PREVENTING FETAL ALCOHOL SYNDROME (FAS) Release Date: November 18, 1998 RFA: AA-99-002 P.T. National Institute on Alcohol Abuse and Alcoholism Office of Research on Women's Health Letter of Intent Receipt Date: February 23, 1999 Application Receipt Date: March 23, 1999 THIS IS A RE-ISSUANCE OF RFA AA-99-002, WHICH WAS ORIGINALLY PUBLISHED IN THE NIH GUIDE ON OCTOBER 8, 1998. PURPOSE The purpose of this Request for Applications (RFA) is to stimulate research that develops and/or tests interventions that have the potential for preventing fetal alcohol syndrome among human populations and thereby reducing its incidence and prevalence. Investigators may themselves design, develop, modify, or adapt the interventions they plan to test; or they may take advantage of opportunities to test or evaluate interventions that occur (or have occurred) "naturally" in society as a whole or selected segments of it. Investigators who design their own interventions may focus on specific dimensions of the environment in which alcohol is distributed, sold, and consumed; on groups and individuals at excess risk; and/or on families and significant others of persons at risk. In developing and implementing these interventions, investigators are encouraged to collaborate with public and private organizations that can help ensure that the prevention approaches are appropriate and effective. Naturally-occurring preventive interventions may include public, community-based, or health-care policies that specifically attempt to reduce drinking by pregnant women (e.g., point-of-purchase messages, counseling programs within health maintenance organizations), strategies that attempt to reduce alcohol abuse in general (e.g., constraints on the legal availability of alcohol), and policies that have positive implications for preventing alcohol abuse even though they are implemented for other reasons (e.g., taxes on beverage alcohol). The Office of Research on Women's Health (ORWH) is interested in the effects of high alcohol consumption on the health of women and families and, therefore, joins with the National Institute on Alcohol Abuse and Alcoholism in co- sponsoring this RFA. 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 activity for setting priority areas. This RFA 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. 170-011-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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 Research support may be obtained through applications for a research project grant (R01) or Investigator-Initiated Interactive Research Project Grants (IRPG). An IRPG requires the coordinated submission of related regular research project grant applications (R01s) 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 applications. Applications may be from one or several institutions. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995, and from the NIAAA program staff listed under INQUIRIES. FUNDS AVAILABLE The NIAAA intends to commit $2 million in total costs and the ORWH intends to commit approximately $100,000 in total costs for the first year of awards under this RFA. It is anticipated that four to six awards will be made under this RFA in FY 1999. This level of support is dependent on receipt of applications of high scientific merit. The usual policies governing grants administration and management, including facilities and administrative costs, will apply. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. The earliest possible award date is July 1, 1999. RESEARCH OBJECTIVES Background Fetal alcohol syndrome (FAS) refers to a constellation of abnormalities that include facial dysmorphology, growth retardation, and central nervous impairment (neurological, cognitive, and behavioral). The disorder occurs as the direct result of the mother's consumption of beverage alcohol during her pregnancy. Estimates of FAS prevalence vary from .6 to 3 per 1000 live births in most populations, but some communities show much higher rates (e.g., as high as 9 per 1000 live births). FAS is arguably the most common known nongenetic cause of mental retardation in the United States. Two other categories of alcohol-related birth disorders have also been defined, and together they significantly increase the magnitude of the overall problem. Alcohol-related birth defects (ARBD) refers to alcohol-induced physical anomalies; and alcohol-related neurodevelopmental disorders (ARND) refers to alcohol-induced cognitive and behavioral problems without the characteristic facial or growth abnormalities. For several reasons, it is impossible to estimate with reasonable certainty the financial costs of FAS, ARBD, and ARND. Estimates of the incidence and prevalence of these disorders are imprecise, and the full lifetime extent of health and other problems experienced by persons with these birth defects is unknown. Thus, cost estimates for the United States have varied from a low of $75 million annually to a high of $9.7 billion. It is, however, generally agreed that FAS, ARBD, and ARND are completely preventable birth defects and neurodevelopmental abnormalities. According to the Institute of Medicine (IOM) report on FAS (1996), there are two viable approaches to its prevention: Women should stop drinking alcohol at all phases of pregnancy; or, alternatively, women who drink alcohol should not become pregnant unless and until they can control their drinking. Ordinarily, in alcohol-focused prevention research the concept of prevention does not encompass the actual treatment of