EFFECTIVENESS OF STRATEGIES FOR PREVENTING DUI RECIDIVISM Release Date: December 4, 1998 PA NUMBER: PAS-99-023 P.T. National Institute on Alcohol Abuse and Alcoholism National Highway Traffic Safety Administration, Department of Transportation Center for Substance Abuse Treatment, SAMHSA Application Receipt Date: March 18, 1999; standard receipt dates thereafter PURPOSE The purpose of this program announcement is to stimulate research that addresses the problem of recidivism among people convicted of drinking and driving offenses. This includes individuals who are apprehended for driving under the influence (DUI), driving while intoxicated (DWI), or related offenses such as driving after suspension for a DUI and violation of zero tolerance laws, and are either convicted or otherwise sanctioned for such illegal behavior. Applicants who respond to this program announcement are encouraged to develop research applications that design, develop, implement, and/or test interventions that have the potential of preventing or reducing DUI recidivism. Such interventions may be investigator initiated and implemented in collaboration with appropriate members of judicial, administrative, and policy-making bodies specifically to test or compare their efficacy in preventing or reducing DUI recidivism. Alternatively, the interventions to be studied may occur naturally in society as laws, regulations, policies, and practices implemented by legally constituted bodies and may be tested for their effectiveness by researchers who use the established methodologies of studying "natural experiments." Over the past 15 years, there has been a marked decrease in alcohol-related fatalities and in alcohol-impaired driving among the U.S. driving population as a whole. Research indicates that these reductions have resulted in part from the adoption and implementation of several laws by all or many States. These legal changes include raising the minimum legal drinking age to 21 by all States, implementing administrative license revocation, increasing the severity and expanding the types of sanctions for convicted DUI offenders, and reducing legally acceptable BAC levels to .08 for drinking drivers. However, much remains to be learned about the relative effectiveness of specific sanctions, singly and in combination, for violators of the aforementioned new laws. Of particular concern is how to deal most effectively with persons with multiple DUI offenses. The goal of this program announcement is to expand research in this domain as a means of building a firmer knowledge base to assist judges, prosecutors, and other decision makers in making choices among the various options available to them in sanctioning DUI offenders. 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 is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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: 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, 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 research support may be obtained through applications for a regular research project grant (R01), small grant (R03), or exploratory/developmental grants (R21). R21 grants are limited to up to 2 years for up to $100,000 for direct costs per year. Applicants for Exploratory/Developmental Grants will need to cite the program announcement for Secondary Analysis of Existing Health Services Data Sets (PA-97-066) in addition to this program announcement in their application. Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications from investigators who wish to collaborate on research. Further information on the IRPG mechanism is may be obtained in PA- 96-001, which is available on the internet at http://www.nih.gov/grants/guide/pa- files/PA-96-001.html. Potential applicants for Exploratory/Developmental Grants may obtain copies of the specific announcements from the NIAAA Home Page at http://www.niaaa.nih.gov or from the Office of Scientific Affairs, NIAAA, 6000 Executive Boulevard, Suite 409, MSC 7003, Bethesda, MD 20892-7003, telephone: 301-443-4375 or FAX 301-443-6077. Further information on grant mechanisms and areas of research interest may be obtained from program staff listed under INQUIRIES. FUNDS AVAILABLE At least $1,300,000 in total costs will be available for three to five awards in the first year of awards. 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 September 30, 1999. RESEARCH OBJECTIVES Background In spite of the decreasing prevalence of DUI, it remains a major alcohol-related problem in the United States and the leading cause of death for persons between the ages of 1 and 24. The extent of the problem is illustrated by the following data: o Of the 41,967 persons killed in traffic crashes in 1997, 16,189 (39 percent) died in alcohol-related crashes. This translates into one alcohol-related death every 32 minutes during 1997. o An additional 327,000 persons (about 10 percent of all those injured in crashes) received their injuries in alcohol-related crashes. o At some point in their lives, three in every 10 Americans will be involved in an alcohol-related crash. o About 1.5 million people were arrested in 1996 for driving under the influence (DUI) or driving while intoxicated (DWI). Drunk driving recidivism rates are high: approximately one-third of drivers arrested or convicted of DWI each year are repeat offenders. A 1994 study published in the New England Journal of Medicine concluded that drivers involved in alcohol-related fatal crashes were eight times more likely to have had DWI convictions