and Human Services (HHS)
EXPIRED
INTERNATIONAL TOBACCO AND HEALTH RESEARCH AND CAPACITY BUILDING PROGRAM Release Date: June 25, 2001 RFA: RFA-TW-02-005 (This RFA has been reissued, see RFA-TW-06-006) Fogarty International Center (http://www.nih.gov/fic/) National Cancer Institute (http://www.nci.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Nursing Research (http://www.ninr.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) Letter of Intent Receipt Date: September 4, 2001 Application Receipt Date: October 26, 2001 PURPOSE This Request for Applications (RFA) solicits research and capacity building projects that address the burden of tobacco consumption in low- and middle- income nations by 1) pursuing observational, intervention and policy research of local relevance and 2) building capacity in these regions in epidemiological and behavioral research, prevention, treatment, communications, health services and policy research. The level of research and research training specialization in any given research project grant will vary based on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions. The overall intent of the program is to encourage transdisciplinary approaches to the international tobacco epidemic to reduce the global burden of tobacco-related illness. The program is designed to promote international cooperation between investigators in the U.S. and other high-income nation(s) pursuing research programs on tobacco control, and scientists and institutions in low- and middle-income nation(s) where tobacco consumption is a current or anticipated public health urgency. The major portion of the research must be conducted in a low- and/or middle-income nation(s), and greater than 50 percent of the direct costs requested must be used in a low- and/or middle-income nation(s) or in-country for either research and/or capacity strengthening of foreign institutions. Thus, the program allows U.S. and other high-income nation investigators to gain expertise working under low- and middle-income nation-specific conditions and strengthens the research base of the U.S. and foreign institution(s), especially those institutions in low- and middle-income nations. To this end, capacity strengthening must be integrated into the research proposal. In this RFA, the term tobacco includes both smoking and smokeless (chewing or unburned) tobacco. RESEARCH OBJECTIVES Background Despite the continuing devastation caused by infectious diseases, tobacco consumption remains the leading cause of preventable deaths and disability in adults globally. As cited by the World Health Organization (WHO), at present, seven and one half percent of the world's 53 million annual deaths are attributable to tobacco use. If current smoking patterns persist, the number of tobacco deaths will rise to ten million deaths annually by 2025, surpassing the combined deaths of AIDS, tuberculosis, automobile accidents, maternal mortality, homicide and suicide. Notably, 70 percent of this increase will occur in developing nations. The WHO has termed tobacco control the quintessential challenge of sustainable development, since it carries implications for trade and taxation, agricultural subsidies, the environment, social policies, and health care expenditures, among other sectors. Blunting the epidemic requires a better basic understanding of the addictive properties of nicotine, including the manifestations, determinants and outcomes of dependence for the individual and society. While aware that the complications of nicotine risks and tobacco exposure in low- and middle-income countries may be distinct or different from those in high-income nations, this RFA is not directed at repeating research that is already well-established. Trends show that most smokers begin at a young age. In high-income nations, about eight out of ten smokers begin in their teens, while most smokers in low- and middle-income nations begin in their early twenties. The peak age of tobacco uptake in low- and middle-income nations, however, is dropping. The younger the smoker, the less likely the individual will quit at a later time. Half of all long-term smokers will eventually be killed by tobacco, and of these, half will die during their most productive middle years, losing 20 to 25 years of life. While the impact of tobacco mortality is well-studied in established market economies, important questions remain unresolved in other regions, particularly in low- and middle-income nations. There is little research in low- and middle-income nations of the possible interaction of smoking and shifting dietary patterns on the pathogenesis of ischemic heart disease. Evidence clearly implicates Environmental Tobacco Smoke (ETS) as a cause of lung cancer, excess respiratory disease and cardiovascular disease mortality in non-smokers. Few studies document the interactions of tobacco and occupational and ambient air pollution in contributing to chronic obstructive pulmonary disorders in developing countries, or the importance of ETS as a risk factor for the already high burden of childhood respiratory infections. The disease burden of tobacco is of such magnitude that even minor epidemiological differences among populations may have major implications for control. There is also a dearth of information on gender and age differences with respect to incentives and disincentives for tobacco use and cessation. According to the World Bank, in low- and middle-income nations, the prevalence of smoking among women is low (nine percent), as compared to men (49 percent). However, there is already evidence that this index is rising, particularly among younger, educated, affluent women living in larger cities. An increased prevalence among women will have grave consequences not only for the health of