and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
TRANSDISCIPLINARY RESEARCH ON ENERGETICS AND CANCER
RELEASE DATE: July 8, 2004
RFA Number: RFA-CA-05-010
November 24, 2009 - This RFA has been reissued as (RFA-CA-10-006).
(see NOT-CA-04-010)
EXPIRATION DATE: November 17, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399
LETTER OF INTENT RECEIPT DATE: October 15, 2004
APPLICATION RECEIPT DATE: November 16, 2004
THIS 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 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) invites center grant applications,
using the cooperative agreement (U54) mechanism, to establish the
Transdisciplinary Research on Energetics and Cancer (TREC) Centers in
nutrition, energetics*, energy balance, and physical activity. These
Centers will involve scientists from multiple disciplines and will
encompass projects spanning the biology and genetics of behavioral, socio-
cultural, and environmental influences on nutrition, physical activity,
weight, energy balance, and energetics.
The TREC Centers will focus on two great challenges in the area of
energetics/energy balance and cancer. They are: 1) to enhance our
understanding of the mechanisms underlying the association between energy
balance and carcinogenesis across the cancer continuum from causation and
prevention through survival, and 2) to develop effective innovative
approaches with broad population impact at the social-environmental and
policy levels for prevention of obesity with particular emphases on
children and critical time periods during adulthood where weight gain is
likely to occur, such as during smoking cessation, cancer treatment, and
major life transitions involving work or family. These challenges require
integration of diverse disciplines, spanning the full range of cancer
research from the molecular biology of carcinogenesis to public policy
research. The primary mission of the TREC Centers is to foster
collaboration among transdisciplinary teams of scientists with the goal of
accelerating progress toward reducing cancer incidence, morbidity, and
mortality associated with obesity, low levels of physical activity, and
poor diet (see Figure 1: TREC Conceptual Model at
http://cancercontrol.cancer.gov/TREC/). The second mission of these
Centers is to provide training opportunities for new and established
scientists who can carry out integrative research on energetics, energy
balance, and their consequences.
* Energetics -- The study of the flow and transformation of energy through
living systems – The American Heritage Dictionary, 2000.
RESEARCH OBJECTIVES
Background
Existing research indicates that weight, physical activity, and nutrition
alter cancer risk and carcinogenesis for many cancers, and evidence is
building on the effects of these health factors on cancer prognosis and
quality of life among cancer survivors. This research began with animal
studies on diet composition and caloric restriction in the 1930s and
expanded to studies in human populations in the 1960s and 1970s. A 2002
International Agency for Research on Cancer (IARC) review, “Weight Control
and Physical Activity,” summarized the evidence across basic and
population research and identified that avoidance of adult weight gain is
likely to have a substantial cancer-preventive effect for cancers of the
colon, breast (postmenopausal), uterus, kidney, and esophagus. The report
also noted that physical activity is likely to have a substantial cancer-
preventive effect for cancers of the colon and breast. The IARC report
estimated that, for many of these common cancers, between one-quarter and
one-third of the cases may be attributable to the combined effect of
increased body weight and inadequate physical activity (IARC 2002). In
April 2003, a study in the New England Journal of Medicine extended prior
research of weight and cancer within a very large prospective cohort of
900,000 adults in the United States (Calle et al., 2003). This research
found increases in mortality from cancer associated with an increased body
weight for many cancers, including non-Hodgkin’s lymphoma, multiple
myeloma, and cancers of the esophagus, colon and rectum, liver,
gallbladder, pancreas, and kidney. In addition, trends for increasing
risk were observed for cancers of the stomach and prostate in men and for
cancers of the breast, uterus, cervix, and ovary in women. The study,
which focused only on the effect of body weight, estimated that in the
United States, being overweight and obese could account for 14 percent of
all deaths from cancer in men and 20 percent of all deaths from cancer in
women.
National health surveillance data provide evidence of progress related to
these factors in several areas that may reduce cancer risk, incidence, and
mortality. For example, specific changes in diet that may reduce risk and
improve prognosis include reductions in total and saturated fat and
increases in fruit and vegetable intake. Modest reductions in saturated
fat intake and increases in fruit and vegetable consumption have occurred
in the past decade. Some evidence also suggests that leisure time
physical activity may be increasing in some population groups, despite the
fact that results from several surveys indicate that over 25-28 percent of
U.S. adults report no leisure time physical activity. It also seems
likely that overall levels of physical activity are declining due to more
sedentary occupations and increasing automation. Further, the marked
increase in the epidemic of being overweight and obese suggests that
levels of energy expenditure from overall physical activity are still too
low to adequately balance energy expenditure with current levels of energy
intake within the United States.
The prevalence of obesity has changed dramatically over the last 40 years.
It was relatively stable at approximately 10 percent for men and 15
percent for women from the early 1960s to the late 1970s. During the late
1980s and early 1990s, rates of obesity increased, and the most current
estimates from the 1999-2000 National Health and Nutrition Examination
Survey (NHANES) indicate that the prevalence of obesity has increased to
28 percent for men and 33 percent for women (Flegal et al., 2002). Rates
are highest among non-Hispanic black women who experience a 50 percent
prevalence of obesity. When the prevalence of overweight, defined as a
Body Mass Index (BMI) of 25 and higher, is considered, about 65 percent of
the U.S. adult population is affected. Of particular concern are
increases in rates of overweight among children and adolescents.
Prevalence rates, which were approximately five percent during the 1960s,
have tripled to over 15 percent in 1999-2000 among school-aged children
and adolescents. Rates rose by 10 percentage points or more between 1988-
1994 and 1999-2000 for both Mexican American and non-Hispanic black
adolescents (Ogden et al., 2002). These national health surveillance data
provide a strong rationale for a research focus on innovative approaches
to improving energy balance, weight control, and the prevention of
overweight and obesity to address this area of urgent and expanding need.
A recent Institute of Medicine (IOM) report, “Fulfilling the Potential of
Cancer Prevention and Early Detection,” lists the development of a
national strategy to prevent obesity and sedentary behavior as its second
major goal, yet proven methods to achieve the goal are lacking (IOM,
2003).
As suggested by the 2002 IARC report on Weight Control and Physical
Activity, the combination of efforts to improve diet, physical activity,
and body weight may have even larger effects. Yet, research has typically
examined single cancer prevention-related factors, such as nutrition, in
depth while few studies have used a multidisciplinary approach to assess
these factors simultaneously and integrate their effects (IARC, 2002).
Given that these factors are often closely inter-related in human
populations, it is even more surprising that so little research has
focused on the intersection of diet, physical activity, and weight.
Although research studies of diet and cancer risk and prognosis have
examined potential mechanisms in some detail, cancer research in the areas
of weight and physical activity has largely been focused on defining the
existence and extent of the association of these factors with cancer
outcomes. Very little research has explored the combined effects of
weight, body composition, physical activity, and diet on the many
physiologic systems that are affected by these factors individually, and
virtually none have examined the combined influence of these factors on
mechanisms related to carcinogenesis. These mechanistic pathways are
likely to involve the steroid hormones, insulin-like growth factors,
insulin resistance, lipid metabolism, immune functions, and inflammatory
factors, such as cytokines and prostaglandins. The identification of
which changes lead to cancer and adverse health outcomes among specific
groups of people is fundamental to the development of global public health
initiatives and to personalized strategies for intervention. Genomics and
post-translational (i.e., proteomics) technological advances have the
potential to assist in deciphering the molecular basis by which these
health factors influence the cancer process and may also assist in
identifying intervention targets based on personalized risk assessment.
A second major gap limiting progress in advancing evidence-based
interventions to prevent obesity and support weight control at the
population level is the lack of research evidence on which social-
environmental, policy, or structural-level changes can most effectively
facilitate cost-effective approaches for prevention and weight control.
The state of this field is similar to that of tobacco control in the 1980s
before NCI and other organizations supported research on innovative
initiatives to advance tobacco control beyond the level of the individual.
Research innovations in this area identified changes in work- and school-
based policies and practices, pricing of tobacco products, and other
legislation that supported progress in tobacco control. Similarly, in the
area of cancer screening, major gains were made in use of cancer
screening, with efforts focused not solely on the individual patient or
provider, but also on the health care delivery system at the
organizational level. For example, utilizing data from clinical trials
and population practice, economic research helped to identify the most
cost-effective technological approaches to cancer screening as well as
changes in health care delivery systems to enhance adoption of these new
technologies. This research has been used by federal health care delivery
organizations to determine reasonable reimbursement levels for major
cancer screening technologies. In addition, organizational level research
on cancer screening led to the identification of measures, such as
mammography screening, that are used to evaluate the performance of health
care delivery systems as part of the Health Employer Data Information
System (HEDIS). Such HEDIS measures have been credited with having a
major impact in enhancing the adoption of cancer screening within managed
care organizations and other health care delivery systems within the U.S.
In the areas of weight control, diet, and physical activity, policies
related to school food and physical activity practices, urban planning,
and health insurance could have important roles in changing health
behaviors at the population level. However, the effectiveness of these
efforts has not been adequately tested. At present, in the United States,
insurance coverage for treatment of obesity is allowed only if an
individual has a secondary co-morbid condition, such as hypertension,
hyperlipidemia, or diabetes mellitus. There is currently no coverage for
obesity prevention, or for the treatment of existing obesity to prevent
the development of other diseases in the future.
