TRANSDISCIPLINARY TOBACCO USE RESEARCH CENTERS
RELEASE DATE: October 3, 2003
RFA Number: RFA-CA-04-012 (see NOT-CA-03-040, NOT-CA-03-042, and NOT-CA-03-043)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.399, 93.279, 93.891
LETTER OF INTENT RECEIPT DATE: December 26, 2003
APPLICATION RECEIPT DATE: January 23, 2004
This RFA is a reissue of RFA-CA-98-029, which was published in the NIH
Guide on December 11, 1998.
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Pre-Application Meeting
o Submitting an Application
o Supplementary Instructions
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 Cancer Institute (NCI), the National Institute on Drug
Abuse (NIDA), and the National Institute on Alcohol Abuse and
Alcoholism (NIAAA) invite center grant applications (P50) for
Transdisciplinary Tobacco Use Research Centers (TTURCs). The reissue
of this RFA reflects recognition of the public health impact of tobacco
use and the scientific need for integrative transdisciplinary research
across the full spectrum of basic and applied research on tobacco use
and control. Tobacco use control and addiction research spans diverse
areas ranging from molecular biology, genetics, neuroscience and
epidemiology to imaging, primary care, behavioral science,
communication, health policy, biostatistics, economics and marketing.
Collaborative research across disciplinary boundaries permits
scientific exploration of the complex and interactive determinants of
tobacco use. Transdisciplinarity is a process by which researchers
work jointly using a shared conceptual framework that draws together
discipline-specific theories, concepts, and approaches to address a
common problem.
A TTURC is required to have a minimum of three major research projects;
must provide career development opportunities for new investigators and
established investigators who wish to pursue active research careers in
transdisciplinary tobacco use research; provide developmental funds for
innovative pilot projects; and participate with other TTURCs on a
regular basis to share information, assess scientific progress in the
field, identify new research opportunities, and promote inter-TTURC
collaborations to promote discovery and to resolve areas of scientific
controversy. The use of shared methodologies between TTURCs will
promote collection of comparable data across several lines of research
and allow greater generalizability of results. The centers also are
encouraged to form partnerships with industry, e.g., to advance
medication development. Collaborations with NIH intramural programs
also are encouraged. In addition, collaborations also should be
considered with universities, public health agencies, and other
organizations that have strong ties to minority communities with high
smoking rates. Each TTURC and the "network" of TTURCs are expected to
conduct research that will lead to major scientific advances in
knowledge about tobacco use and its prevention and treatment. The
centers funded by this initiative are expected to both broaden and
integrate the expertise required to advance the science of tobacco use
and control. Centers are expected to be creative, innovative, and
involve investigators from a broad range of disciplines and
perspectives. It is expected that the research will engage the
appropriate range of transdisciplinary tools and approaches to allow
significant advances to be made, and to translate research findings to
the next step in utility and application.
The purpose of the TTURCs is to facilitate a transdisciplinary approach
to the full spectrum of basic and applied research on tobacco use,
including: etiology of tobacco use and addiction (including the impact
of advertising and marketing), prevention of tobacco use, the treatment
of tobacco use and addiction, the identification of biomarkers of
tobacco exposure, and the identification of genes related both to
addiction and susceptibility to harm from tobacco. The translational
nature of these research programs will inform public health efforts to
reduce the disease burden of tobacco use.
RESEARCH OBJECTIVES
Background
Cigarette smoking remains firmly entrenched in American society today,
although the demographics of smokers vary from those when the first
Surgeon General's Report on Smoking was published nearly 40 years ago.
Approximately 48 million adult Americans, representing 25% of the
population, are smokers. Overall, smoking prevalence and the
trajectory of tobacco use initiation among America's youth continue to
be alarming: 26.7% of 12th graders report current smoking and 16.9%
report daily smoking. About 1/2 to 1/3 of teens who try smoking will
become regular smokers and 75% of daily teen smokers will smoke as
adults. This is particularly striking given the increase in policies
regulating smoking, litigation against the tobacco industry, and
heightened public awareness of the negative health consequences of
smoking.
