Full Text PA-95-059 LOCAL POPULATION/AREA EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-059 P.T. Keywords: National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research on the local population/area epidemiology of drug abuse and its correlates and consequences. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Local Population/Area Epidemiologic Research on Drug Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include research project grants (R01), small grants (R03), and First Independent Research and Transition (FIRST) (R29) awards. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. Small grants provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST awards provide support for five years and up to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES Background Many national-level drug abuse epidemiologic studies have been conducted to date, but at present, compelling public health needs have mandated the development of a coordinated program of research on the local-level population/area epidemiology of drug abuse and its correlates and consequences. Epidemiology, which is the study of disease/health problems within and across populations and across time, is both a method and a perspective that seeks to elucidate factors associated with the causes of the disease/health problems as well as with the progression of these problems and the variance in their clinical manifestation. These factors and their relationships form "webs of causation," which need to be scrutinized through a mix of epidemiologic research approaches. In this respect, the need for epidemiologic studies of local populations to determine underlying connections between drug abuse, infectious diseases, and violence and accidents was recognized at the recent (Nov 1994) White House Conference on Health, Safety, and Food. Various forms of local-level drug abuse epidemiologic research have been undertaken in the past but rarely in a manner that coordinated both quantitative (e.g., probability-based surveys) and qualitative (e.g., "trained observational") approaches so as to maximize both their unique contributions and their complementary/combined or synergistic potential. This program announcement encourages such coordination. Additionally, while the major focus of this program announcement is on local drug abuse epidemiology, attention is encouraged on closer coordination of epidemiology with, thus helping to guide, prevention planning. Such coordination has not been undertaken on a wide scale and particularly with applicability for meeting local-level public health needs. Local-level applications of epidemiology together with prevention will help to meet national-level public health needs. "Local" in this case refers to the state level down to the community level. Community can be defined in census tract, mental health catchment area and other geographic terms, as well as by demographic terms, including cultural/racial groupings in defined local areas (e.g., Hispanic or African American clusters in cities) and in undefined geographic areas (e.g., Native Alaskan communities). Community can also include groups designated by sexual orientation (e.g., gays) in local geographic settings and also by numerous other definitions. Other terms for community include but are not limited to "street-level," and "neighborhood." The direction towards local population/area research, coupled with better coordinated quantitative and qualitative research approaches and with epidemiology more closely allied with and helping to direct the dispersal of prevention resources, is important now as never before, especially considering the public health prominence of drug abuse and related correlates and consequences such as AIDS. This direction is also important because, in an era of both pressing public health needs and major budget constraints, resource distribution needs to be guided more efficiently. Investigators are encouraged to build on existing locally-based initiatives such as the Community Epidemiology Work Group (CEWG) sites, Drug Use Forecasting (DUF) sites, Center for Substance Abuse Prevention (CSAP)-funded Community Coalitions, and AIDS outreach community systems. Program Description Two areas of research are sought through this program announcement. These areas include methodological and content research as applied to the local population/area epidemiology of drug abuse and its associated problems. Examples of the research areas to be addressed are provided below. Research Areas: Methodology and Content Applications are encouraged that focus on methodological research dealing with improving our means (e.g., cross-sectional versus longitudinal survey approaches) for determining the epidemiology of local-level drug abuse and related problems. Applications are also encouraged that concern "content" or the determination of specific epidemiologic patterns of local drug abuse and associated problems (e.g., transitions from non-injecting to injecting drug use and vice versa among African Americans, Hispanics, and whites in designated inner city areas; implications for the spread of HIV or violence and crime). The areas of methodology and content are not meant to be mutually exclusive, however, and creative applications are encouraged that address in a coordinated manner the need for better information in both areas. Additionally, methodological and/or content studies are encouraged that strengthen bridge-building and coordination between local population/area epidemiology and prevention. Such enhanced coordination, particularly in light of special public health problems such as drug abuse's high association with AIDS and violence, is of great importance. Researchers are thus encouraged to test new methods or new combinations of methods that meet the need for greater understanding the epidemiology of these problems and their interrelationships at the local level and with attention paid to how epidemiology may guide prevention. The following are intended as examples of areas of research interest: Methodology o Refine and strengthen the procedures and parameters for both determining and predicting local population/area drug abuse epidemiology. o Refine our understanding of the strengths and weaknesses of quantitative and qualitative research methodologies. a. Clarify the appropriateness and applications of quantitative methods to provide accurate incidence, prevalence, trend, and predictive estimates of local population/area drug abuse and its correlates and