and Human Services (HHS)
EXPIRED
TRANSDISCIPLINARY TOBACCO USE RESEARCH CENTERS RELEASE DATE: October 3, 2003 RFA Number: RFA-CA-04-012 (see NOT-CA-03-040, NOT-CA-03-042, and NOT-CA-03-043) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.399, 93.279, 93.891 LETTER OF INTENT RECEIPT DATE: December 26, 2003 APPLICATION RECEIPT DATE: January 23, 2004 This RFA is a reissue of RFA-CA-98-029, which was published in the NIH Guide on December 11, 1998. THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Pre-Application Meeting o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Cancer Institute (NCI), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) invite center grant applications (P50) for Transdisciplinary Tobacco Use Research Centers (TTURCs). The reissue of this RFA reflects recognition of the public health impact of tobacco use and the scientific need for integrative transdisciplinary research across the full spectrum of basic and applied research on tobacco use and control. Tobacco use control and addiction research spans diverse areas ranging from molecular biology, genetics, neuroscience and epidemiology to imaging, primary care, behavioral science, communication, health policy, biostatistics, economics and marketing. Collaborative research across disciplinary boundaries permits scientific exploration of the complex and interactive determinants of tobacco use. Transdisciplinarity is a process by which researchers work jointly using a shared conceptual framework that draws together discipline-specific theories, concepts, and approaches to address a common problem. A TTURC is required to have a minimum of three major research projects; must provide career development opportunities for new investigators and established investigators who wish to pursue active research careers in transdisciplinary tobacco use research; provide developmental funds for innovative pilot projects; and participate with other TTURCs on a regular basis to share information, assess scientific progress in the field, identify new research opportunities, and promote inter-TTURC collaborations to promote discovery and to resolve areas of scientific controversy. The use of shared methodologies between TTURCs will promote collection of comparable data across several lines of research and allow greater generalizability of results. The centers also are encouraged to form partnerships with industry, e.g., to advance medication development. Collaborations with NIH intramural programs also are encouraged. In addition, collaborations also should be considered with universities, public health agencies, and other organizations that have strong ties to minority communities with high smoking rates. Each TTURC and the "network" of TTURCs are expected to conduct research that will lead to major scientific advances in knowledge about tobacco use and its prevention and treatment. The centers funded by this initiative are expected to both broaden and integrate the expertise required to advance the science of tobacco use and control. Centers are expected to be creative, innovative, and involve investigators from a broad range of disciplines and perspectives. It is expected that the research will engage the appropriate range of transdisciplinary tools and approaches to allow significant advances to be made, and to translate research findings to the next step in utility and application. The purpose of the TTURCs is to facilitate a transdisciplinary approach to the full spectrum of basic and applied research on tobacco use, including: etiology of tobacco use and addiction (including the impact of advertising and marketing), prevention of tobacco use, the treatment of tobacco use and addiction, the identification of biomarkers of tobacco exposure, and the identification of genes related both to addiction and susceptibility to harm from tobacco. The translational nature of these research programs will inform public health efforts to reduce the disease burden of tobacco use. RESEARCH OBJECTIVES Background Cigarette smoking remains firmly entrenched in American society today, although the demographics of smokers vary from those when the first Surgeon General's Report on Smoking was published nearly 40 years ago. Approximately 48 million adult Americans, representing 25% of the population, are smokers. Overall, smoking prevalence and the trajectory of tobacco use initiation among America's youth continue to be alarming: 26.7% of 12th graders report current smoking and 16.9% report daily smoking. About 1/2 to 1/3 of teens who try smoking will become regular smokers and 75% of daily teen smokers will smoke as adults. This is particularly striking given the increase in policies regulating smoking, litigation against the tobacco industry, and heightened public awareness of the negative health consequences of smoking. Smoking has been the chief preventable cause of illness and death in the U.S. for more than three decades and is responsible for 440,000 deaths annually. Cigarette smoking is a primary cause of death from lung cancer, coronary heart disease, chronic obstructive pulmonary disease, and stroke. Worldwide, more than 3 million people will die every year because of tobacco making it the largest preventable cause of death in history. The World Health Organization estimates that this figure will increase to nearly 10 million annual deaths by 2030. In order to understand