Full Text PA-93-47 PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-47 P.T. 34, FF Keywords: Alcohol/Alcoholism Social Psychology Risk Factors/Analysis National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications related to the prevention of alcohol-related problems among ethnic minority groups of African Americans, Americans, Asian Americans, and Pacific Islanders. Most of these groups are at elevated risk for specific alcohol problems or may have changing patterns of increased alcohol consumption. All of these minority groups require the development and evaluation of culturally relevant programs of alcohol abuse prevention. NIAAA promotes innovative prevention research within a broad range of populations and is particularly interested in receiving methodologically sound and conceptually grounded outcome-oriented research applications. The primary objective of this program announcement is to expand the limited information available about the prevention of alcohol-related problems among ethnic minorities . While differential rates of alcohol problems have been well documented within minority communities, the link between ethnic identity and successful alcohol abuse prevention interventions has not. Research proposed within the domain of this program announcement should address factors that facilitate or impede the development, implementation, and evaluation of prevention strategies among diverse sociocultural populations. Attention should be focused on (1) the culturally-appropriate development or adaptation of interventions within these minority settings and (2) how ethnic minority identity relates to prevention research outcomes. In general, the impact of ethnicity on alcohol use and prevention of its abuse should be studied within a particular context, such as, alcohol availability control, server training, price increases, media messages, or psychosocial antecedents of high-risk behavior. 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, Preventing Alcohol-Related Problems Among Ethnic Minorities, is related to the priority area of alcohol abuse reduction. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (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 Applications may be submitted by domestic and foreign public and private non-profit and for-profit organizations, such as, universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01), small grant (R03), or FIRST award (R29). Applicants for R01s may request support for up to five years. The average direct cost per year for R01s is approximately $220,000. Small Grants are limited to two years for up to $50,000 per year for direct costs. FIRST award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST awards and small grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Annual continuation awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background Information on Alcohol-Related Problems and Use Among Ethnic Minorities In the United States, alcohol use is involved in nearly 100,000 deaths annually, including approximately one-half of the nearly 45,000 fatalities in traffic crashes; 27,000 deaths due to cirrhosis of the liver; and a high proportion of the deaths due to homicide, suicide, drowning, falls, burns, and other accidents. Alcohol abuse results in alcohol-related injuries and violence, marital discord, job loss, and serious medical consequences including birth defects. Alcohol-related problems and costs are unevenly distributed across racial and ethnic groups this uneven distribution may be related to cultural differences in drinking patterns. Surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among African Americans, Hispanic Americans, and Native Americans. In contrast, Asian Americans and Pacific Islanders have been found to have lower levels of alcohol use. However, recent evidence indicates that consumption may be increasing among these two groups. African Americans Alcohol-related Problems: African Americans comprise the largest ethnic minority in the United States, accounting for 12 percent of the total population. Results of a 1983 national study of drinking problems and patterns found that African Americans, especially males, are at high risk for acute and chronic alcohol-related diseases; such as, cirrhosis, alcoholic fatty liver, hepatitis, heart disease, and cancers of the mouth, larynx, tongue, esophagus, and lung. High rates of problem drinking and alcoholism in high-density, urban African American communities have been associated with assaults, homicides, accidents, trouble with the law, and family problems. Several studies have concluded that African Americans are at greater risk of accidents due to drinking than Caucasians. Patterns of Consumption: While overall rates of alcohol consumption are similar for African American males and Caucasian males, the two groups differ with respect to the age distribution of drinking and related problems. Among Caucasian males, frequent heavy drinking is most prevalent between 18 and 29 years of age; among African American males in that age group, heavy drinking is less frequent. Between 30 and 39, the rates of heavy consumption continue to be high for Caucasian males; however those of African American males rise sharply, surpassing those of Caucasians. Rates of heavy consumption gradually decrease for men of both races after 40. Racial differences in consumption patterns are even more pronounced among women, but in the opposite direction: i.e., African American women tend to drink