This Program Announcement expires on January 10, 2005, unless reissued. RESEARCH ON ALCOHOL AND HIV/AIDS Release Date: December 17, 2001 PA NUMBER: PA-02-039 See Replacements PA-07-028 (R01), PA-07-064 (R03) and PA-07-063 (R21) National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov) 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) seeks applications to support research to identify and characterize the role of alcohol, drinking behaviors, and drinking environments in the epidemiology and natural history, pathogenesis, prevention, treatment and control of HIV/AIDS. The goal of this Program Announcement is to encourage multidisciplinary, interdisciplinary, and collaborative studies that focus on a range of epidemiologic and intervention issues within HIV and alcohol. It advances research goals set forth in the NIH Fiscal Year 2002 Plan for HIV-Related Research. Relevant objectives identified in the plan include: o Characterize the relative importance of alcohol and drug use in the acquisition and subsequent transmission of HIV in order to identify and apply appropriate alcohol and drug use interventions as public health measures. o Investigate the social and environmental factors that contribute to HIV infection, behaviors after infection, and co-occurring conditions (e.g., substance use, mental illness, homelessness, hepatitis, STDs, tuberculosis), including the causes and implications of stigma. This Program Announcement is intended to appeal to a broad audience of alcohol and HIV/AIDS researchers, including alcohol researchers with no prior experience in HIV/AIDS research, but with a keen appreciation for the relationship between problem drinking and HIV/AIDS and a strong interest in acquiring such experience, HIV/AIDS researchers with no prior alcohol research experience who realize the importance of more intensive alcohol interventions to improving clinical outcomes among HIV+ individuals, and those with prior research experience in the area of co-occurring HIV/AIDS and alcohol and other substance abuse. Given the breadth of research objectives included in this announcement, potential applicants are encouraged to carefully review all sections of the announcement for research opportunities. 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, Research on Alcohol and HIV/AIDS, 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), and small grant (R03)award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants for R01s may request support for up to 5 years. Applications requesting direct costs of $500,000 or more in any one year must obtain written agreement from the NIAAA that the application will be accepted for consideration of award, in accordance with NIH policy, which is available at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. Currently, small grants (R03) are limited to 2 years for up to $50,000 per year for direct costs, and exploratory/developmental grants (R21) are limited to $100,000 per year for direct costs for up to 3 years. Exploratory/developmental grants and small grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. BACKGROUND Alcohol consumption and its consequences together with HIV/AIDS are major public health burdens in many parts of the world. Chronic abusive alcohol use can lead to life threatening organ system damage. Light to moderate consumption can induce behavioral and organ system changes which may influence HIV transmission, pathogenesis, and disease progression. There is overlap between persons at risk for alcohol-related problems and individuals at risk for HIV infection. Regardless of the level consumed, alcohol is likely to influence the health status and behaviors of persons infected with HIV and those whose behaviors place them at risk for acquiring the virus. An estimated 14 million Americans suffer from alcohol abuse and dependence and an additional 50,000 new cases of HIV infection are reported each year. Estimates of the co-occurrence of alcohol abuse/dependence among individuals infected with HIV range from approximately 30 to 70% in different samples. For example, more than 60% of HIV-infected participants in the MIDAS (Miami HIV Infected Drug Abuser Study) reported current heavy alcohol use. The prevalence of alcohol dependence among HIV-infected men is approximately three times that of women, and both prevalences substantially exceed those for alcohol dependence for men and women in the U.S. population overall. As HIV/AIDS research becomes more focused, there is growing evidence that alcohol consumption may play an important role in sexual transmission, susceptibility to infection, and progression of HIV disease. In addition, alcohol use, abuse, and dependence may have a significant impact on the occurrence and course of comorbid conditions such as HCV and TB, adherence to medications and provider advice, provider and patient attitudes towards treatment, and survival. Special emphasis has been given to research which examines the effectiveness of interventions that extend beyond the level of the individual, with the aim of bringing all of the resources of a given community to bear on the twin epidemics of alcohol and other substance abuse and HIV/AIDS. This focus is, in turn, consistent with goals articulated by the