientific core, quality
assurance activities that evaluate the operation, resources, quality
and utilization of the core and that are directed at problem
identification and improvement of core functioning are appropriate.
In renewal applications, ongoing or completed core activity that has
enhanced or facilitated alcohol research should be described. Past
performance and accomplishments of cores should be described, as should
the effect of services provided by cores on investigators'
productivity.
Research Components
For each proposed research component, a clear description of the major
goals, objectives, and its integration with the other components in
relation to the overall Center program should be provided.
o The question(s) to be addressed and the hypotheses to be tested by
the proposed research should be highly focused and fully explained.
o A discussion of the design and procedures should describe the
strategies proposed to accomplish the specific aims of the project
and highlight innovative aspects of the approach.
o A description of the resources and working arrangements required to
implement and conduct the proposed research should be fully
elaborated with particular attention devoted to a description of
necessary resources, subjects, clinical populations, tissue
resources, etc., which will be involved in proposed studies. If
core facilities are utilized, information on their use should be
provided.
Education Component (for P60 applications)
For each education/translation component, a clear description of the
major goals, objectives, and its integration with the research
components in relation to the overall center program should be
provided. Specific projects for translational education/information
dissemination activities should be described. While the specific
number of education projects is at the discretion of the applicant,
requested funding for education component activities may not exceed
$100,000 or 10 percent (whichever is larger) of the direct cost budget
proposed for any one year. A staffing plan and rationale for
organization of this component should be presented. Methods,
techniques and technologies to be used for proposed activities should
be defined as well as the targeted audience or participants. Issues of
cultural sensitivity with regard to intended audience should be
addressed. When appropriate, activities should be designed to
effectively reach minority populations and/or subgroups based on age or
gender.
o The scientific knowledge base and research topics or areas upon
which proposed translational activities will be developed should be
identified and explained.
o A discussion of the design, plans and procedures for development
including time lines should describe strategies proposed to
accomplish specific aims of the project(s). Innovative aspects of
the approach to be used should be highlighted.
o A description of the resources, facilities, agencies, and/or
institutions with working arrangements to plan, implement and
conduct the proposed activities should be fully elaborated.
Particular attention must be devoted to a description of necessary
resources, including specialized expertise, and the target audience,
or participants who will derive benefit from the activity. If core
facilities or services are utilized, information on their use should
be provided.
o A description of plans to evaluate the success and/or effectiveness
of educational translational activities with emphasis on their impact on
knowledge, attitudes, and behaviors.
Pilot Project Component
The process for selecting pilot projects should be fully, though
concisely described. For the first 2 years that funds are requested
for pilot projects, the application must provide descriptions of the
projects to be supported. For years 03-05, the application must provide
the specific number of pilots planned in each year and a brief
description of the anticipated direction of these pilots. While the
specific number of pilot projects to be proposed is at the discretion
of the applicant, requested funding for pilot studies may not exceed
$100,000 or 10 percent (whichever is larger) of the direct cost budget
proposed for any 1 year. All proposed pilot projects need not be
ongoing at any one time, but may be phased in at different points
during the life of the proposed Center grant. It is recognized that the
relative priority or need for specific pilot projects may change over
the course of time.
While the Center's framework for management of pilot funds and the
mechanism for operating the program are left to the discretion of the
Center, the application must provide specific information to enable
adequate scientific evaluation by a peer review committee. The
application should include:
o A full description of the management of the pilot project component,
including a description of the process to be followed by the Center
Director in selecting new pilot projects and replacing projects
proposed in the application, should it become necessary.
o A full description of each pilot study proposed in the first 2
years, including its rationale, objectives, approach, investigators,
and significance for the Center. A description of the number and
anticipated direction of pilot projects in the 03-05 years,
including their significance to the Center. The research
description of any individual pilot project may not exceed five
pages; the entire narrative for this Pilot Project Component may not
exceed 25 pages irrespective of the number of pilot projects
proposed.
o For competing renewal applications, information should be provided
in the pilot project component description on the past experience of
the Center in utilizing pilot funds to further the goals. The
narrative should include an assessment of the overall benefits
derived from the availability of pilot resources.
A budget should be submitted for the pilot project component as a whole
for each year in which pilots are proposed. For years 01 and 02, this
budget will reflect costs of pilots proposed in the application. For
years 03-05, the budget will estimate cost based on the number and kind
of work to be pursued. In addition, budget information should be
provided for each individual pilot project including those for the 03-
05 years.
Supplemental Instructions provide further information on pilot project
description requirements.
