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BRAIN DISORDERS IN THE DEVELOPING WORLD: RESEARCH ACROSS THE LIFESPAN RELEASE DATE: November 7, 2002 (see addendum NOT-TW-03-005) RFA: TW-03-007 Fogarty International Center (FIC) (http://www.nih.gov/fic/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/ National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) Canadian Institutes of Health Research (CIHR)/Institute of Neuroscience, Mental Health and Addiction (INMHA) (http://www.cihr.ca/) Mexico - Consejo Nacional de Ciencia y Tecnología (Conacyt) (http://www.conacyt.mx/) LETTER OF INTENT RECEIPT DATE: February 11, 2003 APPLICATION RECEIPT DATE: March 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Training Plan o Mechanism(s) 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 Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA This Request for Applications (RFA) solicits applications to plan and develop collaborative research and capacity building projects on brain disorders throughout life relevant to low- and middle-income nations. Applicants are expected to develop innovative, collaborative research programs that would contribute to the long-term goal of building sustainable research capacity in neurological/neurodevelopmental (including sensory, motor, cognitive and behavioral) impairment throughout life. This RFA is joined by the following Institutes and Centers: NIH sponsors include the Fogarty International Center (FIC), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS) and the Office of Dietary Supplements (ODS); for Canada, the Canadian Institutes of Health Research (CIHR) and for Mexico, the Consejo Nacional de Ciencia y Tecnología (Conacyt). These sponsoring organizations seek domestic and international collaborative applications which address brain disorders in the developing world and which build research capacity of low- to middle-income countries to address brain disorders within their country or region. This first phase of the "Brain Disorders in The Developing World: Research Across the Lifespan" initiative, beginning in fiscal year 2003 (FY03), will consist of two-year planning/development grants using the R21 grant mechanism. The R21 grant will provide support to initiate preliminary studies and to organize, plan, prepare, and assemble an application for a more comprehensive R01 grant involving collaboration between high-income and low- to middle-income country investigators and which incorporates both research and capacity building. The main goals of the R21 applications should be to assess needs, develop collaborations and needed resources, show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission. The applicants should propose specific milestones and a timeline to meet these goals. During the R21 award period, the applicant should: o further define the type and area of research to be developed; o develop and solidify collaborative relationships and understandings with the partners in the developed and developing countries involved; o assess current resources and needs, such as and including the need for an institutional review board (IRB) for studies involving human subjects; o develop and initiate a plan to address these needs to enable the proposed research and capacity building to be successfully carried out; o identify the training and other capacity-building opportunities to be incorporated into the research application in the context of the proposed research; o initiate cross-training of collaborators where necessary for the proposed research; and o conduct pilot studies and generate preliminary data; Projects should: 1) Involve a partnership between high-income and low-to middle-income country individuals or research teams; 2) lead to pursuit of basic, epidemiological, clinical, prevention, intervention or health services research in the area of brain disorders of relevance to low- to middle-income countries; and 3) build capacity as necessary in the proposed research area to enable further research to take place. An RFA for the second competitive phase of the "Brain Disorders in The Developing World: Research Across the Lifespan" initiative is currently planned to be issued in fiscal year 2005 (FY05), subject to availability of funds. That RFA is planned to provide support for collaborative research and capacity building to high-income and low- to middle-income country partners through the R01 mechanism. The second phase RFA competition, as currently planned, will not be limited to the R21 grantees under this competition, but will be open to all eligible applicants. RESEARCH OBJECTIVES The overall intent of the program is three-fold: 1) to encourage interdisciplinary collaborative approaches to identify and address brain disorders of particular importance to low- and middle-income countries; 2) to address brain disorders of significance to low- to middle-income nations by promoting international cooperation between scientists and institutions in these countries and investigators in the U.S. and other high-income nations who are pursuing relevant research programs and 3) to build and enhance the research capacity of low- to middle-income nations to identify and address relevant