Full Text PA-95-072 INTERNATIONAL RESEARCH ON THE EPIDEMIOLOGY OF DRUG ABUSE NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA NUMBER: PA-95-072 P.T. 34 Keywords: Drugs/Drug Abuse AIDS Epidemiology National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate international research on similarities and variations in drug abuse behaviors, factors influencing the initiation, progression, and cessation of drug abuse, and social and health consequences of drug abuse including HIV transmission. This program initiative expands and advances the study of the interrelationship of the agent, host, and environment to include environments across and within different countries. Increased understanding of the role of social, cultural, political and economic factors on drug abuse behaviors, obtained by examining configurations of these factors in varying national and regional environments, is sought. Comparative studies with U.S. populations are encouraged. HEALTHY 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, International Research on the Epidemiology of 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 or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the research project grant (R01), small grant (R03), and FIRST (R29) award. There are special requirements for the R03 and FIRST mechanisms. Applicants intending to apply for either of these mechanisms should contact the program person listed under INQUIRIES for further information. 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. Potential applicants should contact the program staff listed under INQUIRIES for further information. Research project grants (R01) provide support for up to five years for domestic grants and for domestic grants with foreign components; for research project grants to foreign institutions, the initial project period and each competitive segment thereafter may be awarded for up to three years. Small grants (R03) provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST awards (R29) provide support for five years and up to $350,000 in direct costs for the entire project period. RESEARCH OBJECTIVES Background and Significance Once considered an "American Disease," drug abuse is now recognized as a global problem that is having an increasingly negative impact on emerging as well as developing countries. The political and economic changes that have been taking place over the past 10 years have resulted in increases in cross-border and cross-national communication and commerce. These changes, in turn, have had a major impact on drug abuse, including manufacture and production, trafficking patterns, drug use patterns, and consequences. Political and economic conditions and events in other countries/regions often directly impact the U.S. population through large influxes of new populations. U.S. border populations are directly affected by public health issues, as well as economic and political conditions, in Mexico and Canada. Furthermore, there is increasing evidence that the U.S., once the trend-setter in emerging new drug abuse patterns, is becoming the recipient of such behaviors (e.g., the use of flunitrazepam (Rohypnol or "rophies") and drug use at "rave" scenes). These changing conditions, as well as the expanded knowledge base for understanding the dynamic nature of drug abuse and the increased sophistication of the methodological tools for conducting epidemiologic research, make this an opportune time for an international epidemiologic research initiative. Finally, cross-national studies offer opportunities to examine the direction and strength of interrelationships between agent, host, and environment in different cultural and political settings. The following definitions and examples may be used in conceptualizing research questions. "Nation" or "national" refers to a political state or country. "Cross-national" refers to two or more countries, not necessarily geographically proximate. "International" refers to that which transcends national limits; with regard to this program announcement, "international" studies could include single country projects focussed on research concepts of relevance to more than one country such as, for example, the impact of childhood traumatic experience on subsequent drug use, or could include projects examining research questions in two or more countries. "Border" refers to the geopolitical boundary between countries. Residents of border areas may constitute unique populations while having different national identities. For example, research in the area of the U.S. Mexico Border suggests that drug use patterns among populations on each side of the border are more similar to each other than either is to the U.S. or Mexican general populations. "Region" refers to a geographically circumscribed area including two or more proximate countries. Drug abuse patterns in a country may be influenced by factors such as drug production, trafficking, laws, enforcement, and political and economic instability in neighboring countries. Program Objectives The primary goal of this program announcement is to improve the knowledge base on the similarities and variations in drug using behaviors in different national and regional environments with the goal of gaining a better understanding of the influence of environmental factors including social, cultural, political, and economic variables on the initiation, progression, and cessation of drug using behavior and on the social and health consequences of the behaviors including HIV transmission. Very little drug abuse epidemiologic research has been conducted outside the U.S.; theoretical models and related epidemiologic research instruments pertaining to vulnerability, resiliency, drug use progression, and health and social consequences have primarily been based on research conducted in U.S. populations. Research on minority populations within the U.S. has revealed wide variation in patterns of drug use among different ethnic/racial sub-groups and has highlighted the influence of social, economic, and cultural variables on drug using behaviors. This program announcement encourages the use of international research to provide a broader context for the examination of social and cultural variables as well as the opportunity for assessing these variables in differing political and economic environments. Comparative studies with U.S. populations and the assessment of the cross-cultural applicability of theoretical models and epidemiologic instruments are encouraged. Studies are also sought that investigate mediating and protective