Renewal Applications
A comprehensive progress report is required for competing continuation
(renewal) applications. A statement must be included in the application
regarding the progress made by the Center as a whole in its development
as a national or regional research resource. In addition, for each
research component of the existing Center grant, a succinct account of
its published and unpublished results must be provided, indicating
progress toward achieving aims regardless of whether the component has
been submitted for renewal. More specific details are provided in the
Supplemental Instructions.
Facilities and Environment
Applicants must demonstrate the availability of adequate laboratory,
clinical, and other office facilities needed to carry out the
objectives of the proposed Center program. Although not required, it
is desirable for all Centers to have a commitment for sufficient
contiguous space so that the Center has a high degree of cohesion and
visibility. Reference facilities affording access to relevant
literature must be readily available. It is expected that such
reference facilities will be the primary repository of additional
reference materials that may be obtained through Center funding.
Relevant support services, including adequate data processing
facilities, must also be readily accessible within or through the
institution. Assurances of such support must be included with the
proposal.
Organization and Administration
A Center must be an identifiable organizational unit with an
administrative structure and clear lines of authority which will
facilitate coordination among Center personnel to assure maximum
accountability and efficiency in Center operations. The Director of the
Center will have responsibility for planning and coordination of the Center
program, preparation of the budget and oversight of expenditures, staff
appointments, space allocation, and other aspects of management and
operation of the Center.
Overall program management, coordination, communication, progress
assessment, and quality control are typically responsibilities of the
Director and are facilitated through the administrative core. The
administrative core should be described in sufficient detail to assure
that all proposed components and related activities will function
optimally. In addition, day-to-day operations involving procurement,
finances, personnel, planning, and budgeting should be detailed in the
description of this core.
The applicant may also designate a Scientific Director who will be
responsible to the Center Director and provide direct supervision of
the scientific and operational aspects of the research program. Such a
person should be an individual who has established scientific
credentials and who is capable of providing the leadership essential to
the success of the center program. The Scientific Director will be
responsible for assuring interaction and collaboration among scientists
conducting research within the Center to facilitate a concerted
approach to the research goals of the Center. The Scientific Director
also will be responsible for the direct monitoring of ongoing research
and for identifying (with the assistance of colleagues) research and
educational activities to be expanded or decreased and needs for
additional resources or reallocation of resources. If the Center
Director also serves as the Scientific Director, his or her functions
as Scientific Director should also be described.
Key professional staff, such as directors of individual research
components and core components of the Center, should have the necessary
training/experience to assure that the objectives and goals of the
proposed studies will be achieved. Such persons must be independent
investigators with scientifically recognized standing.
A Program Advisory Committee shall be established and chaired by the
Center Director. Its membership, selected by the Center Director from
individuals outside the Center, should be composed of at least five
members. These members should be persons of recognized scientific standing
who are generally familiar with the Center's activities and represent a
cross-section of disciplines that are relevant to the work of the proposed
Center. It shall be the responsibility of this Committee to review and make
recommendations to the Center Director on the conduct of all activities
of the Center, including the management of pilot projects. If
committees other than the Program Advisory Committee are included,
specific plans regarding committee selection and function should be
provided in the application.
Training
While the primary function of each Center is the conduct of high-
quality interdisciplinary research, an important component related to
the Center and its research efforts is the training of research and
clinical personnel. The applicant institution must therefore
demonstrate or give reasonable assurances that it has:
(a) the capacity to train predoctoral and/or postdoctoral students
for careers in alcohol research; and
(b) the capacity to conduct programs of continuing education in the
Center's designated research theme in the medical, behavioral,
epidemiological, or health service fields.
While the Center need not necessarily have formal training programs of
its own, there must be specific provision for coordination between the
Center and the training programs of the applicant institution and/or
affiliated institutions. Center grant funds may not be used to pay
stipends or other trainee costs; however, Center staff may participate
in the development of training programs, and Center resources may be
made available for use of trainees.
8. WHERE TO SEND INQUIRIES
Written and telephone inquiries concerning this RFA are strongly
encouraged. The opportunity to clarify any issues or questions from
potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Ernestine Vanderveen, Ph.D.
Centers Program
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 302
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-2531
FAX: (301) 480-2358
Email: tvanderv@willco.niaaa.nih.gov
Direct inquiries regarding fiscal matters to:
Judy Fox Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
(Rockville, Maryland 20852 for express/courier service)
Telephone: (301) 443-2434
Email: jsimons@willco.niaaa.nih.gov
9. 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 IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Ernestine Vanderveen, Ph.D.
Centers Program
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 302
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-2531
FAX: (301) 480-2358
Email: tvanderv@willco.niaaa.nih.gov
10. 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) 435-0714,
Email: GrantsInfo@nih.gov.
