From owner-sci-resources@net.bio.net Mon Feb 01 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 31 January 1993 Message-ID: Date: 2 Feb 93 06:41:08 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 66 ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 92-139 Academic Research Infrastructure Program File size (bytes): 35714 STIS Filename: nsf92139 Title: NSF 93-6 - EHR Activities for Women and Girls in Science, Engineering, and Mathematics File size (bytes): 66413 STIS Filename: nsf936 Document Type: Recruit Title: Director, Division of Research, Evaluation and Dissemination File size (bytes): 6908 STIS Filename: vep933 Title: Head, Office of Systemic Reform (OSR) File size (bytes): 6865 STIS Filename: vep934 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vep934, the text of your message should be as follows: get vep934 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vep934, you would enter: ftp> get vep934 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Wed Feb 03 22:00:00 1993 Path: biosci!NSF.GOV!parzberg From: parzberg@NSF.GOV (Peter Arzberger) Newsgroups: bionet.sci-resources Subject: nsf9310 - NSF 93-10 GRAND CHALLENGE APPLICATIONS GROUPS (fwd) Message-ID: Date: 4 Feb 93 02:58:16 GMT Sender: kristoff@net.bio.net Reply-To: Peter Arzberger Distribution: bionet Lines: 351 Title : NSF 93-10 GRAND CHALLENGE APPLICATIONS GROUPS Type : Program Guideline NSF Org: CISE / ASC Date : February 3, 1993 File : nsf9310 GRAND CHALLENGE APPLICATIONS GROUPS Fiscal Year 1993 Program Announcement a component of the U.S. High Performance Computing and Communications Program NATIONAL SCIENCE FOUNDATION The National Science Foundation (NSF) announces opportunities for group oriented research for Fiscal Year 1993 in connection with the U.S. High Performance Computing and Communications (HPCC) Program. Six to eight proposals are expected to receive funding as Grand Challenge Application Groups as a result of the opportunities described in this announcement. Seven awards were made under this activity in Fiscal Year 1992. Activities supported under this announcement are expected to achieve significant progress on (1) fundamental problems in science and engineering whose solution could be advanced by applying high performance computing techniques and resources, and (2) enabling technologies which facilitate those advances. In addition, it is anticipated that these activities will generate significant new research in mathematics, computer science, engineering and other scientific disciplines. This HPCC activity will provide funding for multidisciplinary groups of scientists, engineers, mathematicians and computer scientists to apply emerging high performance computing and communications systems to advance the solution of diverse science and engineering problems. The emphasis will be on support for groups requiring HPCC capabilities, where such focused, cross disciplinary support is generally unavailable or difficult to obtain. Any area of science and engineering supported by NSF is eligible for funding under this solicitation. Grand Challenge Applications Groups are expected to employ testbed systems exploiting new and emerging computer and communications architectures to prepare the groundwork for the HPCC goal of sustained teraflop computing on important application problems by the mid 1990's. Projects funded through this effort will focus on the fusion of disciplinary research with emerging high performance computing environments and architectures, within the framework of the HPCC program goals. It is anticipated that projects will include aspects of design of models, algorithms and software, as well as problem solving environments, to fully realize the potential of parallel, distributed and heterogeneous computing systems on Grand Challenge Application problems and enabling technologies. These opportunities for support have been created through the cooperation of disciplinary sub-activities within NSF and other federal agencies participating in the HPCC program. This Federal interagency HPCC program seeks to expand U.S. technological leadership, speed the pace of innovation, and spur gains in U.S. productivity and competitiveness through advances in high performance computing and communications. The program responds to the opportunities for advances inherent in the use of advanced computer models incorporating the basic science of parallel processing and the improved productivity derived by the interaction of people who are spatially separated sharing networked access to information processing and computing resources. Additional information on NSF HPCC activities in conjunction with the interagency HPCC effort can be obtained from the NSF HPCC Coordinators listed as contacts in this document. Supported Activities Proposers are encouraged to provide innovative, collaborative approaches to formulating solutions to Grand Challenge problems. Among the activities that are appropriate for support include: research time for individual investigators, postdoctoral researchers, graduate students, HPCC equipment, testbed development, access to high performance computing systems, networking and communications, supplemental HPCC educational activities, and salary for technical support personnel. Criteria for Review All proposals to NSF are subject to the review criteria described in the NSF brochure, Grants for Research and Education in Science and Engineering (GRESE), NSF 92-89. Single copies