TREC COORDINATION CENTER  

RELEASE DATE:  July 8, 2004

RFA Number:  RFA-CA-05-011 

Update: The following update relating to this announcement has been issued:

December 3, 2009 - This RFA has been reissued as (RFA-CA-10-501).

(see NOT-CA-04-010)

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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The Division of Cancer Control and Population Sciences (DCCPS), National 
Cancer Institute (NCI), invites applications for cooperative agreements 
(U01 mechanism) to support the establishment of a Transdisciplinary 
Research on Energetics* and Cancer (TREC) Coordination Center.  This 
Coordination Center will support the TREC Centers, which focus upon the 
research areas of nutrition, energetics*, energy balance, and physical 
activity.  The primary mission of the Coordination Center is to foster 
collaborations among transdisciplinary teams of scientists, to facilitate 
data analyses, to examine common research questions across sites, to 
coordinate and facilitate semi-annual meetings of the TREC Centers, to 
develop training modules, and to evaluate progress, with the goal of 
accelerating progress toward reducing cancer incidence, morbidity, and 
mortality associated with obesity, low levels of physical activity, and 
poor diet.   This RFA is occurring in tandem with RFA CA-05-010 entitled, 
Transdisciplinary Research on Energetics and Cancer (TREC) Centers, which 
utilize the U54 cooperative agreement funding mechanism to establish up to 
five TREC Centers.  

*Energetics -- The study of the flow and transformation of energy through 
living systems – The American Heritage Dictionary, 2000.   

The TREC Centers will encompass projects that range from the biology and 
genetics of energy balance to the behavioral, socio-cultural, and 
environmental influences on nutrition, physical activity, weight, energy 
balance, and energetics.  The mission of the TREC Centers will focus on 
two great challenges in the area of energetics/energy balance and cancer: 
1) Enhancing our understanding of the mechanisms underlying the 
association between energy balance and carcinogenesis across the cancer 
continuum from causation and prevention though survival, and 2) 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.  (Refer to Figure 1: TREC 
Conceptual Model at http://cancercontrol.cancer.gov/TREC/.) 

Because of the central requirement for interactions across TREC Centers, a 
TREC Coordinating Center will be established under a cooperative agreement 
mechanism (U01) to facilitate the required interactions.  This 
facilitation will include: (1) working with NCI program staff and 
Principal Investigators (PIs) to organize the biannual meetings of the 
TREC Centers; (2) identifying commonalities in research questions being 
explored across sites; (3) compiling state-of-the-art instruments for 
diet, weight, and physical activity assessments in use across sites; (4) 
identifying of common data elements in research across sites that could be 
compared or combined to examine more detailed questions in specific 
populations; (5) bringing together special working groups on key 
scientific topics; (6) providing state of the art cross-site communication 
and a project web site; (7)and/or developing training modules in diverse 
disciplines, such as genetics and proteomics; or developing advances in 
self report and technologies for assessment of diet and physical activity 
to support transfer of knowledge across disciplines.  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.    

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. 

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 to 28 percent 
of adults in the United States report no leisure-time physical activity.  
It also seems likely that overall levels of physical activity are 
declining due to more sedentary occupations, decreased transportation-
related physical activity, and increasing automation.  Furthermore, the 
marked increase in the epidemic of overweight and obesity 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 U.S. population. 

As suggested by the 2002 International Agency for Research on Cancer 
(IARC) report, the combination of efforts to improve diet, physical 
activity, and body weight may have significant effects.  Yet, research has 
typically examined single cancer prevention-related factors, such as 
nutrition, in depth, and few studies have used a multidisciplinary 
approach to assess these factors simultaneously and integrate their 
effects on health (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 few research studies have explored the 
combined effects of body 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.  In the areas of weight control, diet, and physical 
activity, policies related to school food and physical activity practices, 
urban planning, and health insurance may 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.  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).  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 treatment 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.  

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.   