international AIDS research community in its attempt to stem the spread of HIV/AIDS in resource poor areas of the world. With increasing knowledge of the dimensions of the HIV epidemic in parts of Asia and Africa has come heightened awareness of the critical importance of involving community members as equal partners in every aspect of the research process. In addition to being a possible risk factor in the contraction and progression of HIV disease, alcohol misuse is likely to impact adherence to complex HIV medication regimens and to physician advice. Recent evidence has indicated interactive effects of alcohol use and HIV infection on brain functioning and cognitive processes. Whether alcohol consumption increases susceptibility to opportunistic infections in HIV+ patients and whether alcohol-induced immunosuppression affects pathogenesis and disease progression are important questions. However, carrying out research on the effects of alcohol consumption and drinking behaviors on HIV-related health outcomes is challenging. While clinical findings have associated increased levels of chronic alcohol consumption with diminished immune function, as evidenced by reduced levels of CD4 and CD8 activity, many questions about the relationship between alcohol consumption, increased susceptibility to HIV infection, and accelerated progression to AIDS remain unanswered. Strain variations of HIV, individual differences in susceptibility, long incubation time following seroconversion and varying patterns of adherence to HIV medications are only some of the challenges in studying disease progression. Comorbid mental and somatic illnesses and environmental stress are additional confounding factors. It is therefore of continuing importance to conduct research which seeks to clarify the role of alcohol in HIV transmission and disease progression, and to develop and test preventive interventions which both reduce the risk of alcohol-related HIV transmission and improve the treatment of HIV infected alcohol abusing and/or alcohol dependent individuals. RESEARCH OBJECTIVES The complex and global nature of unresolved questions surrounding alcohol and HIV/AIDS relationships indicates the need for a multidisciplinary approach to research. Investigators representing a broad array of academic disciplines and engaged in cross-cutting fields of science are encouraged to consider designing hypotheses-driven studies that utilize rigorous methodologies from epidemiological, clinical, and experimental research. Special emphasis areas include: Epidemiology and Natural History of Alcohol Use and HIV/AIDS: Improved understanding of the epidemiology of alcohol use, abuse, and dependence in HIV infection and AIDS will help to identify high-risk groups and promote development of effective HIV prevention and treatment efforts, including medical management of HIV/AIDS disease. For example, studies are needed to: o Gain insight into the alcohol-HIV/AIDS relationship through population-based research on alcohol consumption patterns of groups at-risk for HIV infection. o Identify and model the impact of alcohol consumption patterns on the spread of HIV infection and associated opportunistic infections over time. o Examine patterns of HIV infection and variability in strains of HIV in heavy drinking populations both in the U.S. and abroad to guide vaccine development. o Characterize alcohol use and alcohol use disorders in high-risk groups with HIV/AIDS and co-occurring medical and psychiatric conditions. o Describe more fully the role of gender, race/ethnicity, cultural and environmental factors in the intersection of alcohol and HIV/AIDS epidemics. o Examine the impact of alcohol-related social policies, including those affecting legal and illegal alcohol production, access, taxation, etc., on the spread of HIV and other STDs. Prevention of HIV Risk Behaviors Related to Alcohol: Behavioral, affective, and cognitive factors affect the risk for HIV infection and the efficacy of HIV prevention and treatment among alcohol users and abusers. Models should be developed for interrelating these individual factors with contextual and social factors that influence alcohol misuse, sexual risk-taking, and other HIV risk behaviors. Development and testing of new interventions are needed at various levels, including: individual, dyadic, social network, organizational, and community. The following areas are suggested and not exclusive: o Develop community-based interventions, e.g., bar-based server training, to alter alcohol availability and to improve linkage of alcohol and HIV preventive services. o Develop school-based interventions, including middle school, high school, and college curricula focusing on the relationship between alcohol-related sexual risk behaviors and HIV/AIDS. o Target and retain the highest risk drinkers (including those from difficult- to-reach, underserved populations)in HIV/STD prevention and treatment interventions - including trials for prophylactic vaccines. o Motivate drinkers-including those who perceive themselves to be at low risk for HIV infection-to decrease risky sexual and substance use behaviors. o Assess relationship of alcohol consumption, alcohol-related sexual expectancies, social norms, and decision-making