the epidemiology and natural history of tobacco use and nicotine addiction, an integrated approach is required to explore the interplay of social, psychological, biological and genetic factors. Social influences are broad, including peer and family modeling, tobacco, industry marketing and media influences. Depressed or anxious mood and attention-deficit hyperactivity disorder are examples of psychological factors that affect smoking, from initiation to maintenance to cessation. The effects of these overarching determinants are mediated by behavioral, neurochemical, and physiological factors to influence tobacco use, dependence, cessation, and relapse in the individual. Because of the intransigence of tobacco use and its disease consequences, and its complex, multidimensional determinants, the scientific community called for new multilevel research models and paradigms that were integrated across disciplines. Scientific leaders identified transdisciplinary research as having the potential to accelerate discovery. Transdisciplinary research is differentiated from other cross-disciplinary research by its degree of collaboration and conceptual integration. Renewal of this RFA is responsive to NCI's Bypass Budget: "renew and expand support of the Transdisciplinary Tobacco Use Research Centers program in collaboration with relevant public and private organizations"; facilitate rapid development from discovery to application by using established mechanisms and creating novel special awards to encourage transdisciplinary and collaborative research. Objectives TTURCs are expected to conduct research that will lead to major scientific advances in knowledge of tobacco use, nicotine addiction, prevention and treatment interventions, and the translation of this knowledge into practice. There are several overarching goals: o Increase the number of investigators from relevant disciplines who focus on the study of tobacco use as part of transdisciplinary teams. o Generate basic research evidence to improve understanding of the etiology and natural history of tobacco use. o Produce evidence-based tobacco use interventions that can translate to the community and specific understudied or underserved populations. o Increase the number of evidence-based interventions that are novel, including the development, testing and dissemination of innovative behavioral treatments and prevention strategies based upon findings from basic research. o Train transdisciplinary investigators capable of conducting cutting- edge tobacco use research. o Increase the number of peer-reviewed publications in the area of tobacco use, nicotine addiction, and treatment. The TTURC initiative is fundamentally translational in nature, and it is anticipated that success will require extensive collaboration. In order to maximize effectiveness and minimize budgetary needs, it is expected that applicants will avail themselves of existing infrastructure wherever possible. These collaborations, while strongly encouraged, are not required (nor are centers limited to collaborations with those listed here). For example, TTURC applications with medication development and delivery dimensions might collaborate with the NIDA Clinical Trials Network (CTN), with NIDA's Intramural Research Program, with SAMHSA, with the Veteran's Administration Cooperative Studies Program or with NCI's designated Comprehensive Cancer Centers, Cancer Information Service, Special Populations Networks, and other NCI-funded research projects, such as the Cancer Family Registries, Mouse Models Consortium, Cancer Genetics Networks, Rapid Access to Preventive Intervention Development (RAPID) medication development program, Centers for Excellence in Cancer Communications (CCERS) and the Specialized Programs of Research Excellence (SPOREs). Other organizations that may be considered are the Centers for Disease Control and Prevention, the American Cancer Society and other voluntary health associations, the Robert Wood Johnson Foundation, National Science Foundation grantees, and industry. In addition, collaborations should be considered with universities, including Schools of Public Health, historically Black Colleges and Universities, public health agencies, substance abuse agencies, community technology centers and other organizations. The active participation of advocacy groups and appropriate community organizations is encouraged. Relevant collaborations with NIH intramural programs can be included as well. Training There is an urgent need for new investigators who have the quality and breadth of training necessary to conduct cutting-edge research related to tobacco use and nicotine addiction. Such training should expose investigators to the multiple levels of research that address tobacco- related issues. Because tobacco research scientists are widely dispersed by geography and discipline, this type of training is difficult to obtain. By emphasizing meaningful integration and collaboration among scientists, the centers will provide a challenging and unique venue for training the next generation of tobacco researchers. Career development should not be limited to doctoral or post-doctoral scientists; cross-training of established investigators is also encouraged. Developmental/pilot research program Centers must establish a developmental research plan with processes for conceiving, vetting, and evaluating studies