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.  The TREC Coordination Center will partner with the TREC 
Centers to establish a cohesive foundation on which to explore 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

The Coordinating Center (U01) will provide the scientific and 
organizational leadership necessary to facilitate the interactive and 
integrative functions essential to foster transdisciplinary interaction 
across the TREC Centers.  The primary mission of the TREC Coordination 
Center is to foster collaboration and communication 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.  
The second mission of the TREC Coordination Center is to coordinate 
training opportunities for new and established scientists to carry out 
integrative research on energetics, energy balance, and its consequences.  
Finally, the TREC Coordination Center, under the leadership of NCI, will 
have an integral role in the overall evaluation process. 

The successful applicant will facilitate transdisciplinary research and 
training through scientific leadership and organizational support in the 
areas of communication, coordination, and collaboration across multiple 
research institutions, as well as consultation and oversight from the NCI 
program director and other NCI professional staff.  Significant research 
resources in genetics, bioinformatics, dietary assessment, and animal 
models have been developed by the NCI for use by the research community.  
The center will provide close interaction with NCI staff; facilitate 
utilization of any identified common resources; and enhance interactions 
across research centers in diverse areas such as assisting research 
centers in identifying and developing scientific working groups, providing 
cross disciplinary training opportunities, and facilitating the use and 
development of common and new measures of exposure.  These relationships 
can be best supported by the cooperative agreement mechanism (U01).

Because of the central requirement for interaction across TREC Centers, 
the TREC Coordinating Center will facilitate activities such as the 
biannual meetings of the TREC Centers and the development and maintenance 
of a web site for shared communications.  Under the leadership of the 
Steering Committee, the TREC Coordination Center will support the process 
to identify and develop commonalities in methodologically-based research 
questions being explored across sites, compile state-of-the-art 
instruments for diet, weight, and physical activity assessments in use 
across sites, identify common data elements in research across sites that 
could be compared or combined to examine more detailed questions in 
specific populations, bring together special working groups on key 
scientific topics, or develop 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.  

The TREC Coordinating Center will work under the guidance of the Steering 
Committee and NCI Program Director 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 collect relevant data 
on identified performance variables and for NCI to compare site 
performance to that of other TREC Centers, as well as enable evaluation of 
the initiative as a whole. The aim of this requirement is to enhance the 
processes of communication and collaboration among the TREC Centers and 
ensure that those processes contribute to the achievement of the goals of 
the TREC initiative.

The TREC Center, in partnership with the TREC Coordinating Center, must 
provide career development opportunities for new and established 
investigators who wish to pursue active, transdisciplinary research 
careers in nutrition, physical activity, weight, and energy balance; and 
provide developmental funds for innovative developmental projects.  An 
essential part of this initiative is 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). 

Under the direction of the TREC Coordinating Center, Principal 
Investigators from all TREC Centers will be required to participate in 
biannual meetings, and must budget accordingly.  The TREC Coordination 
Center Staff will work with NCI and Steering Committee Staff to plan and 
coordinate each meeting.  The purpose’s of these meetings are to share 
scientific information, to assess scientific progress in the field, to 
identify new research opportunities and developmental projects, to promote 
inter-TREC collaborations in order to foster discovery, and to resolve 
areas of controversy.  

The TREC Coordination Center will be used to archive data for common use 
and to support common resources that can be shared across each TREC 
Center.  Where pertinent, TREC Centers will be encouraged to use common 
measures that allow pooling of data. These efforts should be informed by 
an awareness of initiatives coordinated by the NCI’s Center for 
Bioinformatics (http://cabig.nci.nih.gov/). Related cores relevant to the 
support of cross-site developmental projects will be identified and 
selected by the Steering Committee.  Developmental projects will have a 
transdisciplinary focus.  Each TREC Center application should include, 
within its budget proposal, resources to support these cross-collaborative 
efforts.  The Steering Committee, TREC Centers, and TREC Coordination 
Center application should work together to maximize shared resources 
toward these efforts. 