women, but also their families. Research is needed to assist low- and middle- income nations to maintain or, preferably, decrease the currently low prevalence that exists among women, and to better understand how tobacco use can be decreased within the family. Two recent studies in the Journal of the American Medical Association focus on the association of cigarette smoking with psychiatric disorders among adolescents and young adults and the propensity to smoke if an individual has a mental illness (1), (2). In low- and middle-income nations, studies are needed to trace links between mental illness, smoking uptake and cessation rate to better explain the unique health situation in low- and middle-income nations, where links between mental illness and tobacco are rarely diagnosed. Such studies would also provide an opportunity for investigators to learn whether heavy smokers in low- and middle-nations are more likely to experience mental illness as a result of tobacco use or whether individuals with mental illness have a predilection towards tobacco use. Furthermore, little is known about risk taking behavior among adolescents and young adults. In this group, tobacco may be linked with other risk taking behaviors such as alcohol use, drug abuse, unprotected sexual activity and reckless driving of vehicles, all of which could have a unique profile in low- and middle-income nations. Several countries have begun to explore programs to prevent and treat tobacco use and dependence, but the data are sparse on the effectiveness of those interventions. For example, data from the recent U.S. Public Health Service Treatment Guideline, Treating Tobacco Use and Dependence, indicate that telephone based quitlines may be effective and cost-effective (3). It is unknown, however, whether such related approaches would work in low- and middle-income nations. Within the U.S., a positive influence has been shown from nurse researchers, nursing schools, and community health workers who educate the public on tobacco prevention and cessation. Nurse investigators have conducted a number of studies related to tobacco use and smoking cessation. A recent study in the Journal of Community Health highlighted the contribution of nurse researchers in identifying tobacco consumption variables (i.e., demographic, cultural, cognitive, and behavioral factors and patterns of consumption) among rural Ohio Appalachians (4). Findings from this study are being used to develop effective smoking cessation interventions targeting this high-risk population. Nurse investigators have contributed to the growing body of research related to tobacco use and smoking cessation interventions across the life span, primarily in the United States. However, it is unknown whether international nursing research focusing on tobacco use would help reduce the tobacco burden in low- and middle-income nations. Finally, in those countries that have implemented policy-based controls, including legislation, research is needed to assess the impact and effectiveness of these measures. This RFA is intended to support research that clarifies important issues on tobacco consumption and risks that are relevant to low- and middle-income nations. Such studies will provide a better understanding of the tobacco burden in low- and middle-income nations and the possible actions and interventions that may be taken to reduce the epidemic. Statistical trends demonstrate the steady geographic shift in tobacco production and consumption. In the early 1960s, low- and middle-income nations constituted 53 percent of the world’s tobacco production; by the late 1980s, this share had expanded to almost 75 percent. Global consumption has also increased. In the mid-1970s, 41 percent of the world's cigarettes were consumed in the developing world. In the 1980s, total cigarette consumption in these countries had increased to 60 percent. Tobacco use in low- and middle-income nations is now considered to have reached 82 percent of global consumption with a dramatic increase in local production. In addition to the human costs associated with tobacco-related morbidity and mortality, enormous economic costs are associated with tobacco use, including medical care for treatment of tobacco-related diseases, absenteeism from work, decreased productivity, losses due to fire, and lost income due to early mortality. A 1993 World Bank study estimated that tobacco use results in a global net loss of $200 billion per year, half of which occurs in low- and middle-income nations (5). The impact of tobacco related losses on the world economy exceeds the total current health expenditures in all developing countries combined. Individuals spend significant personal and household income to support their tobacco use. Expenditures on tobacco products can be as much as 17 percent of household income and 60 percent of personal income. Some governments are hesitant to curtail tobacco production and may be diffident towards aggressive tobacco controls, since they can draw significant revenue from excise taxes and exportation. Furthermore, most tobacco reporting lacks data to substantiate the magnitude of the international tobacco epidemic and the effectiveness of interventions. Much of the available research on tobacco control is based on the experiences of established market economies. This research is only partially relevant to the social, economic, and cultural climate in many low- and middle-income nations. Recent epidemiological data from Brazil, India, South Africa, and the Republic of China allows for more accurate projections of other low- and middle-income nations than those previously attempted with data from high- income nations. The implication of these trends for morbidity, mortality and lost productivity is enormous