in the previous 5 years than drivers randomly selected from the general population of licensed drivers. The National Highway Traffic Safety Administration (NHTSA) indicates that in 1996, about one in six drivers with positive BAC levels who died in traffic crashes had been convicted of driving while intoxicated during the three previous years. And a 1995 California study suggests that 44 percent of drivers convicted of DUI in that State are reconvicted of DUI within 10 years. The magnitude of the DUI recidivism problem prompted NHTSA and NIAAA to collaborate in sponsoring a series of working groups of judges, prosecutors, and alcohol researchers to discuss what is known about effective prevention and treatment interventions for DUI offenders and to develop two guides for judges, prosecutors, and other relevant administrators to help them confront the problem of DUI offenders. A Guide to Sentencing DUI Offenders, published in 1996 by the Department of Transportation (DOT HS 808 365), discusses the sentencing process, factors influencing risk for recidivism, specific sanctions and remedies, rehabilitation options for offenders sentenced to treatment, compliance and reporting, and research needs. The second guide, Sentencing and Dispositions of Youth DUI and Other Alcohol Offenses, (referred to below as the Youth Guide) is currently in press and focuses on youthful offenders. Because all States have adopted laws making age 21 the minimum legal drinking age, sales to and purchase, possession, and consumption of alcohol by minors usually are illegal (although laws and specific penalties vary among the States). For that reason, the Youth Guide has a broader focus of interest including laws and sanctions directed at alcohol-related offenses by persons under age 21, including DUI. Preparing the guides has made abundantly clear to NIAAA and NHTSA that the existing knowledge base regarding the effectiveness of specific sanctions for DUI offenders provides limited guidance for judges and other decision makers who daily must choose among the available options. For that reason, these two agencies, as well as the Center for Substance Abuse Treatment (CSAT), which served in an advisory role in the preparation of the Guides and which has a strong interest in the effectiveness of interventions with DUI offenders, are jointly inviting the research community to propose new studies that can help address the fundamental unanswered questions about the outcomes and effectiveness of various sanctions singly and in combination, and which populations and under what conditions the interventions are most effective. Applicants should justify their choice of interventions for study based on relevant theories of behavior change for individuals and, where possible, on existing data suggesting positive intervention effects. Applicants should explain why the chosen intervention should be expected to prevent DUI recidivism. Applicants also may propose small-scale feasibility or pilot studies as a prelude to later designing more complex intervention research. Possible Interventions for Study In the field of alcohol-problem prevention research, a popular way of conceptualizing interventions is to distinguish between universal, selective, and indicated approaches in terms of certain characteristics of the target group. This typology takes into account the breadth of the target group, its risk of having the disorder or problem of concern, and the benefit/cost ratio of committing resources to its prevention in that particular target group. 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. Since the objective of this research endeavor is to prevent DUI recidivism, the critical target population is that group of people who have already been arrested or apprehended for committing DUI, and the proposed interventions must show promise of preventing (or reducing) their drinking, their driving, or the combination of these behaviors. The risk of recidivism varies across the heterogeneous DUI offender population, depending on such factors as the frequency of driving after drinking, number of prior DUI offenses, and the offender's age, sex, ethnicity, and history of alcohol-related problems. Specific subpopulations may be the focus of a proposed study. Of particular interest are persistent DUI offenders who pose an especially difficult problem for both public safety and the courts, and thus are a highly desirable focus of proposed research to reduce recidivism. Several factors known to facilitate reduction of recidivism across the spectrum of DUI offenders also should be considered, including consistency, certainty, and coordination of sanctions. In addition, it is important that such legally prescribed policies as mandated screening for alcohol and other drug problems and other mandatory sanctions be fully and consistently implemented; that sanctions be made increasingly severe for repeat offenders; that courts, evaluators, probation officers, and treatment providers be integrated into a coordinated system to ensure compliance with the sentence, since failure to address non- compliance greatly undermines the effectiveness of a sanction and the authority of the court. Sanctions imposed on DUI offenders may have several objectives. They simultaneously seek to 1) protect the road-using public, 2) hold the offender accountable to the victim and/or the community, and 3) provide education and/or treatment to the offender through a combination of retribution, general and specific deterrence, incapacitation, rehabilitation, and