The successful applicant for the TREC Coordinating Center (U01) will 
demonstrate the capacity to collaborate with the TREC Centers and NCI 
Program Staff to develop an evaluation system that will be integrated into 
the Coordination Center’s design and operations.  This system will make it 
possible to track each TREC Center’s performance and compare its 
performance to that of other TREC Centers, and will enable NCI to monitor 
the evaluation of the initiative as a whole. For example, 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 the TREC Centers, and the interdisciplinary and 
multilevel nature of the research.  Evaluation variables may include items 
such as: peer-reviewed publications, developed web sites, theoretical-
based models within new initiatives, evidence-based diffusion or 
dissemination strategies, or new collaborations and partnerships.  

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 goal of reducing cancer incidence, 
morbidity, and mortality associated with obesity, has been enhanced 
through the sharing of resources within and among TREC Centers; (3) 
collaborative relationships within and among TREC Centers have been 
established; (4) training and career development opportunities exist for 
new and established investigators; (5) a “transdisciplinary research 
culture” has been engendered which takes into account the perspectives of 
multiple disciplines and multiple levels of analysis; and (6) TREC Center 
investigators’ abilities to compete for future R01 grants and participate 
in other research mechanisms have 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 energy balance and obesity based on 
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.

MECHANISMS OF SUPPORT
 
This RFA will use the NIH cooperative agreement (U01) award mechanism.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and will 
be reviewed according to the customary NIH peer review procedures.  The 
anticipated award date is September 1, 2005.  Applications that are not 
funded in the competition described in this RFA may be resubmitted as NEW 
investigator-initiated applications using the standard receipt dates for 
NEW applications described in the instructions to the PHS 398 application.  
  
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).  Follow the 
instructions for non-modular budget research grants 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 U01 is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant 
roles 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 $1 million in FY 2005 to fund one new 
grant in response to this RFA.  An applicant may request a project period 
of up to 5 years and may request a maximum annual direct cost of $600,000.  
Of that, $100,000 per year should be budgeted as a set-aside for Core 
Funds that will be used to support cross-site developmental projects.  The 
cross-site developmental projects will be identified and selected by the 
Steering Committee.   Facilities and administrative costs (F&A) for third 
parties (e.g., subcontractors or consortium partners) are not included 
within the $600,000 direct cost cap.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of the award will also vary.  
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. 

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; and
o Faith-based or community-based organizations.
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their institution 
to develop an application for support.  Individuals from underrepresented 
racial and ethnic groups, as well as individuals with disabilities, are 
always encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS

Applicants are permitted to apply for consideration to become a TREC 
Center under RFA-CA-05-010 and the TREC Coordination Center under 
RFA-CA-05-011.  The Coordination Center, which is required for facilitating 
important interactions, will be responsible for: 

o Working with NCI program staff and PIs to identify commonalities in 
research questions being explored across sites, to compile state-of-the-
art instruments for diet, weight, and physical activity assessment in use 
across sites; to identify common data elements in research across sites 
that could be compared or combined to examine more detailed questions in 
specific populations; to bring together special working groups on key 
scientific topics, or the development of training modules in diverse 
disciplines, such as genetics, proteomics, advances in self reporting and 
technologies for assessment of diet and physical activity; and to support 
transfer of knowledge across disciplines.  

o Facilitating communications, coordination, and collaborations across 
multiple research institutions including but not limited to the TREC 
Centers, as well as consultation and oversight from the NCI program 
director and other NCI professional staff.  This is managed by a 
communications core, that will support all cross-site communications 
efforts among the TREC Centers, NCI Program Staff, and Steering Committee 
members, develop and maintain the TREC project web site and group email 
lists, and facilitate group meetings.

o Facilitating the utilization of the significant research resources in 
genetics, bioinformatics, dietary and behavioral assessments, and animal 
models that have been developed by the NCI for use by the research 
community.  

o Building the capacity of current resources to provide core for all TREC 
Centers.  Shared core services and resources used to support cross-site 
developmental projects will be identified, selected, and monitored by the 
Steering Committee. For example, genomic and proteomic analyses, the 
capacity for collection of survey data, and the centralized measurement 
and analysis of physiological data such as serum hormone levels, analysis 
of body composition from imaging techniques, or diverse rodent phenotyping 
services could be offered efficiently from a Coordinating Center.  Such 
centralized services could contribute to collaboration and data 
standardization.