because tobacco control research capacity in low- and middle-income nations is severely circumscribed. Evidence from the World Bank Report, Curbing the Epidemic, shows that price increases, particularly through increased taxes, advertising bans and counter- advertising, and ETS restrictions have a measurable impact to decrease smoking (6). These factors are likely to require measures to change behaviors, reduce the initiation of smoking and use of smokeless tobacco products, specifically in youth and adolescents, and enhance permanent cessation by those addicted to nicotine. Behavior change is favored when context-specific causes and motivations are understood. Policy change is favored when committed individuals in leadership positions have relevant information available to them, especially information showing economic gain from policy changes. Ideally, a variety of research will be conducted since a single strategy is unlikely to suffice for most low- and middle-income nations. Progress in global tobacco control will depend upon standardized and comparable surveillance data; international research networks and information; and heightened capacity for tobacco control research among developing nations. In recent years, there have been a number of reviews to identify international tobacco control research needs. In 1998, the Institute of Medicine’s Board on Global Health outlined research needs in a report on cardiovascular disease prevention (http://www.nap.edu/catalog/6218.html). Also in 1998, a working group was convened at the 10th World Conference on Tobacco or Health to identify research fields and public health data with the highest potential to affect tobacco control policy. The Research for International Tobacco Control (RITC) group, hosted by the Canadian International Development Research Centre convened regional workshops in the Caribbean, Southeast Asia and Sub-Saharan Africa to outline regional agendas. In 1999, the World Bank produced Curbing the Epidemic, a monograph on the economics of tobacco control, including areas of needed research. These analyses have been instrumental to the development of this RFA. The goal of this RFA is to solicit applications for hypothesis testing and hypothesis generating studies, and to train low- and middle-income nation investigators who will examine the manifestations, determinants and outcomes of tobacco use, including smokeless tobacco products, and evaluate interventions in a range of areas. Scientific Objectives 1. Research: This RFA encourages trans-disciplinary research. Applications may address one or more of the provided categories of research. Both research and capacity strengthening must be included in the application. Categories of research may include, but are not necessarily limited to, the following activities: a) Epidemiological and Surveillance Research: A broad spectrum of epidemiological and surveillance research may be pursued to enhance the knowledge of tobacco-related health problems and risks relevant to low- and middle-income nations. o Characterize the prevalence and trends of tobacco initiation, use and consumption patterns, including oral tobacco use, particularly to identify high-risk groups; o Describe patterns and trends in tobacco-attributable morbidity and mortality; o Document and monitor trends in the nature, extent, and patterns of co- occurring tobacco and drug use and/or abuse (including polydrug use) and drug- related behavioral and social consequences in general and in special populations, especially in youth, adolescents and young adults; and o Determine tobacco’s effect on responses to other abused drugs, including the inclination to self-administer. b) Susceptibility and Risk: Examine the differences of tobacco initiation, consumption and cessation by gender, ethnicity, culture, income and education relevant to low- and middle-income nations. o Identify susceptibility factors that initiate tobacco use and prompt tobacco dependence, including gender, ethnicity, culture, income and education, to better characterize high-risk individuals and populations. Develop new targets for interventions; o Examine differential rates of tobacco addiction and their association with factors such as nicotine content and other product characteristics; o Examine the potential interaction between ETS and occupational or ambient air pollutants and local exposure in the pathogenesis of respiratory diseases, including its effect on childhood respiratory diseases, Sudden Infant Death Syndrome (SIDS), middle ear disease; and o Identify biomarkers for quantitating human exposure to ETS in the home and workplace and for predicting potential health risks for exposed individuals, especially youth, adolescents and young adults. c) Biobehavioral and Social Research: Behavioral and social research may emphasize tobacco advertising and awareness, smoking uptake and quit rate, and intervention strategies relevant to the cultural differences and needs of low- and middle-income nations. o Examine factors that influence positive and negative responses to advertising, promotional, mass media, and warning messages aimed at encouraging or discouraging tobacco use; o Identify levels of awareness of health risks associated with tobacco consumption among different segments of the population; o Identify sociocultural, psychological, physiological and genetic factors that influence smoking initiation and progression to nicotine addiction, and smoking cessation in all populations, not only high risk groups; o Examine co-morbid and medical disorders (e.g. depression, anxiety, heart disease and cancer) associated with tobacco use. Identify risk and protective factors for co-morbidity, and develop and test new intervention strategies; o Examine tobacco use in mental