restorative justice. Thus, a combination of sanctions often is needed to achieve these goals. It is important to note, however, that the goal of this program of research is to measure the effectiveness of sanctions on recidivism. For this reason, investigators should not focus on the general deterrent effect on the driving public of the countermeasure being studied. However, sanctions that are very effective in reducing recidivism may also have a general deterrent effect if they are highly publicized. A number of specific intervention options identified in the Guide to Sentencing DUI Offenders and the Youth Guide might be rigorously evaluated with various populations in a jurisdiction in which they currently are being used. Alternatively, the sanctions may be deliberately implemented so as to facilitate systematic evaluation in jurisdictions where they are not currently being used. Many of the sanctions identified in the guides have been assessed only with adult populations or have included such small samples of youth that their effectiveness with this population has not been determined. Offender Sanctions Offenders most frequently are sentenced to jail terms (including weekend detention), probation (with a wide range of conditions of probation), fines, and court-mandated license suspension/revocation. Each of these sanctions may vary widely in length or amount, as well as the conditions of supervision and may be the subject of assessment under specific conditions or with particular subpopulations. o Based on studies available through 1995, the Guide to Sentencing DUI Offenders concludes that jail may be effective as a general deterrent, but it appears to be no more effective as a specific deterrent for reducing DUI recidivism than other sanctions, and it is far more costly. Moreover, mandatory jail sentences may so overload the court and correctional system that the implementation of jail sentences actually is curtailed. Nevertheless, incarceration may be the most appropriate and/or effective sanction with certain offenders. o Weekend interventions programs provide opportunities to assess the offender's alcohol and other drug problems, permit individualized treatment plans, and allow offenders to remain on the job. One study suggests that repeat offenders in such programs have lower recidivism rates than those sentenced to jail or given suspended sentences and fines. However, more research is needed. o Detention in facilities dedicated to DUI offenders incapacitates high-risk offenders for various lengths of time and may offer opportunities for rehabilitation services, but research on the impact of detention combined with treatment programs is very limited. o Probation is not a single program or strategy; rather, the conditions of probation vary widely. Moreover, there is little data on the effectiveness of particular programs of varying length and scope as conditions of probation. Research might explore the short and longer-term outcomes with DUI offenders of each of the following sanctions or combinations of them as a condition of probation: intensive probation, home detention, electronic monitoring, license or vehicle restrictions, fines and/or community service, and attendance at victim impact panels or at Alcoholics Anonymous. For example, a NHTSA study found that recidivism rates one year after sentencing were 33 percent lower for the experimental subjects sentenced to home detention and electronic monitoring (6 percent) than for those of individuals in a control group (4 percent). However, the effectiveness of most other conditions of probation, both through the probationary period and beyond it, and the extent of compliance with these conditions, have not been carefully assessed. o Since offenders often fail to comply with all the terms of their sentence, investigators may explore the costs and benefits of implementing various mechanisms to increase compliance with sanctions. These might compare scheduled meetings with the sentencing judge; increased phone monitoring by probation officers, and brief incarceration for even minor infractions. o Based on findings that suggest drug courts have been effective in reducing the recidivism rates of drug offenders, it would be useful to test and evaluate the drug court model with DUI offenders. Administrative Licensing Actions The courts share responsibility for managing DUI offenders with State departments of motor vehicles (DMVs). DMV agencies maintain critical records and have administrative power to suspend a driver's license and vehicle registration and to determine when a suspended offender is eligible for reinstatement. Although administrative license suspension (ALS) and revocation (ALR) are civil actions, they have been found to be among the most effective in reducing DUI recidivism. In contrast, judicial license suspension is a post-conviction action ordered by the court. o Studies of administrative license suspension clearly indicate that it is effective in reducing DUI recidivism and the risk of crash involvement among drinking drivers. Optimal suspension periods appear to be between 12 and 18 months, but suspension periods tend to be shorter, in part, because it is believed that suspension has a negative impact on a driver's employment and family welfare. Although some research suggests that job loss is not a major problem, it continues to be a significant factor in persuading courts not to impose license restrictions as a sanction. The length and impact of this sanction merits further rigorous