factors and processes in populations with very low drug use where results could be used to help in the development of effective prevention methods that could be transferred or adapted to populations where drug abuse is more prevalent. Methodological studies assessing the impact of social, cultural, political, and economic factors on the accuracy, collection, and reporting of epidemiologic data are also encouraged under this program announcement. Studies should focus on hypothesis generation and testing. Quantitative and/or systematic qualitative methodological approaches may be used, as appropriate. All applications should address project feasibility, collaborative arrangements, study design, sampling procedures, instrumentation, measurement, data collection, quality control, follow-up, and data analysis, as appropriate. If research is to be conducted in two or more countries, applicants must address project implementation for each site and describe procedures to ensure data comparability across sites. Applications should also describe how the project presents special opportunities for furthering the field of drug abuse epidemiology through the use of unique resources, populations, or environmental conditions in other countries and explain how the project has the potential to advance knowledge in the field of drug abuse that will benefit the United States. Examples of areas of research interest include, but are not limited to, the following: o The influence of socioeconomic and political factors on the availability of illicit drugs, on patterns of drug use, and differences by gender. This includes the effect of cross-border free trade on illicit drug availability, perception of availability, and drug use patterns. Studies of drug use patterns and determinants along the U.S./Mexico and U.S./Canada borders are encouraged; o The impact of drug production and drug trafficking patterns and mechanisms on the spread of drugs between countries or regions and on the initiation of drug use in specific populations; o The extent to which cultural factors such as attitudes, beliefs, perceptions, norms, and religion determine or influence drug use patterns, description of the nature of these relationships, and assessment of differences by gender; o In countries where there is a tradition of a particular pattern of drug use (such as opium smoking among older men in Thailand or Laos), identification of factors that alter the nature and extent of such use (i.e., use documented among young men or women), and/or introduce new forms or types of drug use (e.g., heroin intravenous use); o For countries with several ethnic groups, description of the patterns of drug use among these groups and identification of the determinants of the behaviors; o Drug use patterns within special populations such as (1) refugee populations displaced by political instability, unrest, persecution, or war, (2) seasonal cross-national migrant workers, (3) homeless children, or (4) children working in the streets; o The impact of migration (rural to urban and cross-national) on drug use including the extent to which migration history (1st, 2nd and 3rd generation) or acculturation play a role in drug using patterns. With cross-national migration, comparison of patterns of drug use in country of origin with populations that migrated out of the country. Studies comparing drug use patterns, determinants, and consequences in U.S. ethnic minority populations with drug use patterns, determinants, and consequences in the country of origin are encouraged. Studies of mediating and protective factors in these populations are also encouraged; o Similarities and differences in the pathways and distal and proximal determinants for the initiation, progression and maintenance of comparable drug using behaviors across countries; o The impact of traumatic (political/economic/familial) childhood experiences on subsequent drug abuse and, among vulnerable populations, mediating factors that protect against initiation or progression of drug abuse; o The extent to which variations in modes of administration of drugs of abuse, such as heroin and cocaine, have differential physical, health, social and psychological consequences in different national environments; o The influence of social, cultural, political, and economic factors on the relationship between drug use and HIV transmission. How injecting practices and needle sharing behaviors differ among subgroups of drug users in different national environments; o How abusers with similar patterns of drug use and similar characteristics in different countries seek treatment for drug abuse and drug abuse consequences; o Cross-cultural validity of epidemiologic instruments; The impact of social, cultural, political, and economic factors on the accuracy, collection, and reporting of drug abuse epidemiologic data. Examples of possible variables include trust in government or authority, legal sanctions on behaviors, religious proscriptions pertaining to substance use, and social or religious barriers to accessing specific populations such as women or ethnic minorities. 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 below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted, in English, on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional business offices or from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 3032 - MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267. The title and number of the program announcement must be typed in Item 2a of face page of the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award 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/courier 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 established NIH referral guidelines. 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 and assigned a priority score and will receive a second level of review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; 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 provision of 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. 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 regarding the programmatic issues to: Moira O'Brien Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6637 Email: mobrien@aoada2.ssw.dhhs.gov Direct inquires regarding fiscal issues to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 4/94), which may be available from your office of sponsored research. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care of 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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