illness, and the role of depression and other psychiatric disorders in risk and relapse; and o Analyze the meaning of branding (i.e. to mark as desirable) and tobacco marketing images as determinants of tobacco uptake and continuance. Develop interventions aimed at testing consumer reaction to plain packaging. d) Intervention Research: Building on established intervention research conducted in high-income nations, investigators may engage in studies that examine different methods of tobacco control implementation and interventions and that are appropriate to developing country needs, infrastructure and resources. o Evaluate prevention and treatment programs and sociocultural studies to elucidate differences in responsiveness to interventions among different ages, ethnic and racial groups, and gravid and non-gravid women; o Examine the effectiveness and consequences of prevention interventions that employ single-risk versus multiple-risk strategies, especially in youth, adolescents, and young adults; o Examine community-based interventions that have the potential to impact large populations, such as those using evidence-based behavioral, sociological, and communication methods; o Evaluate new pharmaceutical or behavioral interventions and delivery mechanisms, their cost-effectiveness and impact in diverse sociocultural, physiological and genetic subgroups. Compare pharmaceutical interventions, behavioral therapy and combination pharmaceutical and behavioral therapy in children, adolescents, young adults, and gravid and non-gravid women; o Examine the combined impact of tobacco control measures, (i.e. the optimal policy mix ) with respect to prevalence in different groups, especially in children, adolescents, young adults, and gravid and non-gravid women; and o Examine the effectiveness of various health service settings to assess smoking rates, to prevent initiation and to promote quitting. In particular, evaluate tobacco prevention and cessation education interventions of nurse researchers, nurse practitioners, schools of nursing, community health workers, and physicians. e) Policy-Related Research: Policy-related research may examine current tobacco control policy and enforcement, or lack thereof, in low- and middle- income nations. Studies may also determine the impact of current and needed tobacco control policies, regulations and trade on public health and the risk factors associated with tobacco consumption relevant to low- and middle-income nations. o Assess the use of morbidity and mortality data and other information on the development of government tobacco reduction policies; o Examine the effectiveness of price increases, ETS restrictions, youth access measures, advertising and marketing bans and restrictions, and regulatory and legal approaches to reducing tobacco initiation and promoting tobacco cessation; o Examine the availability and effectiveness of the range of information, advertising and marketing approaches to increase the cessation rate in study populations; o Encourage research on the effect of counter-advertising and stigmatizing tobacco use, including smokeless tobacco, on uptake and sustained tobacco use by different age and gender groups, especially in youth, adolescents and young adults; o Assess the long-term health and economic implications of failure to control future tobacco-related health efforts; and o Examine the political economy of tobacco control and its impact on health. 2. Capacity and Infrastructure Strengthening: A strategic goal of this RFA is to strengthen capacity and infrastructure within low- and middle-income nations. Capacity building and infrastructure strengthening promote the advancement of research and the enhancement of the number and the knowledge of tobacco investigators in low- and middle-income nations. A long-term outcome of capacity and infrastructure strengthening is the ability to augment scientific competence and skills nationally and internationally, and develop a cadre of tobacco researchers with proper research training and support who will continue to carry out tobacco control research in a low- and middle- income nation(s). Capacity and infrastructure strengthening provide important opportunities for investigators from high-income nations to gain knowledge of and experience in tobacco control issues of both high-income and low- and middle-income nations. Capacity strengthening provides investigators in low- and middle-income nations with the skills and infrastructure to expand and enhance their work in tobacco control research. Capacity strengthening is a requirement of this RFA. Applicants should address the following: o Support research training of faculty to meet the goals of the proposed research as well as the needs of the low- and/or middle-income nation(s). Capacity strengthening will focus on the outcomes of tobacco consumption, and evaluation of public health and policy interventions relevant to the low- and/or middle-income nation(s). This research training will provide opportunities to augment field experiences and perspectives of investigators from low- and/or middle-income nations. Collaborations should extend or enhance in a mutually beneficial manner the tobacco control research interests of the principal and co-investigators. At the same time, the potential capacity of the low- and/or middle-income nation investigator and institution should increase to provide sustainable and productive behavioral, intervention and policy research capacity, which will address the tobacco burden in the participating low- and/or middle-income nation(s); o Promote institutional strengthening in tobacco control research through support for and linking of relevant departments or institutions working on tobacco-related scientific research; o Encourage research