and Human Services (HHS)
EXPIRED
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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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) 710-0267; Email: [email protected]. 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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