Controversy exists regarding the level of physical activity that should be
recommended for different elements of overall health. For example, a
recent Institute of Medicine (IOM) report (IOM, 2002), suggests that up to
60 minutes of physical activity per day may be needed to prevent weight
gain, substantially more than the minimum of 150 minutes per week
recommended by the American College of Sports Medicine (ACSM) for
cardiovascular benefit. The ACSM has stated that the amount of physical
activity needed to “gain optimal health benefits” is still unknown, but it
maintains that the 150 min/week is the minimum needed to derive some
health benefits (ACSM, 2002). This controversy serves to highlight the
possibility that different recommendations are needed for different
outcomes (cardiovascular health benefits, prevention of weight gain, and
weight reduction). Current studies suggest that the physical activity
dose needed to prevent weight gain versus that needed to reduce weight and
prevent weight regain do not appear to be the same (Jakicic, 2002;
McCaffree, 2003). This hypothesis has not been studied in a randomized,
controlled clinical trial. It has also been suggested that increasing
energy expenditure or reducing energy intake by 100 kcal/day would prevent
weight gain, however, this has not been empirically tested (Hill et al.,
2003). Finally, what type of physical activity (i.e., moderate-intensity
versus vigorous) is needed to prevent weight gain has not been identified
(Jakicic, 2002). Despite the epidemiological evidence linking cancer to
obesity and to lack of physical activity, even less is known about the
appropriate level and type of physical activity required to aid in cancer
prevention and control (IARC, 2002).
Current evidence indicates that obesity prevention efforts should focus on
children to avoid the difficulty of treating obesity once established
(Jakicic, 2002; Hill et al., 2003; Mercer et al., 2003). For tobacco use,
prevention strategies have focused on children because most people start
smoking before age 18. In addition to efforts to target obesity
prevention in children, it is also important to prevent weight gain in
adults given the evidence from NHANES showing that obesity increases
tremendously from the third to the sixth decade of life. Weight gain is
more likely during life transitions, such as with physical injury,
marriage, and parenting, and with some types of treatment, such as with
smoking cessation or treatments for depression and some types of cancer
(Muller et al., 2001). Therefore, key target populations for prevention
strategies should include children as well as adults undergoing high-risk
events for weight gain, such as smoking cessation, injuries, or cancer
treatment. Significant advances are required to optimize treatment and
prevention strategies for children and adults differing in demographic,
social economic status (SES), and individual characteristics.
Tobacco research has demonstrated that individual-based or single modality
interventions have little impact on preventing the initiation of smoking
or on increasing smoking cessation (Mercer et al., 2003), and preliminary
research suggests similar effects may be observed for physical activity
and nutrition. Unlike in the area of tobacco control, comprehensive
population-wide strategies that have specifically addressed obesity have
not been evaluated (Muller et al., 2001) despite several comprehensive
population-wide interventions that have included physical activity and
nutrition for cardiovascular risk reduction. Examples include the North
Karelia Project, the Five-City Project, and the Minnesota Heart Health
Program; these programs led to decreases in some cardiovascular disease
risk factors but did not reduce BMI. In fact, the long-term follow-up of
the Five-City Project and Minnesota Heart Health Programs showed that BMI
increased in both the control and intervention groups (Muller et al.,
2001).
Significant advances are required to integrate our current and future
understanding of these pathways into a population perspective that will
allow use of such knowledge for cancer prevention and control. Such
advances depend critically on programs that bring together researchers
with diverse perspectives and give them the support needed to facilitate
collaboration. TREC Centers are expected to elucidate how these factors
interrelate in transdisciplinary, integrative approaches that span the
cancer continuum, and range from basic and clinical metabolic studies to
behavioral- and population-based studies.
OBJECTIVES AND SCOPE
Centers should have at least three of the four following goals and should
effectively include basic and population sciences within the initiatives
proposed. Primary goals include:
o Enhancing our understanding of the mechanisms underlying the association
between energy balance and carcinogenesis across the cancer continuum from
causation and prevention through survival;
o Developing effective innovative approaches with broad population impact
at the social-environmental and policy levels for prevention of obesity,
focusing on children and critical time periods during adulthood where
weight gain is likely to occur, such as with smoking cessation, cancer
treatment, and major life transitions involving work or family;
o Bringing together diverse disciplines in creative new ways by
facilitating collaborative endeavors between researchers from cancer
centers, schools of public health, and academic departments from diverse
disciplines such as molecular biology, genetics, psychology, anthropology,
urban planning, informatics, social sciences, and communications; and
o Creating significant new opportunities for interdisciplinary training of
scientists at every stage in their careers in the area of energy balance
and cancer.
Investigators should represent a broad range of disciplines, working
together to increase knowledge across the full spectrum of basic and
applied research in nutrition, physical activity, energetics, and
carcinogenesis. Meaningful collaboration across geographically separate
sites is permitted, and will be expected across the funded TREC Centers.
TREC Centers must establish a developmental research program with
processes for conceiving and evaluating studies that allow exploration of
novel directions, especially those that might arise with the progression
of major projects.
These goals build on lessons learned from the Transdisciplinary Tobacco
Research Centers (RFA CA-04-012), an example of a successful
transdisciplinary program. Nevertheless, care should be taken to realize
that the challenges of energy balance research are likely to differ from
those in tobacco research.
STUDY DESIGN
Applications must include explicit discussions of both the specific aims
of the research projects and the applicant’s efforts at forging creative
new links between disciplines. A minimum of three research projects, up
to a maximum of five research projects, is expected per TREC Center. The
ability of applicants to articulate a coherent transdisciplinary research
agenda that will accelerate progress toward understanding links between
energy balance and carcinogenesis and efforts to curb the obesity epidemic
is a key evaluation criteria for this RFA.
Priority Research Topics
Examples listed below represent a small subset of the potential areas in
which NCI's goals could be pursued. These examples are intended to be
illustrative of the kinds of efforts encouraged and are not comprehensive.
Example 1, Energy Balance and Carcinogenesis Throughout the Life Cycle:
Explosive growth in the understanding of genetics, molecular biology, and
physiology of obesity is occurring in animal models, through the use of
transgenic animals, and in clinical metabolic studies, and through
randomized controlled interventions in the areas of physical activity,
weight, and diet to elucidate mechanisms of carcinogenesis. Yet these
advances are not often integrated because they occur in divergent
departments, are funded through different mechanisms, and require
understanding various physiological pathways. Research devoted to energy
balance and carcinogenesis throughout the life cycle that involves
integrating the areas of obesity, exercise physiology, behavioral
sciences, nutrition, genetics, and molecular carcinogenesis could
accelerate progress toward understanding mechanisms linking energy balance
and carcinogenesis.
Example 2, Ecological Models of Health Behaviors:
Past work has emphasized individual determinants of health behaviors,
particularly in the area of weight and physical activity. Ecological
models of health behavior postulate a combination of environmental,
social, cultural, individual, and biological influences. Research
focusing on teasing apart the relative importance of these factors could
profit from collaborations between faculties from departments such as, but
not limited to, those in: transportation, sociology, public health, and
psychology. Research in a TREC Center might advance the development of
innovative behavioral, policy, and organizational interventions to address
the prevention and control of obesity among at-risk groups across the life
course. Such interventions might be strengthened by drawing samples of
participants from existing research and demonstration efforts. In areas
related to examining effects of interventions on mechanisms of
carcinogenesis, the use of samples drawn from groups with increased
susceptibility to cancer or with more detailed information about their
underlying cancer risk may enhance potential for understanding how such
interventions may influence cancer outcomes.
Example 3, Disparities:
Much recent effort has been devoted to understanding health disparities in
cancer incidence and outcomes. Differences in energy balance over the
life course across different population groups defined by race, ethnicity,
gender, social class, environmental deprivation, and other important
characteristics related to health disparities may provide proximate
explanations for some of these disparities, as well as potentially lead to
further disparities in the coming decades. Collaborations between
biologists, epidemiologists, and behavioral scientists are required to
develop creative ways of understanding the causes and consequences of
associations between these demographic and social class characteristics
and energy balance-related health behaviors. In addition to examining
these questions in human populations, progress has been made in the
development of basic science and animal models to examine the effect of
environmental stress and deprivation on health outcomes. Such models
could be applied to examining the question of how these factors interact
with energy balance in influencing cancer outcomes as well as successful
adoption of recommended health behaviors related to energy balance. This
area of research has the potential to identify key targets for the
reduction of health disparities.
Example 4, Methodologies:
There is a pressing need for better methods of dietary, physical activity,
and anthropometric assessment. Advances in psychometric and statistical
methods, technologies for coding self-report and objective measures of
activity, and new biological markers offer promise. However, evaluating
how such advances can be utilized in assessment of diet, physical
activity, and body composition requires collaboration between biologists,
epidemiologists, nutritionists, and exercise scientists. Support for such
methodological advances can be difficult to obtain and research devoted to
this area could help lead development of the next generation of assessment
tools that are urgently needed to clarify associations between energy
balance and cancer and to evaluate efforts aimed at behavior change. In
addition, it is anticipated that integrative, transdisciplinary research
that includes efforts at the individual, health system, and community
levels may lead to the development of new, more synthetic measures in this
area.
Example 5, Population-level Effects:
The identification of successful approaches to the prevention of obesity
will require research at the individual and system levels. One critical
research issue is the development of effective population-level
interventions, particularly directed at the prevention of obesity among
children. Research integration across diverse disciplines including those
related to health services, policy, economics, urban planning,
informatics, and communications can facilitate progress in identifying
effective population-level interventions in prevention of obesity at the
social-environmental or policy level across diverse at-risk populations.