Smoking has been the chief preventable cause of illness and death in
the U.S. for more than three decades and is responsible for 440,000
deaths annually. Cigarette smoking is a primary cause of death from
lung cancer, coronary heart disease, chronic obstructive pulmonary
disease, and stroke. Worldwide, more than 3 million people will die
every year because of tobacco making it the largest preventable cause
of death in history. The World Health Organization estimates that this
figure will increase to nearly 10 million annual deaths by 2030.
In order to understand the epidemiology and natural history of tobacco
use and nicotine addiction, an integrated approach is required to
explore the interplay of social, psychological, biological and genetic
factors. Social influences are broad, including peer and family
modeling, tobacco, industry marketing and media influences. Depressed
or anxious mood and attention-deficit hyperactivity disorder are
examples of psychological factors that affect smoking, from initiation
to maintenance to cessation. The effects of these overarching
determinants are mediated by behavioral, neurochemical, and
physiological factors to influence tobacco use, dependence, cessation,
and relapse in the individual.
Because of the intransigence of tobacco use and its disease
consequences, and its complex, multidimensional determinants, the
scientific community called for new multilevel research models and
paradigms that were integrated across disciplines. Scientific leaders
identified transdisciplinary research as having the potential to
accelerate discovery. Transdisciplinary research is differentiated
from other cross-disciplinary research by its degree of collaboration
and conceptual integration.
Renewal of this RFA is responsive to NCI's Bypass Budget: "renew and
expand support of the Transdisciplinary Tobacco Use Research Centers
program in collaboration with relevant public and private
organizations"; facilitate rapid development from discovery to
application by using established mechanisms and creating novel special
awards to encourage transdisciplinary and collaborative research.
Objectives
TTURCs are expected to conduct research that will lead to major
scientific advances in knowledge of tobacco use, nicotine addiction,
prevention and treatment interventions, and the translation of this
knowledge into practice. There are several overarching goals:
o Increase the number of investigators from relevant disciplines who
focus on the study of tobacco use as part of transdisciplinary teams.
o Generate basic research evidence to improve understanding of the
etiology and natural history of tobacco use.
o Produce evidence-based tobacco use interventions that can translate
to the community and specific understudied or underserved populations.
o Increase the number of evidence-based interventions that are novel,
including the development, testing and dissemination of innovative
behavioral treatments and prevention strategies based upon findings
from basic research.
o Train transdisciplinary investigators capable of conducting cutting-
edge tobacco use research.
o Increase the number of peer-reviewed publications in the area of
tobacco use, nicotine addiction, and treatment.
The TTURC initiative is fundamentally translational in nature, and it
is anticipated that success will require extensive collaboration. In
order to maximize effectiveness and minimize budgetary needs, it is
expected that applicants will avail themselves of existing
infrastructure wherever possible. These collaborations, while strongly
encouraged, are not required (nor are centers limited to collaborations
with those listed here). For example, TTURC applications with
medication development and delivery dimensions might collaborate with
the NIDA Clinical Trials Network (CTN), with NIDA's Intramural Research
Program, with SAMHSA, with the Veteran's Administration Cooperative
Studies Program or with NCI's designated Comprehensive Cancer Centers,
Cancer Information Service, Special Populations Networks, and other
NCI-funded research projects, such as the Cancer Family Registries,
Mouse Models Consortium, Cancer Genetics Networks, Rapid Access to
Preventive Intervention Development (RAPID) medication development
program, Centers for Excellence in Cancer Communications (CCERS) and
the Specialized Programs of Research Excellence (SPOREs). Other
organizations that may be considered are the Centers for Disease
Control and Prevention, the American Cancer Society and other voluntary
health associations, the Robert Wood Johnson Foundation, National
Science Foundation grantees, and industry. In addition, collaborations
should be considered with universities, including Schools of Public
Health, historically Black Colleges and Universities, public health
agencies, substance abuse agencies, community technology centers and
other organizations. The active participation of advocacy groups and
appropriate community organizations is encouraged. Relevant
collaborations with NIH intramural programs can be included as well.