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)
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. If so, a letter of agreement from either the GCRC program
director or principal investigator should be included in the
application materials.
At the time of submission, two additional copies of the application
plus appendices must also be sent to:
RFA: AA-03-001
Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
FAX: (301) 443-6077
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.
11. SUPPLEMENTAL INSTRUCTIONS
Supplemental instructions for preparing your application may be found on the
NIAAA website at:
http://www.niaaa.nih.gov/extramural/supplemental.htm
12. PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the appropriate IC.
Incomplete applications will be returned to the applicant without further
consideration. And, if the application is not responsive to the RFA, CSR
staff may contact the applicant to determine whether to return the
application to the applicant or submit it for review in competition with
unsolicited applications at the next appropriate NIH review cycle.
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 IC 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 NIAAA or NCCAM National Advisory
Council.
13. REVIEW CRITERIA
The initial review for scientific and technical merit of applications
will emphasize two major aspects: (1) review of the Center as an
integrated research effort focused on a central theme, including the
administrative core; and (2) the review of each research component,
education component, all other core components, and the pilot component
as applicable. This review will also include an assessment of the
academic and physical environment and special considerations, e.g.,
compliance with human subject and animal welfare requirements, and
compliance with policies concerning inclusion of women, minorities and
children in clinical research study populations.
A) ADMINISTRATIVE CORE
1) Key Staff
o Qualifications, experience, commitment and administrative
competence of the Center Director
o Ability of the Center Director to devote substantial time and
effort to the Center
o Scientific ability of the Scientific Director and his or her
professional experience and leadership
o Ability of the Scientific Director to devote substantial time and
effort to the Center
o Scientific qualifications and ability of the directors of the
research components, education components, and core components
and their commitment to the center
2) Arrangements and Organizational Structure
o Processes to facilitate and monitor attainment of Center
objectives
o Plans for communication and cooperation among investigators
involved in the Center
o Quality control and oversight mechanisms for ongoing projects
o Day-to-day management
o Long-term management and periodic evaluation of goal attainment
o Contractual and consortium arrangements (as applicable)
o Procedures for replacement of key personnel, if necessary
B) SCIENTIFIC CORE COMPONENTS
o Need/justification for the core service/resource
o Scientific and technical merit of the service/resource provided
o Plans for resource allocation
o Quality control procedures
o Qualifications, experience, and commitment of the component
director
o Adequacy of component director's time and effort
o Adequacy of the resources and environment
C) RESEARCH COMPONENTS
o Significance: Does this study address an important problem? If the
proposed aims are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
o Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to
the aims of the project? Does the investigator acknowledge potential
problem areas and consider alternative tactics?
o Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
o Investigators: Is each investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to
the experience level of the component director and other researchers
(if any)?
o Environment: Does the scientific environment in which the work will
be done contribute to the probability of success of the project?
Does the proposed research take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
Is there evidence of institutional support?
D) EDUCATION/TRANSLATIONAL COMPONENTS (for P60 applications)
o Significance: Does this project address an important topic? If the
proposed aims are achieved, how will the level of science based
knowledge be enhanced? What will be the effect of these projects on
knowledge, attitudes and behaviors?
o Approach: Are the conceptual framework, design, methods, and
evaluations adequately developed, well-integrated, and appropriate
to the aims of the project? Does the project director acknowledge
potential problem areas and consider alternative tactics?
o Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
o Investigators: Is each investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to
the experience level of the component director and other
professional staff (if any)?
o Environment: Does the environment in which the work will be done
contribute to the probability of success of the project? Does the
proposed project take advantage of unique features of the academic
and community resources and employ useful collaborative
arrangements? Is there evidence of institutional support?