training opportunities for low-and middle-income nation investigators, including long-term research training as part of the research, practical and applied short-term courses and workshops in-country for professionals or technicians; and course work, laboratory or field research training in essential research skills for technical assistants, graduate degree candidates, or other health professionals; o Promote the advancement of tobacco control-related training for tobacco control investigators and health professionals from low- and/or middle-income nation(s) by career enhancement and institutional capacity strengthening in low- and/or middle income nations. The research grants funded from this RFA will provide research training for individuals considered associated with an institution and designated as Research Associates. This research training should not be confused with National Research Service Award (NRSA) support, where trainees do not have an employee-employer relationship. The following types of training may be included: long-term (more than nine months and up to three years) research training in pre- or post-doctoral programs; short-term (less than three months) research training (could encompass workshops focused on program and grants administration, technology transfer, protocol development of projects, and data management and analysis); intermediate-term research training (could include specialized activities in support of tobacco control research). The emphasis for research training for this RFA will be on intermediate to longer-term training, including mid-career training. This approach will accelerate building an enduring tobacco control research environment, facilitate the adoption of tobacco control policies, and strengthen public health capacity at foreign in country sites; o Post-doctoral and degree candidates must be listed as research associates on PHS application form 398, page DD, and would be considered as having an employee-employer relationship. Salaries, tuition remission, and other forms of compensation paid as, or in lieu of, wages to degree candidates or post- doctoral trainees to conduct research related to the goals of this RFA are allowable. Costs and plans must be included in the text of the proposal and reflected in the proposal's budget; o Enhance low- and/or middle-income nation(s) investigators observational, intervention and policy research on tobacco control by promoting multidisciplinary approaches to research training. Institutional capacity strengthening could encompass basic, social and behavioral sciences, economics, community-based research, and legal studies. Using resources available under this award, applicants could broaden their knowledge of tobacco-related disease or illnesses with courses related to polydrug abuse, cardiovascular disease and cancer control and prevention. An example of an appropriate curriculum would be a course concentrating on the principles and practice of cancer prevention and control, with discussions on a range of issues, including genetics and cancer biology, and behavioral science and community interventions (http://dcp.nci.nih.gov/pob/courses/index.html); o Promote clinical, operational and health services research on the effects, risk assessment and risk reduction related to tobacco use; o Support tobacco-related institutional infrastructure development and research training in bioethics, informatics, economics and other crosscutting disciplines; and o Support the development of in-country tobacco control infrastructure at the institution, academic, and Non-Governmental Organization (NGO) level, including laboratory and field research on a country- and project-specific basis. SPECIAL REQUIREMENTS Collaborations This program is intended to generate useful scientific information and promote collaboration between investigators and institutions in the United States or other high-income nations and low- and middle-income nations with shared interests in reducing the consequences of tobacco consumption. To achieve this, research and capacity strengthening may reflect new or on-going activities and may demonstrate a collaboration between a Principal Investigator (PI) (U.S. or other high-income investigator(s)) and a co- investigator(s) from a low- and/or middle-income nation(s). If the PI is from a low- or middle-income nation, the proposal will be developed jointly by the PI and one from the U.S. or other high-income nation. Collaboration between the foreign investigator and a U.S. investigator(s) is highly encouraged. Research findings must be relevant to the collaborating low- and/or middle- income nation(s). (For operational and analytic purposes, the World Bank’s main criterion for classifying economies, gross national product per capita, will be employed for this RFA to determine eligibility. A list of countries representing low- and middle-income economies, which are eligible for this program may be found at http://www.worldbank.org/data/countryclass/ classgroups.htm). Interdisciplinary approaches to examining the dynamics of tobacco consumption are especially encouraged. Advances are most likely to be achieved through interdisciplinary collaborations (i.e. economics, epidemiology, demography, anthropology, sociology, communications, behavioral science, basic biological sciences, psychology and pediatrics). Co-Sponsors This RFA is co-sponsored by WHO’s Tobacco Free Initiative http://tobacco.who.int/. The WHO Collaborating Centres are eligible and encouraged to apply for funding under the terms of reference of this RFA and other applicants are encouraged to apply in conjunction with WHO Collaborating Centres http://tobacco.who.int/en/tfi/radvisers.html. The WHO will participate in the annual network meeting of awardees, co-funding