STIGMA AND GLOBAL HEALTH RESEARCH PROGRAM RELEASE DATE: June 20, 2002 RFA: TW-03-001 PARTICIPATING INSTITUTES AND CENTERS (ICs): Fogarty International Center (FIC) (http://www.nih.gov/fic/) Health Research Services Administration (HRSA) (http://www.hrsa.gov) National Center on Minority Health and Health Disparities (NCHMD) (http://ncmhd.nih.gov/) National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/default.htm) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.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/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) Office of AIDS Research (OAR)/ NIH Office of the Director (http://www.nih.gov/od/oar/) Office of Behavioral and Social Science Research (OBSSR)/ NIH Office of the Director (http://obssr.od.nih.gov/) Office of Research on Women"s Health (ORWH)/ NIH Office of the Director (http://www4.od.nih.gov/orwh/) Canadian Institutes of Health Research (CIHR)/Institute of Neurosciences, Mental Health and Addiction (INMHA) with the International Development Research Centre (IDRC) (http://www.cihr.ca/, http://www.idrc.ca/) LETTER OF INTENT RECEIPT DATE: October 14, 2002 APPLICATION RECEIPT DATE: November 14, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this initiative is to stimulate investigator-initiated research on the role of stigma in health, and on how to intervene to prevent or mitigate its negative effects on the health and welfare of individuals, groups and societies world-wide. Collaborative interdisciplinary applications are particularly encouraged. The following Institutes and Centers from the U.S. Department of Health and Human Services (DHHS): the Health Research Services Administration (HRSA), the NIH including: the Fogarty International Center (FIC), National Center on Minority Health and Health Disparities (NCHMD), National Institute of Neurological Disorders and Stroke (NINDS), National Human Genome Research Institute (NHGRI), National Institute of Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Office of AIDS Research, Office of Behavioral and Social Science Research (OBSSR), Office of Research on Women"s Health (ORWH), and the Canadian Institutes of Health Research (CIHR), seek domestic and international applications which address stigma-related issues, across a variety of global public health problems, among individuals and in society. Relevant issues include: 1. How stigma and its consequences, such as discrimination affect health (e.g. through physical and psychological abuse, denial of economic opportunities, poor provision and seeking of health care), 2. How stigma associated with specific health conditions interacts with stigma associated with individual or group characteristics (such as gender, race, religion, sexual orientation and nationality), 3. How to prevent and mitigate the negative effects of stigma and discrimination on health and health care, 4. Development of quantitative and qualitative methods and techniques to investigate, measure and analyze the extent, degree and effects of stigma and the effectiveness of current and new interventions, 5. Examination of the cultural, social, political and economic dimensions of stigma and its manifestations, 6. Methods and safeguards to ensure safety of vulnerable research subjects. Such research, which may range from basic to clinical and operational, requires expertise across a broad range of bio-medical, social and behavioral science fields. The participants in this RFA therefore encourage interdisciplinary, domestic and international collaboration to build the scientific foundation of stigma research related to health. Meritorious applications must also be relevant to the mission and interests of one or more of the participating Institutes or Centers. This RFA is based on recommendations developed in conjunction with the NIH sponsored International Conference on Stigma and Global Health: Developing a Research Agenda, September 5-7, 2001, Bethesda, MD. Applicants are encouraged to refer to the stigma conference website (www.stigmaconference.nih.gov) for extensive information related to the topic of this RFA including the agenda with links to speaker abstracts, commissioned background papers and a video-cast of the conference. RESEARCH OBJECTIVES The objectives of this initiative are to encourage research across a variety of scientific disciplines including the biomedical, social and behavioral sciences, to elucidate the etiology of stigma in relation to public health as well as to develop and test interventions to mitigate the negative effects of stigma on health outcomes. Studies may examine stigma and public health in domestic, international and cross-cultural contexts, with an emphasis on studies that are relevant to global health issues. Applicants are encouraged to undertake interdisciplinary studies, where possible, using behavioral, social and biomedical science approaches. The initiative is also designed to attract investigators across a broad range of biomedical and non-biomedical fields, including but not limited to anthropology, epidemiology, infectious and non-infectious diseases, geography, sociology, psychology, psychiatry, neuroscience, law, genetics, ethics, economics, political science, biostatistics, evaluation and others. Background According to a seminal work by sociologist Erving Goffman (1963 "Stigma: Notes on the Management of Spoiled Identity") a stigma is an attribute that — according to prevailing societal attitudes - is deeply discrediting and reduces a person to one who is in some way tainted and