less. Nearly half of African American women were found to be abstainers, compared with one-third of Caucasian women. A smaller proportion of African American women than Caucasian women are heavy drinkers. African American women in the 18-29 age group are significantly less likely to drink at all or to drink heavily than are Caucasian women. Prevention Research: An intensive search of the prevention research literature identified a number of primary and secondary prevention efforts focused on alcohol-related problems in the African American population of the United States, but none reported a systematic evaluation of program effects. Among the 130 demonstration projects initiated by the Office for Substance Abuse Prevention (OSAP) in 1987, 24 focus on African American high-risk youth and their families. Comparisons between the different minority-based demonstration projects have not been extensively reported. Studies of African Americans might focus fruitfully on men who are moderate drinkers, since African Americans are experiencing higher rates of alcohol-related problems than Caucasians with similar levels of consumption, for reasons that are not clearly understood. The increase in heavy drinking and alcohol-related problems among African Americans and Hispanics during their 30s suggests the need for interventions with this age group. Hispanic Americans Alcohol-related Problems: The growing Hispanic population consists of several distinct groups (Mexican Americans, Puerto Ricans, Cuban Americans, and persons from other countries of Central America, South America, and the Caribbean). These groups now comprise nine percent of the U.S. population. Hispanic males suffer disproportionately from alcohol dependence and problems related to alcohol abuse compared with African American and Caucasian males in the United States. Several studies suggest that Mexican American men drink more and are more likely to have alcohol-related problems than men in other major Hispanic subgroups. In contrast, Hispanic women are at lower risk for alcohol dependency and alcohol-related problems than are Caucasian women in the U.S. population. Nevertheless, the proportion who drink and have alcohol problems has been rising among second and third generation Hispanic women, as has the proportion experiencing related family problems. Patterns of Consumption: Several epidemiological studies have found that alcohol-use patterns among Hispanics differ somewhat from Caucasians. Specifically, Hispanic males drink less frequently but consume larger amounts, have more instances of very heavy or binge drinking, and have more instances of alcohol-related problems that continue throughout adulthood than Caucasian males. Hispanic females abstain or drink infrequently, usually in a family context. Consumption rates among Mexican American females are somewhat higher than those of females in other Hispanic groups. Hispanic drinking patterns are related to degree of acculturation, although the relationship differs by gender and nationality group. Male immigrants appear to quickly adopt a drinking pattern that blends the high frequency characteristic of U.S. male drinking with the Hispanic high quantity-per-occasion practice. Among Hispanic females, acculturation is associated with increases in both the proportion of women who drink and the amount they consume. In contrast to the men, however, this change in drinking patterns usually occurs in the first generation born in the United States rather than in the immigrant generation. Prevention Research: A comprehensive review of alcohol prevention programs targeted at Hispanic populations found that only one of these (the Ganadores "Winners" project) was systematically evaluated. The interventions implemented in that program included mass media messages and community-based activities designed to increase awareness of the dangers of alcohol and to change attitudes toward alcohol use and drinking behavior. The community activities included dissemination of educational materials and oral presentations by community leaders designed to make people think more about their own drinking. The program resulted in an increase in reported awareness and knowledge of the dangers of alcohol, but it did not change drinking behavior. Nine other current projects aimed at alcohol prevention among Mexican Americans have been recently described but have not been evaluated. Several aspects of the Mexican American culture may have implications for alcohol abuse prevention strategies and research. For example, cultural values may affect the identification of heavy drinking and the recognition of alcohol abuse as a health problem. There is a need to address the role of cultural values as contributors to (and potential moderators of) problematic drinking practices. In addition, interventions designed to increase awareness of the seriousness of alcohol problems should be tested. Where appropriate, research on alcohol use and abuse by Hispanics should also examine changes in immigrants' attitudes toward drinking. Native Americans Alcohol-related Problems: The Native American population consists of approximately two millon people and over 300 distinct tribal and ethnic groupings within the continental United States and Alaska. It is a young, diverse, rapidly growing population living in urban, rural, and reservation settings. Data for 1978-1980 and 1983-1985, indicate that alcohol abuse is a contributing factor in 4 of the 10 leading causes of death for Native