that allow exploration of novel directions, especially those that might arise with the progression of the major projects. Promising pilot studies are expected to spawn applications for independent funding. Scope Investigators should represent a broad range of disciplines working together to increase knowledge across the full spectrum of basic and applied research on tobacco use and addiction. Meaningful collaboration across geographically separate sites is permitted, and will be expected across the funded Centers. The level of specialization in different dimensions of tobacco use and control research will vary from center to center, e.g., themes, topics, points on the discovery-development-delivery continuum, populations, levels of analysis and types of research. However, the centers should focus thematically on areas in which there are significant gaps in knowledge and critical needs where focused, collective, interdisciplinary efforts could make the greatest difference in reducing tobacco use and tobacco-related disease. It is incumbent upon investigators to articulate the gap areas. It is expected that the TTURCs will catalyze problem solving and lead to more rapid advances in knowledge than would be possible by depending on individual investigators working in relative isolation. TTURCs should contribute to understanding what works and what does not work and why. Essential elements of the Centers consist of at least 3 theoretically strong research projects with an integrative theme, cores and plans for career development and use of developmental funds. Centers may vary in their breadth or concentration across research foci (e.g., gene to individual to community to culture, etc). Some may choose to be tightly organized; others may have a broad span. Centers are encouraged to study interactions across research foci (e.g., the variation of cultural and individual variables and treatment response) when possible. Research integrated across projects, where findings from one major project inform or complement those in another, is also strongly encouraged. Disciplinary integration within a center, and within projects (again, where feasible) is encouraged particularly with regard to combining perspectives that reflect innovation. Finally, disciplinary diversity in a center must support the objectives of the science and not merely reflect the training of the scientist. Priority Research Topics The initial period of TTURC funding has demonstrated that transdisciplinary research not only works, but that it can lead to advances in science not possible with uni-disciplinary approaches. The demonstration that transdisciplinary research can lead to unique scientific progress allows NIH to use this approach to address critical research questions needed to advance public health. NIH has identified several priority areas for research. These thematic areas, along with examples of specific research questions, are identified below: o Adolescents & young adults: Recent advances have identified key factors genetic, social and environmental that contribute to the etiology of youth tobacco use. Yet, key research questions remain: Are there critical social or environmental events that together with a genetic predisposition to nicotine addiction increase or decrease the likelihood that young tobacco users will become addicted? And, if we can identify those at greatest genetic risk, are there pharmacological (e.g. vaccine) or social (e.g. counter-advertising) interventions that can prevent tobacco use from progressing to addiction? o Women (Gender differences): Some clinical studies have suggested that women have more difficulty quitting than men, suggesting that there may be broader gender differences in the nature of nicotine addiction. Important research questions include the nature of genetic/biologic factors that interact with gender in explaining treatment response, whether treatment impacts be improved by addressing social and cultural variables, and the salience of gene-hormone- environment interactions in gender differences in tobacco use and cancer susceptibility. The other broad issue that relates to women is smoking during pregnancy, and the consequences for fetal and post-natal development. o Psychiatric comorbidity: Tobacco use is higher and cessation rates are lower among some psychiatric populations (e.g., depression, schizophrenia). What are their common pathways? How does tobacco use, treatment and cessation affect psychiatric symptomotology? Is it possible to effectively treat tobacco dependence when psychiatric conditions have not been addressed? o Concurrent Tobacco and Alcohol Abuse/Dependence: The high comorbidity between alcohol and tobacco abuse/dependence presents health risks over and above the risks posed by smoking or alcohol consumption alone. What are the mechanisms underlying the conjoint use of these substances and how might the understanding of this linkage at the molecular, genetic, pharmacokinetic and behavioral levels inform the development effective treatments for concurrent use? o Disparities: There are disproportionate rates of smoking among those of low income, less education, American Indian/Alaskan Natives, Southeast Asians, the unemployed, and particular categories of workers (e.g. blue collar, service workers, and farm workers). How do social contextual (e.g. social networks, social ties, discrimination, historical