can therefore be denigrated. Individuals may internalize the stigmas applied to them by others. Researchers, therefore, differentiate between the "felt" stigma a person perceives and "enacted" stigma, which refers to actions upon the individual expressed through various forms of discrimination. Stigma, when applied to health conditions, is a globally pervasive problem threatening psychological and physical health at the individual and group level. Stigma helps to perpetuate health inequalities. The poor treatment of an individual because of the stigma of the condition itself, or of another aspect of that individual"s being or position in society (such as gender, race, sexual orientation or socio-economic status), leads to poor outcomes and perpetuates other adverse health, social and economic consequences for the individual, their families and communities. Felt stigma prevents individuals from coming forward for timely diagnosis and treatment and impairs their ability for self-care, to access care or to participate in research studies designed to find solutions. Enacted stigma perpetuates public health problems and prevents societies from appropriately addressing health care issues at the community and national levels with the appropriate delivery, funding and support of research, health care services and legal and educational interventions. Many diseases and conditions, which persist or worsen if left untreated, affect a person"s ability to fulfill necessary, culturally expected and economically productive roles in society. The burden of their continued care may then fall upon families and communities lacking adequate resources or support. For this reason, stigma and discrimination may greatly magnify the social and economic, as well as personal consequences of such diseases and conditions, often well beyond their prevalence in the population. In the case of infectious disease (for example, sexually transmitted diseases), stigma and discrimination related to the mode of transmission and preexisting attitudes towards some affected individuals can lead to fear of disclosure, inadequate and inappropriate treatment of all affected, and the further spread of a disease which might otherwise be contained. The effects on individuals, families, communities and nations can be devastating, as illustrated by the HIV/AIDS epidemic, particularly in Sub-Saharan Africa. The disability and loss of productivity due to treatable mental illnesses and neurological disorders (such as depression, schizophrenia, epilepsy, movement disorders, substance abuse disorders, mental retardation and cerebral palsy), when inadequately treated due to stigma and discrimination, contribute greatly to the burden of illness on societies around the world (for more information please see the "World Health report 2001: Mental Health-New Understanding, New Hope" and the Institute of Medicine report on "Neurological, Psychiatric and Developmental Disorders: meeting the Challenge of the Developing World", 2001, available at http://books.nap.edu/books/0309071925/html/). The same is true of other physical and developmental health conditions (including those which are disfiguring such as craniofacial disorders, and those that are physically disabling, such as spinal cord injury leading to paralysis) which if treated, mitigated or accommodated need not serve as barriers to full and productive lives. Yet stigma and discrimination often prevent the necessary societal action to treat, research and accommodate such conditions. Other public health problems, such as domestic violence and abuse, when ignored because of the associated stigma, perpetuate the same problems in individuals and across generations, along with other, often stigmatized health problems such as mental illnesses, drug and alcohol addiction and abuse. To have an impact, research on stigma-related health problems requires the participation of investigators across a broad range of biomedical and non- biomedical fields. Interdisciplinary studies are needed which use current behavioral, social and biomedical approaches to elucidate the etiology of stigma in relation to health as well as develop and test interventions to mitigate the negative effects of stigma on health outcomes. Finally, researchers must better understand the policy-making process so they can work to ensure that research results have an impact. Understanding the causes, consequences and effective interventions for stigma-related issues and problems has the potential to significantly improve treatment and care particularly for public health problems of global importance. In the same way that the effects of stigma magnify the personal and societal problems related to such diseases and disorders, preventing or mitigating stigma and its effects can profoundly improve the lives of individuals and, by extension, their families and the larger society. The public health community has demonstrated increasing awareness of the role of stigma in many diseases and disorders. Recent conferences have focused on the role of stigma in mental illnesses including depression and schizophrenia, HIV/AIDS and epilepsy. These conferences were convened by organizations including the Health and Development Networks with UNAIDS, the United States Substance Abuse and Mental Health Services Administration, the World Health Organization, and the World Psychiatric Association. This RFA is informed as well by the recent U.S. National Institutes of Health International Conference on Stigma and Global Health: Developing a