SURVEY RESEARCH ON DRUG USE AND ASSOCIATED BEHAVIORS NIH GUIDE, Volume 22, Number 39, October 29, 1993 PA NUMBER: PA-94-007 P.T. 34 Keywords: Drugs/Drug Abuse Behavioral/Social Studies/Service National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is encouraging research on the epidemiology of drug use, including survey design and methodological issues as they relate to surveys of drug use. Specifically, this program announcement invites research applications in any of the following areas: (1) secondary analysis using state-of-the-art statistical methodologies and existing drug use research data bases to enhance our knowledge of the epidemiology of drug use, including prevalence, trends, patterns, incidence, risk and protective factors, natural history, consequences, treatment, and co-morbidity factors of drug use; (2) research leading toward improved survey design methods for conducting surveys of drug use or estimating drug use outcomes from new surveys or existing databases; and (3) survey research of hard to enumerate or underserved population groups (particularly those inadequately sampled in epidemiological surveys) such as the homeless, criminally-involved, and runaways. 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, Survey Research on Drug Use and Associated Behaviors, is related to the priority area of alcohol and other drug abuse. 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 organizations, by public, private, or non-profit agencies such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Support mechanisms include research project grants (R01), small grants (R03), FIRST (R29) awards (R29). 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 also vary. For details on a particular support mechanism, contact the appropriate staff listed under INQUIRIES. RESEARCH OBJECTIVES Summary Investigation into the nature and extent of drug use behavior as well as improving the measurement of drug use continues to be a priority research area at the NIDA. Another focus of NIDA is to enhance and expand the study of the etiology and epidemiology of drug use through secondary analysis; to foster the development of methodological improvements to the sample design, data collection, measurement, and analysis of data from drug surveys; and to conduct special population studies exploring drug use patterns among subgroups that are not included or are underrepresented in major national epidemiological drug surveys. Secondary Analysis There is a continuing need for secondary analyses of major national data sets containing drug use data, for integrated analyses that draw together data from multiple sources to address a particular set of issues, and for secondary data analyses of other drug studies that will add to our knowledge of drug epidemiology. Topics of interest include, but are not restricted to: identification of predictors of drug use initiation, progression, and cessation; and investigation of relationships between drug use and criminal behaviors, treatment utilization, and adverse health consequences, and comorbid or related behaviors. Additional topics of interest are: comparison of drug users with those who are drug abusers or drug dependent, prediction of epidemic cycles, the study of factors associated with local use patterns and geographic spread, the investigation of relationships between user characteristics and drugs of choice, the use of substitute or synthetic drugs, combination drug use, studying the characteristics of users with "successful" outcomes such as high socioeconomic status (SES) or good grades, and examining the attributes of non-users who live in neighborhoods where many users reside. Research applications that involve the integration of several data sets are highly encouraged, as are applications that involve the refinement or development of new statistical models or new applications of existing state-of-the-art statistical techniques. Some of the available files, such as those from the National Household Survey on Drug Use (NHSDA) and Monitoring the Future (MTF) Study, contain a large number of cases and cover a broad range of topics on drug use patterns, consequences, and related attitudes and behaviors. The University of Michigan's Inter-University Consortium for Political and Social Research (ICPSR) archives a number of these data sets, including the NHSDA and MTF, and makes them available to the public. Additional data sets with items related to drug use are available by contacting the responsible Government agencies (e.g., the National Center for Health Statistics, the Bureau of Labor Statistics). Principal Investigators of prior drug-related research studies may make their data sets available for secondary analysis. Applications proposing secondary data analyses must ensure access to and the suitability of data sources to evaluate the proposed hypotheses. If necessary, SAAB staff can provide guidance in obtaining access to the data. Methodological Research The sensitivity of collecting data on drug use has always made validity and reliability important issues. There is a critical need for studies to evaluate current survey methods, to assess the validity of survey data, and to develop and test improved methods of sampling, data collection (including questionnaire design), estimation, and analysis. There continues to be a need to develop and refine survey procedures to enhance respondents' cooperation rates and willingness to report honestly about their illicit drug use behavior. Since self-report methods will probably continue to provide the most reasonable and most cost-effective method of large-scale data gathering on drug use, it would be beneficial to develop methods of improving the validity and reliability of self-reporting. Although research generally suggests that self-report techniques provide valid estimates of drug use prevalence, some recent validity studies have questioned the accuracy of self-report (Rouse, Kozel, and Richards, 1985; Wish, 1988; Mieczowski, 1990, McNagny and Parker, 1992, etc.). There are two basic types of validity studies: comparative studies and criterion studies. Comparative studies of validity compare rates for specific reported behaviors (across