on HIV risk behaviors. o Develop and test preventive interventions based on social dynamics and environmental characteristics of high-risk alcohol-related settings and situations (e.g., bars, parties, neighborhoods with a high density of drinking outlets, etc.). o Develop and test family and peer group interventions to reduce alcohol use, unsafe behavior and exposure to co-occurring risks such as violence, poor health care and disease. o Improve methods for assessing and analyzing complex relationships between alcohol use and abuse, psychological, and environmental factors, including alcohol regulations and policies, and HIV-related risk behaviors. Medical Aspects of Treatment Among HIV-Positive Individuals with Alcohol Use Disorders: Alcohol use may be a key determinant in disease transmission and progression, adherence and response to therapeutic regimens, among other effects. Still many questions remain unanswered with regard to how the co- occurrence of HIV/AIDS and alcohol abuse/dependence currently influences clinical decision making, and how provider practices could be modified to improve clinical outcomes. Research is needed to determine whether and how alcohol affects disease progression in various organ systems in HIV+ individuals, to develop and evaluate pharmacological interventions for the treatment of alcohol dependence in HIV+ individuals, to guide the development of HIV treatment regimens tailored to the needs of people with coexisting alcohol abuse/dependence, and to improve motivation for treatment and adherence to treatment. Specifically research efforts are needed to: o Develop and test therapeutic regimens which are based on a)drug-drug interactions between alcohol and antiretroviral medications, b)changes in drug metabolism in individuals with alcohol-related liver dysfunction and other physiologic impairments, c)results of testing for drug resistance, and d)lifestyle factors in heavy drinking populations (e.g., structured treatment interruptions, salvage therapies, etc.). o Study the effects of alcohol on the transmission of HIV from mothers to children. o Compare the efficacy of various pharmacological interventions for the treatment of alcohol dependence (e.g. Naltrexone) in HIV+ individuals. o Advance understanding of the dynamics between alcohol use and abuse and adherence to HIV therapeutic regimens, and test strategies to improve compliance with HIV therapeutic regimens. o Investigate mechanisms by which alcohol consumption affects liver disease progression in individuals with HIV, including those coinfected with hepatitis C (HCV), to improve clinical outcomes in heavy drinking populations. o Improve guidelines for prophylaxis and treatment of opportunistic infections by examining the relationship between alcohol-related host defense impairment and the emergence and course of disease caused by pathogens such as M. tuberculosis, S. pneumoniae, P. carinii and HCV. o Investigate impact of alcohol on HIV-specific complications including neuropathogenesis and pathogenic processes involved in AIDS dementia, peripheral neuropathy, cardiomyopathy, enteropathy and wasting, among other conditions. o Study the impact of alcohol on fat redistribution and other aspects of fat, protein, and carbohydrate metabolism and nutrition in individuals with HIV/AIDS. o Enhance linkage of primary medical care with alcohol prevention and treatment services for HIV-infected alcohol abusers. o Improve medical technology for rapid diagnosis and determination of HIV genetic subtypes and drug resistance patterns in heavy drinking and other high- risk populations. Multi-level Behavioral and Psychosocial Approaches to the Treatment of Individuals with Co-occurring HIV/AIDS and Alcohol Abuse/Dependence: The implementation of research-based behavioral/psychosocial interventions which will complement state-of-the-art pharmacologic interventions for the treatment of alcohol dependence in HIV+ individuals will be critically important to the achievement of improved clinical outcomes. Research is needed to better characterize and address the impact of behavioral and psychosocial factors on access to treatment and on drinking and HIV/AIDS outcomes, and to ameliorate negative behavioral, affective, physical, cognitive and social consequences of HIV infection in alcohol-using and -abusing populations through multilevel interventions. Such interventions may target, separately or in combination, individuals, families, treatment programs and networks of programs, and communities. Specifically, research efforts are needed to: o Integrate alcohol risk reduction goals into HIV/AIDS treatment programs, including behavioral, psychosocial, and pharmacological interventions. Evaluate effectiveness of behavioral/psychosocial interventions to help individuals stop drinking and avoid relapse. Develop tailored treatments as needed for special populations such as underserved minorities, pregnant women, and those with comorbid psychiatric diagnoses. o Integrate HIV risk reduction goals into alcohol abuse treatment programs, including behavioral, psychosocial, and educational interventions. Evaluate the effectiveness of HIV risk reduction strategies in alcohol treatment settings. Develop tailored treatments as needed for special