For example, communications, particularly entertainment media such as
television, have been implicated in contributing to the growing epidemic
of obesity in the United States, both in terms of being associated with
declining physical activity and increases in energy-dense eating patterns.
Research centers might examine issues such as the role played by mass
media in influencing diet and physical activity, in contributing to the
recognition of obesity as a public health problem, and in interacting with
other social and structural factors in contributing to obesity and
sedentary lifestyles. In addition, TREC Centers might examine the effect
of different policy or economic interventions to improve physical activity
and eating patterns across different periods of life. Animal models or
interventions among specific at-risk groups might be used to explore
whether different interventions result in different outcomes based on
genetic or other factors that define susceptibility to either obesity or
cancer.
Example 6, Transdisciplinary Partnerships:
Applicants are encouraged to include programmatic components linking their
efforts widely to the spectrum of activities involved in energy balance
and carcinogenesis. For example, investigators devoted to elucidating
mechanisms of energy balance and carcinogenesis could form collaborative
relationships with clinical research centers, modeling trials in humans
and generating hypotheses about influences of interventions on new
pathways, which could in turn be examined via serum samples or tissue
repositories. Similarly, investigators emphasizing social and behavioral
sciences should reach out and embrace biology to ensure that their work
contributes to and informs the challenge of understanding both the
biological and behavioral aspects of energy balance and carcinogenesis.
Finally, basic, epidemiological, and intervention research all depend on
assessments of health behaviors. Coordination among and between
investigators in the uses of different instruments for assessing diet,
physical activity, and anthropometry could also greatly enhance the future
utility of data generated at multiple centers.
MECHANISMS OF SUPPORT
This RFA will use NIH cooperative agreement (U54) 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 1, 2005.
This RFA uses just-in-time concepts. It also uses the non-modular
budgeting format (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Applicants
should 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_2003/NIHGPS_Part2.htm.
The NIH U54 is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the Principal Investigator retains the
primary responsibility and dominant role for planning, directing, and
executing the proposed project, with NIH staff being substantially
involved as a partner with the Principal Investigator, as described under
the section "Cooperative Agreement Terms and Conditions of Award."
FUNDS AVAILABLE
NCI intends to commit approximately $14 million in FY 2005 to fund four to
five U54 cooperative agreements for establishing TREC Centers in response
to this RFA. An applicant may request a maximum annual direct cost of
$1.5 million per year, up to five years. Future year increases in total
direct costs are limited to three percent increases. Although the
financial plans of the NCI 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.
(Please note that facilities and administrative [F&A] costs requested by
any consortium participants are excluded from the direct cost limit per
NIH Guide Notice NOT-OD-04-040.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html )
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
o Foreign institutions are not eligible to apply--however, domestic
applications with foreign components are permitted
o Faith-based and community-based institutions.
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 transdisciplinary activities must include an overarching objective
that will: (1) delineate mechanisms by which diet and physical activity
interact to influence weight, body composition, energy balance, and the
carcinogenic progress across the cancer continuum, and (2) identify
innovative approaches to the prevention of obesity, particularly among
children, young adults, and individuals in high-risk groups (e.g., cancer
survivors).
The TREC U54 Centers must include three to five individual research
projects, which reflect hypothesis-driven research, plus common
methodologically-based research projects (Developmental Projects) and
shared resources (Cores facilities and resources or “Cores”). TREC
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.
As evaluation of progress is an increasing priority for NCI, TREC Centers
will be required to participate in evaluation activities that will be
established in partnership with the TREC Coordination Center. Examples of
outcomes produced from these efforts include: peer-reviewed publications,
new theories or applied model development, new intervention formats, and
opportunities for effective dissemination. TREC Centers are encouraged to
form partnerships with industry, public health agencies, and other
organizations that have strong ties to minority communities with high
rates of obesity and cancer. The purpose of the evaluation component is
to monitor and assess the performance of the TREC Centers in achieving the
goals of the RFA. This component includes evaluating the quality and
innovativeness of the science conducted by the TREC Centers as well as
assessing critical intermediate indicators of success such as
infrastructure development and capacity building, career development,
linkages, and resource sharing arrangements within and among Centers; and
the interdisciplinary and multilevel nature of the research. Criteria for
the evaluation component will be developed in partnership with the TREC
Coordination Center and NCI program staff.
Because of the central requirement for interaction across TREC Centers, a
central TREC Coordinating Center will be established concurrently under
another funding mechanism in order to facilitate the required
interactions. (See RFA CA-05-011) This facilitation will include
activities such as biannual meetings of the TREC Centers; development and
maintenance of a web site for shared communications; identification and
development of commonalities in methodologically-based research questions
being explored across sites; the compilation of state-of-the-art
instruments for diet, weight, and physical activity assessments in use
across sites; identification of common data elements in research across
sites that could be compared or combined to examine more detailed
questions in specific populations; bringing together special working
groups on key scientific topics; or the development of training modules in
diverse disciplines, such as genetics and proteomics or advances in self
report and technologies for assessment of diet and physical activity to
support transfer of knowledge across disciplines. Applicants will be
asked to collaborate with other TREC Centers and the TREC Coordinating
Center to develop an evaluation system that will be integrated into the
TREC Centers’ design and operations. This system will make it possible
for each TREC Center to monitor its own performance and for NCI to compare
site performance to that of other TREC Centers, and will enable evaluation
of the initiative as a whole.
Objective criteria for the evaluation component will include the extent to
which: (1) the overall capacity to study the mechanisms underlying the
association between energy balance and carcinogenesis across the cancer
continuum, from causation and prevention through survival, in the TREC
Centers has increased as a result of the new funding; (2) the capacity to
study the relationship between nutrition, physical activity, and
energetics, as they relate to the goals of reducing cancer incidence,
morbidity, and mortality associated with obesity, has been enhanced
through the sharing of resources within and among Centers; (3)
collaborative relationships within and among Centers have been established
and institutionalized; (4) training and career development opportunities
exist for new and established investigators; (5) a “transdisciplinary
research culture” has been engendered that takes into account multiple
levels of analysis; and (6) TREC Center investigators’ ability to compete
for future R01 grants and participate in other research mechanisms has
been enhanced.
The evaluation will also examine intermediate markers of the importance
and potential impact of the science conducted by the TREC Centers in
addressing the relationship between the integration of social, behavioral,
and biological sciences into more comprehensive study design. Possible
metrics include the development of: 1) new theories or conceptual models
ranging from genetics, psychology, molecular biology, and anthropology to
urban planning, informatics, social sciences, health behavior, and
communication; 2) new measures of dietary, physical activity, and
anthropometric assessment, or psychometric and statistical methodology for
coding self-reported data; 3) new biological markers of genetics,
molecular biology, and physiology of obesity; and 4) new treatments or
interventions that address the individual-level determinants of behavior
to the effective population-level interventions in prevention of obesity
and the social-environmental or policy level across diverse at-risk
populations. These markers will be identified from the conceptual
framework presented earlier and from other theoretical models and
empirical evidence in the literature.
This initiative encourages investigators to build research projects in
association with such activities as one means to facilitate
institutionalization of effective interventions into practice. As part of
NCI’s commitment to the rapid translation of research evidence into
practice, applications should include explicit plans for diffusion of
research results into practice.
In addition to state-of-the-art research, a TREC Center must provide
developmental funds for cross-site methodologically-based projects, and it
must provide career development opportunities for new and established
investigators who wish to pursue active research careers in
transdisciplinary nutrition, physical activity, weight, and energy
balance. These areas will be coordinated by the TREC Coordination Center
to enhance efforts across sites and diminish duplication, as well as
maximize common measures assessment.
Cooperative Agreement Terms and Conditions of Award
Cooperative agreements are assistance mechanisms and are subject to the
same administrative requirements as grants. The following Terms and
Conditions of Award are in addition to, and not in lieu of, otherwise
applicable U.S. Gov’t Office of Management and Budget (OMB) administrative
guidelines, DHHS grant administration regulations in 45 CFR Part 74 and 92
and administered under the NIH Grants Policy Statement.
The administrative and funding instrument used for this program is a
cooperative agreement (U54), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and
programmatic involvement with the awardee is anticipated during the grant
award. The NIH purpose is to support and stimulate the activity by
working jointly with the recipient in a partner role, but it is not to
assume direction, prime responsibility or a dominant role in the activity.
The prime responsibility for the research resides with the awardees,
although some activities may be carried out in collaboration among the
awardees with coordination and facilitation by the NCI Project Coordinator
as described below.