study. o Researchers might assess the effectiveness of various civil remedies or court- based sanctions for driving after suspension, which is a serious offense that occurs frequently, but appears to be addressed inconsistently. Vehicle-related Sanctions Several recent studies suggest that efforts to reduce illegal driving by convicted alcohol-impaired drivers through vehicle impoundment, license plate impoundment and tagging, and/or use of alcohol ignition interlocks may all be effective, both during and after the sanction period. While there is a growing body of research on ignition interlocks, research on other vehicle restrictions is limited; thus, investigators might usefully explore the effectiveness of other vehicle sanctions during and after the sanction period. o Recent data on the effectiveness of vehicle impoundment suggests that recidivism and crashes can be reduced for suspended license offenders. Data on vehicle forfeiture are limited and might be further studied, particularly the conditions under which this intervention can be effective. For example, whether forfeiture is equally effective with all groups of offenders and the optimal duration of different vehicle-related sanctions are unclear. o Vehicle tagging (the placement of a sticker over portions of the license plate indicating that the owner has a suspended driver's license) appeared to reduce traffic violations and crashes when it was implemented in Oregon. Further examination of this administrative approach would be valuable. Treatment and Rehabilitation Options The research literature on the treatment of alcoholism is largely silent on the specific treatment needs and most effective approaches for the subcategory of persons who enter the treatment system as a result of a court order following apprehension and/or conviction for DUI. It is unknown, for example, whether treatment programs found to have been effective with voluntary patients (e.g., cognitive behavioral therapy) also are effective with those ordered by the court to enter them. A meta-analysis of 225 intervention/treatment programs for DUI offenders (including educational programs and well as self-help, outpatient, and inpatient treatment programs), indicated that such programs could reduce recidivism by 7 to 9 percent. For many first offenders, the shock of being arrested and exposure to offender education classes may have been sufficient to deter further DUI. Nevertheless, the content, format, and number of educational materials probably varied widely and was not rigorously assessed. Since recidivists tend to exhibit higher rates of alcoholism and more alcohol-related problems than first-time DUI offenders, treatment interventions in a criminal justice setting with the recidivist population also merit further examination. Other treatment-related research questions include how to sustain abstinence and prevent relapse with various groups of DUI offenders following treatment interventions. o Educational programs may include didactic lectures on the medical and legal consequences of drinking or DUI, discussions that more actively involve offenders, and/or video presentations. One study found that for non-alcoholic DUI offenders, education reduced recidivism somewhat more than did fines alone. It is unclear, however, what program content is most effective and what period of involvement is most effective in reducing recidivism. o Data on treatment effectiveness is limited but suggests that recidivism may be reduced among DUI problem drinkers if they are required to participate for at least a year in an intensive treatment program that involves weekly therapy sessions and bi-weekly individual interviews with either a therapist or probation officer. Project MATCH found that alcohol dependent (but not necessarily DUI offender) clients treated in both inpatient and outpatient sites were equally likely to reduce their drinking in response to three treatments (cognitive- behavioral therapy, motivational enhancement therapy, and twelve-step facilitation). The effectiveness of these treatment regimes under conditions of court coercion with the DUI offender population might be usefully explored. o Research findings are mixed, and further study is needed concerning the effectiveness of diversion programs where prosecution is deferred while the offenders undergo long-term treatment. Similarly, studies might be undertaken that test the effects of deferred prosecution following informal probation and community service, or other such conditions. o Alcoholics Anonymous (AA) is the most popular self-help group for alcoholics. However, it is not clear how AA can be used most effectively as an intervention strategy for DUI offenders. An additional challenge to the court and to researchers is how to integrate the three sanction areas-- license suspension, alcohol education and treatment, and punitive sanctions such as jail -- that currently are used to manage DUI offenders. Combining treatment with incarceration or brief interventions with court processing and screening, for example, may be occurring and should be evaluated. Specific Issues for Youth-Focused Research In the absence of tested adolescent-specific interventions, many of the sanctions identified above (whether age-appropriate or not) have been applied to youthful DUI offenders as well as adults but have not been rigorously evaluated with a youthful population. In addition, there is a need to develop and test interventions specifically tailored to the developmental and social needs of