of this brochure are available at no cost from the NSF Forms and Publications Unit, (202) 357-7861, or via e-mail (Bitnet: pubs@nsf or Internet: pubs@note.nsf.gov). The review criteria in GRESE deal with: quality of scientific effort proposed; competence of investigators; relevance of research; and impact on infrastructure. Proposals for Grand Challenge Applications Groups will also be subject to specific criteria that reflect the objectives of the interagency HPCC program: potential for impact in a critical area of science and engineering; creating significant interaction between focused scientific and engineering applications and computational activities that has broad implications in high performance computational activities beyond the specific scientific or engineering problem area or discipline being studied; development of new computational techniques for high performance systems with potential benefit for the broader scientific community; record of accomplishment and potential for advancing frontiers of high performance parallel, distributed or heterogeneous computing environments; extent to which the research proposed provides a testbed for the deployment of new high performance computing and communications systems; educational activities to increase the research participation and training of students and researchers. Reviewers will also consider the extent of involvement of women and minorities at all levels of the groups; innovative partnerships with national laboratories and private industry; and institutional participation and budgetary levels. Proposal Submission, Review and Award Processes Review of proposals will be coordinated across the Foundation, across all programs related to the proposed project. Proposals reviewed under this solicitation that overlap other inter-agency or NSF initiatives such as Global Change or Advanced Materials and Processing, will be referred to these activities for joint consideration. A combination of mail, panel, and site visit review may be used as needed. Awards are planned to be jointly funded between the programs involved, and coordinated among Federal inter-agency HPCC programs. Awards are planned to be in the range of $300,000 to $800,000 per year for a period of three to five years, but there are no firm restrictions on size or duration. The number and size of awards will be based on the quality and potential impact of the proposals reviewed, and the availability of funds. Preproposals Preproposals will be used to facilitate planning by NSF and to minimize work on potential proposals that are inappropriate or less likely to be competitive. Proposers interested in submitting a formal proposal must submit 12 copies of a preproposal by March 15, 1993 to: HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 The preproposal must contain the following information in the order indicated: 1 Page Title of group activity List of PI and Co-PI's with departmental and institutional affiliations Mailing and e-mail addresses, phone and FAX numbers, of PI only Abstract 3-4 Pages Outline of project plan Evidence of multidisciplinary interactions 1 Page Estimated first year budget (not binding on final proposal) 1 Page List of individuals with whom the PI or Co-PI's have had a close working relationship in the last 48 months Following Biographical sketch as per GRESE with a limitation Pages of 2 pages per PI and Co-PI's Since preproposals are not formal proposals, participant or institutional agreements are not necessary at this stage. Preproposals will be reviewed by a panel. The outcome of this review process will determine which groups will be encouraged to submit formal proposals. Groups not receiving encouragement are not prohibited from formally applying. It is anticipated that the results from the preproposal review will be announced during the first week of May. Final Proposal Deadline The deadline for receipt of proposals is June 16, 1993. Fifteen copies of final proposals, including one copy bearing original signatures and institutional approval, must be mailed to: HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 Only one copy of NSF Form 1225, Information about Principal Investigator/Project Director should be sent attached to the original signed copy. Proposals must be: i) received by NSF no later than June 16, 1993; ii) postmarked no later than five (5) days prior to the deadline date; or iii) sent via commercial overnight mail no later than two (2) days prior to the deadline date to be considered for an award. Proposals submitted in response to this announcement must be prepared and submitted in accordance with the guidelines provided in the NSF brochure, GRESE (92-89). However, the following are exceptions to the guidelines and specific to this activity only: the project description is limited to 15 pages (single spaced); each PI and Co-PI may use up to an additional 2 pages each to describe results under prior NSF support, focusing on those results relevant to the proposed project. Except for the above, proposals not conforming to these guidelines will be returned to the proposer. The review process will be concluded by mid-summer 1993, with announcement planned for September 1993. Inquiries For details on the U.S. High Performance Computing and Communications Program see the OSTP FCCSET report by the Committee on Physical, Mathematical, and Engineering Sciences entitled "Grand Challenges 1993: High Performance Computing and