1. Awardee Rights and Responsibilities
o The Awardee has primary authority and responsibility to define
objectives and approaches and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of studies conducted under this
program in accordance with the terms and conditions of the award.
o The Awardee (with the TREC Coordinating Center Awardee as lead) will
facilitate the establishment of the TREC Steering Committee for this
initiative. The Principal Investigator (PI) from each site will be the
voting member on the Steering Committee. An essential part of this
initiative is to establish interactions among TREC Centers (e.g., research
collaborations, exchange of scientists on a visiting basis, special issue
working groups, resource sharing and other innovative mechanisms). A
requirement for all TREC Centers is that the Principal Investigators (PI)
and key project co-investigators will participate in two meetings each
year. The purpose of the meetings are to share scientific information,
assess scientific progress in the field, identify new research
opportunities, and promote inter-TREC collaborations to promote discovery
and resolve areas of controversy. It is possible that each PI may be
required to attend up to four TREC-related meetings per year. TREC
Centers will be encouraged to use common measures that allow pooling of
data.
o The TREC Center (U54) Awardee will be a voting member of the Steering
Committee and is required to attend the biannual Steering Committee
meetings.
o The TREC Center (U54) Awardee will be responsible for accepting and
implementing the goals, priorities, procedures, and policies agreed upon
by the Steering Committee. Awardees will retain custody of, and have
primary rights to, the data developed under these awards, subject to
Government rights of access consistent with what are the current
Department of Health and Human Services (DHHS), Public Health Service
(PHS), and NIH policies throughout the length of awards under the auspices
of this RFA. Awardees will be responsible for implementing the approved
data-sharing plan for their project.
o Awardees will be required to accept and implement the common processes
and procedures approved by the Steering Committee.
o The NCI anticipates that awardees under the auspices of this RFA will
develop unique research resources. The policy of the NIH is to make the
results and accomplishments of the activities that it funds available to
the public.
o Awardees will be responsible for implementing the approved research
resource sharing plan and intellectual property plan for their project.
o Awardees may be required to participate in the development of a process
for identifying and funding adjunct developmental and methodologically-
based research to facilitate new collaborations and support common
research questions across sites. The interest here is in the process of
solicitation and selection of common research questions. It is important
that the TREC Centers, in collaboration with the TREC Coordination Center,
plan for funds to stimulate projects that take maximum advantage of new
research opportunities once the TREC Centers are established. Such
projects are expected to be collaborative among scientists within one or
more TREC Center. The TREC Centers, in partnership with the TREC
Coordinating Center, are expected to establish an institutional review
process that selects common research questions and methodological issues
that represent the most innovative and interdisciplinary ideas across
sites.
2. NCI Staff Responsibilities
The NCI Project Coordinator will have the following roles and
responsibilities.
o The NCI Project Coordinator will have substantial scientific-
programmatic involvement during conduct of this activity, through
technical assistance, advice, and coordination beyond normal program
stewardship for grants. The Project Coordinator will be the primary
agent responsible to identify and provide relevant content expertise to
this project from within NCI staff scientists.
o The NCI Project Coordinator will work in cooperation with the PI to
support the development of and to facilitate the TREC programs (e.g.,
training and evaluation), will attend and participate as a voting member
in all meetings of the TREC Steering Committee, and will provide liaison
between the Steering Committee, the TREC Centers, the TREC Coordination
Center, and the NCI. On behalf of the NCI, the Project Coordinator will
be the primary agent (among any involved NCI staff members, including the
NCI Program Director) who is responsible for the identification and
provision of relevant content expertise to this project.
o The NCI Project Coordinator will assist the Steering Committee in
developing and drafting operating policies and policies for dealing with
recurring situations that require coordinated action.
An NCI Program Director will be responsible for the normal stewardship of
the awards, as described below.
o The NCI Program Director will review the scientific progress of
individual U54 research projects and cores, and review them for compliance
with the operating policies developed by the Steering Committee.
o The NCI Program Director may recommend withholding of support,
suspension, or termination of a U54 award for lack of scientific progress
or failure to adhere to policies established by the Steering Committee.
o The NCI Program Director will transmit to the appropriate NIH Institute
Scientific Director any recommendation from the Steering Committee
concerning failure of the TREC Center to adhere to policies established by
the Steering Committee.
o The NCI Program Director may also serve as the NCI Project Coordinator.
3. Collaborative Responsibilities
Steering Committee
o The NCI Project Coordinator and the Principal Investigators will be
responsible for forming a Steering Committee, the main governing board of
the TREC research projects, as defined below. An arbitration system, as
detailed further below, will be available to resolve disagreements between
the NCI Project Coordinator and the members of the TREC Steering
Committee.
o The TREC Steering Committee will be composed of a Principal Investigator
from each TREC Center; the Principal Investigator from the Coordinating
Center, and the NCI Project Coordinator; each representative will have one
vote. The Steering Committee may also include one non-voting
representative from each extramural NCI Program Division (Division of
Cancer Control and Population Sciences; Division of Cancer Prevention; and
Division of Cancer Biology.
o The Steering Committee chairperson may not be an NCI staff member. The
Steering Committee may establish sub-committees, as it deems appropriate;
the NCI Project Coordinator will serve on sub-committees, as s/he deems
appropriate. The Steering Committee members will provide scientific,
statistical, and technical input into discussions of pooled and
collaborative research projects where relevant.
o The Steering Committee may, when it deems it to be necessary, invite
additional, non-voting scientific advisors to the meetings. The NCI
reserves the right to augment the scientific or consumer expertise of the
Steering Committee when necessary. Content-specific working teams,
comprised of scientific experts from the TREC Centers, the TREC
Coordination Center, the NCI, or outside content experts, may be
established by the Steering Committee to address specific research
questions developed by the group.
o The Steering Committee will meet twice every year, separately from the
TREC Center biannual meetings, at locations selected by the Steering
Committee in consultation with the NCI. The Principal Investigator from
each TREC U54 Research Center and the Coordination Center must attend
every Steering Committee meeting.
o The Steering Committee, in partnership with the TREC Coordination
Center, will identify ways that the individual TREC Center’s Cores could
potentially function as part of a coordinated, shared resource for other
or all TREC Centers and minimize duplication of effort.
o The Steering Committee will evaluate the merit of all proposed cross-
site developmental projects and identify common resources to support such
efforts. In addition, the Steering Committee, in partnership with NCI
Program Staff, will monitor the progress of these projects and facilitate
common data sharing, evaluation, and group publications.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of the award) between award recipients and the NCI may be
brought to arbitration. An arbitration panel will be composed of three
members--one selected by the Steering Committee (with the NCI member not
voting) or by the individual awardee in the event of an individual
disagreement, a second member selected by NCI, and the third member
selected by the two prior selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with the PHS regulations
at 42 CFR Part 50, Subpart D and DHHS regulation at 45 CFR Part 16.
PRE-APPLICATION Conference
The NCI will hold a pre-application telephone conference to which all
prospective applicants are invited
(http://www.scgcorp.com/trec-call2004/). Program staff and staff from the
Division of Extramural Activities (DEA) will make brief presentations that
review the goals and objectives for the Transdisciplinary Research on
Energetics and Cancer (TREC) Centers as well as the policies and
procedures for peer review of the applications; questions from the
attendees will be entertained. Prospective applicants are urged to
monitor the NIH Guide Notice for date and time of the meeting at
NOT-CA-04-010 (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-04-010.html).
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:
Linda Nebeling, Ph.D., M.P.H., R.D.,
Chief, Health Promotion Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6120 Executive Boulevard, EPN Room 4080
Bethesda, MD 20892-7335
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 451-9530
FAX: (301) 480-2087
Email: nebelinl@mail.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
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:
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (for courier/express service)
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: 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; and
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:
Linda Nebeling, Ph.D., M.P.H., R.D.
Chief, Health Promotion Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6120 Executive Boulevard, EPN Room 4080
Bethesda, MD 20892-7335
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 451-9530
FAX: (301) 480-2087
Email: nebelinl@mail.nih.gov
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 Grants Info;
Telephone: (301) 435-0714; Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS:
Face Page:
Use the Face Page of the PHS 398 form for the TREC application as a whole.
This is Page 1 of the application. On item 2, check “YES,” and type
Transdisciplinary Research on Energetics and Cancer Centers RFA CA-05-010.
Where human subjects and animal subjects approvals are requested, type
“see page __ for summary”. These summary instructions are provided below.
Description, Performance Sites and Personnel Page:
Write a Description that provides the theme and aims of the project as a
whole, enumerates and briefly describes the individual components, and
outlines the interdisciplinary strategy for the TREC Centers. Performance
Sites and Personnel (all Sites and all Key Personnel in the TREC Centers)
are to be entered as described in the PHS 398 instructions. Use extension
pages as necessary.
Table of Contents Page for the TREC application as a whole:
Use Attachment 1 as the Table of Contents for the entire TREC, which shows
the order of all forms and subsections. Number pages sequentially through
the entire application. Use Attachment 2 as the Table of Contents page
for the individual Research Project Plans and Attachment 3 for Cores.
Human Subjects protocol summary:
Refer to PHS 398. Certification of Institutional Review Boards (IRBs)
review and approval is a “Just in Time” item and need not be included in
the application. If the application is successful, the applicant will be
asked to provide all of the “Just in Time” items during the award process.
Gender and Minority Inclusion – Use a separate target plan enrollment
table from PHS 398 form for each clinical research project.
Animal Subjects protocol summary:
Refer to PHS 398. Provide a list summarizing the Institutional Animal
Care and Use Committee (IACUC) status of all research project plans,
Cores, and developmental projects. You will also need to include IACUC
approval at the time of submission of the application or within 60 days.
Biographical Sketch:
As described in the PHS 398. Include the TREC Principal Investigator’s
Biosketch first and then list Biographical Sketches for all other co-
investigators and key personnel in alphabetical order.
Other Support:
Information on Other Support is “Just in Time” and need NOT be submitted
with the application. This information is required, however, for all
applications that are to receive grant awards. NIH will request complete
and up-to-date "Other Support" information from applicants at an
appropriate time after peer review. The NCI’s scientific program and
grants management staff will review this information prior to award.