Core Funds for the TREC Coordination Center 

Core Funds will be available to the Chair of the Steering Committee (SC), 
with budget recommendations provided by the members of the SC. Applicants 
responding to this RFA should not apply for the Core Funds in their U01 
applications.  Core Funds are reserved for post-award collaborative 
research and for a variety of other functions; the allocation of core 
funds must be approved by the NCI program director prior to dissemination.  

1. Core Funds are used to expand participation within the TREC Centers 
through the provision of funds to an investigator who may have content 
expertise that is not part of the existing TREC Centers but is relevant to 
developmental projects.  However, receipt of these Core Funds does not, in 
and of itself, imply membership on the SC.

2. Core Funds can also be used to support cross-site developmental 
projects, evaluate common measures, or develop new methodologies which can 
be validated at multiple centers and in larger populations. However, Core 
Funds should not be used to pay for activities that have been supported 
under the TREC Centers.  

A set-aside in the Coordination Center’s budget allowance of $100,000 per 
year for cross-site developmental projects should be included in the 
budget plans.   

Supplements from the Core Funds may provide direct costs and appropriate 
facilities and administrative costs up to 20 percent indirect cost. The 
following example illustrates the functions of the TREC Centers and the 
support that it offers for moving basic research findings into practice. 

Example: An investigator within the TREC Centers identifies a possible 
dietary or other related biomarker through original laboratory research. 
Based on pilot data, the dietary or biological marker, related to steroid 
hormones, insulin-like growth factors, insulin resistance, lipid 
metabolism, and immune or inflammatory factors seems to be useful as a 
potential mechanism to evaluate the effects of energy balance and cancer 
outcomes. The investigator can then approach the SC to support evaluation 
of the marker and possible further testing as part of a cross-site 
collaboration among TREC Centers. The SC then has the responsibility to 
review the data on the potential marker using its standing formal criteria 
as a guide. The SC can consult the NCI to obtain information on the 
requirements and need for additional research on the marker.  If 
necessary, scientific resources from other Centers can be pooled to 
conduct studies. 

o Planning and implementation of semi-annual meetings for the duration of 
the RFA.  Potential models for these semi-annual meetings could include 
the successful Gordon Summer conferences or the Centers for Disease 
Control and Prevention (CDC) at the University of North Carolina (UNC) 
summer course on Physical Activity and Public Health. 

o Organizing sessions at relevant national meetings such as American  
Association for Cancer Research (AACR), North American Association for the 
Study of Obesity (NAASO), Society for Behavioral Medicine (SBM), and 
American Association for the Advancement of Science (AAAS).  These 
sessions could be designed to include representatives from several TREC 
Centers as well as other experts.

o Coordination of efforts by the TREC Steering Committee in the 
performance and evaluation component of the TREC Centers in achieving the 
goals of the RFA.

o Providing scientific leadership and institutional commitment, with prior 
experience in coordinating multi-center initiatives, meetings, and career 
development training. 

o Providing complementary scientific expertise to the TREC Centers and 
providing core resources.  

o Developing a comprehensive budget proposal that includes all leadership 
activities, meetings, common core resources, and cross-site activates.

Cooperative Agreement Terms and Conditions of Award 

These special Terms 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 at 45 CFR 
Parts 74 and 92, and other DHHS, PHS, and NIH Grants Administration policy 
statements.  (Part 92 applies when state and local governments are 
eligible to apply as a "domestic organization.")
 
The administrative and funding instrument used for this program is a 
cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NCI scientific and/or 
programmatic involvement with the awardee is anticipated during 
performance of the activity.  Under the cooperative agreement, the NCI 
purpose is to support and/or stimulate the recipient's activity by 
involvement in, and otherwise working jointly with, the award recipient in 
a partner role, but it is not to assume direction, prime responsibility, 
or a dominant role in the activity.  

