RFA-AA-00-002: STUDYING SPIRITUALITY AND ALCOHOL

Department of Health
and Human Services (HHS)

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STUDYING SPIRITUALITY AND ALCOHOL Release Date: February 7, 2000 RFA: AA-00-002 National Institute on Alcohol Abuse and Alcoholism The Fetzer Institute Letter of Intent Receipt Date: April 24, 2000 Application Receipt Date: May 24, 2000 THIS REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT AND JUST-IN- TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The Fetzer Institute (http://www.fetzer.org) in Kalamazoo, Michigan is a non-profit foundation that supports scientific research and education exploring the relationship of the physical, mental, emotional, social, and spiritual dimensions of life. It joins with the National Institute on Alcohol Abuse and Alcoholism (www.niaaa.nih.gov) in co-sponsoring this RFA. This RFA is intended to support research to better understand the role of religiousness and spirituality in the prevention and treatment of and recovery from alcoholism and alcohol-related diseases. There is a growing interest in the impact of religious and spiritual commitment and activities on health outcomes. Medical scientists, in general, have understudied the role and relationship of religion and spirituality in health and this has also been the case for alcoholism research. Yet, the history of alcohol use and alcoholism is intertwined with spirituality and religion. Many religious traditions express strong beliefs about alcohol use and some encourage specific practices with regard to the consumption of alcohol. Some treatment programs insist that spirituality be at the core of any enduring recovery from alcohol addiction. Further work is needed to better understand the role of religiousness and spirituality as protective and/or risk factors in the development of alcohol disorders. Studies are needed on the role and efficacy of spirituality in intervention programs, and on the effects of race, gender and ethnicity on the relationship between spirituality and alcohol abuse and alcoholism. This RFA builds upon the presentations and discussions held in a conference entitled Studying Spirituality and Alcohol, held February 1-2, 1999, and co-sponsored by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health and the Fetzer Institute. The meeting brought together experts from a variety of disciplines, including alcohol researchers, neuroscientists, treatment professionals, religion researchers, and general health experts to examine spirituality and alcoholism from a multi-disciplinary perspective. The conference reviewed conceptual issues, the current state of knowledge, the best available methodologies, and promising avenues for future research. Copies of the conference summary are available and may be obtained by sending a request to Madhu Gola, Office of Collaborative Research Activities, National Institute on Alcohol Abuse and Alcoholism at mgola@willco.niaaa.nih.gov or (301) 443-7043 (fax). This RFA follows the conference and is designed to stimulate research on the influence of spirituality on the prevention of alcohol abuse, the development and treatment of alcohol dependence and alcoholism, and on the maintenance of long-term recovery from alcohol dependence. Applications will be submitted to the NIH and will be reviewed according to normal NIH peer review procedures. Applications judged meritorious, but not funded by the NIAAA, will be eligible for funding by the Fetzer Institute. Applicants eligible for funding consideration by the Fetzer Institute will be notified following completion of the NIH peer review process. At that time it will be the applicant’s responsibility (following the application guidelines of the Fetzer Institute) to submit the application, along with the NIH prepared summary statement, to the Fetzer Institute to be eligible for Fetzer Institute funding. 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 Request for Applications (RFA), Studying Spirituality and Alcohol, is related to the priority areas of alcohol abuse and alcoholism. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21) award mechanism. Normally Exploratory/Developmental Research Grants supported under this RFA will be for $50,000 or $75,000 per year (direct costs) for up to two years, but maybe for up to $100,000, if well-justified. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an Exploratory/Development Research Grant application submitted in response to this RFA may not exceed two years, although requests for no-cost extensions may be considered. R21 awards are not renewable, however, it is the expectation that successful exploratory/developmental projects supported through this RFA will lead to the subsequent submission of regular research project grant (R01) applications. Applications for competitive supplements to existing R01 research grants for $100,000 (direct costs) or less a year for up to two years will also be accepted. In planning to submit an application for a supplement to an existing grant, the investigator should assure that the grant meets the requirements to be supplemented. Competing supplements cannot exceed the parent grant project period. The program administrator should be consulted before submission of a competing supplement application. This RFA is a one-time solicitation. The anticipated award date is September 29, 2000. FUNDS AVAILABLE The National Institute on Alcohol Abuse and Alcoholism and the Fetzer Institute intend to commit up to $1 million in FY 2000 to fund 7 to 10 new grants in response to this RFA. An applicant may request a project period of up to two years and a budget for direct costs of up to $100,000 per year for an R21 or a competitive supplement to an existing grant. