TRANSDISCIPLINARY PREVENTION RESEARCH CENTERS
RELEASE DATE: December 19, 2002
RFA NUMBER: DA-03-008
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
Letter of Intent Receipt Date: March 28, 2003
Application Receipt Date: April 28, 2003
THIS REQUEST FOR APPLICAIONS (RFA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms 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 Drug Abuse (NIDA) invites exploratory center grant
applications (P20) to support the development of transdisciplinary prevention
research centers (TPRCs). These centers will extend the work of NIDA's
National Prevention Research Initiative (NNPRI: Community Multi-site
Prevention at http://www.nida.nih.gov/researchtraining/traininghome.html)
by creating environments in which scientists from the basic and
applied/clinical disciplines can come together to develop a coherent program
of transdisciplinary research. The ultimate goal of these centers is to
overcome the barriers inherent in integrating cross-disciplinary concepts,
methods, and findings that hold promise for the development of innovative
prevention intervention questions and approaches. Thus, it is expected that
a transdisciplinary approach will explore and catalyze new ways of
conceptualizing prevention research. These centers are intended to maximize
creativity through establishing environments for ongoing interactions and
collaborations focused on theory-driven research.
RESEARCH OBJECTIVES
Background
Previous research has identified significant risk and protective factors that
influence drug abuse. Discoveries from the basic biological (e.g.
neurobiological), psychological (e.g. emotional, behavioral, cognitive, and
developmental) and social (e.g. social learning, peer network, and
communications) sciences have elucidated individual and group vulnerabilities
to drug use initiation and escalation from occasional use to abuse. Based on
these findings and their underlying theoretical frameworks, over two decades
of prevention research have produced prevention programs with proven efficacy
and effectiveness, from which a general set of science-based prevention
principles has emerged. However, much existing research on biological,
psychological, and social processes and mechanisms has not been fully
utilized for purposes of developing and testing innovative, potentially
efficacious, drug abuse prevention interventions.
Research Goals and Scope
NIDA recognizes the need to maximize the use of existing underutilized
approaches and research findings from biological, psychological and
behavioral sciences for the development of innovative preventive
interventions targeted to the initiation and escalation of drug abuse. Thus,
transdisciplinary collaborations in these exploratory research centers
should: (1) stimulate the translation of basic science discoveries to the
design of innovative preventive intervention components, and (2) capitalize
on prior drug abuse prevention research to inform basic science hypotheses
that have implications for the development of new intervention paradigms or
refinement/improvement of existing programs.
To stimulate the development and testing of new prevention paradigms, a
number of research directions could be taken. For example, existing findings
from the basic sciences could facilitate: (1) identification of malleable
biological and social mediators as targets for intervention; (2) development
of interventions targeted to specific patterns of interactions between
environmental, neurobiological or genetic factors that produce vulnerability
to drug abuse; and/or (3) integration of knowledge about patterns of abuse
and context-specific factors into the development of tailored interventions.
Findings from these studies could then inform the development of new
intervention components.
In developing and testing research hypotheses derived from science-based
intervention findings, the underlying biological, psychological, and social
processes that contribute to outcome success could be explicated. For
example, a more complete understanding of critical biological, psychological,
and social processes and mechanisms targeted by interventions would allow
for: (1) the identification, modification, or elaboration of critical
underlying features responsible for successful program results or impact at
the group and/or individual level; (2) the development and pilot testing of
new paradigms based on what is learned about sustained behavior change or
alteration of developmental trajectories; and (3) ultimately the testing of
new or evolved features of prevention approaches in laboratory or small-scale
efficacy trials.
Inherent in these lines of research is the challenge to better characterize
individuals and subgroups in regard to traits or characteristics (e.g., endo-
phenotyping using neurobiological assessments, sensation-seeking, impulse
control, arousal level, stress reactivity, environmental deprivation or
enrichment, social cohesion) that may influence their responsivity to
interventions, and can subsequently inform targeted intervention strategies.
It is the intent of this RFA to support transdisciplinary collaborations
along a continuum of prevention-related research ranging from basic science
in the interest of program component development, to pilot testing, and
feasibility studies. Three types of studies, laboratory, pilot, and
efficacy, are appropriate for inclusion in project areas. The following are
examples of these study types:
(a) Laboratory studies: Basic biological, psychological, and social research
studies, with imminent application to the development and testing of theory-
based or hypothesis-driven innovative prevention intervention components or
programs in human laboratory settings;
(b) Pilot studies: Research that integrates discoveries from basic
biological, psychological, or social research into the development,
refinement and testing of prevention intervention strategies in small, highly
controlled pilot studies with particular attention to moderators and
mediators of effects;
(c) Efficacy studies: Feasibility testing of novel intervention strategies
that show promise in laboratory or pilot studies through the use of small-
scale efficacy studies with random assignment to control or intervention
condition conducted in highly structured real world settings.