Consistent with this concept, the dominant role and prime responsibility 
for the activity resides with the awardee for the project as a whole, 
although specific tasks and activities in carrying out the studies will be 
shared among the awardees and the NCI Project Coordinator.
  
1.  Awardee Rights and Responsibilities 

The Awardee (i.e, the Principal Investigator) 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. 

The Awardee will facilitate the establishment of the TREC Steering 
Committee for this initiative.  

The Awardees and Principal Investigator from each of the TREC Centers 
(RFA CA-05-010) are voting members of the Steering Committee and are required 
to attend the twice-yearly Steering Committee meetings. The TREC Centers 
and the Coordination Center each have one vote, as does the NCI Program 
Coordinator. 
  
The Awardee will be responsible for accepting and implementing the goals, 
priorities, procedures, and policies agreed upon by the Steering 
Committee.

The Awardee will be responsible for close coordination and cooperation 
with the Principal Investigators from the U54 TREC Centers RFA and with 
NCI staff for all components of the TREC initiative, e.g., research 
collaborations, exchange of scientists on a visiting basis, special issue 
working groups, resource sharing, and other innovative mechanisms for data 
sharing and inter-TREC collaborations.

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.  

Awardees will be required to accept and implement the common processes and 
procedures approved by the Steering Committee.

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.  

Awardees will be responsible for implementing the approved research 
resource sharing plan and intellectual property plan for their project.   

The Awardee will ensure that there are appropriate core services for the 
integration of data emerging from the TREC Centers.  Any activities funded 
on the individual U54 grants will be required to be coordinated with the 
activities of the TREC Coordinating Center.     

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 NCI’s 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, and the NCI.

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 award 
and its components as well as 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 U01 award for lack of scientific progress 
or failure to adhere to policies established by the Steering Committee.

o The NCI Program Director will notify, as warranted, the appropriate NIH 
offices concerning failure of the TREC Centers or Coordinating Center to 
adhere to policies established by the Steering Committee.

o The NCI Program Director will have access to all data generated under 
collaborative studies conducted under this award, consistent with current 
DHHS, PHS, and NIH policies.  The Program Director, or designee, will 
review periodically data management and analysis procedures approved by 
the Steering Committee.  On-site program review will be conducted as 
necessary.

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 Centers Program, as defined below.  An arbitration system, which 
is detailed below in the next subsection, will be available to resolve 
disagreements between the NCI Project Coordinator and the members of the 
Steering Committee.

o The Steering Committee will be composed of the Principal Investigator 
from the U01 Coordination Center; a Primary Investigator from each U54 
Research 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(s) may not be an NCI staff member(s).  
The Steering Committee may establish subcommittees, as it deems 
appropriate; the NCI Project Coordinator will serve on subcommittees, 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.

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 Awardee of the U01 
Coordination Center, the PI, and a senior investigator from each U54 
Center must attend every Steering Committee meeting.  TREC Centers may 
budget travel support for up to five project co-investigators to attend 
the biannual meetings.  The Steering Committee has the final authority to 
approve the attendance of any non-voting participants at the biannual 
meeting.

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, 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.

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, MSC 7335
Bethesda, MD 20892-7335
Rockville, MD 20852 (for express/courier service)
TEL: (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, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters 
to:

Crystal Wolfrey
Grants Administration Branch 
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD  20892-7150
Rockville, MD 20852 (for express/courier 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, MSC 7335
Bethesda, MD 20892-7335
Rockville, MD 20852 (for express/courier service)
TEL: (301) 451-9530
FAX: (301) 480-2087
Email: nebelinl@mail.nih.gov

PRE-APPLICATION Conference 

The NCI will hold a pre-application telephone conference to which all 
prospective applicants are invited (see http://www.scgcorp.com/trec-call2004/
).  Program staff and staff from the NCI 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 and answer questions from the attendees.  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.)