brain/neuro-developmental disorders across the lifespan. The main goals of the R21 application should be to: 1) assess needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question), 2) develop collaborations and needed resources, 3)show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission and 4) Integrate capacity building/ research training into the proposed research program. To meet the goals of the R21 application the application should provide a clear plan with milestones and a time-line for the development of the collaboration. Such efforts must include pilot research projects to demonstrate feasibility of certain aspects of the research approaches and to develop further research directions. Training, informal meetings, workshops and small conferences necessary to develop the research and collaboration and assess needs may be part of the plan. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed. Each exploratory grant should also present a description of the anticipated longer-term goals of the collaboration as it develops into an application for an R01 research grant with capacity building and training built in. As one outcome of the work under the R21, grantees will be expected to provide a detailed assessment of the specific research issues and capacity building/training needs in the developing country that the proposed follow-up R01 or other future application will address. The relevance of the focus of the proposed research to the health of the host endemic country should be justified. The assessment may include, but is not limited to, needed skills and expertise in laboratory, clinical, epidemiological and social science research. In addition, the involvement, if any, of the developing country institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted. The applicants will also initiate development of needed resources and infrastructure. Research training in the context of the proposed research may take place at any of the collaborating sites and may vary, depending on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions. However: 1) any research at the high-income site must also involve training for participating low- to middle-income investigators and 2) the major portion (greater than 50 percent) of the proposed research must be conducted at the low- to middle income country site or sites. The purpose of this mechanism is to foster initial development of collaborative work focused on brain disorders across the lifespan and relevant to developing countries; accordingly, investigators need not demonstrate any history of prior collaboration. However, those factors in the investigators' background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated. Relevant research for the R21 and follow-up applications may range from basic science to epidemiological, translational (e.g. translation of basic research to therapy and of clinical research to applications in the field), clinical, operational and health services research. Background: During the past several decades, improvements in health care have led to a decrease in infant mortality in the developing world. The continuing burden of infectious disease and malnutrition, along with a growing burden of chronic disease associated with aging populations, has resulted in a complex epidemiological situation. Developed nations have relatively high proportions of people aged 65 and over, but the most rapid increases in elderly populations are in the developing world. The current aggregate growth rate of the elderly population in developing countries is more than double that in developed countries, and also double that of the total world population. This increase in life expectancy is further complicated by the widespread incidence of neurological, psychiatric, and developmental disorders. With the exception of sub-Saharan Africa, brain disorders are the leading contributor to years lived with disability in all regions of the world. Measures of mortality and disability do not include the social isolation and stigma experienced by individuals affected with brain disorders, as well as the financial hardship borne by affected individuals, their families, and the communities in which they live. As a result of negative attitudes, prejudice, and stigma, many affected with brain disorders remain undiagnosed and untreated. In addition to poverty and gender inequality that underlie many of the key risk factors for brain disorders, available care is frequently inadequate. In some countries, the overall physician-patient ratio can be low as 1:20,000, with even fewer psychiatrists and neurologists. Despite the enormous burden of disease, brain disorders have been largely absent from the international health research agenda. Policy makers began to recognize the social and economic impact of brain disorders as a result of the 1993 publication of the Global Burden of Disease Study. This landmark report compared the total cost of various diseases on the basis of disability-adjusted life years (DALYs), a measure that accounts for the overall burden of disease by combining years of potential life lost as a result of premature death with years of productive life lost because of disability. Responding