Communications." Copies can be obtained from the Directorate for Computer and Information Science and Engineering, NSF, 1800 G Street, NW, Room 306, Washington DC 20550. Inquiries relative to this announcement should be addressed via electronic mail to: hpccgrps@nsf.gov (Internet) or hpccgrps@nsf (Bitnet). Written inquiries may be made to HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 Related Computational Science and Engineering Activities The HPCC program at NSF is coordinated across all disciplinary research directorates to encourage joint review and support of proposals with ongoing computational science and engineering programs. All NSF disciplines continue to support base activities in computational science and engineering research within their disciplinary research programs in addition to their involvement with this Grand Challenge Applications Group activity. The Grand Challenge Applications Groups represent one, but not the only approach to support HPCC activities. CONTACT PERSONS AND RELATED ACTIVITIES General information on the HPCC program may be obtained from the NSF coordinator; particulars on a specific directorate's involvement from the relevant directorate level coordinator; and advice on specific projects from the appropriate disciplinary program manager. The NSF directorates are: BIO (Biological Sciences), CISE (Computer & Information Science & Engineering), EHR (Education and Human Resources), ENG (Engineering), GEO (Geosciences), MPS (Mathematical and Physical Sciences), and SBE (Social, Behavioral and Economic Sciences) NSF HPCC Coordinator: Merrell Patrick, (202) 357-7936, mpatrick@nsf BIO HPCC Coordinator: Peter Arzberger, (202) 357-7652, parzberg@nsf CISE HPCC Coordinator: Susan Gerhart, (202) 357-9747,sgerhart@nsf EHR HPCC Coordinator: Nora Sabelli, (202) 357-7751,nsabelli@nsf ENG HPCC Coordinator: Lawrence Goldberg, (202) 357-9618,lgoldber@nsf GEO HPCC Coordinator: Clifford Jacobs, (202) 357-9889, cjacobs@nsf MPS HPCC Coordinator: Robert Eisenstein, (202) 357-7985, reisenst@nsf SBE HPCC Coordinator: Paul Chapin, (202) 357-7696, pchapin@nsf Selected Computational Science and Engineering Activities Computational Biology, BIO: Peter Arzberger, (202) 357-7652, parzberg@nsf Computational Chemistry, MPS: Richard Hilderbrandt, (202) 357-7951, rhilderb@nsf Computational Engineering, ENG: George Lea, (202) 357-9618, glea@nsf Computational Materials, MPS: G. Bruce Taggart, (202) 357-9789, gtaggart@nsf Computational Mathematics, MPS: Alvin Thaler, (202) 357-3691, thaler@nsf Michael Steuerwalt, (202) 357-3691, msteuerw@nsf Computational Physics, MPS: Richard Isaacson, (202) 357-3464, isaacson@nsf Information, Robotics & Intelligent Systems, CISE: Y.T. Chien, (202) 357-9572, ytchien@nsf New Technologies, CISE: Robert Voigt, (202) 357-7727, rvoigt@nsf Numeric, Symbolic and Geometric Computation, CISE: Kamal Abdali, (202)357-7345, kabdali@nsf Theory of Computing, CISE: Dana Richards, (202) 357-7345, richards@nsf Computational Neuroscience, BIO: Donald Edwards, (202) 357-7040, dedwards@nsf The National Science Foundation (NSF) provides awards for research in the sciences and engineering. The awardee is wholly responsible for the conduct of such research and preparation of the results for publication. The Foundation, therefore, does not assume responsibility for such findings and their interpretation. The Foundation welcomes proposals on behalf of all qualified scientists and engineers, and strongly encourages women, minorities and persons with disabilities to compete fully in any of the the research and research-related programs described in this document. In accordance with Federal statutes and regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, denied the benefits of, or be subject to discrimination under, any program or activity receiving financial assistance from the National Science Foundation. Facilitation Awards for Handicapped Scientists and Engineers provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on an NSF project. See program announcement NSF 91-54, or contact the Facilitation Awards Coordinator, Directorate for Education and Human Resources, Washington, DC 20550, (202) 357-7461. The Foundation has TDD (Telephonic Device for the Deaf) capability, which enables individuals with hearing impairment to communicate with the Division of Personnel and Management about NSF programs, employment, or general information. The telephone number is (202) 357-7492. (202) 357-7492 This program is described in the Catalog of Federal Domestic Assistance category 47.070, Computer and Information Science and Engineering. Electronic Dissemination You can get information fast through STIS (Science and Technology Information System), NSF's online publishing system, described in NSF 91-10 (Revised 10/4/91) the "STIS flyer" (elsewhere in this publication). To get more copies of the flyer, call the NSF Publications Section at (202) 357-7861. For an electronic copy, send an e-mail message to stisfly@nsf.gov (Internet) or stisfly@nsf (Bitnet). Ordering by Electronic Mail If you are a user of electronic mail and have access to either Bitnet or Internet, you may order publications electronically. Bitnet users should address requests to pubs@nsf. Internet users should send requests to pubs@nsf.gov. In your request, include the NSF publication number and title, number of copies, your name, and a complete mailing address. Publications will be mailed with 2 days of receipt of request. NSF 