agencies, and selected international tobacco researchers outlined in this RFA. Establishing Research Priorities The applicant should demonstrate that the research proposed relates to the burden of tobacco and reflects the priorities of the low- and/or middle-income collaborating nation(s) and should describe in detail the procedures to ensure that both research and research training reflect these priorities. Strategy for Regional Impact The applicant should emphasize tobacco control capacity building at the collaborating foreign institution(s) and in low- and/or middle-income nations. The applicant should describe in detail strategies and specific activities to achieve a wider regional impact. This will occur by strengthening other institutions and/or international organizations in the low- and/or middle- income nation(s) and/or in neighboring countries, with the long-term strategic goals of disseminating and educating the public on tobacco control and policy and building a regional center. The program would offer training on tobacco research and control to other areas and countries consistent with regional resources. National Support for the Program Letters of support for the proposed research and capacity strengthening program from the collaborating foreign academic and governmental institution(s) must be submitted with the application. Evidence should be provided in writing of national support for the program through cost-sharing, (e.g.. supplies, funds, salaries, equipment, laboratory space, personnel, etc.) support by the host country, and willingness of the foreign government to utilize investigators experience and knowledge gained from the program to build policy and initiatives in tobacco control and research, and capacity strengthening. This could be done, for example, through a regional or national research-training center in the collaborating foreign country supported by the program. Note that cost-sharing funds will be subject to NIH cost-accounting rules. Additionally, NIH hopes that the research and training funded through this RFA will have a long-term positive impact to reduce tobacco use in low- and middle-income nations. NIH hopes that collaborating low- and/or middle-income nations(s) will utilize the expertise of those who receive research training under this RFA; that, following their training, trainees will be able to return to the host country and assume positions of responsibility in research and/or public health in tobacco control and prevention. For this reason, the review process will include the criteria of sustainability: whether or not an application demonstrates the ability to sustain and utilize the research and training provided through this RFA after the completion of the grant period. Continued Collaboration Descriptions of plans for continued collaboration with foreign collaborators and investigators once trainees return home must be included in the application, including strategies for continued mentoring of trainees and tracking career paths of trainees after they have returned home. Tracking of short- and long-term research training and other institutional capacity strengthening, including mentoring, will be done by a web-based reporting system, Annual Reports and through other means. Assurances Before an award will be made, the grantee institution must show written evidence of formal approval (assurances) from responsible authorities at the collaborating institution, from an institutional (or ethical) review board or committee at both the U.S. and foreign institution(s) and from the relevant government authority. Please see Procedures for Registering Institutional Review Boards and Filing Federal wide assurances of Protection for Human Subjects (FWAs) http://www.hhs.gov/ohrp/assurances/assurances_index.html. Annual Meetings There will be periodic annual network meetings of awardees, co-funding agencies, and selected international tobacco researchers in Bethesda, MD. Those receiving awards will be expected to participate in these meetings (generally one annual two-day meeting). The purpose of these meetings will be to exchange and benefit from research and research-training experiences and to coordinate program activities. In Year One, PIs should budget for themselves and their co-investigator(s) to attend the annual network meeting. In subsequent years, PIs should budget for themselves, their co-investigator(s) and two to three other project personnel (selected trainees and/or program administrators) to attend. Funds for this two-day activity (travel, lodging, and per diem) should be included in the budgetary requests. Consideration will be given to holding annual network meetings in developing countries when this would provide benefits to those persons and be cost-effective. Inclusion of Student and Postdoctoral Research Assistants/Associates Post-doctoral and degree candidates must be listed as research associates on PHS application form 398, page DD, and would be considered as having an employee-employer relationship. Salaries, tuition remission, and other forms of compensation paid as, or in lieu of, wages to degree candidates or post- doctoral trainees to conduct research related to the goals of this RFA are allowable. Costs and plans must be included in the text of the proposal and reflected in the proposal's budget. Dissemination All applications should include a detailed discussion of a) how the results of the research being proposed can be rapidly disseminated and adopted on a large scale and b) why the results of the research being proposed, if disseminated and adopted on a large scale, could have a significant effect on the reduction of tobacco use in the community, host country or region. RESEARCH INVOLVING HUMAN SUBJECTS If the proposed research involves human subjects, applicants must inform the Fogarty International Center program staff that approval of research protocols involving human subjects has been obtained from U.S. and developing country institutional review boards and required U.S. and foreign government agencies before an award will be made. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) award mechanism. Responsibility for the planning, direction and management of the proposed project will be that of the Principal Investigator in consultation with their co-investigator(s). A Principal Investigator may request a project period of up to five years and a budget for direct costs of up to $400,000 per year. FUNDS AVAILABLE It is expected that approximately $3.5 million per year in total costs (direct costs plus facilities and administrative (F & A) costs) from all supporting collaborating NIH Institutes and Centers will be available for up to five years, beginning in fiscal year 2002, to fund an estimated six to eight new grants in response to this RFA. This support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the participating Institutes and Centers, awards are contingent upon the availability of funds from FIC and collaborating partners for this purpose and the receipt of a sufficient number of meritorious applications. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. This RFA is open to all qualified investigators. Principal Investigators from the U.S. or other high-income nation(s) are required to collaborate with an investigator(s) from a low- and/or middle-income nation(s). Principal Investigators from a low- and/or middle-income nation are strongly encouraged to collaborate with a U.S. and/or other high-income nation(s). Racial/ethnic minority individuals in the U.S., women, and persons with disabilities are encouraged to apply as PIs. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only in accordance with NIH policy governing such awards. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: FIC Joel Breman, M.D., D.T.P.H. Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 Fax: (301) 402-0779 Email: [email protected] NCI Michele Bloch, M.D., Ph.D. Tobacco Control Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Plaza Blvd., Room 4032 Bethesda, MD 20892 Phone: (301) 496-8584 Fax: (301) 496-8675 Email: [email protected] NICHD Lynne Haverkos, M.D., M.P.H. Center for Research for Mothers and Children (CRMC) National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05B Bethesda, MD 20892-7510 Telephone: (301) 435-6881 Fax: (301) 480-7773 Email: [email protected] NIMH Peter Muehrer, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health, National Institutes of Health 6001 Executive Boulevard, Room 6189, MSC 9615 Bethesda, MD 20892-9615 Telephone: (301) 443-4708 Fax: (301) 480-2920 Email: [email protected] NINR Janice Phillips, Ph.D., RN, FAAN National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6152 Fax: (301) 480-8260 Email: [email protected] NIDA Steve Gust, Ph.D. International Program National Institute on Drug Abuse 6001 Executive Blvd., Room 5274 Bethesda, MD 20892 Telephone: (301) 443-6480 Fax: (301) 443-9127 Email: [email protected] Programmatic inquiries can also be addressed to the NIH program contacts listed on the FIC web site (http://www.nih.gov/fic/programs.html) for the International Tobacco and Health Research and Capacity Building Program. Frequently asked questions and responses to these inquiries will also be listed at this web site. Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8326 Rockville, MD 20852 (express courier) Bethesda MD 20892-8326 Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] Direct inquiries regarding fiscal matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center Building 31, Room B2C29 31 Center Drive, MSC 2220 Bethesda, Maryland 20892-2220 Telephone: (301) 496-1670 Fax: (301) 594-1211 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit, by September 4, 2001, a Letter of Intent that includes a descriptive title of the proposed research, the name, address, telephone number and email, if available, of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a Letter of Intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to estimate the potential review workload and to plan the review. The Letter of Intent is to be sent to Dr. Joel Breman at the address listed under INQUIRIES by the Letter of Intent receipt date. SCHEDULE Letter of Intent Receipt Date: September 4, 2001 Application Receipt Date: October 26, 2001 Peer Review Date: February/March, 2002 Review by appropriate Board/Council: May, 2002 Earliest Anticipated Start Date: July, 2002 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail: [email protected]. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. Because we expect that there will not be any applications requesting less than $250,000 in direct costs for each of the five years, applications should be in the standard (non-modular) format with a detailed budget. The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies of the application 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) Additionally, at the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8326 Bethesda, MD 20892-8326 Rockville, MD 20852 (for express/courier service) Applications must be received by October 26, 2001. If an application is received after that date, it will be returned to the applicant without review. 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. CSR will also not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of previously reviewed applications with substantial revisions. Such applications must include an introduction addressing the previous critique. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this RFA. 