E) PILOT PROJECT COMPONENT
1) Pilot Project Component
o Adequacy of the selection process for new and replacement pilot
projects
o Monitoring and oversight procedures and continuation decisions
o Adequacy of the resources and environment for all projects
2) Individual Pilot Projects
o Importance of topic
o Grounding in the literature or empirical findings
o Reasonableness of the approach
o Potential to develop into full-scale independent project
o Qualifications of the project director
F) CENTER AS AN INTEGRATED WHOLE
1) Significance
o Significance of the overall research goals
o Development of a well-defined central theme
o Multidisciplinary scope
2) Coordination and Cohesiveness
o Interrelatedness of administrative core, scientific cores,
research components and education components with each other
o Usefulness of scientific core components to research components
and to independently supported investigators who use them
o Synergistic potential among Center components and core units
o Justification for each research component in terms of the central
theme and the overall research goals of the Center
o Justification for each scientific core component in terms of
accomplishing center objectives
3) Resources and Environment
o Institutional strength, stability, commitment to research, and
support of the Center, including fiscal responsibility and
management capability to assist the Center Director and staff in
complying with DHHS, PHS, and NIH policies
o Opportunities for research training and education for persons
from various disciplines and professions
o Potential for interaction with scientists from other departments
and institutions
o Academic and physical environment in which the research will be
conducted, including availability of space, equipment, research
subjects, and materials
4) Potential as a Resource
o Potential of the Center to become or maintain itself as a
regional and national resource
o Capacity to provide quality research training, opportunities for
independent research career development
o Plans for research information dissemination and educational
activities
5) Renewal Applications
o Degree to which the Center achieved stated goals with special
attention to:
- scientific merit of completed research
- recruitment of new scientists into alcohol research
- development of a multidisciplinary team
- coalescence of Center staff into an effective team
OTHER CONSIDERATION
For the Center as a whole and all components/cores. In addition to the
above criteria, in accordance with NIH policy, all applications will
also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and
their subgroups, and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention
of subjects will also be evaluated.
o The reasonableness of the proposed budget and duration in
relation to the proposed research.
o The adequacy of the proposed protection for humans, animals or
the environment, to the extent they may be adversely affected by
the research proposed in the application.
o The adequacy of the proposed plan to share data, if appropriate.
14. RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 12, 2002
Application Receipt Date: December 10, 2002
Peer Review Date: Spring 2003
Council Review: September 18, 2003
Earliest Anticipated Start Date: December 1, 2003
15. AWARD CRITERIA
Center grant funds may be requested for support of core components,
individual research components and education components associated with
the Center program. Administrative core resources may include, for
example, salaries of personnel responsible for management of the
Center, program enrichment activities for investigators and staff such
as special lectures, visiting scientists, symposia, seminars,
workshops, etc., and costs related to dissemination of research
information to the scientific community and lay public. Funds may be
requested for costs associated with individual components that are part
of the Center program. Examples of such costs include: research staff
salaries, supplies, travel, special consultation, research patient
costs, publication costs, and the like. Funds also may be requested
for the allowable indirect costs of the applicant organization. In
addition, costs of advisory committees and consultants may be included
in the administrative core. Consultants for specific components should
be included in the budgets for those components.
Alcohol Research Center grant funds may be used only for costs that are
necessary to carry out the research, research support and education
activities of the Center program, and must be in conformance with HHS
cost principles (encompassed in 45 CFR Part 74) and the NIH Grants
Policy Statement (effective 10/98). This publication should be
available from your office of sponsored research.
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 PHS grants policy limitations. Funds provided
through Center grants may not be used for support of trainee stipends,
fees, or other expenses directly relating to training activities.
Research, research information dissemination and training activities
associated with the Center may receive additional funding from Federal
sources as well as from State and local sources. The NIAAA expects and
encourages the institution and scientists attracted to such Centers to
seek and compete actively for such funding. Research staff in funded
Centers may submit applications for independent research project grants
for support of research projects that do not overlap with their Center
project(s).
Centers will be required to submit detailed annual progress reports
including substantive information about research results to date,
status of ongoing research, research plans for the next year, and any
modifications in long-term research plans. Also required are reporting
of inventions, reports of expenditures, final reports, and other
reports in accordance with NIH policy.
In view of the special significance of this program, close coordination
and communication between the NIAAA staff and staff of the Alcohol
Research Centers is intended. The NIAAA program official will have
responsibility for maintaining liaison with appropriate Center
leadership, serving as resource consultant to the Center program, and
keeping NIAAA staff informed on progress and accomplishments of the
Centers. In addition, the program official with other NIAAA staff and
consultants will, from time to time, make on-site visits for purposes
of program coordination and exchange of information.
Applications recommended by the National Advisory Council
on Alcohol Abuse and Alcoholism will be considered for funding on the
basis of the overall scientific merit of the application as determined
by peer review, as well as such considerations as program balance,
relevance to the mission and goals of NIAAA, research program
priorities, equitable geographic distribution, continuity of support,
and availability of funds. Awards will be made for up to 5-year
project periods with separate fiscal awards made annually.
16. REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND 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: 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.
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.
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 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.
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. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.891. Awards are made under the authorization of the
Public Health Service Act, Sections 301 and 464J, and administered
under the Federal Regulations at Title 42 CFR Part 549, "Grants for
National Alcohol Research Centers" and 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 PHS strongly encourages all grant 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.
Return to NIH Guide Main Index
|
|
Office of Extramural Research (OER) |
|
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
|
Department of Health and Human Services (HHS) |
|
||||
|
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |
||||||||||