Training
There is an urgent need for new investigators who have the quality and
breadth of training necessary to conduct cutting-edge research related
to tobacco use and nicotine addiction. Such training should expose
investigators to the multiple levels of research that address tobacco-
related issues. Because tobacco research scientists are widely
dispersed by geography and discipline, this type of training is
difficult to obtain. By emphasizing meaningful integration and
collaboration among scientists, the centers will provide a challenging
and unique venue for training the next generation of tobacco
researchers. Career development should not be limited to doctoral or
post-doctoral scientists; cross-training of established investigators is
also encouraged.
Developmental/pilot research program
Centers must establish a developmental research plan with processes for
conceiving, vetting, and evaluating studies that allow exploration of
novel directions, especially those that might arise with the
progression of the major projects. Promising pilot studies are
expected to spawn applications for independent funding.
Scope
Investigators should represent a broad range of disciplines working
together to increase knowledge across the full spectrum of basic and
applied research on tobacco use and addiction. Meaningful
collaboration across geographically separate sites is permitted, and
will be expected across the funded Centers.
The level of specialization in different dimensions of tobacco use and
control research will vary from center to center, e.g., themes, topics,
points on the discovery-development-delivery continuum, populations,
levels of analysis and types of research. However, the centers should
focus thematically on areas in which there are significant gaps in
knowledge and critical needs where focused, collective,
interdisciplinary efforts could make the greatest difference in
reducing tobacco use and tobacco-related disease. It is incumbent upon
investigators to articulate the gap areas. It is expected that the
TTURCs will catalyze problem solving and lead to more rapid advances in
knowledge than would be possible by depending on individual
investigators working in relative isolation. TTURCs should contribute
to understanding what works and what does not work and why. Essential
elements of the Centers consist of at least 3 theoretically strong
research projects with an integrative theme, cores and plans for career
development and use of developmental funds. Centers may vary in their
breadth or concentration across research foci (e.g., gene to individual
to community to culture, etc). Some may choose to be tightly
organized; others may have a broad span. Centers are encouraged to
study interactions across research foci (e.g., the variation of
cultural and individual variables and treatment response) when
possible. Research integrated across projects, where findings from one
major project inform or complement those in another, is also strongly
encouraged. Disciplinary integration within a center, and within
projects (again, where feasible) is encouraged particularly with
regard to combining perspectives that reflect innovation. Finally,
disciplinary diversity in a center must support the objectives of the
science and not merely reflect the training of the scientist.
Priority Research Topics
The initial period of TTURC funding has demonstrated that
transdisciplinary research not only works, but that it can lead to
advances in science not possible with uni-disciplinary approaches. The
demonstration that transdisciplinary research can lead to unique
scientific progress allows NIH to use this approach to address critical
research questions needed to advance public health. NIH has identified
several priority areas for research. These thematic areas, along with
examples of specific research questions, are identified below:
o Adolescents & young adults: Recent advances have identified key
factors genetic, social and environmental that contribute to the
etiology of youth tobacco use. Yet, key research questions remain:
Are there critical social or environmental events that together with a
genetic predisposition to nicotine addiction increase or decrease the
likelihood that young tobacco users will become addicted? And, if we
can identify those at greatest genetic risk, are there pharmacological
(e.g. vaccine) or social (e.g. counter-advertising) interventions that
can prevent tobacco use from progressing to addiction?
o Women (Gender differences): Some clinical studies have suggested
that women have more difficulty quitting than men, suggesting that
there may be broader gender differences in the nature of nicotine
addiction. Important research questions include the nature of
genetic/biologic factors that interact with gender in explaining
treatment response, whether treatment impacts be improved by addressing
social and cultural variables, and the salience of gene-hormone-
environment interactions in gender differences in tobacco use and
cancer susceptibility. The other broad issue that relates to women is
smoking during pregnancy, and the consequences for fetal and post-natal
development.
o Psychiatric comorbidity: Tobacco use is higher and cessation rates
are lower among some psychiatric populations (e.g., depression,
schizophrenia). What are their common pathways? How does tobacco use,
treatment and cessation affect psychiatric symptomotology? Is it
possible to effectively treat tobacco dependence when psychiatric
conditions have not been addressed?