1) Budget(s):
The budget(s) should be presented in logical, discrete units for each
section of the application using the standard PHS-398 form pages 4-5. The
budgets to be submitted should include:
a) A detailed composite budget for the entire TREC Center;
b) A separate budget for Administrative and Organizational activities;
c) A separate budget for each individual Research Component;
d) A separate budget for each Core Resource;
e) A single separate budget section for the Developmental Component; and
f) A single separate budget for the Career Development Component.
Additional pages for budget justification are to be used when necessary.
Detailed Budget for Initial Budget Period (DD):
Include this page in the front section of the TREC application. This page
is a summation of all project costs in the first year of funding. The
TREC PI should show his or her percent effort and salary information where
appropriate in the individual research project plans, Cores, and
Developmental Projects. Total effort should be listed on this form as
well.
Budget for Entire Proposed Project Period (EE):
Provide aggregate figures that encompass all Administrative and Research
Project Plans, Cores, and Developmental Projects across all project years.
Also, provide budget justification information here if it relates to the
TREC as a whole. This form should also be used in the Individual Research
Project Plans, Cores and Developmental Projects.
Consolidated Direct Costs for First Year of Requested Support:
Use Attachment 4 for the overall TREC budget, across all Research Project
Plans, Cores and Developmental Projects. Note that standard 398 budget
pages and justifications of budget items and personnel should be embedded
within the individual sections, as outlined in the PHS 398 application
packet.
Percent Distribution of Professional effort on this application: Use
Attachment 5.
Percent Distribution of Core Resources: Use Attachment 6.
Resources:
This page relates to the TREC as a whole, including off-site collaborative
facilities, if any. Use extension pages if necessary.
2) Research Plan
The following format is suggested for completing the “Research Plan”
section (see pages 19 through 23 of the PHS 398 application brochure).
The application should be as concise as possible to ensure a thorough
review.
a) TREC Center Description (not to exceed 10 pages, see description
below.)
This section should be used to present the overall vision for the TREC
Center. This summary should contain the long- and short-term scientific
objectives, specifically addressing what questions in energy balance and
obesity will be explored and what new approaches and collaborations that
will result from the establishment of the TREC Center. Summarize the
organizational structure for the TREC Center, concisely defining Research
Components, Shared Resources (i.e. Cores), the Developmental Fund, and the
Career Development Component, and their relationships to each other. In
addition, relationships between the TREC Center, TREC Coordination Center,
or other research, academic, and administrative units of the institution
(such as centers, institutes, departments) and the central administration
should be described in this section. The description should serve as an
overview of the TREC Center, with a more detailed description of each
component to be presented in a later section.
Part A.
Research Plan of the TREC Center as a whole
Introduction and overview of the entire TREC Center application:
This section should not exceed five pages, exclusive of literature
references.
Sub-sections of the overview should include:
o Specific Aims of the TREC Center, including brief descriptions of each
Center component (including Core[s]). Include here a brief overview of
the interdisciplinary strategy with regard to interactions and
collaborations.
o Setting and Facilities, including a statement of institutional
commitment (this does not supplant the Resources form). Describe here how
the institution will make the TREC an area of high priority. If the TREC
is being submitted from an institution already designated as an NCI-
designated clinical or comprehensive cancer center, clearly delineate the
relationship of the TREC Center U54) to the NCI-designated cancer center
(P30).
o Proposed animal models and species, and/or proposed use of human
volunteers (e.g., patient populations, epidemiological samples).
o TREC Center organization and administration, including a brief
description of the roles and responsibilities of the Principal
Investigator and other Scientific Leadership.
o Applicants are strongly discouraged from naming individual members of
“advisory committees” or “scientific boards” until the time the
application has been funded.
Part B.
Detailed Description of the Interdisciplinary Collaboration. Explain how
all of the projects fit together across disciplines to promote synergy and
syntheses. This section also should identify creative strategies to
foster intra- and inter-center collaborations of a formal and informal
nature to identify and address overarching scientific and methodological
issues. The NIH is especially interested in opportunities to engage arts
and sciences university faculties and schools of public health in
collaboration with medical schools or cancer center faculty. Budget
pages and other 398 forms should be included in this section if relevant.
Five page limit, exclusive of forms and literature references.
b) Organization and Administration (not to exceed 20 pages, including any
organizational charts). A separate budget should be prepared and included
for centralized administrative and organizational activities. The
Organizational and Administrative Component should describe all of the
infrastructure and decision-making needs of the TREC Center. Appropriate
for inclusion in this component would be (not necessarily in the following
order):
o description of the role(s) and responsibilities of lead investigators,
internal and external advisory committees as well as participating
investigators;
o description of decision-making and oversight responsibilities for each
Research Component;
o description of decision-making, oversight responsibilities and
anticipated utilization for each Shared Resource
o description of decision-making and oversight responsibilities for the
Developmental Fund, including the process for selecting, monitoring and
terminating the Developmental Projects;
o description of decision-making and oversight responsibilities for the
Career Development Component, including the process for selecting,
monitoring, and terminating trainees;
o description of TREC-sponsored activities designed to foster
multidisciplinary interactions, such as regularly scheduled forums for the
presentation and discussion of multidisciplinary research topics;
o detailed description of Institutional commitment to the TREC Center;
and
o description(s) of commitment(s) to interact with other TREC Centers.
c) Research Components (not to exceed 25 pages each)
Research Components will define the scientific projects supporting the
long-term goals of the TREC Center, and are to be presented using the
format of a traditional research project [Research Plan: Include Sections
a-i (Instructions for PHS 398, Pages 15-17)]. The leader(s) of each
Research Component will be responsible for ensuring that ongoing research
project(s) are relevant to the TREC Center’s goals, and that the
investigators and projects remain highly integrated with other ongoing
TREC research. Research Components may rely on the support of the
Specialized Resources. To ensure a sufficient level of multidisciplinary
interaction, no fewer than three Research Components should be included in
the application; the maximum number will be determined by the identified
needs of the investigators and budgetary constraints. The total number of
pages for each Research Component (sections a-d)is not to exceed 25.
Describe each Research Component in sufficient detail to enable reviewers
to judge the scientific merit from the written application. Do not
present separate "subprojects." All projects are to have a single theme,
project leader and budget.
Following the description of the scientific goals, each Research Component
should include a summary of exactly how the project integrates with the
goals of the TREC Center, how it will directly support or impact the
project mission, how it will communicate and complement the other Research
Components, and how it will utilize the Shared Resources (Cores).
Describe in this section the relevance of the project to the primary theme
of the TREC Center and the collaborations with investigators within the
TREC Center. Explicitly state which Cores will be used by this Research
Component, and, if possible, quantitate the anticipated usage of Cores in
tabular format. This summary should not exceed 1-2 pages, which are
included in the 25 page limit for each Research Component section.
Individual Research Projects, Cores, and Developmental Projects:
There is required, at minimum, three research projects concurrently active
in any given year of the TREC. It is not necessary, however, for all
projects in the TREC to span the 5-year period. An application can, for
example, propose an initial project to begin and end in 2 years followed
by a different 3-year project, while two other projects concurrently span
the entire 5-year period. Across all projects, different aspects of
cancer communications research should be addressed; ideally, these should
include research, from basic to applied, oriented toward critically needed
areas, and should stimulate and sustain novel collaborations and test
novel ideas. Although a detailed description of the interdisciplinary
collaboration (above) will describe the overall interdisciplinary
collaboration across all of the TREC’s projects and cores, it would be
helpful within each Project, Core, and Developmental Project to discuss
its integration with the entire TREC.
Each Research Project Plan of the TREC should be written as a separate and
contained application that is based on the PHS 398 form and instructions.
Do not, however, use the face page of the 398 package for the title page
of the individual Research Project Plans or Cores. Use the title page
format provided in Attachments 2 and 3. Otherwise, use all of the
required 398 budget and other forms and sections for each individual
research project plan. Each Research Project Plan is limited to 25 pages.
The page limit refers to the Specific Aims, Background and Significance,
Preliminary Studies, and Research Design and Methods sections. Refer to
the PHS 398 instructions for guidance regarding human subjects research
and inclusion of women, minorities, and children in research protocols.
d) Core Resources (not to exceed 15 pages each)
Similarly, each Core of shared administrative, clinical, statistical,
training or other resources and activities (e.g., Administrative Core,
Scientific Core) should be written as a separate 398 application, again
using the title page format provided in Attachment 2, followed by the 398
forms and sections as appropriate. The Core sections need not conform
exactly to the layout of the Research Project Plans (for example, a
research design and methods section may be inappropriate for a Core
description). Try to follow the table of contents outline, but if a
section category is not applicable, type a dash “-“ in the page number
column in the table of contents page. Each Core description is limited to
15 pages, exclusive of forms and literature references.
Core Resources may include laboratory and clinical facilities, equipment,
and services. For each Core Resource, describe in detail the resource(s)
that it will provide to the TREC Center. In addition, describe its role
in the overall functioning of the TREC Center, including how each resource
will enhance multidisciplinary research, and a description of the projects
that will be supported by the Core Resource.
1. Using a Form PHS 398 Continuation Page, denote "Core Resource" and the
Core Resource director's name. If there is to be more than one core
component, prepare a separate section for each core (i.e., Core Resource
A, Core Resource B, etc.).
2. For each Core Resource, describe the role of the Core Resource to the
TREC Center as a whole. Clearly present the facilities, resources,
services, and professional skills that the core component provides.