NOTE: Investigations supported through this RFA must simultaneously or
sequentially address drug abuse prevention questions at two or all of these
levels.
Centers must focus thematically on areas of research for which: (1) there are
significant gaps in the integration of knowledge from several disciplines;
(2) there is imminent potential for contributing to the development of new
approaches to drug abuse prevention; and (3) there is evidence that the
thematic focus can benefit from transdisciplinary collaboration. Applicants
are encouraged to include the study of developmental, gender, racial/ethnic,
cultural, sexual orientation, geographic, and socioeconomic differences when
possible and appropriate.
The following examples of scientific themes that might benefit from
transdisciplinary collaborations are not intended to be inclusive; many other
topics may be significant and appropriate:
o Examination of drug use decision-making processes of adolescents, with
emphasis on the identification of modifiable elements (e.g., presumed risk,
predicted outcomes and expectancies, interactions between cognitive processes
and emotional states) that can be used to develop potential intervention
components;
o Studies that develop and test intervention components based on established
basic science findings on malleable psychological and social factors (e.g.,
selective disinhibition, negative attributional biases, and poor affect
management);
o Integration of new methodologies or techniques into existing science-based
prevention intervention components to develop more precise targeting (e.g.,
examination of the relation between brain development, drug using behaviors
and other domains of behavioral functioning; patterns of activation in
cortical and subcortical circuits underlying emotional and cognitive
responsivity to prevention messages);
Characterization of underlying biological, psychological or social processes
resulting in positive changes among drug abuse prevention intervention
participants (e.g., identification and modulation of markers or indicators of
stress reactivity or impulsivity, role of socialization and other social
factors);
o Exploration and adaptation of models of behavioral change used in
prevention interventions for diseases, disorders, or risk behaviors outside
of the area of drug abuse;
o Studies that incorporate findings on the processes and mechanisms by which
family interactions, peer dynamics, social networks and other contextual
variables confer vulnerability or resiliency for drug abuse (e.g., sibling
drug use, subtle reinforcement of antisocial attitudes and behaviors) into
the development of novel targeted interventions.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) exploratory center
grant award (P20) mechanism (see
http://www.nida.nih.gov/Funding/GrantGuidelines.html). The P20 mechanism
provides the opportunity for a transdisciplinary group of investigators to
focus on a common problem through facilitation of coordinated communication
and research across disciplinary and geographic boundaries. For the purposes
of this RFA, transdisciplinary research is defined as a cooperative effort by
a team of investigators from diverse disciplines including meaningful
representation of basic sciences as well clinical or applied sciences.
Normally, a transdisciplinary team of investigators will include persons from
different departments but the key issue is that the team will include members
who bring markedly diverse methods and concepts to bear on the scientific
theme. Thus, the TPRCs are expected to foster transdisciplinary integration
of knowledge and collaborations relevant to the development of novel and
innovative drug abuse prevention interventions. The P20 centers called for in
this RFA must demonstrate the following characteristics: (1) thematic
synergy and interrelationship of the constituent core(s) and project areas;
(2) commitment and ability to capitalize on concepts, approaches and findings
from various scientific areas in the conduct of transdisciplinary research;
(3) ability to conduct transdisciplinary research using laboratory, pilot
and/or feasibility designs; (4) explication of how each project area and core
enhances the overall research goals and synergy of the center; (5) mechanisms
for ensuring information sharing within and across project teams and sites on
a frequent and ongoing basis, which may include a scientific advisory board
comprised of outside scientists and prevention practitioners if this will
foster the research aims of the center; and (6) a research training and
career development component designed to ensure the meaningful development of
transdisciplinary collaborations.
Participation of key center personnel in the NNPRI Network will help to
foster the national presence of each TPRC.
As an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award date
is September 30, 2003.
FUNDS AVAILABLE
NIDA intends to commit approximately $2,500,000 in FY 2003 to fund two to
three P20 awards in response to this RFA. Additional awards will be
considered based on availability of funds. Funding in response to this RFA
is dependent upon the receipt of a sufficient number of applications of high
scientific merit. Although this program is provided for in the financial
plans of NIDA, the award of grants pursuant to this RFA is contingent upon
the anticipated availability of funds for this purpose. This RFA is a one-
time solicitation; subsequent applications will be expected to compete under
NIDA's ongoing Centers PA or through other available mechanisms.