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. BACKGROUND Alcoholism and alcohol-related problems have an enormous impact on our society. Most adults can drink alcohol moderately and responsibly without complications. However, nearly 14 million Americans meet the medical criteria for a diagnosis of alcohol abuse or alcoholism. In addition, it is estimated that about 40 percent of Americans have direct family experience with this issue. Although a dollar figure cannot adequately reflect the social and human devastation caused by these illnesses, it is estimated that the economic and health care costs to society from alcoholism and alcohol abuse are nearly $167 billion annually. Much of this cost is related to lost productivity, motor vehicle crashes, alcohol-related medical expenses and crime. Cirrhosis is the tenth leading cause of death in the United States and a significant portion of this incidence is related to alcohol dependence. Only a fraction of the total cost, around $10.5 billion, is attributable to treating alcohol dependence and its medical consequences. Alcoholism is a disease associated with alcohol seeking and the increasing dominance of alcohol in a person"s life, a dominance that essentially displaces other concerns and responsibilities. Why some people who drink get into trouble from alcohol use, while many others do not has been a central question in alcohol research. It is clear that there are genetic influences on an individual"s risk for alcoholism, but environmental influences are also key factors. Religiousness and spirituality are a part of the internal and external environment which should be considered when dealing with individuals facing the risk of alcoholism and in dealing with and treating people with alcohol problems. Religiousness and spirituality form interlocking pieces of a multidimensional construct. Looking at various aspects some features have emerged. Spirituality may be found within or outside of specific religious traditions. It can be related to attitudes about life"s meaning and purpose, fundamental connections among people, or the value people give to themselves and others. These can be crucial for coping with difficulties and motivating behavior. Studies have typically found less alcohol abuse among people claiming to be very religious than among less religious people. Recovery from alcoholism is often associated with corresponding increases in spiritual measures, although the causal direction is not clear. It is also unclear to what extent some aspects of religion/ spirituality may be risk factors for alcoholism and alcohol-related diseases. As a foundation for the development of rigorous research on these issues, the Fetzer Institute supported the development of an annotated bibliography on spirituality and substance use. The bibliography was developed by Drs. William Miller and Melanie Bennett of the University of New Mexico and is available on the website: http://casaa-0031.unm.edu/bib/fetzer.html. It is the result of a series of literature searches that cross spirituality terms with alcohol terms with the citations entered into a structured database. There are different therapies for alcoholism that may have a spiritual base. Alcoholics Anonymous (AA) is a worldwide organization that advocates a spiritual approach to recovery. AA is a major social movement that has grown in size and significance in shaping public opinion, yet the mechanisms by which members are helped and the nature and degree of that help remain inadequately understood. AA and groups that use this approach can provide solid ground for exploring the relationship between spirituality and treatment. Studies are needed to elucidate the spiritual aspects of AA affiliation, the relationship of spirituality and possible differences in attendance and involvement in AA, and the role of spirituality in mechanisms of change. In addition, there is a need for further study of other programs based on religious and spirituality precepts. A recent multi-site trial found that a 12-step facilitation treatment was at least as effective, and on some outcome measures more effective, than two other treatment approaches, previously well supported by outcome research (Project MATCH Research Group, l997). However, little is understood about 12-step programs from a cross-cultural perspective, and the efficacy of culturally developed programs addressing the spiritual needs and alcohol problems of specific cultural groups, (e.g., American Indians) have been inadequately studied. It is customary to assess drinking behavior together with a broad range of dimensions of functioning to understand the process of recovery. Physical health, psychological adjustment, legal status, employment, emotional stability, and cognitive functioning are typically studied. However, greater attention to spirituality may also lead to a better understanding of the process, prevention, and treatment of alcoholism. Reliable findings will emerge from studies that utilize strong measures, define constructs carefully, and propose clear hypotheses which are tested using rigorous methodology. KEY CONCEPTS, MEASURES, AND METHODS While some may regard religiousness and spirituality as indistinguishable, others see the terms as distinct but intertwined. Generally, religiousness has specific behavioral, social, doctrinal, and denominational characteristics because it involves a system of worship and doctrine that is shared within a group. Spirituality can be characterized as concerning the transcendent (that which is addressing ultimate questions about life"s meaning with the assumption that there is more to life than what we see or fully understand). Spirituality can call one beyond oneself