93-10 OMB 3145-0058 P.T. 34 K.W. 1004000 From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 3, 5 February 1993 Message-ID: Date: 6 Feb 93 00:58:11 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1240 $$XID NIHGUIDE 19930205 V22N05 P3O3 ************************************ On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement (Surgical Management of the Epilepsy) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it to the Division of Research Grants. If the application is for a program project or center grant, please send the original and three copies to the Division of Research Grants. An additional two copies of the program project or center grant application sent to the address below would be useful for expediting the processing of these applications for multidisciplinary efforts. REVIEW CONSIDERATIONS Research project grant (R01) applications and FIRST award (R29) applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant (P01) and center grant (P50) applications will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate national advisory council. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review, o availability of funds, and o program balance among research areas. INQUIRIES Questions concerning scientific aspects may be addressed to: Charlotte B. McCutchen, M.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 114 Bethesda, MD 20892 Telephone: (301) 496-1917 FAX: (301) 496-9916 Questions concerning fiscal aspects may be addressed to: Patricia Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. $$P5 END ************************************************************ $$P6 BEGIN PA-93-51 ************************************************* RESEARCH GRANTS RELATED TO NARCOLEPSY NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-51 P.T. 34; K.W. 0715187, 0755030 National Institute of Neurological Disorders and Stroke National Institute of Mental Health PURPOSE The Division of Convulsive, Developmental, and Neuromuscular Disorders; National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) are revising and reissuing a NINDS program announcement on narcolepsy published in the NIH Guide to Grants and Contracts, Vol. 19, No. 15, April 13, 1990, to notify the scientific community of continuing NINDS/NIMH interest in the submission of research project grant applications related to narcolepsy. 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 priorities. This program announcement is related to the priority area of narcolepsy. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-0) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, 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. Foreign institutions are eligible for research project grants (R01) only. Applications from minority institutions, minority individuals, and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the investigator-initiated research project grant (R01), the First Independent Research Support and Transition (FIRST) award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project grants should contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Narcolepsy is a neurological condition characterized by irresistible episodes of sleep. The classic symptoms of narcolepsy are: (1) sleep attacks - sudden urges to sleep; (2) cataplexy - sudden generalized or partial flaccid paralysis; (3) hypnagogic hallucinations - sleep onset hallucinations; and (4) sleep paralysis - generalized paralysis before or at the time of falling asleep or on awakening. Narcolepsy has its typical onset in adolescence and young adulthood. There is an average 15-year delay between onset and correct diagnosis, that may contribute substantially to the disabling features of the disorder. Cognitive, educational, occupational, and psychosocial problems associated with the excessive daytime sleepiness of narcolepsy have been documented. For these to occur in the crucial teen years when education, development of self-image, and development of occupational choice are taking place is especially damaging. While cognitive impairment does occur, it may only be a reflection of the excessive daytime somnolence. The prevalence of narcolepsy in the United States has been estimated to be as high as one per 1,000. It is a major reason for patient visits to sleep disorder centers, and with its onset in adolescence, it is also a major cause of learning difficulty and absenteeism from school. Normal teenagers often already experience excessive daytime sleepiness because of a maturational increase in physiological sleep tendency accentuated by multiple educational and social pressures; this may be disabling with the addition of narcolepsy symptoms in susceptible teenagers. In clinical practice, the differentiation between narcolepsy and other conditions characterized by excessive somnolence may be difficult. Treatment options are currently limited. There is a paucity in the literature of controlled double-blind studies of possible effective drugs or other forms of therapy. Mechanisms of action of some of the few available therapeutic agents have been explored but detailed studies of mechanisms of action are needed before new classes of therapeutic agents can be developed. The neural control of normal sleep states and the relationship to narcolepsy are only partially understood. In humans, narcoleptic sleep is characterized by a tendency to go abruptly from a waking state to rapid eye movement (REM) sleep with little or