factors) variables contribute to these disparities? And how do social context factors interact with genetic, biological factors, chemical exposures, type of tobacco product (especially new products), and brand (i.e. menthol)? Finally, in what ways might individual, quit-line, health care system-based treatments of tobacco dependence be improved to address disparities? o Treatment development: Treatments of smoking over the past decade have yielded successes but there is substantial room for improvement in outcomes. How might understanding of the relationship between negative emotions and cognitive processing translate to the development of novel smoking cessation interventions? Are there behavioral, health care system, or policy approaches that can be developed that will increase the use and effectiveness of existing smoking treatments so that cessation is more likely? o Treatment Delivery: There is a need to understand how to improve treatment delivery. Components of this might include enhancement of treatment-seeking behavior, health systems augmentations that would facilitate entry to and compensation for treatment services, and system integration that would allow logical and effective cohesion between various extant elements, such as quit lines, primary treatment providers, etc. How might the development of technological devices (e.g., personal digital assistants, virtual reality) be used in the delivery of treatments? Population-based approaches (i.e., defined populations) are particularly encouraged. o Genetic influences on nicotine dependence: There is consensus that nicotine addiction is a result of a gene-environment interaction, yet far more research is needed on which gene variants are critical for the development and maintenance of addiction. Are there multiple gene patterns that increase the likelihood of nicotine addiction, or perhaps specific gene variants that can be triggered by pharmacologic agents that will decrease the likelihood of becoming dependent? And is it possible to tailor specific behavioral or pharmacological treatments for a specific genotype? Understanding the patterns of tobacco use behavior and the relationship between tobacco use and use of other drugs may help us identify unique phenotypes or endophenotypes for genetic analyses. o Medication Development: There is a need for new medications to treat various aspects of tobacco addiction, such as the reinforcing effects of nicotine and early relapse. One broad approach would be to develop and validate new nicotine delivery systems to mimic the rapid delivery of nicotine produced by the inhalation of tobacco smoke, but with much reduced toxicity. Another promising approach would exploit the maturing neuroscience of tobacco addiction, including the discovery of new neurochemical systems and molecular targets in addiction, withdrawal and relapse, and our increasing knowledge of the prominent conditioned effects that play a role in tobacco addiction. MECHANISM OF SUPPORT This RFA will use NIH center grant (P50) award mechanism. Applicants will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 2004. Although support of this program is through the specialized center (P50) grant mechanism, it is not a SPORE. This mechanism supports the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a transdisciplinary approach on a specific disease entity or biomedical problem. These grants differ from traditional program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for transdisciplinary research projects, support is also provided for pilot research projects, specialized resources, career development programs, and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed TTURC program. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. This RFA uses just-in-time concepts. It also uses the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm FUNDS AVAILABLE Eight to nine new and/or competitive continuation grants are expected to be funded in response to this RFA. The NCI intends to commit approximately $9 million in FY 2004 to fund the initial year. The NIDA intends to commit $4.3 million for the initial year's funding. The NIAAA intends to commit $1.5 million for the initial year's funding. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $1.25 million in the initial year (excluding Facility and Administrative costs to consortium participants). Future year increments are limited to 3%. The budget for total costs cannot exceed $1.75 million for the initial year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI/NIDA/NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations. Applicants are encouraged to work with faith-based and community-based institutions. o Foreign institutions are not eligible to apply. However, domestic applications with foreign components are permitted. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The Centers must include three or more individual research projects, which reflect hypothesis-driven research, plus pilot or developmental research projects, shared resources (cores) and career development. Centers must provide clear evidence of a transdisciplinary focus, including an explanation of how the projects fit together across disciplines to promote synergy and syntheses. Evidence of plans and mechanisms for dissemination of research findings and products, including evidence-based tools and interventions must be stated. Interactions among TTURCs are an important part of this initiative. Centers must identify creative strategies to foster formal and informal intra- and inter-center collaborations to identify and address overarching scientific and methodological issues. This may be in the form of research collaborations, visiting scientist, special issue working groups, exchange of data, resources and materials, and other mechanisms. A requirement for all TTURC Principal Investigators and selected project investigators is participation in two meetings per year in the Washington, DC metropolitan area or other mutually convenient location. One meeting will be smaller, with only the center directors and NIH staff and consultants in attendance. At least three project staff should be budgeted for the larger meeting. Support for this travel should be included in the budget. The purpose of these meetings is to share scientific information, assess scientific progress, solve problems, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. Novel opportunities to facilitate collaboration also will be developed. TTURCs will also be required (i) to use common measures that will allow pooling of data and (ii) to participate in evaluation activities. Broad disciplinary representation in centers is expected. TTURC Program Requirements The following information must be provided in the application: o A minimum of three fully developed R01-type research projects; o Evidence of a transdisciplinary focus, including an explanation of how the projects fit together across disciplines to promote synergy and syntheses; o Shared administrative, technical, statistical, and other resources that can be justified; o Demonstration of a consistent and significant commitment to a career development program in tobacco control research. This may focus on graduate students, post-doctoral candidates, junior faculty, or established investigators who wish to develop or refocus their careers on tobacco control research. The description of this program should include the policies, criteria, and processes for selecting candidates, and must include special efforts to recruit qualified women and minorities. The plan should include the number and types of positions that will be made available, the criteria for eligibility and selection of candidates, and a description of the selection process. The plan should not include stipends and trainee costs though salary support for career development candidates may be requested; o A proposed process for funding developmental and pilot research to facilitate new collaborations and support the exploration of new ideas and methods. The interest here is in the process of solicitation and selection of the pilot projects rather than on the pilot projects itself. It is important that TTURCs use pilot funds to stimulate projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more TTURCs, or with scientists outside the TTURC environment. The TTURC application should propose and describe an institutional review process that selects pilot projects for center funding that represent the most innovative and transdisciplinary ideas. Applicants may supply a short description (2 pages maximum per project) of up to two eligible projects as examples. o Creative strategies to foster formal and informal intra- and inter- center collaborations to identify and address overarching conceptual and methodological issues; o Evidence of plans and mechanisms for the dissemination of research findings and products, including evidence-based tools and interventions; All clinical trials supported or performed by NIH require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NIH program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the Data and Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm Applicants are strongly discouraged from naming individual members of "advisory committees" or "scientific boards" until after receipt of an award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Glen D. Morgan, Ph.D. Tobacco Control Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Rm. 4034 6130 Executive Blvd., MSC 7337 Bethesda, MD 20892-7337 Telephone: 301-496-8585 Email: [email protected] Allison Chausmer, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Blvd, Rm. 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 402-5088 Email: [email protected] Joanne B. Fertig, Ph.D. Treatment Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd, Suite 505Bethesda, MD 20892-7003 Telephone: (301) 443-0635 Email: [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, MSC 8329 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: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 E-mail: [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 o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Glen D. Morgan, Ph.D. Tobacco Control Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Rm. 4034 6130 Executive Blvd., MSC 7337 Bethesda, MD 20892-7337 Telephone: 301-496-8585 Email: [email protected] PRE-APPLICATION MEETING The NCI/NIDA/NIAAA will hold a pre-application meeting through a videoconference to which all prospective applicants are invited. Program staff & staff from the Division of Extramural Activities (DEA) will make presentations that explain their goals and objectives for the Transdisciplinary Tobacco Use Research Centers and answer questions from the attendees. Prospective applicants are urged to monitor the NIH Guide Notice for the date and time of the meeting at http://grants.nih.gov/grants/guide/index.html. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: Additional instructions for preparing a TTURC grant application are available from the program staff listed under INQUIRIES and can also be found at the following URL link: http://tobaccocontrol.cancer.gov/tturc/. The instructions must be requested and used in preparing a TTURC application. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate National Advisory Council or Board. REVIEW CRITERIA Competitive applications will reflect more than an interesting collection of projects. It is critical that there be evidence of the potential for a meaningful center with a real theme and identity. The Centers must include three or more individual research projects, which reflect hypothesis-driven research, plus a process for pilot or developmental research projects, shared resources (cores) and career development. The Center and the projects should result in the generation of new knowledge in tobacco control and/or nicotine addiction science. Reviewers will evaluate each center using the criteria listed below. Each criterion will be addressed and considered by the reviewers in assigning the overall score for project merit: A. RESEARCH PROJECTS 1. Significance. The importance of the research objective to tobacco control research and its likelihood of completion within the project period. 2. Approach. The adequacy of the experimental design and methods to achieve the research objectives. Are the theoretical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative transdisciplinary approaches? 3. Innovation. Originality and novelty of the experimental design as it relates to tobacco control theory and research. Does the project develop new methodologies or technologies in tobacco control research? Does the research design reflect sufficient originality, novelty, and innovation to make it highly relevant to the overall goals and objectives of the TTURC? 4. Investigators. The qualifications of investigators to conduct the proposed research and the appropriateness of the time commitments of each member of the team to the conduct of the project. Is the proposed work appropriate to the experience level of the Principal Investigator and project researchers? 5. Environment. The scientific environment in which the research work will be done, and the unique features, if any, of the environment to support the proposed work. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed projects take advantage of unique and transdisciplinary features in the scientific environment and reach out to useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project interactive with other components of the TTURC, conceptually, experimentally, and translationally? 6. Transdisciplinary Collaboration. Is there evidence of significant transdisciplinary basic, clinical and public health interactions in the conception, design, and proposed implementation of the project? Is the proposed research informed by the breadth of relevant scientific literature from multiple disciplines in the social, behavioral, and biological sciences? B. SHARED RESOURCES (CORES) 1. adequacy of the justification for each specialized resource relative to its essential need for the conduct of TTURC research or pilot projects and TTURC collaborative projects. 2. adequacy of qualifications and performance (if applicable) of managers of resources to conduct high quality, reliable resource operations. 3. adequacy of plans for oversight of resources and the prioritization of work C. CAREER DEVELOPMENT 1. adequacy of the process and/or track record for selecting candidates for career development who demonstrate potential for independent research careers in transdisciplinary cancer tobacco control related research or who are established investigators and are changing the direction of their research careers; cross-disciplinary training should enable scientists to bridge scientific domains in tobacco control research, to foster important integrative scientific inquiry; 2. adequacy of the procedures and/or track record to seek out and include qualified minorities, women, and persons with disabilities in the career development program; 3. adequacy of the individuals available in the program to serve as possible mentors of career development candidates; the current availability and adequacy of projects for career development candidates; 4. complementary activities that contribute to the environment for career development; 5. capacity of the overall program to absorb career development candidates and prepare them for independent transdisciplinary tobacco control research careers. D. DEVELOPMENTAL RESEARCH PROGRAM (PILOT PROJECTS) 1. adequacy of the process and/or track record for attracting new ideas for pilot studies within the TTURC. 2. adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) for their quality, innovativeness, transdisciplinary nature and importance to translational research that will have an impact on enhancing tobacco control efforts and developing innovative new intervention and prevention programs. 