o Concurrent Tobacco and Alcohol Abuse/Dependence: The high
comorbidity between alcohol and tobacco abuse/dependence presents
health risks over and above the risks posed by smoking or alcohol
consumption alone. What are the mechanisms underlying the conjoint use
of these substances and how might the understanding of this linkage at
the molecular, genetic, pharmacokinetic and behavioral levels inform
the development effective treatments for concurrent use?
o Disparities: There are disproportionate rates of smoking among
those of low income, less education, American Indian/Alaskan Natives,
Southeast Asians, the unemployed, and particular categories of workers
(e.g. blue collar, service workers, and farm workers). How do social
contextual (e.g. social networks, social ties, discrimination,
historical factors) variables contribute to these disparities? And how
do social context factors interact with genetic, biological factors,
chemical exposures, type of tobacco product (especially new products),
and brand (i.e. menthol)? Finally, in what ways might individual,
quit-line, health care system-based treatments of tobacco dependence be
improved to address disparities?
o Treatment development: Treatments of smoking over the past decade
have yielded successes but there is substantial room for improvement in
outcomes. How might understanding of the relationship between
negative emotions and cognitive processing translate to the development
of novel smoking cessation interventions? Are there behavioral, health
care system, or policy approaches that can be developed that will
increase the use and effectiveness of existing smoking treatments so
that cessation is more likely?
o Treatment Delivery: There is a need to understand how to improve
treatment delivery. Components of this might include enhancement of
treatment-seeking behavior, health systems augmentations that would
facilitate entry to and compensation for treatment services, and system
integration that would allow logical and effective cohesion between
various extant elements, such as quit lines, primary treatment
providers, etc. How might the development of technological devices
(e.g., personal digital assistants, virtual reality) be used in the
delivery of treatments? Population-based approaches (i.e., defined
populations) are particularly encouraged.
o Genetic influences on nicotine dependence: There is consensus that
nicotine addiction is a result of a gene-environment interaction, yet
far more research is needed on which gene variants are critical for the
development and maintenance of addiction. Are there multiple gene
patterns that increase the likelihood of nicotine addiction, or perhaps
specific gene variants that can be triggered by pharmacologic agents
that will decrease the likelihood of becoming dependent? And is it
possible to tailor specific behavioral or pharmacological treatments
for a specific genotype? Understanding the patterns of tobacco use
behavior and the relationship between tobacco use and use of other
drugs may help us identify unique phenotypes or endophenotypes for
genetic analyses.
o Medication Development: There is a need for new medications to
treat various aspects of tobacco addiction, such as the reinforcing
effects of nicotine and early relapse. One broad approach would be to
develop and validate new nicotine delivery systems to mimic the rapid
delivery of nicotine produced by the inhalation of tobacco smoke, but
with much reduced toxicity. Another promising approach would exploit
the maturing neuroscience of tobacco addiction, including the discovery
of new neurochemical systems and molecular targets in addiction,
withdrawal and relapse, and our increasing knowledge of the prominent
conditioned effects that play a role in tobacco addiction.
MECHANISM OF SUPPORT
This RFA will use NIH center grant (P50) award mechanism. Applicants
will be solely responsible for planning, directing, and executing the
proposed project. This RFA is a one-time solicitation. The
anticipated award date is September 2004. Although support of this
program is through the specialized center (P50) grant mechanism, it is
not a SPORE. This mechanism supports the full range of research and
development from basic to clinical and intervention studies. The
spectrum of activities comprises a transdisciplinary approach on a
specific disease entity or biomedical problem. These grants differ
from traditional program project grants in that they are more complex
and flexible in terms of the activities that can be supported. In
addition to support for transdisciplinary research projects, support is
also provided for pilot research projects, specialized resources,
career development programs, and shared core facilities. Applicants
will be responsible for the planning, direction, and execution of the
proposed TTURC program. Awards will be administered under NIH grants
policy as stated in the NIH Grants Policy Statement.
This RFA uses just-in-time concepts. It also uses the non-modular
budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Follow the
instructions for non-modular budget research grant applications. This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
FUNDS AVAILABLE
Eight to nine new and/or competitive continuation grants are expected
to be funded in response to this RFA. The NCI intends to commit
approximately $9 million in FY 2004 to fund the initial year. The NIDA
intends to commit $4.3 million for the initial year's funding. The
NIAAA intends to commit $1.5 million for the initial year's funding.