to concern and compassion for others. There is no need to polarize the two constructs. Religions aim to foster and nourish the spiritual life, and spirituality is often a salient aspect of religious participation, but it is possible to adopt the outward forms of religious worship and doctrine without having a strong relationship to the transcendent. Researchers should be clear in the operationalization of these multidimensional constructs within their specific research programs so it is clear what is being measured. Religiousness and spirituality, like personality and health, are complex, multi-dimensional constructs. In an earlier effort, the National Institute on Aging (NIA) and the Fetzer Institute developed a working document that identified different domains of religiousness and spirituality that may be relevant for studies involving health and health outcomes (see reference below). Domains identified by NIA and Fetzer working group include: meaning, values, beliefs, forgiveness, private religious practices, coping, history, commitment, organizational religiousness, and daily spiritual experience. The working group also concluded that domains to be used in studies for specific populations or disease processes need further refinement. A multi-dimensional approach to the characterization of religiousness and spirituality is a reasonable starting point for conducting research on alcohol and religiousness/spirituality. The multi-dimensional approach can help by focusing on specific aspects or a combination of aspects of religiousness and spirituality that are most relevant to the topic studied. In addition to the NIA/Fetzer supported report on measurement issues, there are a large number of measures of spirituality and religiousness in use in various research. Dr. Peter Hill, a presenter at the conference, and Ralph Hood recently published a book examining many of these measures (see reference below). There is room too, for further development of dimensions of the construct that might have particular relevance for populations suffering from alcohol use disorders. RESEARCH ISSUES The following areas illustrate suitable topics for research. While applicants are not limited to these themes, they are advised to consult with program staff on the relevance of their proposed subject to the RFA. Prevention/Intervention Issues Studies to determine the role of religiousness/spirituality as a protective factor and/or vulnerability influence for alcoholism. Research to explore the aspects of religiousness/spirituality that are most relevant as protective and/or risk factors. Studies to determine the aspects of religious traditions that influence the risk of alcohol abuse. Studies of the role of spirituality in adolescent development and how this relates to alcohol use among adolescents. Research on the role of individual spiritual practices (prayer, meditation, readings, etc.) in intervention programs that are not spirituality based. An exploration of the effectiveness of spiritually focused interventions. An examination of spirituality in the different stages of substance abuse: from initial use, to continued use, to dependence, and in primary prevention vs. secondary prevention. Treatment and Recovery Issues 12-Step Programs Studies of the role of spiritual or religious ingredients in 12-step treatment programs. This might include studies on the association of spirituality/religiousness and personality factors in individuals in spirituality based intervention programs. Determine the relationship of spirituality/religion and cohesiveness of spirituality-based 12 step programs including the relationship of spirituality/religion and attendance vs. engagement in the process of 12 step groups. Examine the effectiveness of spirituality-based 12-step programs in cross cultural contexts. Research to determine whether consideration of a patient"s spirituality might lead to more efficacious assignment to type of treatment. Research in spirituality/religiousness and Alcoholics Anonymous: This might include how spirituality is understood, differences with other treatment adjuncts and behavior associated with core spiritual beliefs. An exploration of the influence of spirituality and religious beliefs in non-spirituality-based treatment programs Encouraged are well thought out qualitative studies which explore the role of religious and spiritual factors on the experience of treatment and recovery. Studies of the effectiveness of treatment programs that incorporate a traditional or cultural spiritual focus. The relationship of spirituality/religion to known personal traits and cognitive and affective variables associated with recovery (e.g., regret/remorse, self responsibility). Examine how an individual’s spirituality changes as the person progresses into dependence and then through treatment and recovery. Evaluate whether clergy trained in therapies, e.g. motivational enhancement techniques, are more effective in supporting those in recovery to maintain sobriety than clergy who are not trained. Studies of the role of religious institutional support, (e.g., African American inner city churches) in the community matrix of care and other integrated approaches to alcoholism treatment. Studies of the possible role of spirituality in natural recovery. Health Services Research Research to determine effective models of formal and informal linkages between organized religion and alcohol services. Studies to determine the effect of religion-based services (e.g., pastoral counseling) on access to alcohol treatment services - the effectiveness of clergy as gatekeepers? An exploration of whether reimbursement for spirituality-based alcohol services affects access, quality and outcomes of those