adolescents. These may be novel approaches (as long as theoretically or empirically justified), or investigators may modify common adult interventions to make them age-appropriate. Researchers should note, however, that there are special challenges and research issues that arise in addressing youthful DUI offenders. Some are related to the fact that their special age status permits many alcohol-related cases involving youth to be handled by the juvenile court. It is not known, for example, whether the court to which a youth's alcohol- related offense is referred (traffic, juvenile, criminal or family court) results in different sanctions and whether these, in turn, result in different compliance and recidivism rates. Other questions are related to the implementation and outcomes of special laws that apply only to youth. These include zero tolerance laws requiring that they have no measurable BAC level when driving or risk loss of driving privileges. Further uncertainties revolve around the role and responsibility of parents for minor children and how best to involve them in the sanctioning process. o There are now more than 280 teen courts operating in 31 States. These are designed to hold offenders accountable for their actions while freeing court dockets. Individual programs have conducted internal evaluations of their effectiveness, but there has been no standardized overall evaluation of teen courts. o License suspension and revocation may be particularly effective among youth since the driver's license is an especially prized possession among them. Studies of license actions among youth might usefully explore the optimum period of license suspension and revocation among young people, which may differ from that of adults due to zero tolerance laws. o The evidence is mixed regarding the effects of community service on recidivism or crashes among adult DUI offenders. It has not been evaluated among youthful offenders but may be particularly appropriate as a form of restorative justice for youth given their limited ability to pay financial restitution and lower likelihood of need for alcohol treatment. Other forms of restorative justice that merit further systematic evaluation particularly among youth include victim- offender mediation, attendance at victim impact panels, and emergency department visitation. o The potential involvement of parents in the youth sanctioning process and the effects of their involvement merit study. For example, does their attendance at court proceedings, in parenting skills classes, or in restitution programs with their children reduce the recidivism of youthful offenders? Methodological Issues and Outcome Measures To assess the efficacy of interventions and the effectiveness of intervention programs for DUI offenders, researchers may propose experimental or quasi- experimental study designs, as well as secondary analyses of existing data sets that permit tests of the effectiveness of sanctions but where the data have not been fully or appropriately exploited. The selection of interventions for testing should be theory-driven whenever possible. Formal theories postulating mechanisms of change from a particular intervention may be drawn from multidisciplinary sources such as the behavioral, biomedical, developmental, and/or social sciences. For example, Jessor's problem behavior theory, Bandura's social learning theory and Prochaska and DeClemente's stages of change theory may be useful. Research to establish the efficacy of an intervention must include appropriate comparison groups. The single most powerful procedure available to provide unbiased comparison groups is the random assignment of subjects to experimental and control conditions. While courts have often opposed randomization as antithetical to individualized sentencing, many judges appreciate the need for randomization and its justice were the alternative sentences appear to be of equivalent severity and their relative effectiveness is unknown. Similarly, a proposed intervention that cannot be assigned to all eligible offenders due to resource limitations may use randomization to offer all eligible offenders an equal opportunity to enter the program or obtain the treatment. Proposals that use quasi-experimental designs, including natural experiments that use time-series analyses, are also welcome. Whatever the chosen methodological design and analysis plan, they must be justified in terms of their appropriateness for the task at hand. Applicants must defend their choice of methods in terms of their scientific credibility, but pragmatic considerations may also be relevant. For example, randomization may not be acceptable to authorities in the particular judicial system in which the proposed study will take place; or the law may mandate that a new naturally occurring intervention that the applicant proposes to evaluate must be universally applied, forcing the investigator to seek appropriate controls elsewhere. Where randomization is proposed, applicants must be able to justify "treatment indifference" from an ethical perspective -- i.e., that the intervention to be tested has not been proven to be superior (or inferior) to the alternative intervention(s). Otherwise, it may be unethical to propose randomization. Researchers also should address potential problems of (a) self selection and (b) sample attrition, as well as assure (c) sufficient statistical power to detect differences in intervention efficacy or effectiveness when they really exist. 