An applicant may request a project period of up to 5 years and a budget
for direct costs of up to $1.25 million in the initial year (excluding
Facility and Administrative costs to consortium participants). Future
year increments are limited to 3%. The budget for total costs cannot
exceed $1.75 million for the initial year. Because the nature and
scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award
will also vary. Although the financial plans of the NCI/NIDA/NIAAA
provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
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 institutions/organizations. Applicants are encouraged to
work with faith-based and community-based institutions.
o Foreign institutions are not eligible to apply. However, domestic
applications with foreign components are permitted.
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
The Centers must include three or more individual research projects,
which reflect hypothesis-driven research, plus pilot or developmental
research projects, shared resources (cores) and career development.
Centers must provide clear evidence of a transdisciplinary focus,
including an explanation of how the projects fit together across
disciplines to promote synergy and syntheses. Evidence of plans and
mechanisms for dissemination of research findings and products,
including evidence-based tools and interventions must be stated.
Interactions among TTURCs are an important part of this initiative.
Centers must identify creative strategies to foster formal and informal
intra- and inter-center collaborations to identify and address
overarching scientific and methodological issues. This may be in the
form of research collaborations, visiting scientist, special issue
working groups, exchange of data, resources and materials, and other
mechanisms. A requirement for all TTURC Principal Investigators and
selected project investigators is participation in two meetings per year
in the Washington, DC metropolitan area or other mutually convenient
location. One meeting will be smaller, with only the center directors
and NIH staff and consultants in attendance. At least three project
staff should be budgeted for the larger meeting. Support for this travel
should be included in the budget. The purpose of these meetings is to
share scientific information, assess scientific progress, solve
problems, identify new research opportunities, and establish priorities
that will accelerate the translation of basic research findings to
applied settings in patients and populations. Novel opportunities to
facilitate collaboration also will be developed. TTURCs will also be
required (i) to use common measures that will allow pooling of data and
(ii) to participate in evaluation activities. Broad disciplinary
representation in centers is expected.
TTURC Program Requirements
The following information must be provided in the application:
o A minimum of three fully developed R01-type research projects;
o Evidence of a transdisciplinary focus, including an explanation of how
the projects fit together across disciplines to promote synergy and
syntheses;
o Shared administrative, technical, statistical, and other resources
that can be justified;
o Demonstration of a consistent and significant commitment to a career
development program in tobacco control research. This may focus on
graduate students, post-doctoral candidates, junior faculty, or
established investigators who wish to develop or refocus their careers
on tobacco control research. The description of this program should
include the policies, criteria, and processes for selecting candidates,
and must include special efforts to recruit qualified women and
minorities. The plan should include the number and types of positions
that will be made available, the criteria for eligibility and selection
of candidates, and a description of the selection process. The plan
should not include stipends and trainee costs though salary support for
career development candidates may be requested;
o A proposed process for funding developmental and pilot research to
facilitate new collaborations and support the exploration of new ideas
and methods. The interest here is in the process of solicitation and
selection of the pilot projects rather than on the pilot projects
itself. It is important that TTURCs use pilot funds to stimulate
projects that take maximum advantage of new research opportunities. Such
projects may be collaborative among scientists within one or more
TTURCs, or with scientists outside the TTURC environment. The TTURC
application should propose and describe an institutional review process
that selects pilot projects for center funding that represent the most
innovative and transdisciplinary ideas. Applicants may supply a short
description (2 pages maximum per project) of up to two eligible projects
as examples.
o Creative strategies to foster formal and informal intra- and inter-
center collaborations to identify and address overarching conceptual
and methodological issues;
o Evidence of plans and mechanisms for the dissemination of research
findings and products, including evidence-based tools and
interventions;
All clinical trials supported or performed by NIH require some form of
monitoring. The method and degree of monitoring should be commensurate
with the degree of risk involved in participation and the size and
complexity of the clinical trial. Monitoring exists on a continuum from
monitoring by the principal investigator/project manager or NIH program
staff to a Data and Safety Monitoring Board (DSMB). These monitoring
activities are distinct from the requirement for study review and
approval by an Institutional Review Board (IRB). For details about the
Policy of the Data and Safety Monitoring of Clinical Trials see
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm
Applicants are strongly discouraged from naming individual members of
"advisory committees" or "scientific boards" until after receipt of an
award.
