This Program Announcement expires on October 5, 2004, unless reissued. SECONDARY ANALYSIS OF EXISTING ALCOHOL EPIDEMIOLOGY DATA SETS Release Date: September 25, 2001 PA NUMBER: PA-01-140 (This PA has been reissued, see PA-05-088) National Institute on Alcohol Abuse and Alcoholism THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications to support the secondary analysis of existing data sets with the goal of enhancing our understanding of patterns of alcohol consumption and the epidemiology of alcohol-related problems. Research grants for the Secondary Analysis of Existing Alcohol Epidemiology Data Sets are intended to provide support for studies that more fully utilize currently available data sets to increase our understanding of the incidence, prevalence and etiology of alcohol related problems and disorders in the population, as well as the risk and protective factors associated with them. Data used in secondary analyses may be obtained from current or past investigator-initiated research activities or from other public or private sources. Research that employs analytic techniques which demonstrate or promote methodological advances in alcohol-related epidemiologic research is also of interest. Research objectives of this program announcement include, but are not limited to: (1) studying patterns of alcohol consumption and the distribution of alcohol-related problems in the population as a whole and in specific sub- populations, (2) studying risk and protective factors for alcohol-related problems in the population as a whole and in specific subpopulations, (3) elucidating disparities among racial/ethnic groups with respect to alcohol consumption and alcohol-related problems, (4) understanding the natural history, course, and short- and long-term outcomes of alcohol consumption. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), Secondary Analysis of Existing Alcohol Epidemiology Data Sets, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, 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 This PA will support research through the National Institutes of Health (NIH) Research Project grant (R01) and the Exploratory/Developmental grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applications for research project grants (R01s) may request support for up to 5 years. Exploratory/developmental grants (R21) are limited to 3 years and $100,000 per year in direct costs. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. Applicants without extensive preliminary data are urged to submit applications for this PA using the exploratory/developmental grant mechanism. More detailed information on the R21 mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html. Exploratory/developmental grants cannot be renewed, however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism seeks to expand knowledge about patterns of alcohol consumption and the epidemiology of alcohol-related problems through the use of secondary analysis of existing data, where appropriate data sets and analytic techniques are available. The specific objectives of this announcement on the Secondary Analysis of Existing Alcohol Epidemiology Data Sets are to provide support for (a) analyzing previously collected data that would advance -- in cost effective ways -- scientific knowledge of alcohol-related epidemiology, or (b) applying new approaches to analyze current data sets that would benefit from further exploration. Grants under this announcement are not intended as a means for carrying out currently ongoing data analysis nor for the maintenance and distribution of data sets. BACKGROUND Epidemiologic research projects typically generate data with potential utility beyond the specific hypotheses and questions that they were designed to address. Often data are not fully analyzed, especially when unexpected research questions emerge after the end of the project’s funding period. Analyzing such existing data sets can therefore provide a cost-effective means to test specific hypotheses that have not been adequately examined. The further analysis of existing research data may also be prompted by a need to confirm new findings or to aid in the development of new research questions. Also appropriate for secondary analyses are relevant cross-sectional and longitudinal survey data collected by Federal, State, and local government agencies. Secondary data analyses of these data may serve as an economical alternative to expensive and time-consuming new data collection projects. A few examples of such publicly available data sets are: the National Longitudinal Alcohol Epidemiologic Survey (NLAES) conducted by NIAAA, the National Longitudinal Survey of Youth (NLSY) conducted by the U.S. Department of Labor, the National Adolescent Student Health Survey, a cooperative project of the U.S. Department of Health and Human Services, Public Health Service, Office of Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, and the National Institute on Drug Abuse, the National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics (NCHS), the National Health Interview Survey conducted by NCHS, the National Household Survey on Drug Abuse conducted by the Substance Abuse and Mental Health Services Administration, and the National Mortality Followback Survey conducted by NCHS. In addition to the examination of specific research hypotheses, existing data sets may also be used to cross-validate exploratory analyses in ongoing studies, to test complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Meta-analysis, in which results from multiple studies may be compared or combined, is considered to be a form of secondary data analysis for the purpose of this program announcement. Moreover, secondary analysis is appropriate for many types of data, including qualitative information, and may also cover the integration of quantitative