alcohol abuse and alcoholism, except when that treatment involves brief motivational counseling or guidance/advice that helps the recipient anticipate problematic situations and reduce personal risk. In the case of fetal alcohol syndrome, however, treatment for alcohol dependency can become a vital component of a comprehensive strategy to prevent alcohol- related birth defects. As the IOM report states the issue, "treatment of alcohol abuse and dependency in a pregnant woman is also prevention of FAS in her fetus." This concept of treatment-as-prevention is particularly important in confronting FAS because alcohol-dependent women are most at risk of giving birth to a child or children with FAS, and because these high-risk women appear to be relatively unresponsive to so-called "universal" prevention strategies that target women in general or those of child-bearing age. NIAAA recognizes that FAS-impaired children themselves need treatment over a long period of time to help them cope with their disorder and their social environment, as well as to prevent future alcohol abuse among them. However, that aspect of prevention and treatment research is beyond the scope of this RFA. The purpose of this initiative is to prevent the occurrence of FAS rather than to deal with its consequences. There is, of course, an exception to this exclusion. To the extent that FAS-impaired girls and women constitute a subpopulation who are themselves at high risk of ultimately giving birth to alcohol-impaired children, then this subpopulation can become the target of prevention research under this RFA. Still, that research should be restricted to the prevention of FAS in the next generation of offspring. Interventions proposed for testing under this RFA should focus on the prevention of drinking by pregnant women and women who are likely to become pregnant. Other Federal agencies are supporting research and demonstration projects aimed at reducing pregnancy among abusers of alcohol and other drugs. Because no safe level of alcohol consumption during pregnancy has been identified, NIAAA and a host of societies of health professionals recommend that women should completely abstain from alcohol use during their pregnancies. That is the ideal goal of efforts to prevent FAS, ARBD, and ARND. However, significant reductions in the quantity and frequency of alcohol consumed by pregnant women can also be considered a beneficial outcome of preventive interventions. Thus, NIAAA defines its mission to be the support of research that targets any drinking and especially abusive drinking by pregnant women. Applications that focus only on the prevention of pregnancy among women who abuse alcohol are not eligible for funding under this RFA; but applicants may propose to confront the problem of FAS from simultaneous dual perspectives: attempting to reduce the use and abuse of alcohol by pregnant women while also encouraging postponement of pregnancy until the abusers of alcohol are able to control their hazardous behavior. Potential Prevention Strategies FAS was first described in the medical literature approximately 30 years ago. Since that time, a number of efforts have been made to prevent its occurrence among the population as a whole and among high-risk drinkers in particular. Yet, only a small group of scientifically-based studies have been conducted for the purpose of informing the selection and implementation of prevention strategies. Moreover, it is difficult to draw convincing inferences regarding the prevention of fetal alcohol syndrome from studies that target other forms of substance abuse among pregnant women (such as cigarette smoking and use of crack/cocaine). Extrapolation must take into account differences in: the strength of the dependencies, deleterious effects on the fetus, legal availability of the substances, perceptions of potential harm to the fetus among the medical profession and the larger society, and/or measures of intervention effectiveness. The IOM report on FAS referred to earlier emphasizes the need for a comprehensive approach to its prevention. However, it is rarely possible for investigators to cover all bases within the confines of a single study, even when the research is community based. Scarce financial resources and the requirements of focused state-of-the-art science constrain comprehensiveness. Thus, applicants are encouraged to develop and/or test a piece or integrated pieces of what will ultimately prove to be a comprehensive approach to FAS prevention. Options include strategies within the domains of primary, secondary, or tertiary prevention or within the newly conceptualized domains of universal, selective, and indicated interventions. Primary prevention focuses on healthy persons and seeks to avoid future problems; secondary prevention focuses on detection and treatment of early or asymptomatic disease; and tertiary prevention attempts to prevent the progression of the disorder and additional impairment. The newer typology takes into account the breadth of the target group, risk of having the disorder, and the benefit/cost ratio of committing resources to its prevention. Universal approaches target entire populations or subpopulations without regard to risk; selective strategies target subgroups known to be at higher than average risk; and indicated interventions target persons with individual risk factors that require more immediate intervention. Clues from prior studies. Applicants are encouraged to review the literature on interventions and