consequences. b. Clarify the appropriateness and applications of qualitative methods, both to provide 1. an in-depth knowledge of behavior (e.g., quantitative surveys have looked at needle sharing behavior among drug users but apparently have ignored and/or been unable to obtain information on needle sharing between drug users and their sexual partners; this is the kind of difficult-to-obtain information necessary for understanding local drug use patterns that can be provided through qualitative methods); and 2. a critical bridgehead into local populations/areas that can then be exploited by quantitative methods (e.g., the original NIDA-supported R01 AIDS outreach research that combined qualitative and quantitative methods to develop epidemiologically-targeted and assessed prevention). o Issues of research design, dealing with cross-sectional versus longitudinal approaches for local-level drug abuse epidemiologic research should be explored. o In both quantitative and qualitative research methodologies, issues of precision, reliability, and validity of measures (e.g., self-report) should be explored. o In methodological research on both quantitative and qualitative approaches, special emphasis should be placed on how to accurately determine race, gender, socio-economic status, community, culture, and other social and structural variables associated singly or in combination (e.g., "webs of causation") with the epidemiology of drug abuse and its correlates and consequences at the local level. Special research emphasis should be placed on women, minorities, and youth. o The use of alternative/complementary measures (e.g., "molecular epidemiology": polymerase chain reaction (PCR), which enables us to determine needle sharing behavior and HIV status independent of, and confirmatory to, self report) and their application to local drug abuse epidemiology should be explored. o Methodological studies are needed that investigate both separate use and integration of such various data elements as a. indicator data, including: data from direct measurement (e.g., blood and urine samples, psychological exams), data from indirect measurement (e.g., "ecological" indicators--census and vital statistics data) b. observational data (e.g., ethnographic studies) c. survey data d. modeling data, which can integrate indicator, observational, and survey data. o Methodological studies should be conducted to develop instruments that are comparable between areas and between populations. Geographic and demographic comparability is essential for the efficacious and equitable allocation (i.e., targeting) of prevention resources to local areas and populations. o Methodological studies should be conducted to specifically address the issue of human subjects protection. This is no small issue but, indeed, grows bigger as the defined area and/or population grow smaller. Drug abuse, itself, and related problems such as AIDS carry serious social stigma. The more delimited the geographic area and/or demographic group, the greater risk of serious leaks of personal information and compromise of human subjects protection agreements. Such leaks can happen directly, as in the case of an acquaintance of a drug user seeing them go into a test site. Leaks can happen indirectly, as in the case of rural drug abuse and AIDS in a southern state, where, because of the public publication of vital statistics data, direct pin-pointing of HIV positive drug users in small communities was undertaken by non-public health persons. Content o Describe incidence, prevalence, trends and predictions of drug abuse patterns and related problems (e.g., HIV, crime, violence) and associated high-risk behavior (e.g., needle sharing, sex for crack), in local populations and areas. o Explore different forms of local drug use (e.g., non-injecting, injecting) and the dynamics contributing to the prevalence of one form versus the other, the transition/evolution from one form to another, and the cessation of drug use (e.g., through death, treatment, prevention, "natural recovery"). Special emphasis should be placed on determining not only risk factors for various forms of drug use but protective factors as well. o Identify situational factors (e.g., shooting galleries, crack houses, economically depressed areas, prisons, migrant camps) that contribute to varying patterns of local drug use and associated problems. o Delineate the role of social and structural factors (e.g., community, culture, socio-economic status, race, gender), separately or in combination (e.g., "webs of causation") in the epidemiology of local drug use and its correlates and consequences. o Specify the role of cognitive processes (e.g., decision making) in local drug use and associated risk taking. o Identify the role of economic forces (e.g., "supply" and "demand"), and social and political forces (e.g., strong grass roots and governmental opposition to the drug trade and drug use) in local drug use epidemiology. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, telephone 301/710-0267. The title and number of the program announcement must be typed in Section 2a on the face page of the application. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710* Bethesda, MD 20817 (for express/overnight delivery service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Small grants (R03) do not receive a second level review. Review Criteria o Scientific or technical significance and originality of the proposed research; o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff; o Availability of resources necessary to the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIDA. The following will be considered in making funding decisions: quality of the proposed project as determined by the peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries on the scientific and programmatic aspects to: Peter Hartsock, Dr.P.H. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6720 Email: ph45z@nih.gov Direct inquiries regarding fiscal matters related to drug abuse relevant studies to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada2.ssw.dhhs.gov AUTHORITIES AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistant No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Grants must be administered in accordance with the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 4/94). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing 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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