populations such as underserved minorities, pregnant women, and those with comorbid psychiatric diagnoses. o Develop and test interventions to improve the quality of life of individuals with coexisting HIV/AIDS and alcohol use disorders (e.g., strategies to reduce the impact of alcohol-related consequences on social, family, vocational functioning and well-being, and on the course of AIDS-related illnesses.) o Increase knowledge of effective collaborative approaches to the organization and management of services for HIV-positive adolescent alcohol abusers, including analyses of barriers to access and utilization of services, and strategies to overcome them (e.g., mobile vans as a means for improving health care access by alcohol abusers). o Improve understanding of the relationship between alcohol use and abuse, access to care, and delivery and cost of services for infected persons. Biological Research on Alcohol and HIV/AIDS: Lack of knowledge on the influence of alcohol on HIV infectivity and viral replication is a major impediment to understanding HIV-related morbidity and mortality. Therefore, research that provides detailed knowledge of how alcohol and HIV, each in its own way or acting in concert, usurp host defense mechanisms and co-opt vital cellular machinery to enhance viral replication is urgently needed. Biological research that delineates the multiple effects of alcohol and HIV on host defense mechanisms and disease progression will provide a rational basis for the development of new methods of therapeutic intervention. The following topics serve to illustrate the types of research that would be responsive to this PA: o Effects of alcohol on viral burden, immune function, and organ system dysfunction in HIV infected individuals or appropriate animal models. o Organ system changes at the cellular, molecular and tissue levels that may influence infectivity, viral load, disease progression and/or therapeutic response. o Animal models of alcohol consumption and AIDS to explore cellular changes and immune state dynamics. o New in vitro models to characterize the effects of alcohol on the response of cellular systems to HIV (e.g., blood brain barrier, placental barrier, etc.) o Drug-drug interactions between alcohol and antiretroviral drugs, including altered pharmacokinetics, metabolism and toxicity due to chronic or acute alcohol consumption. Community-Based Participatory Research: Community-based participatory research in public health is a partnership approach to research that equitably involves, for example, community members, organizational representatives, and researchers in all aspects of the research process. The partners contribute their expertise and share responsibilities and ownership to enhance understanding of a given phenomenon, and to integrate the knowledge gained with action to improve the health and well-being of community members. This Announcement seeks to promote community-based participatory research because it represents a critical distinction from "community-based research," which emphasizes conducting research in a community as a place or setting, rather than conducting research with members of a community who are full and equal partners. Such research recognizes the community as a social and cultural entity with the active engagement and influence of community members in all aspects of the research process. Within the area of community-based participatory research, suggested special emphasis areas include: o Research on the characteristics of community-based organizations and coalitions most likely to be successful in implementing effective science-based interventions in at-risk communities. o Studies which identify and evaluate outcome measures and data collection systems appropriate to the evaluation of research-based HIV prevention interventions implemented in community settings. o Research on models for facilitating cooperation among research and service professionals. o Studies of the mechanisms by which institutions network with other community agents and other community institutions. When and how do such connections and collaborations improve HIV and AOD prevention efforts? When and how do they fail to do so? o Multi-level collaborative research to study patterns of communication between various sectors of society (e.g., Federal, state, and local governments, community-based service organizations, and the business community, etc.) and their impact on the delivery of prevention, intervention, and treatment services to individuals with coexisting HIV/AIDS and alcohol use disorders. o Programs of community-based participatory research involving U.S.