no intervening non-REM sleep. The changes in the motor and proprioceptive systems during REM sleep have been studied in both human and animal models. During normal REM sleep, spinal and brainstem alpha motor neuron hypopolarization produces almost complete atonia of skeletal muscles via an inhibitory descending reticulospinal pathway. Acetylcholine may be one of the neurotransmitters involved in this pathway. In narcolepsy, the reflex inhibition of the motor system seen in cataplexy is believed identical to that seen in normal REM sleep. Despite the experimental evidence in human narcolepsy that there may be an inherited basis for at least some forms of narcolepsy, the mode of inheritance remains unknown. Research Goals and Scope The goal of this announcement is to stimulate research in both basic and clinical aspects of narcolepsy. The scope of this program encompasses both animal and human studies, that would utilize a variety of experimental approaches and methods. If experimental studies on human subjects are proposed, the protocols should contain recruitment procedures to encourage the participation of women and minorities. Examples of areas of potential research include studies on the pathophysiology of narcolepsy; abnormalities of circadian rhythms, particularly anatomical and biochemical substrates; the molecular genetics of narcolepsy; and the development of new therapies. New, more sensitive, and specific objective diagnostic procedures need to be developed and validated. While studies in the naturally occurring narcoleptic dog model suggest an autosomal recessive mode of transmission in that model, genetic analysis of cohorts of narcoleptic patients and identification of informative families are needed to define the mode of inheritance and to facilitate the search for gene markers. STUDY POPULATIONS POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded; however, every effort should be made to include human tissues from women and racial or ethnic minorities when it is important to apply the results of the study broadly. This directive should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. If the required information is not contained within the application, the review will be deferred until the information is provided. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the institutional office of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Applicants for program project grants (P01) should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. 6/92). Receipt dates for new research project grant (R01) applications and FIRST (R29) awards and for program project (P01) and center grant (P50) applications are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and the name of this Program Announcement (Narcolepsy) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it to the Division of Research Grants. REVIEW CONSIDERATIONS Research project grant (R01) applications and FIRST award (R29) applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant (P01) and center grant (P50) applications will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate national advisory council. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions quality of the proposed projects as determined by peer review, availability of funds, and program balance among research areas. INQUIRIES Questions concerning neurological/neuroscientific aspects of this Program Announcement may be addressed to: Charlotte B. McCutchen, M.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 114 Bethesda, MD 20892 Telephone: (301) 496-6701 FAX: (301) 402-0302 Questions concerning psychiatric aspects of the Program Announcement may be addressed to: Susan Blumenthal, M.D. Basic Prevention and Behavioral Medical Research Branch National Institute of Mental Health Parklawn Building, Room 11C06 Rockville, MD 20857 Telephone: (301) 443-4337 FAX: (301) 443-4822 Questions concerning fiscal aspects of this Program Announcement may be addressed to: Patricia Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. $$P6 END ************************************************************ $$XID RFA PA9347 PA-93-47 P1O1 ***************************************** PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-47 P.T. 34, FF; K.W. 0404003, 0414014, 0411005 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications related to the prevention of alcohol-related problems among ethnic minority groups of African Americans, Americans, Asian Americans, and Pacific Islanders. Most of these groups are at elevated risk for specific alcohol problems or may have changing patterns of increased alcohol consumption. All of these minority groups require the development and evaluation of culturally relevant programs of alcohol abuse prevention. NIAAA promotes innovative prevention research within a broad range of populations and is particularly interested in receiving methodologically sound and conceptually grounded outcome-oriented research applications. The primary objective of this program announcement is to expand the limited information available about the prevention of alcohol-related problems among ethnic minorities . While differential rates of alcohol problems have been well documented within minority communities, the link between ethnic identity and successful alcohol abuse prevention interventions has not. Research proposed within the domain of this program announcement should address factors that facilitate or impede the development, implementation, and evaluation of prevention strategies among diverse sociocultural populations. Attention should be focused on (1) the culturally-appropriate development or adaptation of interventions within these minority settings and (2) how ethnic minority identity relates to prevention research outcomes. In general, the impact of ethnicity on alcohol use and prevention of its abuse should be studied within a particular context, such as, alcohol availability control, server training, price increases, media messages, or psychosocial antecedents of high-risk behavior. 