services. Physiological Relationships Research on the use of neuroimaging techniques and electrophysiological assessments to better understand mechanisms involved in spirituality and alcoholism. Multi-disciplinary approaches that include physiological, psychological, and spiritual aspects of prevention, treatment, and recovery from alcoholism. Other Research Areas Research on the relationship of spirituality and spiritual resources of the family of an alcoholic and the family’s ability to cope. Studies of the moderating effects of gender, race, and ethnicity on the relationship between religiousness/spirituality and alcoholism. An examination of the domains and qualities of spirituality and religion often neglected in research (perceptions of guilt, one"s religious history, non-religious spiritual practices, and qualities such as hope and joy) in relationship to treatment outcome. Studies of alcohol problems and spirituality/religiousness over different stages of the life-course. SPECIAL REQUIREMENTS An annual meeting will be held in the Washington, D.C., area to facilitate the exchange of information and coordination among investigators. Applicants must include support for these required meetings in the budget request. 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 was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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. LETTER OF INTENT Prospective applicants are asked to submit 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 Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the following address by the letter of intent receipt date listed in the heading of this RFA. RFA: AA-00-002 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409,MSC 7003 Bethesda, Maryland 20892-7003 Rockville, Maryland 20852 (for express/courier service) APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) 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 Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail: GrantsInfo@nih.gov. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested. 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $100,000 per year for R21 applications. Applications for competitive supplements to existing research grants for less than $100,000 (direct costs) a year for two years will also be accepted. The total project period for an application submitted in response to this RFA may not exceed two years. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications, with full citations. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Be sure to type the RFA number on the label. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. 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. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: RFA :AA-00-002 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. 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 comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional consideration pertinent to the review of Exploratory/Developmental Grant (R21) applications: o 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. Schedule Letter of Intent Receipt Date: April 24, 2000 Application Receipt Date: May 24, 2000 Peer Review Date: July/August, 2000 Council Review: September 13, 2000 Earliest Anticipated Start Date: September 29, 2000 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. As indicated above under the Purpose of the RFA, applications will be submitted to the NIH and will be reviewed according to normal NIH peer review procedures. Applications judged meritorious, but not funded by the NIAAA, will be eligible for funding by the Fetzer Institute. Applicants eligible for consideration by the Fetzer Institute will be notified following completion of the NIH peer review process. At that time it will be the applicant’s responsibility to submit the application, along with the NIH prepared summary statement, to the Fetzer Institute (following the application guidelines of the Fetzer Institute) to be eligible for Fetzer Institute funding. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries should be limited to the persons identified below as NIH administrators. Direct inquiries regarding programmatic issues to: Raye Litten, III, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 505 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 443-0636 FAX: (301) 443-8774 E-mail: rlitten@willco.niaaa.nih.gov Vivian Faden, Ph.D. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 514 6000 Executive Boulevard Bethesda, Maryland 20892-7003 Telephone: (301) 594-6232 FAX: (301) 443-8614 E-mail: vfaden@willco.niaaa.nih.gov Antonio Noronha, Ph.D. Chief, Neuroscience and Behavioral Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 402 6000 Executive Boulevard Bethesda, Maryland 20892-7003 Telephone: (301) 443-7722 FAX: (301) 594-0673 E-mail: anoronha@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Ms. Judy Simon Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 FAX: (301) 443-3891 E-mail: js182a@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) 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. REFERENCES: Multidimensional Measurement of Religiousness/Spirituality for Use in Health Research, January, l999, John E. Fetzer Institute (info@fetzer.org or http://www.fetzer.org)) Hill, P.C. and Hood, R.W., Jr. (1999) Measures of Religiosity. Birmingham, AL: Religious Education Press. Miller, William R. Spiritual Aspects of Addictions Treatment and Research. Mind/Body Medicine. (1997) 2:37-43. Project Match Group. Matching Alcoholism Treatments to client Heterogeneity. Project MATCH Three Year Drinking Outcomes. Alcoholism: Clinical and Experimental Research (1998) 22 (6):1300-1311.

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