Under this RFA, exploratory research center applications (P20) may request
budgets up to a maximum annual of $1.2 million in total costs (including
direct and indirect costs). The total project period for an application
submitted in response to this RFA may not exceed five years. The anticipated
award date is September 30, 2003.
ELIGIBLE 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
o Faith-based and community-based organizations
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 OF TPRCs
1. TPRC Core(s)
Each center will consist, at a minimum, of an administrative core responsible
for developing and maintaining an infrastructure that supports reciprocal
transdisciplinary communication and interaction among researchers and
scientific projects areas (outlined below). To facilitate this interaction,
each center must propose a coherent plan for developing interactions among
center scientific staff that is reflected in the organizational structure of
the center and in the conceptualization, planning and implementation of
scientific project areas of the center. The administrative core will also
facilitate participation of key center personnel in the NNPRI Network for the
purposes of fostering expanded collaborations and ideas to support the
development of transdisciplinary research. Thus, the annual Network meeting
will provide a forum for sharing emerging findings, assessing scientific
progress in the field, mapping new directions for research, and promoting
cross-project and cross-center collaborations. The administrative core is
expected to facilitate cross-site and cross-project area of collaborations to
accelerate the pace of discovery by providing a means for rapid assembly of
research teams and scientific advisory board members, independent of
geographic location. The administrative core must document procedures for
adequate supervision and development of project areas. Finally, the TPRCs
are expected to be ideal settings for training future generations of
transdisciplinary prevention researchers and providing cross-disciplinary
training for their own researchers. Thus, objectives for training and career
development must be addressed in the application. Awardees will be
encouraged to augment training and career development capacity through the
use of National Institutes of Health training and career development
mechanisms (see http://www.nida.nih.gov/researchtraining/traininghome.html.)
An additional core or cores may be included as deemed necessary to provide
shared resources in other critical areas (e.g., subject, data, and
statistical management, laboratory equipment and management).
2. Project Areas
The TPRC must include a minimum of 3, and not more than 5, project areas with
justifiable or demonstrated transdisciplinary potential. Each project area
must, at a minimum, provide: a clear review of the empirical and theoretical
literature that points to the potential of the project area for development
of innovative prevention components; a description of the significance,
importance, and potential impact of the proposed research for drug abuse
prevention; a well-specified plan for integration of concepts and
methodologies from the basic and clinical/applied sciences; preliminary aims
and hypotheses that are clearly related to both the center theme and the
project area; a complete discussion of procedures, data analytic strategies
and expected outcomes of the proposed line of research; at a minimum, one
fully developed laboratory or pilot study; and a conceptual mapping that
anticipates and justifies future studies for the support period requested.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Susan E. Martin, Ph.D.
Division of Epidemiology and Prevention Services
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-1514
FAX: (301) 443-2636
Email: sm458s@nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIDA 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:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for courier or express delivery)
Telephone: (301) 443-2755
Fax: (301) 443-0538
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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS: (Center applications must clearly articulate the
following features:)
1. General Description of the Overall Project (Not to exceed 10 pages):
The applicant must provide an overview of the proposed exploratory research
center including its theme, the background from the included scientific areas
that point to the need for their integration, the current empirical and
theoretical knowledge supporting the theme, the general objectives of the
center, and the scientific integration and contribution of each project area
and core to the overall project. Specifically, centers must provide strong
evidence of thematic integration, synergy and the potential for
transdisciplinary collaborations and interactions between basic and clinical
or applied researchers; an overall scientific theme with clear potential for
informing innovative drug abuse prevention efforts; evidence of
interdependency of the proposed center theme, project areas, and core(s);
potential for basic science to inform the design of innovative drug abuse
prevention interventions and/or for prevention research studies to generate
testable hypotheses at the basic science level that will subsequently
"feedback" to inform prevention intervention development; and explanation of
how a transdisciplinary approach will accelerate research on innovative
prevention intervention approaches.
2. Cores (Not to exceed 10 pages for the administrative core and 5 pages for
any one other core):
The applicant must describe how each core will contribute to the goals of the
overall project as well as how each project area will utilize resources
provided by the core(s). The description of a core must clearly indicate the
facilities, resources, services, and professional skills and expertise that
the core will provide to the project areas. The center may include other
core structures as deemed necessary to provide shared resources in critical
areas (e.g., subject, clinical, data, equipment, statistical management, or
laboratory facilities). If more than one core is included, a clear
description of how the cores will collectively operate to produce a coherent
center must be provided.
