RESEARCH ON CHILDREN OF ALCOHOLICS NIH GUIDE, Volume 21, Number 17, May 8, 1992 PA NUMBER: PA-92-74 P.T. 34, AA Keywords: Alcohol/Alcoholism Risk Factors/Analysis Psychopathology Emotional/Mental Health Violent Behavior National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) makes grant awards for basic and applied alcohol research projects. The NIAAA encourages grant applicants to develop knowledge in a wide range of areas relevant to the causes, consequences, diagnosis, prevention, and treatment of alcohol abuse and alcoholism. This program announcement describes areas of research interest that are related to children of alcoholics. The processes for submission and review of a grant application and the terms and conditions for grant support are described also. This announcement is a revision of and replaces an earlier announcement for Research on Children of Alcoholics dated January 1989. 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, Research on Children of Alcoholics, is related to the priority area of alcohol abuse and alcoholism reduction. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00474- 0) 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 non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. However, foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award (R29). Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT Research support may be requested through applications for a research grant (R01), small grant (R03), FIRST Award (R29), or an exploratory/developmental grant (R21). Specialized announcements for the FIRST Award Program (R29), the small grant program (R03), and for exploratory/developmental grants (R21) are available 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. Applicants for R01s may request support for up to five years. Small grants and exploratory/developmental grants are limited to two years. Applicants for FIRST awards must request five years of support. FIRST awards, small grants, and exploratory/developmental grants are not renewable but continuation of the work may be requested through other grant mechanisms. Grant funds may be used for expenses clearly related and necessary to conduct research projects, including direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention/intervention service program. Support for research-related treatment, rehabilitation, or prevention 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 to make a significant contribution to theoretical concepts. FUNDS AVAILABLE Applications received in response to this announcement will compete with other applications assigned to the NIAAA for funding. The amount of funding available will depend on the quality of research a applications, appropriated funds, and program priorities at the time of the award. While the NIAAA has not set aside funds for this program, it is estimated that a approximately $500,000 will be available annually for two or three new and/or continuation awards. RESEARCH OBJECTIVES Extrapolations from data on drinking practices obtained from household probability surveys suggest that there are approximately 29 million children of alcoholics; an estimated 22 million are 18 years of age or older, and 6.6 million are under the age of 18. Unfortunately, despite the magnitude of this population and the possibility that these individuals may suffer a variety of problems and be at risk for alcoholism themselves, little well-controlled research has been done yet in this area. Descriptive epidemiological investigations and a variety of other kinds of studies are needed. Scientifically sound research can provide a foundation for the development of effective preventive and early intervention programs to alleviate the potential adverse effects of alcoholism and problem drinking in this group. Although children of alcoholics are at increased risk for alcoholism, it should be noted that a large percentage of these children do not develop this disorder. Research has suggested different patterns of alcoholism, including one subtype in which the expression of alcoholism requires both genetic vulnerability and a high environmental risk. It is conceivable that some high-risk individuals do not develop alcoholism because of the coping mechanisms they employ. A variety of coping mechanisms have been clinically observed in children of alcoholic parents and many of these children grow up to be free from alcoholism or other psychopathology. The study of coping mechanisms employed by such "resistant" individuals may be of special value for treatment and prevention programs. Clinical reports concerning children of alcoholics have described a variety of psychological impairments that they experience in addition to alcohol or drug abuse. Psychological problems noted have included the presence of both major and minor types of psychopathology, impaired self-esteem and reality testing, impaired academic and vocational performance, and susceptibility to a large number of acting-out behaviors, including delinquency and running away. Most of these studies were limited to assessing children who were receiving treatment for their problems or whose parents were being treated for alcoholism. Research is needed to examine a broader spectrum of children of alcoholics. Research in large non-clinical populations might address questions such as the following: o What are the psychological characteristics associated with having one or both parents alcoholic? Are these characteristics specific for children of alcoholics or are they similar to those found in offspring of other dysfunctional families? o Do children born after a parent's recovery from alcoholism suffer psychological problems at a rate higher than children from families who have not had a past problem with alcoholism? How do their problem rates compare with those of children of active alcoholics? How do they compare with those of children of individuals with other chronic conditions (e.g., schizophrenics or renal dialysis patients)? o Are there characteristics of "psychological resilience" that buffer the adverse effects of parental alcoholism on some children? If such characteristics exist, what are they, and can they be developed in other children of alcoholics? o Do family factors exist that reduce the risk of problems in children of alcoholics? Do children of male alcoholics have the same problems as children of female alcoholics? Now are type and severity of parental alcoholism related to symptoms in children? o Are there consistent age-related progressions of problems in children of alcoholics? In other words, do