Americans: accidents, chronic liver disease and cirrhosis, homicide, and suicide. Accidents are still among the leading causes of death for Native Americans. An estimated seventy five percent of all traumatic deaths and suicides among Native Americans are alcohol-related. Deaths from alcohol-related causes are particularly prevalent in the 25 to 44 age group. Many tribes, particularly in the West, have dramatically higher accident mortality rates than the national average. Fatal accidents among Native Americans are 2.2 to 2.3 times the national average. Patterns of Consumption: Alcohol use varies tremendously from tribe to tribe. Some tribes have a smaller proportion of drinking adults than the U.S. population, while others have more drinkers. Differences in drinking patterns may also relate to reservation and urban settings. The majority of Native American youth report experimentation with alcohol. Drinking among Native American youth is especially serious since mortality from alcohol-related causes is most common in younger years. Heavy recreational and binge drinking may account for unusually high rates of alcohol-related arrests and accidental deaths among young Native American males. In general, Native American women drink considerably less than men, but the prevalence of drinking among women is growing rapidly in some tribes, which may help account for the increase in the reported incidence of Fetal Alcohol Syndrome (FAS). Prevention Research: Most primary prevention programs aimed at Native Americans in recent years have been school-based, youth-oriented programs emphasizing information about the effects and consequences of alcohol and other substance abuse. Their specific effectiveness is largely unknown, as is the effectiveness of school-based programs in general. Several programs designed to provide youth with coping skills, however, have reliably documented systematic research efforts. For example, a modest success was reported for a bicultural skills-enhancement program delivered in reservation and non-reservation settings in the Pacific Northwest. At a six-month follow-up, the test group had better knowledge of drug effects, better interpersonal skills for managing pressures to use alcohol and other drugs, and lower rates of alcohol, marijuana, and inhalant use than the control group. Native American communities also have instituted community-wide prevention programs using local resources and Federal Government funds. A 1986-1987 survey of community programs funded by the Indian Health Service (IHS) identified a total of 312 communities involved in community-based alcohol/substance abuse prevention and intervention programs. These programs provided a variety of services, including alcohol and drug education activities designed to build self-esteem and coping skills, improve decision-making skills, and promote family bonding and enrichment. However, no systematic evaluation of the effects of these programs was reported in the presentation of survey results. In 1983, the IHS introduced a program to prevent FAS by providing Native American communities throughout the country with the knowledge, skills, and strategies to initiate prevention measures on their own. The chief element of the program was the training of cadres of trainers/advocates in all local communities served by the IHS to impart FAS information to a variety of audiences. Evaluation results showed a significant gain in knowledge and retention over an extended period of time by the target populations. Asian Americans and Pacific Islanders Alcohol-related Problems: The 7.3 million Asian Americans and Pacific Islanders now comprise 2.9 percent of the U.S. population. In the past decade, the size of the Asian/Pacific population has more than doubled, and its diversity has greatly expanded. Currently available data describe low rates of alcohol-related problems among Asian/Pacific Americans, even among those identified as heavy drinkers. This finding has been attributed to ethnic differences in physiological reactions (i.e., the "flushing response") as well as sociocultural and environmental factors. Among the cultural factors contributing to low rates of alcoholism are norms that permit drinking, particularly at social functions, but that discourage drinking to excess, and tight family and community regulation of alcohol use. These factors have been combined into a "reciprocity model" explaining the alcohol consumption of Asians. It has been suggested that the growing numbers and heterogeneity of Asian immigrants, as well as the progressive assimilation of Asian Americans into American value systems, will lead to increases in drinking problems among recent Asian immigrants. Patterns of Consumption: Studies consistently suggest that Asian Americans use and abuse alcohol less frequently than non-Asian individuals. In one study examining differences in alcohol consumption among residents of Hawaii, researchers found that Native Hawaiians and Caucasians reported higher levels of alcohol use than Chinese Americans, Japanese Americans, and Filipino Americans. In several studies focusing on drinking patterns among Asians in the United States, however, the view of Asian/Pacific Americans as non-drinkers was questioned. In an examination of Chinese, Japanese, Korean, and Filipinos in Los Angeles, variations in drinking patterns by ethnicity as well as by age and sex were found. These data suggest that Asian Americans display diverse drinking styles, including a relatively high