Distinguish how each core facility supports the individual TREC Center.
Identify ways the individual Cores, working with the TREC Coordination
Center and Steering Committee, could potentially function as part of a
coordinated, shared resource for other or all TREC Centers.
3. To aid in the review, it is suggested that a table to show the
estimated or actual proportional use of this Core Resource by each
project, be included in the application. Justify this core component by
discussing ways in which these centralized services improve quality
control, produce an economy of effort, and/or save overall costs compared
to their inclusion as part of each project in the U54 TREC Center.
e) Developmental Projects (not to exceed 20 pages)
This section should include a brief description of the Developmental
Project(s) that will be proposed during the first year of TREC Center
funding, including a summary of which Core Resources will support the
projects, and to what level that support will occur. The description of
decision-making and oversight responsibilities, including the process for
selecting, monitoring, and terminating the Developmental Projects should
be included in the "Organization and Administration" Section of the
application. This section should include only the scientific portion of
the Developmental Projects. The Developmental Projects should provide an
avenue for introducing and integrating new investigators and innovative
technologies and/or methodologies into the TREC infrastructure. Since the
Developmental Projects will be flexible, only the first year of projects
should be included in the application. However, applicants should include
in their budgets appropriate funds to also support Developmental Projects
in Years 2-5 of the award. The Developmental Fund projects must be
multidisciplinary, and each is to be presented using the format of a
traditional research project [Research Plan: Include Sections a-d
(Instructions for PHS 398, Pages 15-17)]. The number of Developmental
Projects to be initiated will be determined by the TREC Center applicants.
A minimum of one Developmental Project per site is expected. The
application may also include examples of up to two developmental projects.
Each example should not exceed 2 pages.
Development Research Selection Process:
The TREC Centers, in partnership with the TREC Coordination Center and
Steering Committee are expected to establish an institutional review
process that selects the most innovative developmental projects, based on
common research questions and methodological issues that represent the
most innovative and interdisciplinary ideas across sites. It is
anticipated that there will be at least one developmental collaborative
project between two or more TREC Centers selected for each funded TREC
Center. Applicants should include within the budget, a funding proposal
to support one developmental project, up to $ 250,000 in total cost per
year, for a maximum of 5 years.
f) Career Development Component (not to exceed 15 pages)
Career Development opportunities sponsored by TREC Centers will provide a
limited number of trainees with access to a highly cross-disciplinary
experience. The extent of the Career Development Component is to be
defined by the applicant, based on the needs and capabilities of the TREC
participants. Applicants for career development support may be new
investigators or established investigators who wish to change research
directions. Candidates should be scientists who have demonstrated
outstanding research potential but who need additional time in a
productive scientific environment to establish an independent,
multidisciplinary research program. Recruitment must include
qualified women and minorities. To this end, each applicant should
propose a clear policy and plan for recruitment of career development
candidates. The TREC Center application should propose the number of
slots available, the criteria for eligibility and for selection of
candidates, and describe the selection process. Also, the application
should indicate prospective mentors who are already in place at the
proposed TREC Center, briefly describe their research programs, and
describe complementary activities that contribute to the environment for
career development (e.g., existing training grants, other career
development mechanisms and relevant programs).
As described in the RFA, a Career Development Plan must be included that
will target either new investigators or established investigators who wish
to expand their research skills. Recruitment must include qualified women
and minorities. To this end, propose a clear policy and plan for
recruitment of career development candidates. State the number of career
development candidates proposed, the criteria for eligibility and for
selection of candidates, and describe the selection process. Also
indicate potential mentors who are already in place at the proposed TREC,
briefly describe their research programs, and describe complementary
activities that contribute to the interdisciplinary environment for career
development (e.g., existing training grants, other career development
mechanisms and relevant programs). Do not exceed 15 pages.
Checklist: Use one for the entire TREC application. This is the last
page of the application.
Appendix:
Do not include appendices with the TREC application; they will not be
accepted. Following submission of the proposal, the Scientific Review
Administrator may allow a PI to send original glossy photographs or other
color images. If such permission is granted (and only if) by the SRA,
these photos are to be sent directly to the SRA.
Attachments
Attachment 1: Table of Contents for TREC application as a whole
Attachment 2 & 3: Table of Contents page for individual Research
Project Plans, Cores, and Developmental Projects
Attachments 4-6: Tables for consolidated budget and percent
distribution across TREC components
GUIDANCE FOR PREPARATION OF RESEARCH TOOLS SHARING PLAN AND INTELLECTUAL
PROPERTY PLAN
Restricted availability of unique research resources, upon which further
studies are dependent, can impede the advancement of research. The NIH is
interested in ensuring that the research resources developed through this
grant also become readily available to the broader research community in a
timely manner for further research, development, and application, in the
expectation that this will lead to products and knowledge of benefit to
the public health.
Investigators conducting biomedical research frequently develop unique
research resources. The policy of the NIH is to make available to the
public the results and accomplishments of the activities that it funds.
To address this interest in ensuring research resources are accessible,
NIH requires applicants who respond to this RFA to submit a plan: (1) for
sharing the research resources generated through the grant (e.g., human
biospecimens and novel cancer biomarkers); and (2) addressing how they
will exercise intellectual property rights, should any be generated
through this grant, while making such research resources available to the
broader scientific community consistent with this initiative. Therefore,
the research resources tools sharing plan and intellectual property
management plans must make unique research resources readily available for
research purposes to qualified individuals within the scientific community
in accordance with the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final Notice,
December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf)(“NIH Research Tools
Guidelines Policy”). These documents also: (1) define terms, parties, and
responsibilities; (2) prescribe the order of disposition of rights and a
chronology of reporting requirements: and (3) delineate the basis for and
extent of government actions to retain rights. Patent rights clauses may
be found at 37 CFR Part 401.14 and are accessible from the Interagency
Edison web page, (http://www.iedison.gov); see also, 35 USC § 210(c);
Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on
Government Patent Policy (Feb. 18, 1983). If applicant investigators plan
to collaborate with third parties, the research tools sharing plan must
explain address how such collaborations will not restrict their ability to
share research materials produced with NIH funding. NCI believes that
applicants can satisfy the requirement to submit the research resources
plan and intellectual property plan in a number of ways.
Reviewers will comment, as appropriate, on the adequacy and feasibility of
the sharing of research resources plan and the intellectual property plan.
Comments on the plans and any concerns will be presented in an
administrative note in the Summary Statement. These comments will not
affect the priority score of the application. NIH program staff will
consider the adequacy of the plans in determining whether to recommend an
application for award. The approved plans will become a condition of the
grant award and Progress Reports must contain information on activities
for the sharing of research resources and intellectual property.
Where it is anticipated that there will be an exchange of collections of
human tissues, consideration should also be given to obtaining the
appropriate assurances from the DHHS Office of Human Subject Protections
(http://www.hhs.gov/ohrp/assurances/assurances_index.html) and necessary IRB approvals
and/or exemptions. In addition, issues pertaining to the protection of
patient identifiable information under the Privacy Rule of the Health
Insurance Portability and Accountability Act of 1976 (HIPAA) should be
addressed. For more information concerning the HIPAA Privacy Rule, see
the HIPPA web site at http://www.hhs.gov/ocr/hipaa.
In the development of the research resource sharing and intellectual
property management plans, applicants should confer with their
institutions’ office(s) responsible for handling technology transfer
related matters and/or sponsored research. If applicants or their
representatives require additional guidance in preparing these plans, they
are encouraged to make further inquiries to the appropriate contacts
listed above for such matters. Further, applicants may wish to
independently research and review examples of approaches considered by
other institutions such as those described on the NCI Technology Transfer
Branch web site (http://ttc.nci.nih.gov/intellectualproperty/).
The foregoing guidance is provided by way of example to assist applicants
in preparing the required research resources sharing and intellectual
property management plans in a manner that encourages partnerships with
industry. While these approaches will likely suit most situations, these
approaches are not exclusive and applicants should feel free to submit
alternative versions for consideration.
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 five copies of the appendices must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428 (for express/courier service)
Appendices should be comprised of unbound materials, with separators
between documents.
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 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. An application received after the deadline may
be acceptable if it carries a legible proof-of-mailing date assigned by
the carrier and the proof-of-mailing is not later than one week prior to
the deadline date.
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 non-responsive
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 National Cancer Advisory Board.
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 evaluate the application
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of these criteria in assigning the
application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, an investigator may propose to attack a highly
significant research problem for which some of the details of approach
have not been established through preliminary data.
The Centers must include three or more individual research projects, which
reflect hypothesis-driven research, plus a process for collaborative
developmental, methodologically-based research projects, shared resources
(cores) and career development.
a. Research Projects
SIGNIFICANCE
o Does this Application address an important problem in nutrition,
physical activity, energetics, and carcinogenesis?
o If the aims of the application are achieved, how will scientific
knowledge in energy balance, obesity, and cancer risk be advanced?
o What will be the effect of these studies on the concepts and methods
that drive the field of energy balance and obesity?
APPROACH
o Are the conceptual framework, design, methods, and analyses adequately
developed, well integrated, transdisciplinary in nature, and appropriate
to the aims of the project, within the limits inherent in an emerging,
complex approach to energy balance and carcinogensis?
o Does the applicant acknowledge potential problem areas and consider
alternative tactics?
o Are there appropriate plans to maximize TREC Center flexibility by
incorporating developmental projects and redirecting resources to maximize
progress? Are the plans for oversight of such changes adequate?
o Is the scientific research plan of high quality? Are the exploratory
research components well justified and do they contribute to the goals of
the planning effort?
o Is there an appropriate plan for acquisition, organization, and
deployment of equipment and human resources needed to attain the goals of
the exploratory research? Is there an adequate level of effort from key
personnel?
o Is the plan to develop an effective training/outreach component
appropriate?
o Is the plan to solicit and fund developmental studies adequate?