Research Agenda (www.stigmaconference.nih.gov). This conference was convened by the Fogarty International Center of the NIH in partnership with various other NIH institutes and offices along with other U.S. agencies, and domestic and international organizations. More than 250 participants from 30 nations, including 23 developing countries, discussed stigma associated with a variety of illnesses and conditions including HIV/AIDS, mental health, epilepsy, physical anomalies, alcohol and drug abuse, physical and sexual abuse, genetics, race and gender. Scientists and other experts encompassing the health, social and behavioral sciences, media, law, politics and economics focused on stigma as it relates to global public health. They examined both what is known about the causes and consequences of stigma and what can be done to prevent or minimize its negative effects on the health of individuals and societies. One outcome of the conference was a set of research recommendations for stigma and its relationship to a variety of global public health problems. The recommendations include research to: o Further elucidate the etiology of stigma, o Investigate the health consequences of stigma, o Develop methodology for studying stigma with respect to health, o Evaluate and develop new effective interventions to deal with stigma, o Lay the groundwork for guidelines on ethical conduct of studies on stigmatized individuals and groups who may face further negative effects, including physical violence or social isolation, because of their participation in such studies. Research Topics Studies of stigma are encouraged across physical and mental health conditions (including addictions), care settings, groups, outcomes and interventions, including research on the social, economic, cultural and political factors in both creating and intervening in stigmatization of health conditions. This RFA encourages interdisciplinary studies throughout whenever appropriate to the research question. Ethnographic and other areas of social science research in particular will be necessary to fully understand the role of stigma within a given society or group and to design appropriate interventions. The ways stigma is applied, perceived and measured in other cultures are relevant avenues of inquiry and ethnographic and comparative studies are encouraged alone or as components of other studies. Other relevant research topics include but are not limited to the following: 1. The role of stigma in specific public health problems, diseases or disorders, and its implications for issues from etiology to interventions and public policy, 2. The implications of stigma for access to care and treatment, and how stigma affects outcomes across health conditions, 3. Systematic studies to determine psychological, social, economic, cultural and political factors that operate in the creation of stigma and how they link to stereotypes, discrimination and mistreatment in the context of health problems and health care systems, 4. Approaches to ensure that medical advances, which can be used to treat or prevent stigmatized conditions, effectively reach appropriate populations, 5. Development of tools to study and document stigma and its impact on accurate determination of incidence and prevalence of health conditions, and to estimate the risk for over- or under-diagnosis as a result of stigma- related influences, 6. Evaluation of which interventions work for stigma-related health problems, the characteristics of successful interventions, demonstration of successful interventions that can be scaled up or generalized to other stigmatized public health problems and/or to other populations and cultures, 7.The role of stigma in provision of health care including, quality and extent of available treatment and care, the quality of the patient/health care practitioner relationship, the role of the provider"s attitude in perpetuating stigma and the role of stigma in disclosure of disease status during medical visits, 8. The role of disclosure of disease in an individuals" personal or professional life and its relationship to perceived stigma, 9. Identification of methods to minimize (or eliminate) the consequences of stigma/stigmatization on the recognition and diagnosis of health conditions and on options for treatment and/or rehabilitation, 10. Social, cultural and environmental influences on perceptions of and reactions to stigma/discrimination among individuals, families and communities, and on the resources available for coping with or ameliorating its negative health consequences, 11. The interaction of social systems including gender, culture, politics, economics and the law in creating stigmas and the examination of the interplay between different kinds of stigmas as well as the combined impact on individuals, families, and groups, 12. The involvement of social, political, economic and legal systems in creating appropriate, effective and culturally sensitive interventions to combat stigma and the negative effects of stigma, 13. The actual and potential roles of media in creating, disseminating and intervening in stigma-related attitudes and actions, 14. The relationship between attributions about the causes/etiologies of particular diseases and disorders and the degree to which those with, or at risk for, the disorder are stigmatized. For example: does the public view a disease or disorder as more or less stigmatizing when it may be associated with a specific genetic predisposition, is this perception different for different diseases