studies) to assess the relative validity of different methodologies. Criterion validity studies use a criterion such as a biological measure (e.g., urinalysis or hair sampling) to validate the self-report. In criterion studies, care must be taken to fully understand the limitations of the validation technique presumed to be a superior standard to which self-report can be compared. Other ways to check the validity of self-report may include the use of key informants knowledgeable about the respondent's behavior, institutional systems of records, and debriefing interviews in which respondents are asked how honestly they responded to questions on drug use. Experimental manipulations of various survey conditions and situational factors may help identify the techniques that result in the most valid data. For example, possible survey conditions that could be manipulated include degree of privacy, anonymity and confidentiality assurances, mode of administration, setting, interviewer approach, questionnaire structure and length, remuneration, context of drug use questions, etc. Issues such as examining the reliability and validity of criteria used to assess drug dependence (such as DSM-IIIR or DSM-IV) are also of interest. Also, methods such as CAPI (computer assisted personal interview) and audio-CASI (computer assisted self-interview), and randomized response need exploration. Estimation and sampling methods that could be developed or improved upon include: population modeling to improve estimates of drug use incidence, multiple frame sampling and estimation, the nominative technique, multiple recapture sample designs (including trap mechanisms and tag methods), field procedures to estimate the population prevalence of licit or illicit substance use, regression models to estimate the prevalence of the frequent use of heroin or cocaine (or other substances, either licit or illicit), and model-based estimation or use of mapping and geocoding procedures for developing local area estimates. Another area of interest is the development and testing of new cost-effective sampling and data collection methods that improve extended recall, increase response rates, improve estimation procedures, and decrease the total mean square error of the estimates. Methodological research on any of the above areas could be performed by conducting new surveys to obtain information or through the use of secondary data analysis. Special Population Surveys There continues to be a paucity of research on the patterns, causes, and consequences of drug use among persons who are "underserved" and/or "hard to enumerate," ethnic/racial minority groups, or individuals belonging to high-risk populations. Many populations that are at a high risk of drug use and the resulting adverse social and medical consequences are also disadvantaged and disenfranchised. Examples of such populations include the homeless, transient persons, the chronic mentally ill, juvenile delinquents, school dropouts, emancipated foster care youngsters, and runaways. Nonhousehold and hard-to-reach populations, and persons from inner cities who are unaffiliated and precariously housed tend to be excluded from large national probability surveys because they are not captured in the sampling frames used by these surveys. In addition to the poorest segments of our society, there are many other population subgroups which may be vulnerable to drug use. Other interesting population groups would be: selected occupational groups (e.g., construction workers); persons with disabilities; gay, lesbian, and bisexual individuals; and elementary school children. Most surveys that include substance use focus on different population groups. A major area of interest is the identification and documentation of overlaps in coverage, underrepresented groups, and populations not covered by any major survey. For example, many school surveys do not include dropouts or students with high rates of absenteeism who might have been missing on the day of the data collection. Emphasis should, in part, be on the developmental application of new or more effective sampling procedures and data collection methods for the special population of interest, and on the proposal of appropriate estimation and analysis procedures. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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 disease, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities 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 groups, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of United States racial\ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ 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 and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these sex and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities 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 sex 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 the enrollment of women and men and on the race and ethnicity of the 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. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 9/91) instructions. 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, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of this announcement must be typed in Item 2a on the face page the application. FIRST (R29) 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 of 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. Applications will be assigned in accordance with established Public Health Service referral guidelines and will be reviewed by an initial review group (IRG) for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the project as determined by peer review o Availability of Funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Arthur Hughes or Andrea Kopstein Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-53 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6637 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A-54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. Awards are made under the authority of Section 301 of the Public Health Service Act as amended (42 USC 241). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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