Full Text PAR-95-024 SECONDARY ANALYSIS OF ALCOHOL ABUSE PREVENTION RESEARCH DATA NIH GUIDE, Volume 24, Number 4, February 3, 1995 PA NUMBER: PAR-95-024 P.T. 34 Keywords: Alcohol/Alcoholism Disease Prevention+ National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting exploratory/developmental research grant applications to support the secondary analysis of data relevant to the prevention of alcohol abuse and alcoholism. Exploratory/developmental grants for the Secondary Analysis of Alcohol Abuse Prevention Research Data are intended to more fully utilize currently available data sets and to provide support for substantive exploratory or confirmatory studies that increase knowledge in the alcohol research area. Data used in secondary analyses may be obtained from current or past investigator- initiated research activities or from other archival data sets. In addition, research that employs new analytic techniques that demonstrate methodological advances in the area of alcohol abuse prevention research are of particular interest. Grants supported under this announcement must be limited to a two-year effort and a maximum of $100,000 in direct costs per year. 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, Secondary Analysis of Alcohol Abuse Prevention Research Data, is related to the priority area of alcohol abuse reduction and alcoholism prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Research support may be obtained through an application for an exploratory/developmental research grant (R21). Grant applications must be limited to a maximum of $100,000 in direct costs per year for up to two years. Annual awards will be made subject to continued availability of funds and progress achieved. It is estimated that in Fiscal Year 1996 approximately 8 to 10 awards will be made under this program announcement. However, the number of awards will depend on the quality of applications, the availability of funds, and program priorities at the time of award. RESEARCH OBJECTIVES The NIAAA wishes to promote the use of secondary analyses of data relevant to the prevention of alcohol abuse and alcoholism where appropriate data sets and analytic techniques are available and can be employed. The specific objectives of this program announcement on the Secondary Analysis of Alcohol Abuse Prevention Research Data are to provide support for the purpose of (a) new approaches to analysis of current data sets that would benefit from further exploration or (b) reanalysis of previously collected data that would provide cost effective ways of obtaining additional insights into alcohol abuse prevention research issues. Grants under this program announcement are not intended as a means to carry out ongoing data analysis, maintenance, or distribution of data sets. Background Alcohol abuse prevention research projects often generate data sets with potential usefulness that goes beyond the specific hypotheses and questions for which the study was designed. These data sets may be generated by either preintervention research, which consists of a broad spectrum of studies directly relevant to the development of effective preventive interventions, or intervention research, that tests single or multiple strategies for preventing or reducing alcohol-related problems. Both preintervention and intervention research projects carried out over multiple years, using various sampling designs and often specialized instruments, may yield a wealth of additional information. Very often these data are not fully utilized, sometimes due to a lack of resources once a project's funding has ended. Reanalysis of existing data may be prompted by a need to confirm new findings in the field or to aid in the development of new research questions. Efforts are already being made to increase the use of secondary analyses in the social and behavioral sciences through access to national data sources. Survey and epidemiologic data on alcohol use is available and has been used to track changing trends in alcohol use. However, the evolving field of alcohol abuse prevention research continuously generates new research questions. In some cases, use of existing data sets may provide an expeditious and cost- effective means of advancing knowledge. When appropriate, secondary data analyses may serve as an alternative approach to expensive and time-consuming data collection projects. For example, additional data analyses may be particularly useful in providing information on different age groups, genders, ethnic groups, or other special populations of interest. Existing data sets may be used to cross- validate exploratory analyses in ongoing studies, to test specific hypotheses or complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Meta-analyses, in which effects from many studies may be compared or combined, may also be considered a form of secondary data analysis. Moreover, potential applicants should note that secondary analysis may extend to all types of data such as qualitative information or the integration of quantitative and qualitative data. Areas of Research Interest Applicants may choose to carry out analyses using large, nationally representative data sets relevant to alcohol abuse prevention research. There are a number of such data sets that have been collected by the Federal government, are in the public domain, contain items relevant to alcohol use and abuse, and may not have been fully analyzed. Examples include many longitudinal or cross- sectional surveys carried out by the National Center for Health Statistics and the Centers for Disease Control and Prevention, such as the National Health Interview Survey (NHIS) in the years 1983, 1985, 1987, 1988, 1990, and 1992-93, and The National Health and Nutrition Examination Survey (NHANES) I and II and Follow-up. Alternatively, applicants may of their own initiative secure access to other large data sets not in the public domain, such as those collected under Federal grants or sponsored by private agencies. In general, four types of secondary analysis studies relevant to this program announcement have been identified. These are: (1) large sample or multiple sample comparisons, (2) methodology development, (3) new analysis of a current study, and (4) developmental/pilot studies. Several examples are given below to illustrate the types of secondary analyses that may be considered within the scope of this announcement. However, the investigator is not limited by these examples. Proposed research should be guided by scientific considerations and the potential benefit of the proposed analyses. 1. Large sample or multiple sample comparisons: In this category, investigators may seek large archival data sets with identified subgroups or multiple data sets for comparison with each other. For example, an investigator may wish to obtain two or more data sets for the development and testing of integrated research hypotheses for multiple cohorts, different genders, or different ethnic groups. 2. Methodology development: Single or multiple data sets may be obtained to demonstrate new or improved research design, measurement, or analytic techniques. For example, researchers may wish to develop new analytic techniques for longitudinal designs that take into account transitions between alcohol and other drug use behavior over time, or the simulation of complex systems that predict alcohol use at an individual, group, or community level. Measurement issues may also be addressed for different variable and construct domains to facilitate more accurate item equating, norming and further validation of outcome measures, or the development of new measures. 3. New Analysis of a current study: This would allow the investigator to take advantage of opportunities for additional analyses if they are justified as a new stand alone research project grant for secondary data analysis. These additional analyses may be ideal for cross-validation of results on appropriate comparison groups and lead to improved generalizability of results. 4. Development/Pilot Projects: Before developing a large and complex research grant application, an investigator may choose to examine and pilot test hypotheses, sampling, and analytic techniques used in similar studies. Secondary analyses of available data sets may provide a way to develop and pilot test a large scale study. This approach may be particularly appropriate where little is known in the area of the proposed research; or where the investigator needs to pilot test the hypothesis prior to the development of a large and complex research grant. 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 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, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-710-0267. The title and number of the program announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed 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. 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 the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level 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; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIAAA. The following will be considered in making funding decisions: quality of the proposed project as determined by 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 programmatic issues to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: kbryant@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. Awards are made under authorization of the Public Health Service Act, Sections 301 and 464H and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Howard, J. (1993) Alcohol Prevention Research: Concepts, Phases, and Tasks at Hand. Alcohol Health and Research World, Special Focus: Prevention of Alcohol-Related Problems. Vol 17, No 1. Collins, R.L. and Windle, M. (In press) Secondary Data Analysis: Advantages, Limitations, and Considerations in Substance Use Research. In J.E. Trimble, C. Bolek, & S. Niemcryk (Eds.), Conducting cross-cultural drug abuse research: Emerging strategies and Methods. New York, NY: Haworth Kiecolt, K.J. & Nathan, L,E, (1985) Secondary analysis of data. Beverly Hills, CA: Sage Kozlowski, L.T. Data waste: The ethical challenge of the underdone and unfinished. APS Observer. Jul/Aug 26-28, 1993. Stewart, D.W. (1984). Secondary research: Information sources and methods. Beverly Hills, CA: Sage. .
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