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. Since the purpose of this program announcement is to stimulate research on interventions to prevent or reduce DUI recidivism, outcome measures (or endpoints) must be relevant to this objective. Direct evidence of recidivism may include alcohol-related crashes, and reconvictions, rearrests, or new citations for DUI. Because offender self-reports of violations would in many instances constitute an admission of illegal behavior that could lead to additional sanctions, self reports are likely to produce biased and unreliable data. If used as an outcome measure, they should be augmented with corroborative information from collaterals or archival data. With respect to reducing DUI recidivism and alcohol-involved traffic crashes, mediating and moderating variables may affect the outcome. Both program inputs (e.g., more intense monitoring) and program outputs (e.g., increased perception of the risk of sanctions for drinking and driving) may contribute to such intermediate changes as reduced drinking or modified driving behaviors. In creating intervention programs, researchers need to identify and model the anticipated mediating and moderating factors that are likely to contribute to intermediate and more distal changes in the outcome measures. Such factors may include dispositional and personality characteristics (e.g., sensation-seeking), offender perceptions of risk of apprehension for violating the sanction and actual enforcement mechanisms, and integrity of the delivery of the intervention (e.g., whether the education program is delivered as described by the provider). While the DUI outcome is the ultimate measure of program effectiveness, explanatory models of the change process, measures of program implementation and integrity, and data identifying the sociodemographic and personality characteristics of the study population are essential elements in the cumulative process of understanding program success or failure and linkages between the intervention processes and their outcomes. The complexity of the problem and difficulties in establishing new programs for study suggest that some investigators may prefer to design feasibility studies. These might address such issues as how best to operationalize interventions for use in specific real-world legal or jurisdictional environments; the feasibility, costs, and relative effectiveness of having different types of individuals in a community (e.g., professionals, paraprofessionals, or community-based volunteers who receive special training) perform offender screening or act as probation officers; or constructing or adapting protocols for use among culturally diverse or youthful populations. Given the complex nature of the specific research problem and the desirability of implementing a true experimental design if possible, collaborative efforts between researchers and justice system practitioners are strongly encouraged. For example, researchers with expertise in alcohol treatment, criminal justice, and traffic safety research may wish to collaborate with criminal justice system practitioners including judges, treatment providers, and/or probation department personnel to maximize the competence of the study team investigating different aspects of the common topic. 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 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 20, 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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (e.g., 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 a the following URL address: http://www.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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted on March 18, 1999 and on the standard application receipt dates each year thereafter. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7710, Bethesda, MD 20892-7910, telephone 301-710-0267, Email: [email protected]. 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. The completed original application and five legible copies must be sent or delivered 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 that are complete 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national 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. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers 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 a major scientific impact and thus to 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. 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? 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? Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? Budget: Is the requested budget and estimation of time to completion of the project appropriate for the proposed research? In addition, plans for the recruitment and retention of subjects will be evaluated as will the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goal 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 will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this program announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Susan E. Martin, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8767 FAX: (301) 443-8774 Email: [email protected] Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4706 FAX: (301) 443-3891 Email: [email protected] 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 or 45 CFR Part 95, as applicable. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The Public Health Service (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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