to the growing awareness of brain disorders in the developing world, the U.S. Institute of Medicine was charged to prepare a report that would define the increasing burden, identify opportunities for effectively reducing the burden, and identify areas for intervention, research, and capacity building. The results were compiled in a report entitled "Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenges in the Developing World" (2001, available at http://books.nap.edu/books/0309071925/html/). Study sponsors included the National Institutes of Health (Fogarty International Center, the National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, and the National Institute of Mental Health), the U.S. Centers for Disease Control and Prevention, and the Global Forum for Health Research. The report brings together a growing body of evidence indicating that the social and economic impact of neurological, psychiatric, and developmental disorders is large and increasing. Present figures almost certainly underestimate the impact of brain disorders, particularly in the developing world. A sustained, comprehensive, and integrated research effort is key to reducing the burden of brain disorders in the developing world. Among the main recommendations of the report was the need to create both national centers for training and research, as well as programs to facilitate competitive funding for research on developmental disabilities and epilepsy in resource–poor nations. This RFA focuses on neurodevelopmental disabilities, as well as on other conditions and influences on the nervous system that affect cognition, learning and memory across the lifespan. Neurodevelopmental disabilities include conditions such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy that result from abnormal prenatal development or influences during the prenatal period, or from injury or insult to the brain and central nervous system during infancy or childhood. In the U. S., approximately 12 to 18percent of children are disabled. Many of the causes of developmental disabilities – including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events – are particularly common in resource–poor countries, suggesting that the prevalence is expected to be even higher. Examples of specific conditions that affect brain function across the lifespan, include, but are not limited to, neurodegenerative diseases (such as Alzheimer's and Parkinson's Diseases), neurotoxic insults, infection of the nervous system by viral and parasitic diseases (such as HIV/AIDS and malaria), pre- and post-natal environmental insults and trauma (e.g., fetal alcohol syndrome, drug abuse/exposure, child abuse and neglect, shaken baby syndrome). Epilepsy is an example of a treatable brain disorder that affects an estimated 40 million people in developing countries, roughly 85 percent of the total number affected worldwide. Epilepsy commonly affects young adults in the most productive years of their lives and frequently leads to their being unemployed. Although cheap and effective treatments are available, epilepsy is frequently untreated and even unrecognized in the developing world often because of stigmatization and false beliefs. In such disorders, research into interventions taking social and cultural factors into account and involving education, media, policy and behavior are especially appropriate. HIV infection is an example of an infectious disease which is a major public health problem in developing countries and that also has significant neurological consequences. At the end of 2001, approximately 28.5 million people in sub-Saharan Africa and 5.6 million people in South and South East Asia were living with HIV/AIDS. In the developed world, neurological complications such as HIV-1-associated dementia can occur in 20 percent of symptomatic individuals. Symptoms of HIV-associated dementia include slowing of motor and mental function with memory loss and language difficulty. Other neurological complications, such as peripheral neuropathy and HIV-associated myelopathy, can occur in 15 to 50percent of HIV patients in the developed world. In addition, opportunistic brain infections, such as cryptococcus, Toxoplasma gondii and JC virus, are seen in HIV-infected individuals. Although a large number of individuals are HIV-infected in developing countries, very limited data is available on the epidemiology, natural history and pathogenesis of neurological disease caused by HIV and associated opportunistic infections in these settings. In order to address these and other health research issues relevant to brain disorders in developing countries, the NIH is proposing a new research and capacity building program on brain disorders with a focus on neurological (including sensory, motor, cognitive and behavioral) impairment throughout life, in low- to middle-income countries. Research Topics Relevant research topics should be related to neurodevelopmental disabilities and neurological disorders, including cognitive, motor, sensory and behavioral impairment from birth to advanced age. Research findings must be relevant to the collaborating low- and/or middle-income nation(s). Some examples are: mental retardation, seizure