proportion of heavy drinkers among Japanese and Filipino men. The same study found that those Asian/Pacific Americans most likely to drink are men under the age of 45 who have higher social status. Their attitudes toward alcohol use were permissive and their friends tolerant of drinking. Prevention Research: Low rates of alcohol-related problems have contributed to the paucity of prevention research targeted at the various Asian/Pacific subpopulations. Six of the ongoing Center for Substance Abuse Prevention demonstration projects, however, are targeted at Asian/Pacific youth and community groups. Areas of research interest Despite the relatively large number of findings describing broad ethnic differences in drinking behaviors and alcohol-related problems, the nature of the linkage between ethnic identity and alcohol use or abuse has not been established. There are few theoretical paradigms to guide research into these variations. However, there is a need to understand the relationships in order to increase the potential effectiveness of prevention strategies within communities. The paucity of rigorous research on the prevention of alcohol-related problems indicates a need for a variety of prevention and pre-prevention studies directed specifically to these populations. Environmental Prevention Strategies A systematic program of research that investigates the effectiveness of environmental prevention strategies in minority settings is needed to explore interventions that are designed to change the incentives, opportunities, risks, and expectations that surround drinking. This includes examinations of the impact on African American, Hispanic, Native American, Pacific Islanders, and Asian communities (or high-risk groups within them) of national, State, or community-wide policies designed to control alcohol availability and reduce demand for such products. Policy changes might be expected to have diverse effects on minority ethnic populations because of differences in sociocultural patterns of drinking, as well as differences in the manner in which such policies are viewed in different communities and the ways they are enforced. Availability Control: Strategies that might be tested in ethnic minority contexts that attempt to control the physical, social, and economic availability of alcoholic beverages include: (1) strengthening and/or enforcing alcohol beverage control (ABC) laws regulating the hours of operation and the location and number of outlets for sales of alcoholic beverages; (2) enhancing enforcement of minimum drinking age laws; (3) implementing server training programs; and (4) raising taxes on alcoholic beverages. Examination of Media Messages: It is widely believed that the mass media have an important impact on perceptions, attitudes, and beliefs regarding alcohol although research evidence is equivocal. There has been increasing concern in the past decade about whether the alcohol industry has tailored advertising to specific ethnic communities. This suggests the need to explore the effects of focused advertising on the definitions of appropriate drinking behaviors specific to minority subcultures and to age, sex, and socioeconomic subpopulations within ethnic groups. Research is needed on reactions of ethnic groups to public service messages and fictional television and radio programming related to alcohol. Who are the most credible communicators within various ethnic groups--and which media channels (print, television, radio) have the most impact? Institutions: Within ethnic communities, institutions such as churches, business groups, schools, and local political bodies may play important roles in addressing alcohol problems. Little is known about whether and in what ways such influence is exerted in ethnic communities to address alcohol problems. To what extent have institutions such as the beverage and hospitality industries contributed to or deterred prevention efforts through; for example, server training programs or the sponsorship of cultural and athletic events? To what extent have organizations such as Mothers Against Drunk Driving (MADD) gained support in implementing prevention programs in minority communities? Server Training: Those who are responsible for serving alcohol have the opportunity to influence individuals' drinking. Recently, server training programs have been implemented to teach those who serve alcohol in bars and restaurants how to moderate patrons' drinking. The few studies to date suggest that such programs have been effective in reducing the rate and amount of consumption by patrons and the probability of patron intoxication. There is a need to test these findings among minority populations. Price Increases: Econometric studies have suggested that an increase in the prices of alcoholic beverages would result in decreases in consumption, alcohol-involved automobile crashes, and rates of cirrhosis mortality. Projections based on these studies have indicated that a tax on beer amounting to 35 percent of the retail price would halve the number of alcohol-related fatalities among 16-to 20-year-old drivers. Research is needed to determine whether these relationships and projections also apply to various ethnic minority groups. Prevention Strategies Focusing on the Individual Prevention efforts targeted at individuals, distinct from those that target changes in the environment, have attempted to change consumption practices by increasing individual knowledge of alcohol effects and by altering