and qualitative data. AREAS OF RESEARCH INTEREST Alcohol epidemiology is the study of the distribution in the population of alcohol-related problems and disorders. Research in this area includes the investigation of patterns of alcohol consumption and of the incidence, prevalence and etiology of alcohol-related problems and disorders in the population as a whole and in specific subpopulations. It also includes studies that enhance our knowledge about risk and protective factors (personal, environmental and genetic) for alcohol-related problems, and how these factors may vary and/or interact in various populations and/or be affected by other factors such as family history, education, health status, socio-economic status and occupation. More specifically, this general area includes, but is not limited to: (a) the epidemiology (causes, course and outcomes) of alcohol-related problems including alcohol use disorders among the general population and among special populations, for example, youth, racial/ethnic groups, women and the elderly, (b) the relationship of alcohol consumption and alcohol use disorders to other psychiatric disorders and conditions, (c) the relationship of alcohol consumption to the development, course, and outcomes of physical illnesses, including heart disease, cancer, liver disease and HIV/AIDS, (d) the study of prenatal exposure to alcohol, including the epidemiology of fetal alcohol syndrome (FAS) and alcohol-related neurodevelopmental disorders (ARND), and (e) the role of alcohol in intentional and non-intentional injury and death including homicide, suicide, and vehicular and other accidents. Applicants may conduct secondary analyses relevant to alcohol-related epidemiology using large, nationally representative data sets or smaller, regional or locally based data sets. As mentioned above, many data sets in the public domain which contain items relevant to alcohol consumption and alcohol-related problems have not been fully analyzed. Appropriate data sets include those collected or coordinated by agencies of the Federal Government (e.g., surveys carried out by the National Center for Health Statistics and the Centers for Disease Control and Prevention), various State governments, and regional or local governments. Applicants may also secure access to other data sets that may or may not be in the public domain, such as those collected under research grant funds, sponsored by private entities (e.g., philanthropic foundations, motor vehicle administrations, or commercial businesses) or originally collected for purposes other than research (e.g., health care, criminal justice or insurance data). The Alcohol Epidemiologic Data Directory is a resource document that lists data sets of potential relevance to this announcement. It is available on NIAAA’s website at the following address: http://pubs.niaaa.nih.gov/publications/datasys.htm or from an NIAAA contractor: CSR Incorporated, Suite 200, 1400 Eye Street, NW, Washington, D.C. 20005, 202/842-7600. The information provided for each data set includes: title, sponsoring agency, contact person, survey design/purpose, methodology, sample size, alcohol variables, other variables and limitations. Examples of general types of secondary analyses that may be considered within the scope of this announcement are given below. This list is illustrative and not exhaustive, prospective proposals need not be limited by these examples. Scientific considerations and the potential benefit of the proposed analyses should guide any proposed research. o New analyses of past or current studies: Appropriate analyses include: those which explore overarching initial hypotheses further but which are significant enough to justify a new stand-alone analytic research project, and those which investigate hypotheses beyond those tested in the original study. o Large sample or multiple sample comparisons: Investigators may use large archival data sets with identified subgroups or multiple data sets for comparison with one another. For example, an investigator may obtain two or more data sets for the development and testing of integrated research hypotheses for multiple cohorts, different genders, or different ethnic groups. o Methodology development: Single or multiple data sets may be used to demonstrate new or improved research designs, measurement techniques, or analytic approaches. For example, researchers may wish to develop new analytic techniques for longitudinal designs that take into account transitions in alcohol and other drug use behaviors over time, or use existing data to undertake the simulation of complex systems for predicting the use of alcohol or the emergence of alcohol-related problems at an individual, group, or community level. o Developmental Projects: Investigators might examine the feasibility of using certain types of data records or certain kinds of data sets for answering alcohol-related epidemiologic research questions, particularly if these types of data have not been widely used to address alcohol-related hypotheses. Examples include abstracting from medical encounter records, and analyzing general health or criminal justice data. 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 are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific 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 Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Vivian B. Faden, Ph.D. Acting Chief, Epidemiology Branch Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514, MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-594-6232 FAX: 301-443-8614 E-mail: vfaden@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Blvd., MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-2434 FAX: (301) 443-0788 Email: jsimons@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 sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.