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:

BUDGET: 

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 Coordinating Center;
b) A separate budget for Administrative, Communications, Evaluation, 
Training, and Organizational Core activities;

A recommended budget allocation per year is provided for each activity:
-   Administration: $100,000
-   Communications: $150,000
-   Evaluation and Data Sharing:  $200,000
-   Training: $50,000 
-   Organizational Developmental Projects:  $100,000   

Within these core activities, the budget should include support for:

o Fostering communication networks and information exchange.
Serving as the communications hub for project-related activities, 
including: arranging conference calls and biannual steering group 
meetings, and any additional steering committee meetings; developing and 
maintaining a Web site with interactive features for exchanging 
information, resources, instruments and strategies.

o Disseminating results and lessons learned including research 
accomplishments and challenges.  Providing technical assistance for 
enhancing the maintenance, sustainability, and translation of the 
projects.  

o Establishing commonalities in questions, methods and measurement.
Identifying site-specific research questions, measures, and methods that 
are shared across the funded projects (e.g., What research questions do 
funded sites bring to the table?  How can being part of the collaborative 
group provide a forum for asking questions that go beyond what can be 
learned in one study?).  

o Serving as a catalyst for identifying subgroups of investigators who 
will come together to work on common approaches.  Assessing the potential 
for common measures.  Working with the Steering Committee to establish a 
small core of common processes and outcomes.

o Providing technical assistance and expert advice on cross-cutting 
themes, frameworks, and evaluation.

o Facilitating a process for data sharing among the TREC Centers and 
others. Establishing a study-wide presentation and publication policy for 
utilizing shared data and advising on cross-cutting rules and regulations 
regarding shared data.

o Designing a feasible infrastructure and database for shared data sets to 
be used in the study period and a method for public access of data within 
two years after then end of the initial award period.  

o Supplemental funding opportunities will be considered by the Steering 
Committee as a way of supporting collaborative developmental projects.  
Since the Coordinating Center funding runs concurrently with TREC Centers 
funding, post-funding tasks would need to be planned for, but may not be 
supported in this initial award.

o Establishing a mentorship program between more experiences investigators 
and those less experienced investigators (or established investigators 
moving into new directions) involved in research or practice at the TREC 
Centers.  Mentorship opportunities are encourages across all TREC Centers.  
Training opportunities should be coordinated with the biannual Steering 
Committee meetings.

o Incorporating activities to evaluate the performance of the TREC Centers 
RFA.  

Additional pages for budget justification are to be used when necessary.

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. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as 
an investigator-initiated application, is to be submitted in response to 
an RFA, it is to be prepared as a NEW application.  That is the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to indicate 
the changes from the previous unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI.  Incomplete and/or nonresponsive 
applications will not be reviewed. 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities of the NCI in accordance 
with the review criteria stated below.  As part of the initial merit 
review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique 
o Receive a second level review by the 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.

SIGNIFICANCE: Does this Coordination Center provide appropriate technical 
expertise and leadership?  If the aims of the application are achieved, 
how will scientific knowledge be advanced?  Will the TREC Coordination 
Center enhance the TREC Centers’ proposed concepts or methods that drive 
the field?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and 
consider alternative tactics needed to make a coordination center of this 
kind an effective infrastructure?

INNOVATION:  Does the Coordination Center employ state-of-the-art 
resources, approaches, and methods?  Are the aims original and justifiable 
for each of the activities: administrative, communication, evaluation, 
training and organization?  

INVESTIGATOR:  Is the primary investigator appropriately trained and well 
suited to lead this coordination center and oversee this work?  Is the 
leadership and management structure proposed appropriate?  Does the 
leadership team of the Coordination Center provide the experience needed 
to manage an efficient operation? 