attitudes about the use of alcohol. These efforts usually involve the use of media campaigns and school-based instructional programs. Such programs have sometimes produced desired changes in knowledge and attitudes, but have not been able to document long-term behavior changes. School-based programs that teach youth peer pressure resistance and social competence skills for avoiding the use of alcohol and other drugs show promise but have only demonstrated moderate or short-lived effects. Even this conditional effectiveness, however, has not been established for ethnic minority students and calls for further research. The study of how ethnicity affects individual differences in drinking behavior may involve the statistical modeling of personality variables, alcohol use patterns, and prediction of prevention outcomes. In general, the most effective studies of these interrelationships are longitudinal and may monitor a wide range of variables, including income level, availability of alcohol, peer and adult influences, intention to drink, and other identified risk factors (low academic achievement, lack of prohibitions, early alcohol use, low self-esteem, psychopathology, poor family relations, lack of socialization, other drug use, etc.). These constructs allow for a more precise examination of the relationship between ethnicity and effective prevention outcomes. Identifying High-Risk Groups: Within each ethnic minority, it is important to target some intervention efforts at youth and pregnant women. This may call for creative techniques for identifying and engaging these groups in interventions. For example, since school-based programs are the most popular form of intervention, additional strategies may need to be developed to reach students who have dropped out of school. The usefulness of brief questionnaires in targeting high-risk individuals within these populations should be evaluated. Programs to prevent Fetal Alcohol Syndrome might seek to identify individuals who would participate in a support network to facilitate abstinence during pregnancy. Such a network could include peer counseling, family involvement, and community-wide interventions (i.e., a comprehensive, multiple system strategy). Identifying Protective Factors: Research on alcohol-related problems tends to focus on identifying stressful events and other factors that place individuals at high risk. A promising alternative approach is to explore coping resources and protective factors that have reduced alcohol problems among minority individuals, particularly those exposed to "high-risk" environments. Protective factors may function both at the individual level--by influencing personal decisions about engaging in risk-taking behavior--and at the social level--through the perception of social support from friends and family and through family characteristics. Strategies for Program Development One possible research strategy involves taking interventions from programs that have been successfully tested in the general community and adapting those interventions for use with ethnic minorities. Programs using the social influence model that have shown positive outcomes might be adapted for implementation with one or more ethnic minority groups (such as the Midwestern Prevention Project is attempting to do). Another possible research approach is systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but were tested on only a limited scale and/or not systematically evaluated at all. Examples of these include the community-based programs implemented by the Indian Health Service and various demonstration programs that employ social learning models and are targeted at high-risk youth. Similarly, it may be useful to design strategies for increasing awareness of health-related alcohol problems and understanding of the relationship between cultural attitudes and the social/physical environment and alcohol abuse. It may be necessary to determine how the target groups define "excessive" or "inappropriate" alcohol use, before developing educational materials about the prevention of alcohol-related health problems such as cirrhosis. Methodological Issues: Mediating Factors In the development of grant applications researchers may also choose to focus on particular cross-cutting issues concerning the design of ethnically-based programs. Recent research has focused on the methodological pitfalls of attempting to distinguish the effects of ethnicity from other demographic variables such as age, gender, and socioeconomic status and mediating processes such as acculturation. These variables may make it difficult to identify the unique importance of ethnicity in prevention outcomes. Differences in how the researcher and the subject define ethnicity may also impact the interpretation of research results. Furthermore, variations between individuals in how they define their cultural origin may mediate the effects of interventions that rely on culture specific messages. Immigration and Acculturation: The differences observed in drinking patterns of ethnic groups by residence and immigrant cohort suggest the need for further studies of the factors surrounding urbanization, immigration, and acculturation as they relate to alcohol use. To fully understand acculturation, it is also necessary to consider the effects of such factors as immigrants' economic status, social interaction patterns, employment opportunities, and access to alcoholic beverages as intervening variables in the change process. Stages