Full Text AA-94-003 ALCOHOL AND MINORITIES: BIOMEDICAL AND BEHAVIORAL RESEARCH NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: AA-94-003 P.T. 34, FF Keywords: Alcohol/Alcoholism Biomedical Research, Multidiscipl Behavioral/Social Studies/Service National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: January 12, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the medical and behavioral consequences of alcohol consumption on minority groups and individuals, including development of more effective treatment and prevention programs. The primary purpose of this Request for Applications (RFA) is to expand the limited information available on alcohol related problems among and within ethnic minority populations of African Americans, Native American/Alaskans, Asian Americans, Pacific Islanders, and Hispanic Americans. Most of these groups are at elevated risk for specific alcohol problems or have patterns of increased alcohol consumption. The NIAAA encourages innovative research on biomedical, behavioral, clinical, socio-cultural, and epidemiological factors associated with the use or abuse of alcohol; the prevention and treatment of alcohol-related problems; and the consequences of these problems in minority groups and individuals. The NIAAA supports alcohol relevant basic and applied research involving a wide array of health science fields and related academic disciplines. Research on alcohol problems among ethnic minority groups should be directed toward better understanding of how variations in drinking patterns and responses to alcohol among diverse cultural and ethnic sub-groups can serve as the basis for development of more effective treatment and intervention strategies for specific populations, and to do research on the implementation of such approaches. 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 RFA, Alcohol and Minorities: Biomedical and Behavioral Research, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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 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 institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01) or FIRST (R29) award. Applicants for R01s may request support for up to five years. In FY 1992, the average total cost per year for new R01s funded by the NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. 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 cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Applicants for FIRST Awards may obtain copies of the FIRST program announcement from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone: 301-468-2600 or 1-800-729-6686. Program project grants (P01) will not be accepted for this RFA. Applicants may submit Investigator-Initiated Interactive Research Project Grants (IRPG). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on the IRPG mechanism is available in program announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. FUNDS AVAILABLE It is estimated that up to two million dollars in total costs will be available for approximately 8 to 10 grants under this RFA in FY 1994. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The United States encompasses a great number of minority groups. Indeed, one out of every four Americans belongs to a racial or ethnic minority. Many of the alcohol-related problems that affect the majority population also are prevalent in ethnic minority groups. However, national surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among some minority groups. In the United States, about 100,000 deaths per year are attributed to alcohol-related causes, and alcohol-related problems affect approximately 1 in 10 adults and several million adolescents and children. These problems have been found to be more extensive among some groups of African Americans, Hispanic Americans, Native Americans and Alaska Natives than in the general U.S. population. Although it tends to be lower for Asian Americans/Pacific Islanders, recent evidence indicates that alcohol consumption may be increasing among these two groups. African Americans account for 12 percent of the total population and are the largest minority group in the United States. African Americans are at high risk for alcohol related diseases such as cirrhosis, alcoholic fatty liver, hepatitis, heart disease, and certain cancers. Although overall rates of alcohol consumption are similar among Caucasian and African American males, they differ with respect to age of onset of heavy drinking (later in African American), economic status of heavy drinkers, and other factors. Although African-American women tend to drink less on the average than Caucasian women, those who are heavy drinkers may be more prone to develop alcohol-related problems, including having children with fetal alcohol syndrome. The Hispanic population comprises nine percent of the U.S. population and consists of several distinct groups; Mexican Americans, Puerto Ricans, Cuban Americans, and persons from other countries in South and Central America and the Caribbean. Studies suggest that Hispanic males have higher rates of alcohol dependence and other alcohol- related problems that continue throughout adulthood than Caucasian males. Hispanic women abstain or drink infrequently, however, Hispanic women born in the U.S. have rising consumption rates. The Native American/Alaskan population is approximately two million people representing over 300 distinct tribal and ethnic groupings. It is a young, diverse, rapidly growing population living in urban, rural, and reservation settings. Alcohol abuse is a contributing factor in death from accidents, chronic liver disease and cirrhosis, homicide and suicide. Alcohol use patterns vary markedly among tribes, regions and communities. In general, women drink less than men, however, prevalence of drinking among women is growing rapidly in some groups, and the incidence of fetal alcohol syndrome is high in some populations. Death from alcohol related causes are particularly prevalent in the 25 to 44 age group. The size of the Asian/Pacific Islander American population has more than doubled during the last decade, growing to approximately 2.9 percent of the U.S. population. There is increasing diversity among Asian American groups as well. Research on Asian American alcohol use and abuse indicates that they have low rates of alcohol-related problems even among those identified as heavy drinkers. This has been attributed to ethnic differences in physiological reactions (i.e., the "flushing response") as well as socio-cultural and environmental factors. Nevertheless, recent findings suggest an increase in drinking problems among recent Asian immigrants as they assimilate into the American value system. The NIAAA has supported studies of variations in drinking patterns and problems among the different racial and ethnic groups. In the past decade attention has become more focused on understanding why these patterns differ and how this information may be used to design and conduct culturally relevant, methodologically sound research. Further information is needed on how these patterns relate to differential biological and behavioral responses to alcohol and how specific responses may explain adverse outcomes of alcohol use. Knowledge of the causes and consequences of alcohol consumption is critical to achievement of the ultimate goal: development and implementation of effective prevention and treatment strategies for specific ethnic populations. Areas of Research Interest The following list of