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, Preventing Alcohol-Related Problems Among Ethnic Minorities, is related to the priority area of alcohol abuse reduction. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign public and private non-profit and for-profit organizations, such as, universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01), small grant (R03), or FIRST award (R29). Applicants for R01s may request support for up to five years. The average direct cost per year for R01s is approximately $220,000. Small Grants are limited to two years for up to $50,000 per year for direct costs. FIRST award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST awards and small grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Annual continuation awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background Information on Alcohol-Related Problems and Use Among Ethnic Minorities In the United States, alcohol use is involved in nearly 100,000 deaths annually, including approximately one-half of the nearly 45,000 fatalities in traffic crashes; 27,000 deaths due to cirrhosis of the liver; and a high proportion of the deaths due to homicide, suicide, drowning, falls, burns, and other accidents. Alcohol abuse results in alcohol-related injuries and violence, marital discord, job loss, and serious medical consequences including birth defects. Alcohol-related problems and costs are unevenly distributed across racial and ethnic groups this uneven distribution may be related to cultural differences in drinking patterns. Surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among African Americans, Hispanic Americans, and Native Americans. In contrast, Asian Americans and Pacific Islanders have been found to have lower levels of alcohol use. However, recent evidence indicates that consumption may be increasing among these two groups. African Americans Alcohol-related Problems: African Americans comprise the largest ethnic minority in the United States, accounting for 12 percent of the total population. Results of a 1983 national study of drinking problems and patterns found that African Americans, especially males, are at high risk for acute and chronic alcohol-related diseases; such as, cirrhosis, alcoholic fatty liver, hepatitis, heart disease, and cancers of the mouth, larynx, tongue, esophagus, and lung. High rates of problem drinking and alcoholism in high-density, urban African American communities have been associated with assaults, homicides, accidents, trouble with the law, and family problems. Several studies have concluded that African Americans are at greater risk of accidents due to drinking than Caucasians. Patterns of Consumption: While overall rates of alcohol consumption are similar for African American males and Caucasian males, the two groups differ with respect to the age distribution of drinking and related problems. Among Caucasian males, frequent heavy drinking is most prevalent between 18 and 29 years of age; among African American males in that age group, heavy drinking is less frequent. Between 30 and 39, the rates of heavy consumption continue to be high for Caucasian males; however those of African American males rise sharply, surpassing those of Caucasians. Rates of heavy consumption gradually decrease for men of both races after 40. Racial differences in consumption patterns are even more pronounced among women, but in the opposite direction: i.e., African American women tend to drink less. Nearly half of African American women were found to be abstainers, compared with one-third of Caucasian women. A smaller proportion of African American women than Caucasian women are heavy drinkers. African American women in the 18-29 age group are significantly less likely to drink at all or to drink heavily than are Caucasian women. Prevention Research: An intensive search of the prevention research literature identified a number of primary and secondary prevention efforts focused on alcohol-related problems in the African American population of the United States, but none reported a systematic evaluation of program effects. Among the 130 demonstration projects initiated by the Office for Substance Abuse Prevention (OSAP) in 1987, 24 focus on African American high-risk youth and their families. Comparisons between the different minority-based demonstration projects have not been extensively reported. Studies of African Americans might focus fruitfully on men who are moderate drinkers, since African Americans are experiencing higher rates of alcohol-related problems than Caucasians with similar levels of consumption, for reasons that are not clearly understood. The increase in heavy drinking and alcohol-related problems among African Americans and Hispanics during their 30s suggests the need for interventions with this age group. Hispanic Americans Alcohol-related Problems: The growing