and disorders, for example diseases such as cancer, neurological and neuropsychiatric disorders such as epilepsy, movement disorders, schizophrenia and bipolar disorder, or conditions in which there is a clear behavioral component (e.g. drug abuse, obesity)? Specific Research Areas of Interest to Stigma and Global Health RFA Sponsors: The FIC is interested in applications on stigma and health topics relevant to and involving low to middle income countries of the developing world. Special consideration will be given to meritorious interdisciplinary applications from, or in collaboration with, developing country investigators. NCMHD would like to encourage applications that have minority health or health disparity focus. NIAAA is interested in supporting applications that address the association of stigma with the detection, prevention and treatment of alcohol use disorders. Of particular interest are applications that address alcohol abuse and addiction in populations that bear a greater burden of stigma (i.e. pregnant women) and alcohol related birth defects (such as Fetal Alcohol Syndrome). Applications that address the stigma associated with alcohol and other health conditions, such as HIV AIDS, will also be considered. Studies on the role of stigma in the development of alcohol-related policies and the delivery of services are also encouraged. NIAID encourages applications addressing the impact of stigma on control and treatment of infectious diseases. Of particular interest is research to develop and evaluate strategies to prevent or minimize the negative physical, cognitive, and social consequences of HIV infection, including the stigmatization of persons with or at risk for HIV infection. NIAID is particularly interested in applications with an international/developing country focus. NIDA is interested in supporting applications that address the causes and consequences of stigma in drug abusing and addicted individuals and populations, including the impact on stigma on the availability and provision of treatment and prevention services. Studies on interventions directed at reducing stigma in these populations are encouraged as well. NIDCR is interested in supporting research to identify, prevent, or ameliorate consequences of stigma related to socially perceived variations or changes in orofacial appearance or function. Such changes may, for example, result from orofacial injuries or from congenital craniofacial anomalies, such as cleft lip and palate, disfiguring infectious diseases such as noma, oral facial cancers or ablative cancer surgeries affecting orofacial structures, edentulousness, malocclusion, or other orofacial diseases/ conditions. NHGRI would like to encourage applications on stigma-related issues related to genetic disorders. NIMH encourages research on stigma related to neuropsychiatric disorders and research on AIDS stigma and prevention of HIV transmission and its consequences including descriptive cross-sectional studies of stigma, longitudinal research studies and intervention studies. NINDS encourages research on stigma related problems 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. OAR is interested in supporting applications that address the role of stigma and discrimination in the HIV/AIDS pandemic. This includes basic research on the causes and consequences of HIV/AIDS-associated stigma and discrimination, as well as intervention research to ameliorate them. ORWH would like to encourage applications, across the spectrum of possible research topics, which include in the research design scientific analyses aimed at delineating sex/gender differences. The results of such analyses are expected to be particularly important when designing and testing appropriate interventions to have the best possible outcomes. The HIV/AIDS Bureau, HRSA, is interested in supporting the evaluation of interventions to reduce stigma as a barrier to the care and treatment of those living with HIV/AIDS. Examples of potential interventions include training of health care providers, community involvement in HIV program planning, and the inclusion of people living with HIV/AIDS in program planning and as staff or volunteers in care and support programs. Programs that tie decreases in stigma to increased access to care and improved quality of care are of particular interest. The Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) is interested in supporting applications from Canadians or, in collaboration with the Canadian International Development Research Center (IDRC), in co-sponsoring proposals originating in and responding to priorities of developing countries and with a Canadian component. Eligible applications for CIHR/INMHA include those dealing with research on stigma related to neurological disorders, mental illnesses and addictions which are aimed at finding innovative, effective and evidence-based means to reduce discrimination, improve access to services and to raise public awareness through education. Contact the representatives of the participating Agencies, Institutes or Centers (ICs) listed in the "Where to Send Inquiries" section of this RFA or visit individual Agency and IC websites for more information about topics of interest to each. Additional research questions and other information of specific interest to individual participating Agencies and ICs in the context of this RFA can be found at: http://www.nih.gov/fic/programs/stigma.html. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the developmental/exploratory grant (R21) award mechanisms. Note that the R21 mechanism is specifically intended to support innovative ideas 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 and strengthening future research project grant applications (R01). This RFA also uses just-in-time concepts and the modular grant format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format (modules of $25,000). Otherwise follow the instructions for non-modular research grant 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. This RFA is issued for fiscal year (FY) 2003 and the anticipated award start date is July 2003. Applications submitted in response to this RFA may have a project period of up to five years for R01 and up to three years for R21 grant applications. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. At this time, it is not known if this RFA will be reissued. Any future unsolicited competing continuation applications based on this project may compete with all NIH investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The participating ICs intend to commit approximately $2.5 million in FY 2003 to fund up to 12 new competitive grants in response to this RFA. R21 grant applicants may request a project period of up to three years with a total direct cost of $100,000 per year. R01 grant applicants may request a project period of up to five years. An applicant may request a budget up to 1) $500,000 direct costs per year for applications in which comparative or intervention studies at two or more international sites are planned, and which involve an international team of investigators. No one site may be allocated more that half the budget. 2) $200,000 direct costs per year for all other projects (i.e. those that will take place only in a single country, do not propose comparative or intervention studies, do not involve an international collaboration). 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, with multidisciplinary collaborative, international applications requiring more funding and time. Although the financial plans of the IC(s) 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. Each award will be administered by one of the participating NIH ICs or other participating agencies although several may participate in funding of any given application. The Canadian Institute for Health Research (CIHR) along with the Canadian International Development Research Centre (IDRC) will consider meritorious applications, relevant to their missions, from Canadian applicant institutions. CIHR will make the award of grants for meritorious applications of interest to them. Applicants who wish to have their projects considered for funding by CIHR should include with their application a letter stating that their application and summary statement may be shared with CIHR and IDRC. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is in one of the following categories: 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 Agencies of the Federal government o Domestic or foreign institutions or organizations o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Two meetings of grantees of these awards will be held in the Washington, D.C. area (one in the second year and one in the fourth year of the grant period) to share information and discuss new insights on stigma and health, in particular, stigma intervention strategies. For these meetings, funds should be budgeted for travel by the PI and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. o 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 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-435-6031 Fax: 301-402-0779 Email: Michelsk@nih.gov o Direct your questions about SCIENTIFIC/RESEARCH ISSUES to the contacts below (additional specific research questions of interest to participating ICs can be found in the "Research Topics" section of this RFA and at http://www.nih.gov/fic/programs/stigma.html): CANADA: CANADIAN INSTITUTES OF HEALTH RESEARCH and INTERNATIONAL DEVELOPMENT RESEARCH CENTER 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 UNITED STATES: HEALTH RESOURCES AND SERVICES ADMINISTRATION Laura Cheever, M.D., Sc.M. Chief, HIV Education Branch Health Resources and Services Administration Parklawn Building, Room 7-29 5600 Fishers Lane Rockville, MD 20857 Telephone: 301-443-3067 Fax: 301-443-9887 Email: LCheever@HRSA.gov NATIONAL INSTITUTES OF HEALTH: FOGARTY INTERNATIONAL CENTER Kathleen Michels, Ph.D. Program Director Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892 Telephone: 301-435-6031 Fax: 301-402-0779 Email: Michelsk@nih.gov NATIONAL HUMAN GENOME RESEARCH INSTITUTE Jean E. McEwen, J.D., Ph.D. Program Director Ethical, Legal, and Social Implications Program National Human Genome Research Institute National Institutes of Health Building 31, Room B2B07 31 Center Drive, MSC 4997 Bethesda, MD 20892-2033 Telephone: 301-402-4997 Fax: 301-402-1950 Email: jm522n@nih.gov NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM 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 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES Rodney Hoff, D.Sc., MPH Vaccine and Prevention Research Program Division of AIDS, NIAID/NIH 6700B Rockledge, Room 4157, MSC 7620 Bethesda, MD 20892-7620 Telephone: 301 496 6179 Email: rh25v@nih.gov NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH Patricia S. Bryant, Ph.D. Director, Behavioral and Social Science Research Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN24E, MSC 6402 Bethesda, MD 20892-6402 Telephone: 301-594-2095 Fax: 301-480-8318 Email: BryantP@de45.nidr.nih.gov NATIONAL