children of alcoholics experience different problems at different ages? Do particular early problems serve as warning signs of later problems? Can effective prevention strategies be developed and implemented for these at-risk children? What are the positive and negative effects of labeling children at-risk? o What are the characteristics of individuals who are affiliated with adult children of alcoholics groups? How does the age, race, and sex composition of these group compare to Alcoholics Anonymous? What are the psychological characteristics of participants in adult children of alcoholics groups? Studies of the variety of adverse consequences for children of alcoholics may also include the relationship between excessive drinking and sexual abuse of children and of spouses. Research on the role of excessive drinking in other violent behavior directed towards children and spouses is also of particular interest. Any research project on children of alcoholics may be included under this announcement, and research studies on gender differences and similarities are encouraged. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH For projects involving human subjects and human materials, ADAMHA/NIH requires applicants to include minorities in both genders in study populations. Racial/ethnic minority and gender differences in human subjects provide valid scientific and public health reasons for requiring that research involving human subjects includes appropriate minority and gender representation. If one gender and/or minorities are excluded or are inadequately represented in this research, a clear compelling rationale for exclusion or inadequate representation must be provided. ADAMHA/NIH will not make awards that do not comply with this policy. Instructions are provided in form PHS 398 (rev. 9/91), Section IV.C.4. If the required information is not contained within the application, the application will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If there is limited representation, or absence of minority representation or only one gender is represented, AND the scientific justification for the selected study population is inadequate, reviewers will consider this as a scientific weakness or deficiency in the study design and reflect this in the written review statements and in the assigned priority score. Protection of Human Subjects The Department of Health and Human Services (DHHS) has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B59, Bethesda, MD 20892, telephone (301) 496-7041. Specific questions concerning protection of human subjects in research may be directed to the staff member listed under INQUIRIES. An applicant organization proposing to conduct non-exempt research involving human subjects must file an "Assurance of Compliance" with the Office for Protection from Research Risks. As part this Assurance, which commits the applicant organization to comply with the DHHS regulations, the applicant organization must appoint an institutional review board that is required to review and approve all non-exempt research activities involving human subjects APPLICATION PROCEDURES Applicants are to use the grant application form PHS 398 (rev. 9/91). The number and title of this announcement, "Research on Children of Alcoholics - PA-92-74," must be typed in item 2a on the face page of the PHS 398 application form Application kits containing the necessary forms and instructions (PHS 398) may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: National Clearinghouse for Alcohol and Drug Information P 0. Box 2345 Rockville, MD 20852 Telephone: (301) 468-2600 or 1-800-729-6686 The signed original and five permanent, 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 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 GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the a application. REVIEW PROCEDURES 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 IRGs, 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. Only applications recommended by a council may be considered for funding. Application Receipt and Review Schedule Applications will be accepted and reviewed according to the following schedule: Receipt Dates Initial Advisory Earliest New/Renewal Review Council Review Start Date Feb 1/Mar 1* May/Jun Sep/Oct Dec 1 Jun 1/Jul 1* Oct/Nov Jan/Feb Apr 1 Oct 1/Nov 1* Feb/Mar May/Jun Jul 1 * Competing continuation, supplemental, and revised applications are to be submitted on these dates. Consequences of Late Submission Applications received after the above receipt dates may be returned to the applicant without review or assigned to the next review cycle if requested by the applicant. REVIEW CRITERIA Criteria for scientific/technical merit review of research grant (R01) applications will include the following: o The overall scientific and technical merit and significance of the proposed research. o The appropriateness and adequacy of the experimental design, including the adequacy of the methodology proposed for collection and analysis of data. o The adequacy of the qualifications (including level of education and training) and relevant research experience of the Principal Investigator and key research personnel. o The availability of adequate facilities, general environment for the conduct of proposed research, other resources, and any collaborative arrangements necessary for the research. o The appropriateness of budget estimates for the proposed research activities. o Where applicable, the adequacy of procedures to protect or minimize possible adverse effects on humans, animals, or the environment. o Conformance of the application to the NIH and ADAMHA policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03), exploratory/developmental grants (R21), and FIRST Awards (R29) are contained in the relevant program announcements. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact either one of the individuals listed blow for consultation in preparing an application under this announcement. Direct inquires relating to program issues to: Cherry Lowman, Ph.D. Treatment Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-20 Rockville, MD 20857 Telephone. (301) 443-0796 Jan Howard, 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 are to be directed to: Joseph Weeda Chief, 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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authority of Sections 301 and 510 of the Public Health Service Act, as amended (42 USC 241 and 290bb). 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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