Hispanic population consists of several distinct groups (Mexican Americans, Puerto Ricans, Cuban Americans, and persons from other countries of Central America, South America, and the Caribbean). These groups now comprise nine percent of the U.S. population. Hispanic males suffer disproportionately from alcohol dependence and problems related to alcohol abuse compared with African American and Caucasian males in the United States. Several studies suggest that Mexican American men drink more and are more likely to have alcohol-related problems than men in other major Hispanic subgroups. In contrast, Hispanic women are at lower risk for alcohol dependency and alcohol-related problems than are Caucasian women in the U.S. population. Nevertheless, the proportion who drink and have alcohol problems has been rising among second and third generation Hispanic women, as has the proportion experiencing related family problems. Patterns of Consumption: Several epidemiological studies have found that alcohol-use patterns among Hispanics differ somewhat from Caucasians. Specifically, Hispanic males drink less frequently but consume larger amounts, have more instances of very heavy or binge drinking, and have more instances of alcohol-related problems that continue throughout adulthood than Caucasian males. Hispanic females abstain or drink infrequently, usually in a family context. Consumption rates among Mexican American females are somewhat higher than those of females in other Hispanic groups. Hispanic drinking patterns are related to degree of acculturation, although the relationship differs by gender and nationality group. Male immigrants appear to quickly adopt a drinking pattern that blends the high frequency characteristic of U.S. male drinking with the Hispanic high quantity-per-occasion practice. Among Hispanic females, acculturation is associated with increases in both the proportion of women who drink and the amount they consume. In contrast to the men, however, this change in drinking patterns usually occurs in the first generation born in the United States rather than in the immigrant generation. Prevention Research: A comprehensive review of alcohol prevention programs targeted at Hispanic populations found that only one of these (the Ganadores "Winners" project) was systematically evaluated. The interventions implemented in that program included mass media messages and community-based activities designed to increase awareness of the dangers of alcohol and to change attitudes toward alcohol use and drinking behavior. The community activities included dissemination of educational materials and oral presentations by community leaders designed to make people think more about their own drinking. The program resulted in an increase in reported awareness and knowledge of the dangers of alcohol, but it did not change drinking behavior. Nine other current projects aimed at alcohol prevention among Mexican Americans have been recently described but have not been evaluated. Several aspects of the Mexican American culture may have implications for alcohol abuse prevention strategies and research. For example, cultural values may affect the identification of heavy drinking and the recognition of alcohol abuse as a health problem. There is a need to address the role of cultural values as contributors to (and potential moderators of) problematic drinking practices. In addition, interventions designed to increase awareness of the seriousness of alcohol problems should be tested. Where appropriate, research on alcohol use and abuse by Hispanics should also examine changes in immigrants' attitudes toward drinking. Native Americans Alcohol-related Problems: The Native American population consists of approximately two millon people and over 300 distinct tribal and ethnic groupings within the continental United States and Alaska. It is a young, diverse, rapidly growing population living in urban, rural, and reservation settings. Data for 1978-1980 and 1983-1985, indicate that alcohol abuse is a contributing factor in 4 of the 10 leading causes of death for Native Americans: accidents, chronic liver disease and cirrhosis, homicide, and suicide. Accidents are still among the leading causes of death for Native Americans. An estimated seventy five percent of all traumatic deaths and suicides among Native Americans are alcohol-related. Deaths from alcohol-related causes are particularly prevalent in the 25 to 44 age group. Many tribes, particularly in the West, have dramatically higher accident mortality rates than the national average. Fatal accidents among Native Americans are 2.2 to 2.3 times the national average. Patterns of Consumption: Alcohol use varies tremendously from tribe to tribe. Some tribes have a smaller proportion of drinking adults than the U.S. population, while others have more drinkers. Differences in drinking patterns may also relate to reservation and urban settings. The majority of Native American youth report experimentation with alcohol. Drinking among Native American youth is especially serious since mortality from alcohol-related causes is most common in younger years. Heavy recreational and binge drinking may account for unusually high rates of alcohol-related arrests and accidental deaths among young Native American males. In general, Native American women drink considerably less than men, but the prevalence of drinking among women is growing rapidly in some tribes, which may