strategies applicable to the prevention of alcohol-related birth defects, particularly the approach or approaches they intend to test in their proposed research. In a recent working group on FAS prevention, co- sponsored by NIAAA, ORWH and the Interagency Coordinating Committee on Fetal Alcohol Syndrome, relevant intervention studies were discussed. The approaches focused on policy (environmental) changes and on changing the behavior of individuals as individuals, through more personalized interventions that enhance knowledge, motivation, and skills. The following conclusions and inferences can be drawn from the discussion of completed research specifically concerned with FAS, ARBD, or ARND: 1. Community-based programs that attempt to educate the public and train health professionals and teachers about FAS can increase knowledge and concerns about risks, and acceptance of the abstinence goal; but behavior change is more difficult to achieve. 2. Universal approaches are more likely to alter the behavior of light than heavy drinkers; therefore, community-based strategies should also include interventions tailored to the needs of relevant (e.g., pregnant) high-risk or problem drinkers, who may require long-term case management and advocacy programs. 3. Screening women in health-care populations concerning their drinking behavior can identify significantly more women at risk than would the examination of obstetrics/gynecology (OB/Gyn) records; and data suggest that the assessment itself may serve as a useful intervention. 4. Studies indicate that brief interventions, counseling, and treatment for at- risk pregnant women can reduce their drinking, maintain abstinence, and improve health outcomes for subsequently delivered babies. Within health maintenance organizations (HMOs), counseling services should be located on-site, within the OB/Gyn area, to facilitate immediate referral and reduce stigmatization. 5. Exposure to warning labels that mention the risk of birth defects can reduce alcohol consumption among pregnant women, at least modestly for short periods of time; but the labels do not appear to influence the drinking behavior of older pregnant women, those with higher parity, and/or the higher-risk drinkers. Other relevant options. The list of potentially effective FAS intervention strategies that have yet to be tested is lengthy. Ideas are forthcoming from a review of the whole panorama of alcohol-focused prevention research that focuses upon environmental strategies as well as those oriented toward individuals and includes studies of naturally occurring interventions as well as those designed and implemented by the investigators themselves. Historically, studies of policy approaches (such as raising the minimum legal drinking age, lowering legally acceptable BAC levels for drinking drivers, and increasing the taxes on beverage alcohol) have shown important preventive impacts on alcohol abuse and related problems. Functional equivalents for FAS prevention could include policies that focus more specifically on deterring alcohol use by pregnant women. For example, certain jurisdictions require that messages describing the risk of birth defects be posted at points of purchase. Effects of different types of messages and different types of server training might be tested. Where circumstances permit, the interventions might be designed by the research team for testing in the "real world" or in research laboratories. Alternatively, it may be possible for investigators to measure the effects of new or existing naturally-occurring policies and programs. These policies might include controversial attempts by courts (or tribal councils) to protect the fetus by mandating treatment or confinement to treatment for pregnant women with a history of alcohol abuse. In jurisdictions where such policies have been implemented, studies could help decision-makers understand their consequences. Occasional articles in the media indicate that these kinds of interventions have been authorized in special situations, but their effects have not been systematically evaluated. As indicated above, various components of the health-care system (such as HMOs) have established and implemented their own prevention policies and programs that tend to include universal, selective, and/or indicated strategies. In some cases, these interventions have become integral parts of OB/Gyn care, even though they have not been subjected to rigorous tests of their effectiveness. Whether such programs can be studied as "natural experiments" depends on the availability of uncontaminated baseline data, the identification of appropriate comparison or control groups, the ethics of denying the program to the controls, and other scientific considerations (e.g., the frequency of focal outcomes, and clear distinctions between the intervention being evaluated and possible confounders associated with that particular health-care system). Thus, there are strong reasons for applicants to develop and test interventions that they themselves initiate and implement with the collaboration of relevant groups, systems, and/or communities. These interventions may focus on specific dimensions of the environment in which alcohol is distributed, sold, and consumed; on groups and individuals at excess risk; and/or on families and significant others of persons at risk. An expanding body of research indicates that family involvement can be an important and statistically significant prevention approach. However, the types of family