of acculturation, heterogeneity of ethnic groups and individual differences in ethnic identification may confound measures of acculturation. Different ethnic groups may also experience different stresses surrounding their cultural identity. It is important that these psychological mediators and stressors be identified and examined. For example, members of ethnic minorities living in a larger society are, to varying degrees, bicultural. Bicultural membership may produce unique stresses (or provide protective advantages) affecting alcohol consumption. Research is needed to address the effect of biculturality on alcohol consumption. In particular, the possible contribution of value conflicts to alcohol-related problems in different social situations needs to be explored. Alcohol Consumption Patterns: There may be special problems associated with using measures of alcohol consumption formulated for the dominant majority culture. For example, the consistency of consumption, the standard drink equivalents, and the standard time frame referred to may be less familiar and less relevant to some ethnic groups. Moreover, the pattern of heavy drinking followed by periods of abstinence may not be captured by consumption measures based on regular recall periods, or by those that produce a volume-based measure. In general, the validity of standard tests and measuring instruments may have to be explicitly established for the relevant ethnic populations. Peer Group and Cohort Comparisons: Research is needed to determine the norms and values prevalent in specific age and generational cohorts in each of the ethnic minority populations as these norms and values relate to alcohol use and risk-taking. Without knowledge of cultural differences in the development of drinking careers, it is difficult to select appropriate interventions across different age groups. For example, cultural differences in susceptibility to peer pressure will alter the design of interventions that might impede the formation of alcohol-using "peer clusters" and encourage the formation of "peer clusters" that provide sanctions against alcohol use. These interventions may be developmentally appropriate at one age but not another within different cultures. Cultural Sensitivity, Cultural Competence: There is widespread agreement that prevention research on ethnic minorities requires an acquaintance with the culture of the target group. Concern with issues of cultural sensitivity suggests the need to consider, for example, inclusion of members of target minority groups in the planning and implementation of research programs or the use of the language of the target group in communications, data collection, or administration of standardized measures. Both cultural sensitivity and methodological considerations suggest that a clear cooperative arrangement between community organizations or agencies and researchers is an essential ingredient for the successful implementation and evaluation of an intervention strategy. Methodological Considerations Studies concerning the prevention of alcohol-related problems among ethnic minorities must be conceived and executed so as to satisfy the usual criteria of scientific merit. Careful attention should be paid to the specific design requirements for adequate statistical power, particularly if comparisons between or within ethnic minority groups are planned. Research designs that require comparison groups should carefully consider the selection of appropriate control groups, the possibility of differential influence of psychiatric and other drug use patterns, and the effects of possible differential attrition at outcome. Evaluation of Prevention Interventions: Prevention research involving interventions must include comprehensive evaluation components that are conceptually and procedurally integrated into the overall research program. The three areas of evaluation (formative, procedural-or process, and outcome) provide information relevant to the interpretation of the research findings. Evaluation bears directly upon the verification of the research hypotheses connecting interventions to outcomes. Formative evaluation involves community members in the identification of critical issues that should be researched and in the evaluation of instruments and procedures for appropriateness to the particular community. Procedural evaluation refers to the periodic monitoring of the implementation of interventions during the course of the research to assure adherence to protocol and to document what actually was being done or delivered. Outcome evaluation is concerned with determining whether the program achieved its objectives, i.e., whether the outcomes hypothesized to be caused or produced by the interventions did in fact occur. This phase of the evaluation process requires the specification of a verifiable causal linkage between the interventions and the events or behaviors whose encouragement or avoidance is the ultimate target of the interventions. Cross-Institute or Center Areas of Interest Projects may be submitted under this announcement that address issues in common with other agencies. For example, the Center for Substance Abuse Prevention (CSAP), which was an original co-funding agency for the earlier Request for Applications in this area, may be interested in funding the intervention component of an NIAAA prevention research grant responsive to this announcement. CSAP has initiated many prevention service demonstration projects focused on high-risk youth and their families, including prevention projects targeted at ethnic minority groups. It is conceivable that an applicant could carry out the research in the context of a CSAP Community Partnership grant, High Risk Youth grant or other initiative. This would have the benefit of providing a potential applicant with a pool of clients from an ongoing community intervention. Preapplication consultation with the appropriate individual listed below is strongly encouraged. Applications are considered for acceptance and assigned according to standing PHS referral guidelines. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study: special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials and applies to men and women of all ages. If one gender and/or minority group are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear, compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design or sample size appropriate for the scientific objectives of the study. Applications for support of research involving human subjects must use a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypotheses under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minority group is impossible or inappropriate with respect to the purpose of the research because of the health of the subjects, or other reasons or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements, or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. Protection of Human Subjects The Department of Health and Human Services (DHHS) has regulations for the protection of human subjects which include additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects), including those pertaining specifically to children, are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B47, Bethesda, Maryland 20892, telephone 301-496-7041. Specific questions concerning protection of human subjects in research may be directed to the staff members listed under INQUIRIES. An applicant organization proposing to conduct nonexempt research involving human subjects must file an Assurance of Compliance with the Office for Protection from Research Risks (OPRR). As part of this assurance, which commits the applicant organization to comply with the DHHS regulations, the applicant organization must appoint an institutional review board (IRB) which is required to review and approve all nonexempt research activities involving human subjects. APPLICATION PROCEDURES Applications are to be submitted 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 from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST 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 and five permanent, legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. Second level review of small grants (R03s) is by NIH staff. REVIEW CRITERIA Criteria for scientific/technical merit review of applications for regular research grants (R01) will include: 1. The overall scientific and technical merit and significance of the proposed research. 2. The appropriateness and adequacy of the research design, including the adequacy of mechanisms for the implementation of any intervention and the methodology proposed for collection and analysis of data. 3. The adequacy of the qualifications and relevant research experience of the principal investigator and key research personnel. 4. The availability and adequacy of facilities, general environment for the conduct of the proposed research, other resources, and any collaborative arrangements necessary for the research. 5. The appropriateness of budget estimates for the proposed research activities. 6. Where applicable, the adequacy of procedures to protect human subjects. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03) and FIRST awards (R29) are contained in the respective program announcements, available from: National Clearinghouse for Alcohol and Drug Information (NCADI) P.O. Box 2345 Rockville, MD 20892 Telephone: (301) 468-2600 or 1-800-729-6686 AWARD CRITERIA Applications recommended for approval by the appropriate advisory council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, program needs and balance, and the availability of funds. Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to carry out research projects, including both direct costs, which can be specifically identified with the project, and allowable indirect costs of the institution. Research grant support may not be used to establish, add a component to, or operate a prevention, rehabilitation, or treatment service program. Support for research-related prevention, rehabilitation, or treatment services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grants will be administered in accordance with the PHS Grants Policy Statement (rev 10/90) which should be available from your office of sponsored research. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elsie Taylor or Kendall Bryant, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 Inquires relating to prevention service demonstration projects and evaluation may be directed to: Armando Pollack Special Assistant to the Director of Community Prevention and Training Center for Substance Abuse Prevention Rockwall II Building, 9th floor 5600 Fishers Lane Rockville MD 20857 Telephone: (301) 443-0369 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service, Sections 301 and 405, and administered under the PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 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. .
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