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 NIH for Data 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NCI and the other sponsoring Institutes/Centers. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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 assigned a priority score, and receive a second level review by the appropriate Board/Council. Review Criteria The nine criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment: 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? Is there evidence of institutional support? Is there evidence of the ability to sustain and utilize the research and research training provided through the RFA, after the completion of the grant period? 6. Research Capacity Building: Does the proposed program contribute to the capacity of scientists and institutions in low- and middle-income nations to perform research related to tobacco consumption? Does the proposed program contain explicit strategies or plans to strengthen this capacity through research training, career development, mentoring and other modes? Will enhancement of specific departments in foreign institutions lead to overall institutional excellence? 7. International Research Collaboration: In the course of research, will collaborating foreign scientists and their institutions develop the capacity to become independent investigators and national leaders in tobacco research and public health intervention (i.e. develop their independently supported research and capacity development programs and obtain financial support nationally and internationally)? How will this occur? 8. Does the proposed project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources? 9. Does the proposed project have specific relevance to the mission and objectives of the sponsoring Institutes/Center and has the potential for significantly advancing the health sciences in the U.S.? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: (a) The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Detailed plans for the recruitment and retention of subjects will also be evaluated. (b) The reasonableness of the proposed budget and duration in relation to the proposed research. (c) The adequacy of the proposed protections for human participants, particularly the risks that may be posed to groups as well as individuals, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review); o Balance among projects to respond to the questions included in this RFA; o Availability of funds; o Programmatic priorities, including those of co-sponsoring institutions and agencies; o Geographic balance; and o Potential to achieve a sustainable local and regional impact INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. For studies outside the U.S., the U.S. definitions of minorities do not apply. All applicants should describe the racial/ethnic demographic profile(s) of the proposed study population(s) and discuss the rationale for their selection. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 clear and compelling reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators should describe the age range of individuals involved in their proposed study, and describe the rationale for their selection. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: 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 now available online at http://ohsr.od.nih.gov/. For more information on NIH policies regarding human subjects see: http://grants.nih.gov/grants/peer/hum_anim_notice.pdf and http://grants.nih.gov/grants/peer/hs_review_inst.pdf. 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 (PA) 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. 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. Reviewers are cautioned 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, International Tobacco and Health Research and Capacity Building Program, is related to one or more priority areas. Smoking is a major risk factor for heart disease, stroke, lung cancer and other cancers - all leading causes of death. Smoking has major and immediate effects during pregnancy and can lead to serious pediatric disease. Smoking may also be associated with injuries and environmental damage caused by fires. Adverse effects of environmental tobacco smoke (ETS) include increased lower respiratory infection, increased respiratory symptoms, reduced lung growth, exacerbation of asthma, irritation of the eyes, nose, throat and lower respiratory tract, increased risk of middle-ear disease, and increased risk of sudden infant death syndrome (SIDS). 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 No. 93.3 (FIC), 93.393 (NCI), 93.865, Research for Mothers and Children (NICHD), 93.3 (NINR), 93.279 (NIDA), 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 and Title IV, Part A, as amended (42 USC 241, 284, and 287) of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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 1..Johnson JG, Cohen P, Pine DS, et al. Association between cigarette smoking and anxiety disorders during adolescence and early adulthood. JAMA 2000; 284: 2348-2351. 2. Lasser K, Boyd JW, Woolhandler S, et al. Smoking and mental illness, a population-based prevalence study. JAMA 2000; 284: 2606-2610. 3. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000. 4. Wewers ME, Ahijevych KL, Chen MS, et al. Tobacco use characteristics among rural Ohio Appalachians. Journal of Community Health 2000; 25: 377- 388. 5. Barnum H, Greenberg RE. Cancers. In: Jamison DT, Mosely HW, Measham AR et al. eds. Disease control priorities in developing countries. Washington, DC. The World Bank. 1993. 6. Jha P, Chaloupka F. Curbing the epidemic: governments and the economics of tobacco control . Washington, DC. The World Bank. 1999.
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