interventions that have been tested outside the treatment domain tend to be slanted toward parental roles (e.g., monitoring the child's behavior, setting clear and consistent rules, and constraining the availability of alcohol). It remains to be determined whether parents, siblings, spouses, partners, and even children can impact on the drinking behavior of pregnant women. Outcome Variables Because FAS, ARBD, and ARND are rare events, it may be difficult or impossible to measure the extent to which these focal endpoints are affected by the intervention of interest. However, other outcomes such as women's drinking behavior and indices of the baby's health (e.g., birth weight, gestational age) may serve as proxy measures of the effectiveness of the intervention, as long as their relationship to FAS or other alcohol-related birth disorders can be justified. Drinking patterns are generally assessed through self reports, which may be inaccurate or deliberately falsified. Thus, applicants are encouraged to verify these reports through whatever means are possible (laboratory tests, collaboration by significant others, etc.). By definition, the incidence of FAS is affected by pregnant women's consumption of alcohol. Therefore, their drinking behavior is obviously the key mediating variable linking a preventive intervention to FAS outcomes. For this reason applicants should make certain they use state-of-the-art measures of the quantity and frequency of alcohol use and that they take into account variations in drinking rates and other measures on the basis of gender. Methodological Approaches Applicants may propose to use any methodological approach that is appropriate for their research endeavor, qualitative as well as quantitative and quasi- experimental as well as experimental. However, the selected approach should be state-of-the-art for the discipline involved and should be clearly described and justified. Even where the principal investigator has strong methodological skills, it may be advisable to include among the research team an expert in study design and/or statistics. 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). 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 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. NIH POLICY AND GUIDELINES ON THE 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by February 23, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: RFA AA-99-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: grantsinfo@nih.gov The RFA label available in the PHS 398 (rev. 5/95) 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 2 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. Non-conforming applications will be returned without being reviewed. Submit a signed, typewritten original of the application, including the checklist and three signed photo copies 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) At the time of submission, two additional copies of the application must also be sent to: RFA AA-99-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Applications must be received by March 23, 1999. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may 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 that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed assigned a priority score, and receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. 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 review, comments on the following aspects of the application will be made 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 the assignment of the overall score. Significance: Does the study address the goals of the RFA? If the aims of the study are achieved, how will scientific knowledge be advanced? Will the study advance the concepts or methods that drive this field? 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 designs? Feasibility: Can the design be implemented (including recruitment of subjects, cooperation of relevant organizations, and/or collection of necessary data)? Innovation: Does the project employ novel concepts, approaches, theories, or methods? Investigator: Are the principal investigator and key research personnel appropriately trained and well suited to carry out this work? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Budget: Is the requested budget and estimation of time to completion of the study appropriate for the proposed research? In addition, plans for the recruitment and retention of subjects will be evaluated as well as the adequacy of plans to include both genders and minorities and their subgroups and children as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. 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 Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding applications under this RFA to: Suzanne M. Heurtin-Roberts, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 Bethesda, MD 20892-7003 Telephone: (301) 443-0639 FAX: (301) 443-8774 Email: sheurtin@willco.niaaa.nih.gov Joyce Rudick Office of Research on Women's Health National Institutes of Health Building 1, Room 201 Bethesda, MD 20892 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: jr27q@nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@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 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 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. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any 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.
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