-supported researchers and researchers in other nations to evaluate community-level strategies to arrest the spread of HIV infection and its consequences. Dissemination and Diffusion of Research Findings: Despite advances in our knowledge of effective approaches to preventing HIV infection, it is clear that information, strategies, and models for HIV prevention have not always reached community program levels. Likewise, information developed by community programs has frequently not reached or influenced HIV prevention researchers. It is extremely important that more effective collaborative relationships between the research community and the community of public organizations delivering prevention programs to high-risk populations be developed in such a way that a sustainable research infrastructure is established and/or enhanced at the level of local communities. Models of technology transfer need to be developed and validated in large-scale community settings. These models must include effective training for community providers as well as ongoing assessment of what happens to research-based interventions when they are put into practice. Critical to the success of these efforts will be an awareness of the cultures in which the interventions were undertaken and ways in which existing interventions may have to be modified to be successful. Interventions which leave in place infrastructures capable of complex problem solving, program evaluation, and ongoing two-way communication with the research community should facilitate future technology transfer. Suggested areas of research include but are not limited to: o Studies that develop and test different models for transferring effective research-based HIV prevention interventions into relatively resource poor communities. o Studies of mechanisms that would enable community-based organizations to advise and communicate with the research community on needed research to improve responses to ongoing or emerging HIV-related public health issues. o Collaborative programs to train minority investigators to conduct clinical, biomedical, and prevention research which explores the impact of alcohol abuse on HIV transmission, disease progression, and clinical outcomes. 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 sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 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. DATA AND SAFETY MONITORING PLAN As of the October 2000 receipt date, applicants must supply a general description of the Data and Safety Monitoring Plan for ALL clinical trials, this must be included in the application http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. The degree of monitoring should be commensurate with risk. NIH Policy for Data and Safety Monitoring requires establishment of formal Data and Safety Monitoring Boards for multi-site clinical trials involving interventions that entail potential risk to the participants. The absence of this information will negatively affect your priority score. 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 RFA 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 must 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 format. Although applicants are 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 301/435-0714, 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 the original application as well as any subsequent revisions. 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. Although applicants are 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 301/435-0714, Email: GrantsInfo@nih.gov. 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 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 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, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional considerations pertinent to the review of Exploratory/Developmental Grant (R21) applications: Pilot/feasibility studies may contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. 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 concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues related to general NIAAA research priorities to: Kendall Bryant, Ph.D. Scientific Coordinator Alcohol and HIV/AIDS Research, NIAAA Chief, Collaborative and Special Health Programs Branch Office of Collaborative Research Suite 302 National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 402-9389 FAX: (301) 480-2358 Email: firstname.lastname@example.org Direct inquires regarding programmatic issues related to collaborative and medical research Deidra Roach, M.D. Office of Collaborative Research Suite 302 National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-5820 FAX: (301) 480-2358 Email: email@example.com Direct inquiries regarding programmatic issues related to epidemological research to: Vivian Faden, Ph.D. Chief, Division of Biometry and Epidemiology Suite 514 National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Bethesda, MD 20892-7003. Telephone: (301) 594-6232 Direct inquiries regarding programmatic issues related to the clinical and prevention research to: Margaret Mattson, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 443-0638 Fax: (301) 443-8774 E mail: firstname.lastname@example.org Direct inquiries regarding programmatic issues related to basic biological research to: Denise Russo, Ph.D. Chief, Division of Basic Research Suite 402 National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 402-9403 Fax: (301) 594-0673 E mail: email@example.com Direct inquiries regarding fiscal matters to: Judy Fox Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 executive Blvd. (MSC-7003) Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 443-2434 Email: firstname.lastname@example.org 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 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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