ENVIRONMENT:  Does the scientific environment and resources in which the 
work will be done contribute to the probability of success?  Does the 
proposed Coordination Center take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?  Is 
there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of 
the research.  Plans for the recruitment and retention of subjects will 
also be evaluated. (See Inclusion Criteria in the sections on Federal 
Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are 
to be used in the project, the five items described under Section f of the 
PHS 398 research grant application instructions (rev. 5/2001) will be 
assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale 
for not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 15, 2004 
Application Receipt Date:  November 16, 2004 
Peer Review Date:  February 2005
Council Review:  June 2005
Earliest Anticipated Start Date:  September 1, 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review);
o Availability of funds; and
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane 
Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); and efficacy, 
effectiveness and comparative trials (phase III). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to the 
participants.  (See NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)  

Clinical trials supported or performed by NCI require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager or 
NCI program staff or a Data and Safety Monitoring Board (DSMB).  These 
monitoring activities are distinct from the requirement for study review 
and approval by an Institutional Review Board (IRB).  For details about 
the Policy for the NCI for Data and Safety Monitoring of Clinical trials, 
see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I 
and II clinical trials, investigators must submit a general description of 
the data and safety monitoring plan as part of the research application.  
For additional information, see NIH Guide Notice on “Further Guidance on a 
Data and Safety Monitoring for Phase I and II Trials” at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans 
for clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

SHARING RESEARCH DATA: Investigators submitting an NIH application seeking  
$500,000 or more in direct costs in any single year are expected to 
include a plan for data sharing 
(http://grants.nih.gov/grants/policy/data_sharing) or state why this is 
not possible.  Investigators should seek guidance from their institutions, 
on issues related to institutional policies, local IRB rules, as well as 
local, State, and Federal laws and regulations, including the Privacy 
Rule.  Reviewers will consider the data sharing plan but will not factor 
the plan into the determination of the scientific merit or the priority 
score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy 
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health of 
the subjects or the purpose of the research.  This policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants 
and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance with 
the new OMB standards; clarification of language governing NIH-defined 
Phase III clinical trials consistent with the new PHS Form 398; and 
updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase III 
clinical trials that: (a) all applications or proposals and/or protocols 
must provide a description of plans to conduct analyses, as appropriate, 
to address differences by sex/gender and/or racial/ethnic groups, 
including subgroups if applicable; and (b) investigators must report 
annual accrual and progress in conducting analyses, as appropriate, by 
sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and ethical 
reasons not to include them. 

All investigators proposing research involving human subjects should read 
the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving 
human subjects.  You will find this policy announcement in the NIH Guide 
for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research is available online at http://cme.nci.nih.gov/.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of 
research on hESCs can be found at http://stemcells.nih.gov/index.asp and 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).  It is the responsibility of the applicant to 
provide in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s) to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information 
Act (FOIA) under some circumstances.  Data that are (1) first produced in 
a project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic 
scope of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design and 
include information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information,” the “Privacy Rule,” on August 14, 2002.  The Privacy 
Rule is a federal regulation under the Health Insurance Portability and 
Accountability Act (HIPAA) of 1996 that governs the protection of 
individually identifiable health information, and is administered and 
enforced by the DHHS Office for Civil Rights (OCR).    

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution.  The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am I 
a covered entity?”  Information on the impact of the HIPAA Privacy Rule on 
NIH processes involving the review, funding, and progress monitoring of 
grants, cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations.  Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the Internet 
sites.  Furthermore, we caution reviewers that their anonymity may be 
compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under the authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 
241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 
and 92. All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is 
consistent with the PHS mission to protect and advance the physical and 
mental health of the American people. 

REFERENCES

IARC WORKING GROUP. Vanio H, Bianchini F (eds). IARC Working Group on the 
Evaluation of Cancer-Preventive Strategies. IARC Handbooks of Cancer 
Prevention, vol. 6. Weight control and physical activity.  1-315. 2002. 
Lyon, France, IARC Press.

Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity and 
mortality from cancer in a prospectively studied cohort of U.S. adults.  
NEJM 2003 348: 1625-38.

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in 
obesity among US adults, 1999-2000. JAMA 2002 288:1723-1727.

Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in 
overweight among US children and adolescents, 1999-2000. JAMA 2002 
288:1728-1732.

Fulfilling the Potential of Cancer Prevention and Early Detection; Susan 
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