3. general quality of the pilot projects described in the application to demonstrate the effectiveness of the process for selecting pilot projects funding; 4. degree to which developmental funds will be used to stimulate pilot projects with transdisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution, and especially with other NCI/NIDA/NIAAA-funded centers and programs; E. OVERALL PROGRAM ORGANIZATION AND CAPABILITY 1. scientific qualifications and involvement of the Principal Investigator, as well as his/her demonstrated scientific and administrative leadership capabilities; adequacy of the time commitment of the Principal Investigator; 2. transdisciplinary nature of the proposed research activities, integration of the projects around an overarching theme, and plans to effectively pursue transdisciplinary research objectives; 3. adequacy of access to patients and populations for conducting current and projected research; 4. adequacy of the procedures, processes, and plans for promoting transdisciplinary interactions, including coordination, interaction, collaboration and synthesis; 5. facilitation of technology transfer; management of the intellectual property rights of the TTURC under the requirements of the Bayh-Dole Act and NIH funding agreements; 6. written assurance that TTURC interactions with commercial entities will uphold the principles of academic freedom, including the ability of TTURC investigators to collaborate freely, and to send and receive research materials without restriction to other scientific researchers; 7. adequacy of plans to promote and maintain communication and integration of scientific projects of mutual interest with other TTURCs; 8. willingness to interact with other TTURCs and with the NIH in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. F. INSTITUTIONAL COMMITMENT 1. adequacy of facilities, equipment and space to promote transdisciplinary and translational research objectives; 2. adequacy of institutional procedures and plans for monitoring, evaluating, and assuming accountability for the general success of the TTURC; 3. adequacy of the institutional infrastructure for assessing progress and needs. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See url in Federal Citations, below.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research, core resource operations, developmental research program, and career development. Salary support for career development candidates maybe included. However, stipends and trainee costs are not allowable. OVERALL EVALUATION AND SCORING OF APPLICATIONS A single numerical priority score will be assigned to the TTURC application as a whole after discussing all of the review elements listed above. The score will be based on the overall quality of the research projects, the career development program and the developmental research program, the overall effectiveness and adequacy of shared resources, the overall program organization and capability, and the plans for interactions with other TTURCs. Although primary emphasis will be placed on scientific merit, significant consideration will also be given to transdisciplinary interactions, potential for impacting on the disease, inter-Center collaborations and institutional commitment. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 26, 2003 Application Receipt Date: January 23, 2004 Peer Review Date: June, 2004 Council Review: September, 2004 Earliest Anticipated Start Date: September, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants.(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NIH require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NIH program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials is available: http://www.cancer.gov/clinical_trials/ SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Centers for Disease Control and Prevention, Cigarette smoking among adults--United States, 1997. MMWR Morb Mortal Wkly Rep, 1999. 48(43): p. 993-6. Engstrom PE, C.M., Schnoll RA, et al, Prevention of tobacco-related cancers, in Cancer Medicine, F.E. Hollan JF, Editor. 2000, BC Decker: Hamilton, Ontario, Canada. p. 127-140. Fiore, M.C., et al., Treating Tobacco Use and Dependence. Clinical Practice Guideline. 2000, Rockville, MD: U.S. Department of Health and Human Services. Henningfield, J.E., C. Cohen, and J.D. Slade, Is nicotine more addictive than cocaine? Br J Addict, 1991. 86(5): p. 565-9. Johnston LD, O.M.P., Bachman JG., National Survey Results on Drug use from the Monitoring the Future Study, 1975-1993, ed. USDHHS. Vol. 1 and 2. 1994, Rockville, MD: NIH Publication 94-3810. Johnston LD, O.M.P., Bachman JG., Teen smoking declines sharply in 2002, more than offsetting large increases in the early 1990s. University of Michigan News and Information Services: Ann Arbor, MI, 2002. http://www.monitoringthefuture.org McNeill, A.D., The development of dependence on smoking in children. Br J Addict, 1991. 86(5): p. 589-92. Morgan GD, F.P., Matthews E, Leischow S, Smoking cessation. Progress in Oncology, ed. H.S. DeVita V, Rosenberg S. 2002, Sunbury, MA: Jones & Bartlett. 294-312. National Cancer Institute, Changing Adolescent Smoking Prevalence. Smoking and Tobacco Control Monograph. Vol. 14. 2001, Bethesda, MD. National Cancer Institute, The Nation's Investment in Cancer Research. A Plan and Budget Proposal for Fiscal Year 2002. 2000. Peto, R., et al., Mortality from tobacco in developed countries: indirect estimation from national vital statistics. Lancet, 1992. 339(8804): p. 1268-78. Procee
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