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:
Glen D. Morgan, Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Rm. 4034
6130 Executive Blvd., MSC 7337
Bethesda, MD 20892-7337
Telephone: 301-496-8585
Email: gmorgan@nih.gov
Allison Chausmer, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd, Rm. 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 402-5088
Email: achausme@nida.nih.gov
Joanne B. Fertig, Ph.D.
Treatment Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd, Suite 505Bethesda, MD 20892-7003
Telephone: (301) 443-0635
Email: jfertig@niaaa.nih.gov
o Direct your questions about peer review issues to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
o Direct your questions about financial or grants management matters
to:
Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8634
E-mail: crystal.wolfrey@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 NCI 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:
Glen D. Morgan, Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Rm. 4034
6130 Executive Blvd., MSC 7337
Bethesda, MD 20892-7337
Telephone: 301-496-8585
Email: gmorgan@nih.gov
PRE-APPLICATION MEETING
The NCI/NIDA/NIAAA will hold a pre-application meeting through a
videoconference to which all prospective applicants are invited.
Program staff & staff from the Division of Extramural Activities (DEA)
will make presentations that explain their goals and objectives for the
Transdisciplinary Tobacco Use Research Centers and answer questions
from the attendees. Prospective applicants are urged to monitor the NIH
Guide Notice for the date and time of the meeting at
http://grants.nih.gov/grants/guide/index.html.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS: Additional instructions for preparing a
TTURC grant application are available from the program staff listed
under INQUIRIES and can also be found at the following URL link:
http://tobaccocontrol.cancer.gov/tturc/. The instructions must be
requested and used in preparing a TTURC application.
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/labels.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)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to
courier deliveries (i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)
This change in practice is effective immediately. This policy is
similar to and consistent with the policy for applications addressed to
Centers for Scientific Review as published in the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
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. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NCI. Incomplete and/or nonresponsive
applications will not be reviewed.
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 Division of Extramural Activities of the
NCI in accordance with the review criteria stated below. As part of
the initial merit review, all applications will:
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 written critique
o Receive a second level review by the appropriate National Advisory
Council or Board.
REVIEW CRITERIA
Competitive applications will reflect more than an interesting
collection of projects. It is critical that there be evidence of the
potential for a meaningful center with a real theme and identity.
The Centers must include three or more individual research projects,
which reflect hypothesis-driven research, plus a process for pilot or
developmental research projects, shared resources (cores) and career
development. The Center and the projects should result in the generation
of new knowledge in tobacco control and/or nicotine addiction science.
Reviewers will evaluate each center using the criteria listed below.
Each criterion will be addressed and considered by the reviewers in
assigning the overall score for project merit:
A. RESEARCH PROJECTS
1. Significance. The importance of the research objective to tobacco
control research and its likelihood of completion within the project
period.
2. Approach. The adequacy of the experimental design and methods to
achieve the research objectives. Are the theoretical framework, design,
methods, and analyses adequately developed, well integrated, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative transdisciplinary
approaches?
3. Innovation. Originality and novelty of the experimental design as
it relates to tobacco control theory and research. Does the project
develop new methodologies or technologies in tobacco control research?
Does the research design reflect sufficient originality, novelty, and
innovation to make it highly relevant to the overall goals and
objectives of the TTURC?
4. Investigators. The qualifications of investigators to conduct the
proposed research and the appropriateness of the time commitments of
each member of the team to the conduct of the project. Is the proposed
work appropriate to the experience level of the Principal Investigator
and project researchers?
5. Environment. The scientific environment in which the research work
will be done, and the unique features, if any, of the environment to
support the proposed work. Does the scientific environment in which the
work will be done contribute to the probability of success? Do the
proposed projects take advantage of unique and transdisciplinary
features in the scientific environment and reach out to useful
collaborative arrangements? Is there evidence of adequate institutional
support? Is the project interactive with other components of the TTURC,
conceptually, experimentally, and translationally?