disorders such as epilepsy, movement disorders such as Parkinson's and dementias - including those related to age and those caused by HIV, malaria or other infection. Research relevant to this announcement includes basic research and epidemiology, as well as research on early interventions, clinical treatment, prevention, and health services that are culturally appropriate, feasible, and acceptable for implementation within the foreign site. This RFA encourages development of multidisciplinary research, whenever relevant to the research question. Expertise may involve but is not limited to fields such as neurology, cognitive neuroscience (including functional brain imaging), developmental neurobiology, neurotoxicology, neuroendocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, and biotechnology (e.g., for development of diagnostic tools) as well as the behavioral and social sciences. Examples of some cross-cutting areas for research are: o Ethnographic studies and other areas of social science, particularly to address health systems and appropriate interventions within a given society or group. o Research focusing on gender and socioeconomic factors in the etiology and treatment of the disorders to be addressed. Suggested areas of research include, but are not limited to: o Epidemiological studies 1) Descriptive epidemiology to describe and define the problem in the countries in question by assessing needs and determining the magnitude and factors involved in the problem to be addressed (e.g., research on trends in incidence, prevalence or mortality; distribution of disease; determination of populations at risk; determination of case definition/disease classification); 2) Analytical epidemiology to identify potential etiological factors in the populations of interest, including factors responsible for predispositions to the neurological consequences of various infections,infestations, and/or neurotoxins (e.g., identification of risk factors for neurological consequences of disease onset or progression; classification and measurement of exposure; magnitude and distribution of known risk factors). o Genetic factors throughout life, beginning in the prenatal period, that result in cognitive, behavioral, motor or sensory impairment or disorders. o Natural history of common neurological diseases/disorders and the influence of sociocultural or other environmental variables that impact upon this course. o Research on multiple insults, especially common in the developing world, e.g., neurotoxic or traumatic insult plus infectious disease and/or malnutrition. Studies examining the interactions of neurobiological and environmental/social factors that affect brain development and resulting behavioral outcomes are encouraged (e.g., expression of cognitive impairment, coping, adaptation, response to intervention, etc.). o Environmental factors across the lifespan, beginning in the prenatal period, that result in cognitive, behavioral, motor or sensory impairment including: 1. Natural and man-made neurotoxic exposures - e.g. prenatal exposure to drugs of abuse, fetal alcohol syndrome, effects of neurotoxins/neurotoxicants in homes, the outside environment, industrial and agricultural settings; 2. Malnutrition; 3. Infectious diseases such as cerebral malaria, neurocysticercosis/ tapeworm, HIV/AIDS and associated opportunistic infections, and other parasitic diseases; 4. Physical trauma that is both intentional and unintentional (e.g. Shaken baby syndrome, accidental injuries); 5. Psychological trauma (e.g. effects on brain function, including cognitive and behavioral function, in victims of child abuse, neglect or abandonment, torture and rape). o Factors affecting cognitive, emotional and physical health and survival in older persons. o Research on other factors that impact on healthy brain development, such as access to appropriate health care, availability of resources, preventive or screening practices, etc.. o Research on potential interventions and how the success or failure of interventions may be modulated by sociocultural and gender variables. Primary outcomes of the proposed R21 activities should be specification of a further research agenda with needed capacity building. The activities proposed should include design and execution of small, preliminary studies to demonstrate feasibility and obtain pilot data. Other activities undertaken under the planning grant may include, but are not limited to: discussions of the research problems to be addressed; the ways in which the basic research could be applied to clinical issues; critical evaluations of relevant research literatures; visits among the various laboratories and clinics to familiarize members with each others' work in detail; feasibility of co-funding/support from developing countries and public/private institutions to assure sustainability; possible modifications to paradigms and methods that might be necessary for use with patient populations; determination of other research expertise that might need to be added to the group, including social scientists; new statistical approaches or methodologies that may need to be developed; priorities for a collaborative research and capacity