INNOVATION
o Does the project employ novel transdisciplinary concepts, approaches, or
methods? Are the aims original and innovative?
o Does the project challenge existing paradigms or develop new
methodologies or technologies?
o Would the proposed application be innovative in organization, scientific
approach, or resources that could be mobilized, relative to more
established efforts in nutrition, physical activity, energetics, and
carcinogenesis?
INVESTIGATOR
o Does the overall research team have sufficient expertise in all of
the critical aspects of this undertaking, i.e., nutrition, physical
activity, energetics, and carcinogenesis to effectively conduct this
program? Are time commitments appropriate for each co-investigator to
effectively conduct the project and contribute to the overall program?
o Is the Principal Investigator appropriately trained and well suited to
lead and coordinate a planning effort of this kind?
o Is there an adequate pool of expertise at the applicant institution(s)
in all of the critical aspects of integrative cancer biology, or are there
plans to supplement available expertise through collaboration and/or
recruitment?
ENVIRONMENT
o Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ
useful collaborative arrangements?
o Does the applicant institution(s) provide an environment conducive to
the development of a high-quality research effort in integrative
nutrition, physical activity, energetics, and carcinogenesis?
o Is there strong evidence of institutional support? Is the
institution(s) committed to the proposed application in terms of space,
administrative authority, and other necessary resources, e.g., donated
faculty time, use of equipment, etc? Will the Program that is being
developed be recognized as a major element within the organizational
structure of the institution?
o Is there evidence of experienced and available personnel dedicated to
the activities necessary for the project, for example: human subject
consent, data entry, maintenance of database and computer networks,
development of data files for use with TREC Coordination Center.
o Is there adequate access to patients and populations for conducting
current and projected research?
b. Core Facilities and Resources
o Are the proposed core facilities or shared resources or specialized
resources, if any, essential twith regard to interactions and
collaborations.
o Setting and Facilities, including a statement of institutional
commitment (this does not supplant the Resources form). Describe here how
the institution will make the TREC an area of high priority. If the TREC
is being submitted from an institution already designated as an NCI-
designated clinical or comprehensive cancer center, clearly delineate the
relationship of the TREC Center U54) to the NCI-designated cancer center
(P30).
o Proposed animal models and species, and/or proposed use of human
volunteers (e.g., patient populations, epidemiological samples).
o TREC Center organization and administration, including a brief
description of the roles and responsibilities of the Principal
Investigator and other Scientific Leadership.
o Applicants are strongly discouraged from naming individual members of
“advisory committees” or “scientific boards” until the time the
application has been funded.
Part B.
Detailed Description of the Interdisciplinary Collaboration. Explain how
all of the projects fit together across disciplines to promote synergy and
syntheses. This section also should identify creative strategies to
foster intra- and inter-center collaborations of a formal and informal
nature to identify and address overarching scientific and methodological
issues. The NIH is especially interested in opportunities to engage arts
and sciences university faculties and schools of public health in
collaboration with medical schools or cancer center faculty. Budget
pages and other 398 forms should be included in this section if relevant.
Five page limit, exclusive of forms and literature references.
b) Organization and Administration (not to exceed 20 pages, including any
organizational charts). A separate budget should be prepared and included
for centralized administrative and organizational activities. The
Organizational and Administrative Component should describe all of the
infrastructure and decision-making needs of the TREC Center. Appropriate
for inclusion in this component would be (not necessarily in the following
order):
o description of the role(s) and responsibilities of lead investigators,
internal and external advisory committees as well as participating
investigators;
o description of decision-making and oversight responsibilities for each
Research Component;
o description of decision-making, oversight responsibilities and
anticipated utilization for each Shared Resource
o description of decision-making and oversight responsibilities for the
Developmental Fund, including the process for selecting, monitoring and
terminating the Developmental Projects;
o description of decision-making and oversight responsibilities for the
Career Development Component, including the process for selecting,
monitoring, and terminating trainees;
o description of TREC-sponsored activities designed to foster
multidisciplinary interactions, such as regularly scheduled forums for the
presentation and discussion of multidisciplinary research topics;
o detailed description of Institutional commitment to the TREC Center;
and
o description(s) of commitment(s) to interact with other TREC Centers.
c) Research Components (not to exceed 25 pages each)
Research Components will define the scientific projects supporting the
long-term goals of the TREC Center, and are to be presented using the
format of a traditional research project [Research Plan: Include Sections
a-i (Instructions for PHS 398, Pages 15-17)]. The leader(s) of each
Research Component will be responsible for ensuring that ongoing research
project(s) are relevant to the TREC Center’s goals, and that the
investigators and projects remain highly integrated with other ongoing
TREC research. Research Components may rely on the support of the
Specialized Resources. To ensure a sufficient level of multidisciplinary
interaction, no fewer than three Research Components should be included in
the application; the maximum number will be determined by the identified
needs of the investigators and budgetary constraints. The total number of
pages for each Research Component (sections a-d)is not to exceed 25.
Describe each Research Component in sufficient detail to enable reviewers
to judge the scientific merit from the written application. Do not
present separate "subprojects." All projects are to have a single theme,
project leader and budget.
Following the description of the scientific goals, each Research Component
should include a summary of exactly how the project integrates with the
goals of the TREC Center, how it will directly support or impact the
project mission, how it will communicate and complement the other Research
Components, and how it will utilize the Shared Resources (Cores).
Describe in this section the relevance of the project to the primary theme
of the TREC Center and the collaborations with investigators within the
TREC Center. Explicitly state which Cores will be used by this Research
Component, and, if possible, quantitate the anticipated usage of Cores in
tabular format. This summary should not exceed 1-2 pages, which are
included in the 25 page limit for each Research Component section.
Individual Research Projects, Cores, and Developmental Projects:
There is required, at minimum, three research projects concurrently active
in any given year of the TREC. It is not necessary, however, for all
projects in the TREC to span the 5-year period. An application can, for
example, propose an initial project to begin and end in 2 years followed
by a different 3-year project, while two other projects concurrently span
the entire 5-year period. Across all projects, different aspects of
cancer communications research should be addressed; ideally, these should
include research, from basic to applied, oriented toward critically needed
areas, and should stimulate and sustain novel collaborations and test
novel ideas. Although a detailed description of the interdisciplinary
collaboration (above) will describe the overall interdisciplinary
collaboration across all of the TREC’s projects and cores, it would be
helpful within each Project, Core, and Developmental Project to discuss
its integration with the entire TREC.
Each Research Project Plan of the TREC should be written as a separate and
contained application that is based on the PHS 398 form and instructions.
Do not, however, use the face page of the 398 package for the title page
of the individual Research Project Plans or Cores. Use the title page
format provided in Attachments 2 and 3. Otherwise, use all of the
required 398 budget and other forms and sections for each individual
research project plan. Each Research Project Plan is limited to 25 pages.
The page limit refers to the Specific Aims, Background and Significance,
Preliminary Studies, and Research Design and Methods sections. Refer to
the PHS 398 instructions for guidance regarding human subjects research
and inclusion of women, minorities, and children in research protocols.
d) Core Resources (not to exceed 15 pages each)
Similarly, each Core of shared administrative, clinical, statistical,
training or other resources and activities (e.g., Administrative Core,
Scientific Core) should be written as a separate 398 application, again
using the title page format provided in Attachment 2, followed by the 398
forms and sections as appropriate. The Core sections need not conform
exactly to the layout of the Research Project Plans (for example, a
research design and methods section may be inappropriate for a Core
description). Try to follow the table of contents outline, but if a
section category is not applicable, type a dash “-“ in the page number
column in the table of contents page. Each Core description is limited to
15 pages, exclusive of forms and literature references.
Core Resources may include laboratory and clinical facilities, equipment,
and services. For each Core Resource, describe in detail the resource(s)
that it will provide to the TREC Center. In addition, describe its role
in the overall functioning of the TREC Center, including how each resource
will enhance multidisciplinary research, and a description of the projects
that will be supported by the Core Resource.
1. Using a Form PHS 398 Continuation Page, denote "Core Resource" and the
Core Resource director's name. If there is to be more than one core
component, prepare a separate section for each core (i.e., Core Resource
A, Core Resource B, etc.).
2. For each Core Resource, describe the role of the Core Resource to the
TREC Center as a whole. Clearly present the facilities, resources,
services, and professional skills that the core component provides.
Distinguish how each core facility supports the individual TREC Center.
Identify ways the individual Cores, working with the TREC Coordination
Center and Steering Committee, could potentially function as part of a
coordinated, shared resource for other or all TREC Centers.