INSTITUTE ON DRUG ABUSE 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 Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892 Telephone: 301-435-1322 Fax: 301-594-6043 Email: mlynch1@nida.nih.gov Leslie C. Cooper, Ph.D., M.P.H.,B.S.N.,R.N. Research Program Director for the Epidemiology, Etiology and Consequences of Drug Abuse in Special Populations and Health Disparities. Captain/USPHSCC Nurse Epidemiologist NIH/NIDA/DESPR 6001 Executive Boulevard, Room 5167, MSV 9589 Bethesda, MD 20892-9589 Telephone: 301-402-1906 Fax: 301-480-2543 Email: lc58q@nih.gov NATIONAL INSTITUTE OF MENTAL HEALTH Emeline Otey, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6186, MSC 9625 Bethesda, MD 20892-9625 Telephone: 301-443-1636 Fax: 301-443-4611 Email: eotey@nih.gov Christopher M. Gordon, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6204, MSC 9619 Bethesda, MD 20892-9619 Telephone: 301-443-1613 Email: cgordon1@mail.nih.gov NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE Margaret P. Jacobs Program Director, Epilepsy Research National Institute of Neurological Disorders and Stroke, NIH Neuroscience Center 6001 Executive Boulevard, Room 2138, MSC 9523 Bethesda, MD 20892-9523 Telephone: 301-496-1917 Fax: 301-480-2424 Email: mj22o@nih.gov OFFICE OF THE DIRECTOR, NIH: OFFICE OF AIDS RESEARCH Paul A. Gaist, Ph.D., M.P.H. Health Scientist Administrator Office of AIDS Research Office of the Director National Institutes of Health Building 31, Room 4C06 31 Center Drive Bethesda,MD 20892 Telephone: 301-402-3555 Fax: 301-496-4843 E-mail: gaistp@nih.gov OFFICE OF RESEARCH ON WOMEN"S HEALTH Joyce Rudick Director, Programs and Management Building 1, Room 201 9000 Rockville Pike, MSC 0161 Bethesda, MD 20892-0161 Telephone: 301-402-1770 Fax: 301-402-1798 Email: Joyce_Rudick@nih.gov o Direct your questions about peer review issues to: Mariela C. Shirley, Ph.D. Risk, Prevention, and Health Behavior IRG Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1102, MSC 7848 Bethesda, MD 20892-7848 Bethesda, MD 20817 (For express/courier service) Telephone: 301-435-3554 Fax: 301-480-3962 Email: Shirleym@csr.nih.gov o Direct your questions about financial or grants management matters to: FOGARTY INTERNATIONAL CENTER Bruce Butrum Grants Management Officer Grants Office Fogarty International Center Building 31, Room B2C29 31 Center Drive,MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-496-1670 Fax: 301-402-0779 Email: butrumb@mail.nih.gov NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44K, MSC 6402 Bethesda, MD 20892-6402 Telephone: 301-594-2904 Fax: 301-480-8303 Email: George.Hausch@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 Building 31, Room B2C39 31 Center Drive, MSC 2220 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: Description section: If a country other than the home country of the applicant institution is involved in the application, please include the name of the other country or countries in your description. Canadian Applicants: Applicants who wish to have their projects considered for funding by CIHR and IDRC must include with their application a letter stating that their application and summary statement should be shared with CIHR and IDRC. R21 applications: limit of 20 pages for the Research Plan (sections a-d). 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 grants. 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 four 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, one additional copy of the application must be sent to: Kathleen Michels, Ph.D. Program Director Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Phone: 301-435-6031 Fax: 301-402-0779 Email: Michelsk@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 participating Institutes and Centers. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o May 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 National Advisory Council of the relevant participating IC or Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to 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 high 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 related to stigma and health? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do your project use multidisciplinary tools, techniques and expertise to address stigma and health at various levels? (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 other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o SPECIFIC R21 REVIEW CRITERIA: Innovation of the project and potential significance of the proposed research will be the major considerations in the evaluation of the R21 exploratory grant mechanism. Because the R21 is designed to support innovative ideas, preliminary data as evidence of feasibility of the project are not required. However, the applicant is also responsible for presenting the background literature that provides some basis for the approach and for developing a rigorous research plan. Relevant pilot data should be cited when available. 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: October 14, 2002 Application Receipt Date: November 14, 2002 Peer Review Date: February 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 1, 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 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. 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 No. 93.989. Awards are made under authorization of sections 301 and 405 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 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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