building program; evaluation of social, economic, and/or political factors that might impact the research itself or the execution of the research; an evaluation of bioethical and legal issues that could impact research on neurologically impaired populations; an evaluation of other components of the public health system that might impair or enhance research on brain disorders; assessment of potential medical informatics programs that could be developed to store data pertinent to future brain disorders research; exploration of the feasibility for co-funding future research or academic support for researchers from public or private agencies within the collaborating developing country. Specific Research Interests of the RFA Sponsors: NIH: The FIC is interested in all eligible applications that are responsive to this RFA. The NEI conducts and supports research that helps prevent and treat eye diseases and other disorders of vision and which leads to sight-saving treatments, reduces visual impairment and blindness, and improves the quality of life for people of all ages. In the context of this announcement NEI would particularly like to encourage research on eye diseases relevant to developing countries and involving neuronal cell dysfunction and degeneration (such as but not restricted to retinitis pigmentosa, age-related macular degeneration, and glaucoma). The NIA is interested in applications relevant to Alzheimer's disease and other degenerative diseases of the nervous system, and age-related changes in cognition and memory. Of interest also are studies on reducing disability and/or preventing or slowing additional decline among persons with neurological disabilities as they continue to age. The NIAAA is interested in applications which address alcohol-related birth defects (such as Fetal Alcohol Syndrome). The NICHD is particularly interested in encouraging studies in response to this announcement which propose to address problems in child health and development, such as mental retardation, cognitive and behavioral disorders, neurodevelopmental disabilities and learning disabilities. Relevant research includes etiology, pathophysiology, screening, prevention, treatment, and epidemiology. Also of interest are studies on cognitive, social, and affective development, including studies in high-risk settings (e.g., in violent or abusive environments, or families experiencing stressors such as poverty, unemployment or parental depression). Biomedical, behavioral, and biobehavioral research in these areas is encouraged along with investigations of socio- and ethno-cultural, familial, individual, and biological influences. Also of interest are studies investigating the roles played by nutritional and hormonal factors in nervous system development and function. The NIDA is interested in applications which focus on behavioral, cognitive and neurobiological factors as antecedents to, or impacting on, consequences of drug abuse. Of particular interest are studies aimed at reducing drug abuse and addiction and its associated adverse social, behavioral, and health consequences (e.g., violence and infectious diseases transmission and including research related to the interaction between HIV/AIDS and abuse). NIDA especially encourages research capitalizing on unique opportunities to study adverse environmental and socio-cultural effects on drug abuse patterns and behaviors in populations of developing countries (e.g., caregiver neglect or abandonment, high orphan populations or street children at risk for both drug abuse and HIV or HCV). In countries where abuse of high doses of individual drugs is more common than in the U.S. and Europe, NIDA is interested in supporting studies on prenatal effects, cognitive consequences, epidemiological patterns, and associations with HIV/ AIDS and other transmitted diseases. NIDA will give priority to meritorious research that builds upon existing NIDA-funded collaborations between high-income and low- to middle-income country colleagues. The NIEHS is interested in supporting research in the developing world to identify the causes and prevent or ameliorate the consequences of neurotoxic insult to the nervous system throughout life. The Institute would especially like to encourage applications for research with investigators in Vietnam, Cambodia and Laos and research focusing on the consequences of exposure to dioxin. The NIMH is interested in research limited to areas relating to epidemiology, natural history, and pathogenesis of HIV disease of the nervous system.. The NINDS encourages research across the spectrum of neurological disorders to reduce the burden of neurological disease borne by every age group and segment of society all over the world. Canada: The Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) is interested in co- sponsoring collaborative proposals between Canadian and low- to- middle- income country investigators. Eligible applications include those dealing with the spectrum of research related to neurological disorders, mental illnesses and addictions. Mexico: Conacyt/MMH will consider applications from or involving Mexican investigators and proposing research collaborations on brain disorders related to neurological dysfunction, mental illnesses and addictions. Conacyt is particularly interested in research to develop innovative, effective and evidence-based diagnostics and interventions for these disorders along with means to reduce discrimination, improve access to services and to raise public awareness. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory Grant (R21) award mechanism. Applicants for this R21 award may request direct costs of up to $100,000 per year, in increments of $25,000, for a maximum of two years. The funded R21 grants will not be renewable. Note that the R21 mechanism is specifically intended to support development of collaborations, innovative ideas and research where preliminary data as evidence of feasibility are sparse or do not exist. R21 grants are not intended for large-scale undertakings or to support or supplement ongoing research. Rather, R21-supported projects are intended to serve as a basis for planning, strengthening and developing collaborations and conducting pilot studies to obtain preliminary data for future research project grant applications (R01). This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, since you are submitting an application with direct costs in each year of $250,000 or less, use the modular format for all applications. Applications submitted by foreign institutions can request facilities and administrative (F&A;) costs up to a maximum of eight percent. Please see the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on allowable F&A; costs for foreign grants and domestic grants with foreign components. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications submitted in response to this RFA may have a project period of up to two years. This RFA is a one-time solicitation. Any future unsolicited competing continuation applications based on this project will compete with all NIH investigator-initiated applications and be reviewed according to the customary peer review procedures FUNDS AVAILABLE The participating ICs intends to commit approximately $2 million dollars in FY03 to fund approximately fifteen to twenty new grants in response to this RFA. An applicant may request a project period of up to two years and a budget for direct costs of up to $100,000 per year (including the total cost of subcontracts) in modules of $25,000. 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 ICs 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 relevant to the interests of each RFA sponsor. Each award will be administered by one of the participating NIH ICs or other participating agencies although several may participate in the funding of any given application. At this time, it is not known if this RFA will be reissued. The Canadian Institute for Health Research (CIHR) will consider meritorious applications, relevant to their missions, involving Canadian institutions. CIHR will make the award of grants for meritorious applications of interest to them. Applicants who wish to have their projects considered for (co)funding by CIHR should include with their application a letter stating that their application and summary statement may be shared with CIHR. El Consejo Nacional de Ciencia y Tecnología (Conacyt) of Mexico will consider meritorious applications relevant to its mission and which involve Mexican institutions. Conacyt will make the award of grants for meritorious applications of interest to them. Applicants who wish to have their projects considered for (co)funding by Conacyt should include with their application a letter stating that their application and summary statement may be shared with Conacyt. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is among the eligible domestic or foreign institutions that are: 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 Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual from an eligible institution who has the skills, knowledge, and resources necessary to carry out the proposed research under the guidelines of this RFA, 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 and women, are always encouraged to apply for NIH programs. The primary purpose of this announcement is to provide an avenue for investigators to explore and initiate research collaborations between investigators and institutions in the United States or other high-income nations and low- and middle-income nations with shared interests in brain disorders. Therefore, at least two investigators (one from an institution in a high-income country and one from an institution in a low- to middle- income country) must collaborate on the application as Principal Investigator (PI) and Co-Investigator. The Principal Investigator (PI) may be the collaborator from the low- to middle-income nation and institution, or from the U.S. or other high-income nation and institution, but the collaborators must develop the proposal jointly. While there is no cap on the maximum number of investigators, the application needs to discuss how the contributions of each member will be integrated in the proposed activities. 