3. To aid in the review, it is suggested that a table to show the
estimated or actual proportional use of this Core Resource by each
project, be included in the application. Justify this core component by
discussing ways in which these centralized services improve quality
control, produce an economy of effort, and/or save overall costs compared
to their inclusion as part of each project in the U54 TREC Center.
e) Developmental Projects (not to exceed 20 pages)
This section should include a brief description of the Developmental
Project(s) that will be proposed during the first year of TREC Center
funding, including a summary of which Core Resources will support the
projects, and to what level that support will occur. The description of
decision-making and oversight responsibilities, including the process for
selecting, monitoring, and terminating the Developmental Projects should
be included in the "Organization and Administration" Section of the
application. This section should include only the scientific portion of
the Developmental Projects. The Developmental Projects should provide an
avenue for introducing and integrating new investigators and innovative
technologies and/or methodologies into the TREC infrastructure. Since the
Developmental Projects will be flexible, only the first year of projects
should be included in the application. However, applicants should include
in their budgets appropriate funds to also support Developmental Projects
in Years 2-5 of the award. The Developmental Fund projects must be
multidisciplinary, and each is to be presented using the format of a
traditional research project [Research Plan: Include Sections a-d
(Instructions for PHS 398, Pages 15-17)]. The number of Developmental
Projects to be initiated will be determined by the TREC Center applicants.
A minimum of one Developmental Project per site is expected. The
application may also include examples of up to two developmental projects.
Each example should not exceed 2 pages.
Development Research Selection Process:
The TREC Centers, in partnership with the TREC Coordination Center and
Steering Committee are expected to establish an institutional review
process that selects the most innovative developmental projects, based on
common research questions and methodological issues that represent the
most innovative and interdisciplinary ideas across sites. It is
anticipated that there will be at least one developmental collaborative
project between two or more TREC Centers selected for each funded TREC
Center. Applicants should include within the budget, a funding proposal
to support one developmental project, up to $ 250,000 in total cost per
year, for a maximum of 5 years.
f) Career Development Component (not to exceed 15 pages)
Career Development opportunities sponsored by TREC Centers will provide a
limited number of trainees with access to a highly cross-disciplinary
experience. The extent of the Career Development Component is to be
defined by the applicant, based on the needs and capabilities of the TREC
participants. Applicants for career development support may be new
investigators or established investigators who wish to change research
directions. Candidates should be scientists who have demonstrated
outstanding research potential but who need additional time in a
productive scientific environment to establish an independent,
multidisciplinary research program. Recruitment must include
qualified women and minorities. To this end, each applicant should
propose a clear policy and plan for recruitment of career development
candidates. The TREC Center application should propose the number of
slots available, the criteria for eligibility and for selection of
candidates, and describe the selection process. Also, the application
should indicate prospective mentors who are already in place at the
proposed TREC Center, briefly describe their research programs, and
describe complementary activities that contribute to the environment for
career development (e.g., existing training grants, other career
development mechanisms and relevant programs).
As described in the RFA, a Career Development Plan must be included that
will target either new investigators or established investigators who wish
to expand their research skills. Recruitment must include qualified women
and minorities. To this end, propose a clear policy and plan for
recruitment of career development candidates. State the number of career
development candidates proposed, the criteria for eligibility and for
selection of candidates, and describe the selection process. Also
indicate potential mentors who are already in place at the proposed TREC,
briefly describe their research programs, and describe complementary
activities that contribute to the interdisciplinary environment for career
development (e.g., existing training grants, other career development
mechanisms and relevant programs). Do not exceed 15 pages.
Checklist: Use one for the entire TREC application. This is the last
page of the application.
Appendix:
Do not include appendices with the TREC application; they will not be
accepted. Following submission of the proposal, the Scientific Review
Administrator may allow a PI to send original glossy photographs or other
color images. If such permission is granted (and only if) by the SRA,
these photos are to be sent directly to the SRA.
Attachments
Attachment 1: Table of Contents for TREC application as a whole
Attachment 2 & 3: Table of Contents page for individual Research
Project Plans, Cores, and Developmental Projects
Attachments 4-6: Tables for consolidated budget and percent
distribution across TREC components
GUIDANCE FOR PREPARATION OF RESEARCH TOOLS SHARING PLAN AND INTELLECTUAL
PROPERTY PLAN
Restricted availability of unique research resources, upon which further
studies are dependent, can impede the advancement of research. The NIH is
interested in ensuring that the research resources developed through this
grant also become readily available to the broader research community in a
timely manner for further research, development, and application, in the
expectation that this will lead to products and knowledge of benefit to
the public health.
Investigators conducting biomedical research frequently develop unique
research resources. The policy of the NIH is to make available to the
public the results and accomplishments of the activities that it funds.
To address this interest in ensuring research resources are accessible,
NIH requires applicants who respond to this RFA to submit a plan: (1) for
sharing the research resources generated through the grant (e.g., human
biospecimens and novel cancer biomarkers); and (2) addressing how they
will exercise intellectual property rights, should any be generated
through this grant, while making such research resources available to the
broader scientific community consistent with this initiative. Therefore,
the research resources tools sharing plan and intellectual property
management plans must make unique research resources readily available for
research purposes to qualified individuals within the scientific community
in accordance with the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final Notice,
December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf)(“NIH Research Tools
Guidelines Policy”). These documents also: (1) define terms, parties, and
responsibilities; (2) prescribe the order of disposition of rights and a
chronology of reporting requirements: and (3) delineate the basis for and
extent of government actions to retain rights. Patent rights clauses may
be found at 37 CFR Part 401.14 and are accessible from the Interagency
Edison web page, (http://www.iedison.gov); see also, 35 USC § 210(c);
Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on
Government Patent Policy (Feb. 18, 1983). If applicant investigators plan
to collaborate with third parties, the research tools sharing plan must
explain address how such collaborations will not restrict their ability to
share research materials produced with NIH funding. NCI believes that
applicants can satisfy the requirement to submit the research resources
plan and intellectual property plan in a number of ways.
Reviewers will comment, as appropriate, on the adequacy and feasibility of
the sharing of research resources plan and the intellectual property plan.
Comments on the plans and any concerns will be presented in an
administrative note in the Summary Statement. These comments will not
affect the priority score of the application. NIH program staff will
consider the adequacy of the plans in determining whether to recommend an
application for award. The approved plans will become a condition of the
grant award and Progress Reports must contain information on activities
for the sharing of research resources and intellectual property.
Where it is anticipated that there will be an exchange of collections of
human tissues, consideration should also be given to obtaining the
appropriate assurances from the DHHS Office of Human Subject Protections
(http://www.hhs.gov/ohrp/assurances/assurances_index.html) and necessary IRB approvals
and/or exemptions. In addition, issues pertaining to the protection of
patient identifiable information under the Privacy Rule of the Health
Insurance Portability and Accountability Act of 1976 (HIPAA) should be
addressed. For more information concerning the HIPAA Privacy Rule, see
the HIPPA web site at http://www.hhs.gov/ocr/hipaa.
In the development of the research resource sharing and intellectual
property management plans, applicants should confer with their
institutions’ office(s) responsible for handling technology transfer
related matters and/or sponsored research. If applicants or their
representatives require additional guidance in preparing these plans, they
are encouraged to make further inquiries to the appropriate contacts
listed above for such matters. Further, applicants may wish to
independently research and review examples of approaches considered by
other institutions such as those described on the NCI Technology Transfer
Branch web site (http://ttc.nci.nih.gov/intellectualproperty/).
The foregoing guidance is provided by way of example to assist applicants
in preparing the required research resources sharing and intellectual
property management plans in a manner that encourages partnerships with
industry. While these approaches will likely suit most situations, these
approaches are not exclusive and applicants should feel free to submit
alternative versions for consideration.
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 five copies of the appendices must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428 (for express/courier service)
Appendices should be comprised of unbound materials, with separators
between documents.
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 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. An application received after the deadline may
be acceptable if it carries a legible proof-of-mailing date assigned by
the carrier and the proof-of-mailing is not later than one week prior to
the deadline date.
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 non-responsive
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 National Cancer Advisory Board.
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 evaluate the application
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of these criteria in assigning the
application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, an investigator may propose to attack a highly
significant research problem for which some of the details of approach
have not been established through preliminary data.
The Centers must include three or more individual research projects, which
reflect hypothesis-driven research, plus a process for collaborative
developmental, methodologically-based research projects, shared resources
(cores) and career development.
a. Research Projects
SIGNIFICANCE
o Does this Application address an important problem in nutrition,
physical activity, energetics, and carcinogenesis?
o If the aims of the application are achieved, how will scientific
knowledge in energy balance, obesity, and cancer risk be advanced?
o What will be the effect of these studies on the concepts and methods
that drive the field of energy balance and obesity?
APPROACH
o Are the conceptual framework, design, methods, and analyses adequately
developed, well integrated, transdisciplinary in nature, and appropriate
to the aims of the project, within the limits inherent in an emerging,
complex approach to energy balance and carcinogensis?
o Does the applicant acknowledge potential problem areas and consider
alternative tactics?
o Are there appropriate plans to maximize TREC Center flexibility by
incorporating developmental projects and redirecting resources to maximize
progress? Are the plans for oversight of such changes adequate?
o Is the scientific research plan of high quality? Are the exploratory
research components well justified and do they contribute to the goals of
the planning effort?
o Is there an appropriate plan for acquisition, organization, and
deployment of equipment and human resources needed to attain the goals of
the exploratory research? Is there an adequate level of effort from key
personnel?
o Is the plan to develop an effective training/outreach component
appropriate?
o Is the plan to solicit and fund developmental studies adequate?
INNOVATION
o Does the project employ novel transdisciplinary concepts, approaches, or
methods? Are the aims original and innovative?
o Does the project challenge existing paradigms or develop new
methodologies or technologies?
o Would the proposed application be innovative in org
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