6. Transdisciplinary Collaboration. Is there evidence of significant
transdisciplinary basic, clinical and public health interactions in the
conception, design, and proposed implementation of the project? Is the
proposed research informed by the breadth of relevant scientific
literature from multiple disciplines in the social, behavioral, and
biological sciences?
B. SHARED RESOURCES (CORES)
1. adequacy of the justification for each specialized resource relative
to its essential need for the conduct of TTURC research or pilot
projects and TTURC collaborative projects.
2. adequacy of qualifications and performance (if applicable) of
managers of resources to conduct high quality, reliable resource
operations.
3. adequacy of plans for oversight of resources and the prioritization
of work
C. CAREER DEVELOPMENT
1. adequacy of the process and/or track record for selecting candidates
for career development who demonstrate potential for independent
research careers in transdisciplinary cancer tobacco control related
research or who are established investigators and are changing the
direction of their research careers; cross-disciplinary training should
enable scientists to bridge scientific domains in tobacco control
research, to foster important integrative scientific inquiry;
2. adequacy of the procedures and/or track record to seek out and
include qualified minorities, women, and persons with disabilities in
the career development program;
3. adequacy of the individuals available in the program to serve as
possible mentors of career development candidates; the current
availability and adequacy of projects for career development candidates;
4. complementary activities that contribute to the environment for
career development;
5. capacity of the overall program to absorb career development
candidates and prepare them for independent transdisciplinary tobacco
control research careers.
D. DEVELOPMENTAL RESEARCH PROGRAM (PILOT PROJECTS)
1. adequacy of the process and/or track record for attracting new ideas
for pilot studies within the TTURC.
2. adequacy of the proposed process and/or track record for continuously
reviewing and funding a spectrum of pilot projects (e.g., research,
technology development, resources) for their quality, innovativeness,
transdisciplinary nature and importance to translational research that
will have an impact on enhancing tobacco control efforts and developing
innovative new intervention and prevention programs.
3. general quality of the pilot projects described in the application to
demonstrate the effectiveness of the process for selecting pilot
projects funding;
4. degree to which developmental funds will be used to stimulate pilot
projects with transdisciplinary interactions and/or collaborative
interactions with other scientists within or outside of the parent
institution, and especially with other NCI/NIDA/NIAAA-funded centers and
programs;
E. OVERALL PROGRAM ORGANIZATION AND CAPABILITY
1. scientific qualifications and involvement of the Principal
Investigator, as well as his/her demonstrated scientific and
administrative leadership capabilities; adequacy of the time commitment
of the Principal Investigator;
2. transdisciplinary nature of the proposed research activities,
integration of the projects around an overarching theme, and plans to
effectively pursue transdisciplinary research objectives;
3. adequacy of access to patients and populations for conducting current
and projected research;
4. adequacy of the procedures, processes, and plans for promoting
transdisciplinary interactions, including coordination, interaction,
collaboration and synthesis;
5. facilitation of technology transfer; management of the intellectual
property rights of the TTURC under the requirements of the Bayh-Dole Act
and NIH funding agreements;
6. written assurance that TTURC interactions with commercial entities
will uphold the principles of academic freedom, including the ability of
TTURC investigators to collaborate freely, and to send and receive
research materials without restriction to other scientific researchers;
7. adequacy of plans to promote and maintain communication and
integration of scientific projects of mutual interest with other TTURCs;
8. willingness to interact with other TTURCs and with the NIH in
sharing information, in assessing scientific progress, in identifying
new research opportunities and in establishing scientific priorities.
F. INSTITUTIONAL COMMITMENT
1. adequacy of facilities, equipment and space to promote
transdisciplinary and translational research objectives;
2. adequacy of institutional procedures and plans for monitoring,
evaluating, and assuming accountability for the general success of the
TTURC;
3. adequacy of the institutional infrastructure for assessing progress
and needs.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data: Applicants requesting more than $500,000 in
direct costs in any year of the proposed research must include a data
sharing plan in their application. The reasonableness of the data
sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the
proposed data sharing plan into the determination of scientific merit
or priority score. (See url in Federal Citations, below.)
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research, core resource
operations, developmental research program, and career development.
Salary support for career development candidates maybe included.