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 as low- to middle-income countries for this program may be found at http://www.worldbank.org/data/countryclass/classgroups.htm. SPECIAL REQUIREMENTS A single meeting involving grantees of these awards will be held in the Washington, D.C. area, in the second year of the grant period, to share information, discuss new insights and will include a grants-writing workshop. For this meeting, funds should be budgeted for travel by the PIs and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award. Capacity Building: Greater than 50 percent of the direct costs requested must be used in the collaborating low- and/or middle-income nation(s)for either pilot research and/or capacity strengthening of foreign institutions as necessary to carry out the proposed research program in the short- and long- term. Capacity strengthening, which may include development of needed resources and infrastructure (including IRBs at the foreign site for any proposed research involving human subjects) and initiation of needed training for collaborators, must be integrated into the planning process and the research proposal. 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 GENERAL INQUIRIES regarding the scope and content of this Request for Applications should be directed to: Kathleen Michels, Ph.D. Program Director Division of International Training and Research Fogarty International Center Building 31, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-435-6031 Fax: 301-402-0779 Email: Michelsk@nih.gov http://www.nih.gov/fic/ o Direct your questions about SCIENTIFIC/RESEARCH ISSUES to the contacts below: CANADA: CANADIAN INSTITUTES OF HEALTH RESEARCH Astrid Eberhart Institute Liaison Institute of Neurosciences, Mental Health and Addiction Canadian Institutes of Health Research 410 Laurier Avenue W., 9th Floor Address Locator 4209A Ottawa, ON K1A 0W9 Telephone: 613-941-4643 Fax: 613-941-1040 Email: aeberhart@cihr.ca MEXICO: Dr Efrain Aceves Director for International Affairs El Consejo Nacional de Ciencia y Tecnología (Conacyt) Avenida Constituyentes 1046 Col. Lomas Altas, cp. 11950 Delegaciòn Miguel Hidalgo, Mexico DF, Mexico Telephone: 52-55-5327-76-15 Fax: 52-55-5327-75-32 Email: aceves@conacyt.mx UNITED STATES: FIC/NIH: Kathleen Michels, Ph.D. Program Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-435-6031 Fax: 301-402-0779 Email: michelsk@nih.gov NEI/NIH Michael D. Oberdorfer, Ph.D. Director, Strabismus, Amblyopia, and Visual Processing Program Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda MD 20892-7164 Telephone: 301-451-2020 Fax: 301-402-0528 Email: mdo@nei.nih.gov NIA/NIH: Elisabeth Koss, Ph.D. Assistant Director Alzheimer's Disease Centers Program Neuroscience and Neuropsychology of Aging National Institute on Aging National Institutes of Health Gateway Building, Suite 3C307 7201 Wisconsin Ave MSC 9205 Bethesda, MD 20892-9205 Telephone: 301-496-9350 Fax: 301-496-1494 Email: kosse@nia.nih.gov NIAAA/NIH: Margaret M. Murray, M.S.W. Chief, International and Health Education Programs Branch National Institute on Alcohol Abuse and Alcoholism National Institutes of Health 6000 Executive Boulevard, Suite 302 Rockville, MD 20852 Telephone: 301-443-2594 Email: pmurray@mail.nih.gov NICHD/NIH: James W. Hanson, M.D. Chief, Mental Retardation & Developmental Disabilities Branch National Institute of Child Health and Human Development Executive Building, Room 4B09G 6100 Executive Blvd., MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-1383 Email: hansonj@mail.nih.gov NIDA/NIH Minda R. Lynch, Ph.D. Branch Chief Behavioral and Cognitive Sciences Research Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse National Institutes of Health 6001 Executive Blvd., Rm. 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: 301-435-1322 Fax: 301-594-6043 Email: mlynch1@nida.nih.gov NIEHS/NIH: Annette Kirshner, Ph.D. NIEHS-DERT Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: 919-541-0488 Fax: 919-541-5064 Email: kirshner@niehs.nih.gov NIMH/NIH: Jeymohan Joseph, Ph.D. Chief, HIV Neuro-Virology, Genetics and Molecular Therapeutics Program Center for Mental Health Research on AIDS National Institute of Mental Health National Institutes of Health Room 6202, MSC 9619 6001 Executive Blvd Bethesda, MD 20892-9619 Telephone: 301-443-3012 Fax: 301-443-9719 Email: jjeymoha@mail.nih.gov NINDS/NIH: Yuan Liu, Ph.D. Program Director National Institute on Neurological Disorders and Stroke National Institutes of Health NSC/2110B,6001 Executive Blvd, MSC 9529 Bethesda, MD 20892-9529 Telephone: 301-496-1917 Fax: 301-402-0182 Email: yl5o@nih.gov ODS/OD/NIH: Rebecca B. Costello, Ph.D. Deputy Director Office of Dietary Supplements National Institutes of Health 6100 Executive Blvd., Room 3B01, MSC 7517 Bethesda, Maryland 20892-7517 Telephone: (301) 435-2920 Fax: (301) 480-1845 Email: CostellB@od.nih.gov o Direct your questions about peer review issues to: Alan L. Willard, Ph.D. Chief, Scientific Review Branch National Institute on Neurological Disorders and Stroke National Institutes of Health 6001 Executive Blvd, Room 3208 Rockville, MD 20852 (couriers) Bethesda, MD 20892-9529 (for US Mail) Telephone: 301-496-9223 Fax: 301-402-0182 Email: AW135Y@NIH.GOV o Direct your questions about financial or grants management matters to: FIC/NIH: Bruce Butrum Grants Management Officer Fogarty