At a minimum, one administrative core is required to ensure effective and
synergistic functioning among project area teams; to promote the conduct of
innovative, transdisciplinary research by supporting interactions and
collaborations between constituent investigative teams; to provide for
effective administration and organization of the center, effective long-range
planning, evaluation of center activities, quality control, and effective
budget management; to provide administrative structure for the development of
transdisciplinary training and career development; and to facilitate
interactions with other components of the NNPRI. The administrative core
will be directed by a scientifically and administratively qualified principal
investigator with overall responsibility for scientific, administrative,
budgetary and operational aspects of the center; the principal investigator
must demonstrate ability to provide direction and ensure the development of a
transdisciplinary research program and team; the application's principal
investigator (as noted on the face page of the application) must commit 25
percent effort to the activities of the core, in addition to other effort
proposed for the center; and there must be support sufficient for the
effective administration of the center including a minimum of the equivalent
of one full-time support staff to the principal investigator. The processes
must be described through which the TPRC scientists will supervise and
develop the specific project areas over the full period of the TPRC. A full
budget justification must be included. Evidence of institutional commitment,
such as adequacy of facilities, equipment, and space, to promote the
transdisciplinary research objectives must be documented.
3. Project Areas (Not to exceed 15 pages for any one project area):
Applications should include descriptions of a minimum of 3 proposed research
project areas that focus on different aspects of a common significant and
innovative scientific theme or problem with applicability to drug abuse
prevention. Discussion of the current state of the science and limitations of
existing approaches in the thematic area is required. The major aims and
hypotheses of the project area and their relation to the center and the
constituent cores and project areas must be documented. Descriptions of the
transdisciplinary nature and expected contributions of the project area to
the development of transdisciplinary themes of the center are required. The
stated aims and hypotheses of the project area must either fully explicate a
line of research or provide a conceptual map and justification for additional
studies. Detailed plans for at least one laboratory or pilot study must be
developed and included. Proposed project areas should incorporate the
following into the application: A clear description of the project areas
with examples of how theoretical or empirical evidence from existing
preclinical, human laboratory or field research can be immediately integrated
into the design of innovative preventive interventions and/or examples of
findings from drug abuse prevention research that will be used to inform the
design of basic science studies with feedback potential for intervention
development, or modification or elaboration of existing prevention programs;
justification for how the proposed project areas and core(s) address research
questions or problems integral to the scientific theme of the center; a
description of the project areas' contribution to the overall synergy of the
TPRC; and a detailed budget for all proposed and planned work. A data safety
and monitoring (DSM) plan may be required.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/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/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for courier or express delivery)
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 NIDA. 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 NIDA 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 Drug
Abuse
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. Overall Application: In reviewing the overall scientific merit of the
center, reviewers will be asked to address:
The likelihood of a significant impact on the field of drug abuse prevention;
the innovation and transdisciplinary potential of the center's proposed
research activities; the quality of the integration of the center components
in relation to the center theme, including the scientific compatibility of
all center components with the theme; relevance of the planned research
activities to fulfilling the stated goals of the center; mechanisms for
facilitating relationships between center components; involvement of a
variety of scientific disciplines in the planning and conduct of the science;
the appropriateness and adequacy of plans for development of
transdisciplinary competencies among team members; the appropriateness and
adequacy of facilities to the conduct of the science proposed; the
appropriateness and quality of the proposed shared (core) facilities to the
proposed work; the quality of the available supportive analytic,
methodological and technical expertise; ability of the center Principal
Investigator to direct and integrate the center science; the quality of the
investigative team; and evidence in the budget requested that use of this
center mechanism adds to the cost-efficiency of conducting the research.
2. Administrative Core: In reviewing the administrative core, reviewers will
be asked to address:
The ability of the administrative core to coordinate and foster the synergy
of project areas around an overarching transdisciplinary theme or topic
related to drug abuse prevention; the adequacy of plans for effective
implementation of research objectives; the ability to promote and facilitate
collaboration and interaction between basic and applied/clinical researchers;
the ability of the administrative and organizational structure to facilitate
innovative and scientifically rigorous transdisciplinary research studies;
the quality of the plans for development and maintenance of shared resources;
the scientific qualifications, including demonstrated scientific and
administrative leadership capabilities of the Center Principal Investigator
and other key scientific personnel; the adequacy of the plan for submission,
review, and oversight of additional project area research projects; the
adequacy of plans for intra-center and NNPRI network interaction,
communication and collaborations; evidence of the institution's commitment to
the proposed center; the adequacy of internal processes that allow for
program area priority setting; and adequacy of the plans and objectives for
providing cross-disciplinary training and career development.