topics is intended only to illustrate NIAAA interests; topics not mentioned are not necessarily excluded from consideration. Variations in drinking patterns and drinking problems have been noted among different racial and ethnic groups for over 20 years. Many reports provide evidence that the frequency of alcohol problems is distinctly high in some groups. Much of the information regarding alcohol-related problems is based on ethnographic and community studies. Baseline longitudinal studies are needed to better understand consumption patterns and their relationship to chronic alcohol-related diseases. These studies include, but are not limited to: o Studies to identify genetic and environmental factors associated with excessive alcoholic cirrhosis mortality among Native Americans and African Americans. o Studies to identify the factors, either genetic or environmental, associated with increased risk for fetal alcohol syndrome among some Native Americans and African Americans. o Epidemiologic studies of alcohol consumption and alcohol related problems that focus on subgroups of each of the ethnic and racial minority groups. o Studies to identify and assess age, ethnicity and gender associated with the onset of alcohol consumption and development of alcohol-related problems. Studies are needed to examine the effects of policies and practices that alter the physical, social, or economic availability of alcohol and reduce demand for it among minority ethnic populations. Such studies might investigate the effects of: o The impacts of existing alcohol beverage control (ABC) regulations as they pertain to minorities; impacts of price on alcoholic beverage consumption among minorities; and the effects of other culturally appropriate interventions designed to alter social or physical environment in bars. o Advertising and counter advertising focused on particular ethnic groups and on age, gender, and socioeconomic subpopulations within them. o Prevention programs operated through key social institutions in ethnic minority communities, such as churches, schools, recreational organizations, and business organizations. o Minority group appropriate: school-based programs focused on reaching children of alcoholics; family-based interventions designed for adolescent and young women to facilitate abstinence during pregnancy; special programs to reach "not in school" young people. Pre-intervention studies are needed to expand knowledge regarding sociocultural, economic, behavioral, and biological factors related to alcohol use. Such studies include: o Studies of the coping resources and protective factors that have been shown to reduce alcohol problems among minority individuals who are exposed to "high-risk" environments. o Studies of the effects of immigration, urbanization, assimilation, and acculturation, or the phenomenon of bicultural membership and stresses associated with it, as mediators of problematic drinking practices. o Studies to establish the validity of standard tests and instruments for measuring consumption among relevant ethnic populations. o Research on the norms and values related to alcohol use and risk- taking behavior identified with specific age and generational cohorts in specific ethnic minority populations, (e.g., the role of cultural values in the definition of "heavy drinking" and "alcohol abuse" among Hispanic youth) or more broadly applied to cultural definitions of "inappropriate" alcohol use. o Studies of the role of the family in socializing youth to drinking norms and behaviors in different groups. o Studies to examine the influences of the family, peer group, and gender role (particularly the relationship of "machismo" or masculinity) on alcohol consumption among various sub-groups and its contributions to alcohol-related violence. o Studies to identify and characterize biological factors, including cellular and molecular mechanisms, that may account for differences in metabolism and elimination of alcohol among racial groups. o Studies to determine the biological, genetic, behavioral, and environmental effects that specifically relate to a minority population that may interact in contributing to alcoholism and related pathologies such as organ damage. o Research to determine the extent to which alcohol consumption contributes to prevalence of hypertension in African Americans. o Controlled, randomized treatment studies that match on various dimensions related to culture, age, and gender are needed to demonstrate if outcomes for minority populations receiving culture/age/gender-specific treatments differ from outcomes obtained through treatments not specific to culture, age, or gender. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for NIH grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). NIH recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications must include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of people selected to participate. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applications must incorporate in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available, there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). If the required information is not contained within the application, the review will be deferred until it is complete. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If gender and/or minority representation/ justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-710-0267; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Applicants for FIRST Awards (R29) are reminded that such applications must include three letters of reference. Non-conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC), funded by the NIH National Center for Research Resources, may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included in the application material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Telephone: (301) 443-4375 FAX: (301) 443-6077 Applications must be received by January 12, 1994. If an application is received after that date, it will be assigned to the next review cycle and will compete with all investigator-initiated research grant applications. The Division of Research Grants (DRG) 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 DRG 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. REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will 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 review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the Principal Investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. Where applicable, the adequacy of procedures to protect or minimize effects on animal and human subjects and the environment. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. Research grant applications will be reviewed based on standard criteria for scientific and technical merit for regular research grants (R01). The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Potential applicants are encouraged to seek preapplication consultation. The opportunity to clarity any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16C-06 Rockville, MD 20857 Telephone: (301) 443-1273 FAX: (301) 594-0673 Direct inquiries regarding fiscal matters to: Elsie Fleming 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 FAX: (301) 443-3891 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 Act, Sections 301 and 464H, and administered under the PHS 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, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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