International Center National Institutes of Health Building 31, Room B2C29 Bethesda, MD 20892-2220 Telephone: 301-496-1670 Fax: 301-402-0779 Email: butrumb@mail.nih.gov NEI/NIH William W. Darby Grants Management Officer Division of Extramural Research National Eye Institute National Institutes of Health Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda MD 20892-7164 Telephone: 301-451-2020 Fax: 301-496-9997 Email: wwd@nei.nih.gov NIA/NIH: Deborah Stauffer Grants Management Specialist National Institute on Aging National Institutes of Health 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 Email: stauffed@nia.nih.gov NIMH: Brian Albertini Grants Management Branch National Institute of Mental Health National Institutes of Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: 301-443-0004 Fax: 301-443-0219 Email: albertinib2@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions 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 IC 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: Kathleen Michels, Ph.D. Program Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: 301-435-6031 Fax: 301-402-0779 Email: michelsk@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Research Plan: o Page limits for the research plan (sections a-d): 15 pages o R21 Exploratory Grants need not include preliminary data although it is recommended that relevant data be included if it supports the proposed research. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grant applications. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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/label-bk.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 must be sent to: Alan L. Willard, Ph.D. Chief, Scientific Review Branch NINDS 6001 Executive Blvd, Room 3208 Rockville, MD 20852 (couriers) Bethesda, MD 20892-9529 (for US Mail) Telephone: 301-496-9223 Fax: 301-402-0182 Email: AW135Y@NIH.GOV APPLICATION PROCESSING: Applications must be received by 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINDS and the FIC. Incomplete applications will be returned to the applicant without further consideration 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 NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the Advisory Councils or Advisory Boards of the participating RFA sponsors. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge or impact health in the low- to middle-income country? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the Principal Investigator and to that of the other researchers? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: (6) INTERNATIONAL RESEARCH COLLABORATION: In the course of the research, what is the potential for sustainable collaborations between the developed and developing country scientists to be established or strengthened? What is the potential for the developing country institutions to improve their capacity and ability to address important issues in brain disorders research, develop independently-supported research and capacity development programs and obtain financial support nationally and internationally? How will this occur? (7) RESEARCH CAPACITY BUILDING: Does the proposed program contribute to the capacity of scientists and institutions in low- and middle-income nations to perform research on brain disorders across the lifespan? Does the proposed program contain explicit strategies or plans to strengthen this capacity through research training, career development, mentoring and other models? Will the proposed research and collaboration lead to enhancement of specific departments in foreign institutions and contribute to overall institutional excellence? (8) SPECIFIC R21 REVIEW CRITERIA: The potential of the proposed planning grant to lay the foundation for future collaborative research grant applications and the potential significance of the proposed research and capacity building will be major considerations in the evaluation of this R21 exploratory/developmental grant mechanism. Because this R21 is designed to support planning, development and initiation of innovative collaborative research and ideas, preliminary data as evidence of feasibility of the project are not required to apply although it is useful to include or cite pilot data where relevant and available. The applicant is, however, responsible for presenting the background literature that provides some basis for the approach and for developing a rigorous research plan. o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 11, 2003 Application Receipt Date: March 11, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 2003 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 (including geographic balance and programmatic interests of the sponsoring organizations) REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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. 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: FIC - No. 93.989, NIMH - 93.242 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of the Public Health Service Act, as amended (42 USC 241 and 287b) and administered under Public Health Service (PHS) grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.
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