3. Optional Core(s): In reviewing optional cores, reviewers will be asked to
address:
The ability of the core to support the synergy of project areas around an
overarching transdisciplinary theme or topic related to drug abuse
prevention; the ability of the core to promote and facilitate collaboration
and interaction between basic and applied/clinical researchers; the ability
of the core activities to facilitate innovative and scientifically rigorous
transdisciplinary research studies; the quality of the plans for development
and maintenance of shared resources; the scientific qualifications, including
demonstrated scientific and administrative leadership capabilities of core
investigators other key scientific personnel.
4. Project Areas. In reviewing individual project areas, reviewers will be
asked to address:
SIGNIFICANCE. Is there empirical and theoretical literature support for the
potential of the project area for development of innovative prevention
components? Does the project area address issues of substantive importance
for either informing prevention development efforts or formulating novel
questions in basic science that can shape prevention directions? Does the
application provide a well-specified plan for integration of concepts and
methodologies from the basic and clinical/applied sciences? Are the
preliminary aims and hypotheses clearly related to both the center theme and
the project area and is there adequate a complete discussion of procedures,
data analytic strategies and expected outcomes of the proposed line of
research.
APPROACH. Are the conceptual framework, research aims, hypotheses, design,
methods, and analyses adequately developed, well integrated and appropriate
to the project area? Does the application present a conceptual map of how
the work is expected to proceed given confirmation or disconfirmation of
hypotheses? Does the applicant acknowledge potential problem areas and
consider alternative approaches? Are transdisciplinary links apparent in the
description of the project area and associated studies? Does the application
describe specific processes through which reciprocal interactions among basic
and applied/clinical researchers will be facilitated?
INNOVATION. Does the project area utilize or develop methodologies or
technologies in the basic sciences that have the potential to inform the
development of prevention intervention components, or utilize findings from
drug abuse prevention research that provide new hypotheses for investigation
in the basic sciences with feedback potential for the development,
significant modification or elaboration of interventions? Does the proposed
project area reflect sufficient originality, novelty, and innovation to make
it highly relevant to the overall transdisciplinary theme of the center?
INVESTIGATORS. Are the investigators appropriately qualified with
demonstrated competence to conduct research in the proposed project area? Is
the proposed work appropriate to the experience level of the principal
investigator and project researchers? Are the proposed time commitments for
key laboratory and clinical researchers reasonable and adequately reflected
in the proposal?
ENVIRONMENT. Does the scientific environment in which the work will be done
contribute to the probability of success? Does the proposed project area
take advantage of the unique, transdisciplinary features of the scientific
environment and specify scientifically useful collaborative arrangements? Is
there evidence of adequate institutional support? Is the project area
interactive and integrative with other components of the TPRC, thematically,
conceptually, and experimentally? To what extent is this project area an
essential part of, and contributor to the realization of the overall thematic
goals of the center?
LABORATORY/PILOT STUDY. (Each of the project areas must include, at a
minimum, one fully developed laboratory or pilot study, which should
demonstrate the operationalization of the project area's direction, and
reflect on the internal review process used by the Administrative Core to
implement submission, review, and oversight of additional research projects
that may be started in future years.)
(1) Significance: Does this study address an important problem? If the aims of
the application 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 and the project area within the Center?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do they reflect the transdisciplinary goals of the Center? Does
the applicant acknowledge potential problem areas and consider alternative
tactics?
(3) Innovation: Does the project employ novel concepts, approaches, or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
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, including a DSM plan.
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 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 28, 2003
Application Receipt Date: April 28, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phases 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: https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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
https://grants.nih.gov/grants/funding/children/children.htm.
NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on
Drug Abuse recognizes the importance of research involving the administration
of drugs to human subjects and has developed guidelines relevant to such
research. Potential applicants are encouraged to obtain and review these
recommendations of Council before submitting an application that will
administer compounds to human subjects. The guidelines are available on
NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by
calling (301) 443-2755.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG
ABUSE: Researchers funded by NIDA who are conducting research in community
outreach settings, clinical, hospital settings, or clinical laboratories and
have ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling. HIV
counseling should include offering HIV testing available on-site or by
referral to other HIV testing service for persons at risk for HIV infection
including injecting drug users, crack cocaine users, and sexually active drug
users and their sexual partners. For more information see
https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html
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
https://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 https://grants.nih.gov/grants/stem_cells.htm and at
https://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
https://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.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.279, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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 described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.