However, stipends and trainee costs are not allowable.
OVERALL EVALUATION AND SCORING OF APPLICATIONS
A single numerical priority score will be assigned to the TTURC
application as a whole after discussing all of the review elements
listed above. The score will be based on the overall quality of the
research projects, the career development program and the developmental
research program, the overall effectiveness and adequacy of shared
resources, the overall program organization and capability, and the
plans for interactions with other TTURCs.
Although primary emphasis will be placed on scientific merit,
significant consideration will also be given to transdisciplinary
interactions, potential for impacting on the disease, inter-Center
collaborations and institutional commitment.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 26, 2003
Application Receipt Date: January 23, 2004
Peer Review Date: June, 2004
Council Review: September, 2004
Earliest Anticipated Start Date: September, 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is
required for all types of clinical trials, including physiologic,
toxicity, and dose-finding studies (phase I); efficacy studies (phase
II); efficacy, effectiveness and comparative trials (phase III). The
establishment of data and safety monitoring boards (DSMBs) is required
for multi-site clinical trials involving interventions that entail
potential risk to the participants.(NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NIH require special
considerations. The method and degree of monitoring should be
commensurate with the degree of risk involved in participation and the
size and complexity of the clinical trial. Monitoring exists on a
continuum from monitoring by the principal investigator/project manager
or NIH program staff or a Data and Safety Monitoring Board (DSMB).
These monitoring activities are distinct from the requirement for study
review and approval by an Institutional review Board (IRB). For
details about the Policy for Data and Safety Monitoring of Clinical
trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For Phase I and II clinical trials, investigators must submit a general
description of the data and safety monitoring plan as part of the
research application. See NIH Guide Notice on "Further Guidance on a
Data and Safety Monitoring for Phase I and II Trials" for additional
information:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety
monitoring plans for clinical trials is available:
http://www.cancer.gov/clinical_trials/
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000
or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
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 "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.
A continuing education program in the protection of human participants
in research is available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp
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, in the project description and elsewhere in the
application as appropriate, 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 RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as "covered entities") must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This 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 at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm
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.
REFERENCES
Centers for Disease Control and Prevention, Cigarette smoking among
adults--United States, 1997. MMWR Morb Mortal Wkly Rep, 1999. 48(43):
p. 993-6.
Engstrom PE, C.M., Schnoll RA, et al, Prevention of tobacco-related
cancers, in Cancer Medicine, F.E. Hollan JF, Editor. 2000, BC Decker:
Hamilton, Ontario, Canada. p. 127-140.
Fiore, M.C., et al., Treating Tobacco Use and Dependence. Clinical
Practice Guideline. 2000, Rockville, MD: U.S. Department of Health and
Human Services.
Henningfield, J.E., C. Cohen, and J.D. Slade, Is nicotine more
addictive than cocaine? Br J Addict, 1991. 86(5): p. 565-9.
Johnston LD, O.M.P., Bachman JG., National Survey Results on Drug use
from the Monitoring the Future Study, 1975-1993, ed. USDHHS. Vol. 1 and
2. 1994, Rockville, MD: NIH Publication 94-3810.
Johnston LD, O.M.P., Bachman JG., Teen smoking declines sharply in
2002, more than offsetting large increases in the early 1990s.
University of Michigan News and Information Services: Ann Arbor, MI,
2002. http://www.monitoringthefuture.org
McNeill, A.D., The development of dependence on smoking in children. Br
J Addict, 1991. 86(5): p. 589-92.
Morgan GD, F.P., Matthews E, Leischow S, Smoking cessation. Progress in
Oncology, ed. H.S. DeVita V, Rosenberg S. 2002, Sunbury, MA: Jones &
Bartlett. 294-312.
National Cancer Institute, Changing Adolescent Smoking Prevalence.
Smoking and Tobacco Control Monograph. Vol. 14. 2001, Bethesda, MD.
National Cancer Institute, The Nation's Investment in Cancer Research.
A Plan and Budget Proposal for Fiscal Year 2002. 2000.
Peto, R., et al., Mortality from tobacco in developed countries:
indirect estimation from national vital statistics. Lancet, 1992.
339(8804): p. 1268-78.
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