help account for the increase in the reported incidence of Fetal Alcohol Syndrome (FAS). Prevention Research: Most primary prevention programs aimed at Native Americans in recent years have been school-based, youth-oriented programs emphasizing information about the effects and consequences of alcohol and other substance abuse. Their specific effectiveness is largely unknown, as is the effectiveness of school-based programs in general. Several programs designed to provide youth with coping skills, however, have reliably documented systematic research efforts. For example, a modest success was reported for a bicultural skills-enhancement program delivered in reservation and non-reservation settings in the Pacific Northwest. At a six-month follow-up, the test group had better knowledge of drug effects, better interpersonal skills for managing pressures to use alcohol and other drugs, and lower rates of alcohol, marijuana, and inhalant use than the control group. Native American communities also have instituted community-wide prevention programs using local resources and Federal Government funds. A 1986-1987 survey of community programs funded by the Indian Health Service (IHS) identified a total of 312 communities involved in community-based alcohol/substance abuse prevention and intervention programs. These programs provided a variety of services, including alcohol and drug education activities designed to build self-esteem and coping skills, improve decision-making skills, and promote family bonding and enrichment. However, no systematic evaluation of the effects of these programs was reported in the presentation of survey results. In 1983, the IHS introduced a program to prevent FAS by providing Native American communities throughout the country with the knowledge, skills, and strategies to initiate prevention measures on their own. The chief element of the program was the training of cadres of trainers/advocates in all local communities served by the IHS to impart FAS information to a variety of audiences. Evaluation results showed a significant gain in knowledge and retention over an extended period of time by the target populations. Asian Americans and Pacific Islanders Alcohol-related Problems: The 7.3 million Asian Americans and Pacific Islanders now comprise 2.9 percent of the U.S. population. In the past decade, the size of the Asian/Pacific population has more than doubled, and its diversity has greatly expanded. Currently available data describe low rates of alcohol-related problems among Asian/Pacific Americans, even among those identified as heavy drinkers. This finding has been attributed to ethnic differences in physiological reactions (i.e., the "flushing response") as well as sociocultural and environmental factors. Among the cultural factors contributing to low rates of alcoholism are norms that permit drinking, particularly at social functions, but that discourage drinking to excess, and tight family and community regulation of alcohol use. These factors have been combined into a "reciprocity model" explaining the alcohol consumption of Asians. It has been suggested that the growing numbers and heterogeneity of Asian immigrants, as well as the progressive assimilation of Asian Americans into American value systems, will lead to increases in drinking problems among recent Asian immigrants. Patterns of Consumption: Studies consistently suggest that Asian Americans use and abuse alcohol less frequently than non-Asian individuals. In one study examining differences in alcohol consumption among residents of Hawaii, researchers found that Native Hawaiians and Caucasians reported higher levels of alcohol use than Chinese Americans, Japanese Americans, and Filipino Americans. In several studies focusing on drinking patterns among Asians in the United States, however, the view of Asian/Pacific Americans as non-drinkers was questioned. In an examination of Chinese, Japanese, Korean, and Filipinos in Los Angeles, variations in drinking patterns by ethnicity as well as by age and sex were found. These data suggest that Asian Americans display diverse drinking styles, including a relatively high proportion of heavy drinkers among Japanese and Filipino men. The same study found that those Asian/Pacific Americans most likely to drink are men under the age of 45 who have higher social status. Their attitudes toward alcohol use were permissive and their friends tolerant of drinking. Prevention Research: Low rates of alcohol-related problems have contributed to the paucity of prevention research targeted at the various Asian/Pacific subpopulations. Six of the ongoing Center for Substance Abuse Prevention demonstration projects, however, are targeted at Asian/Pacific youth and community groups. Areas of research interest Despite the relatively large number of findings describing broad ethnic differences in drinking behaviors and alcohol-related problems, the nature of the linkage between ethnic identity and alcohol use or abuse has not been established. There are few theoretical paradigms to guide research into these variations. However, there is a need to understand the relationships in order to increase the potential effectiveness of prevention strategies within communities. The paucity of rigorous research on the prevention of alcohol-related problems indicates a need for a variety of prevention and pre-prevention studies directed specifically to these populations. Environmental Prevention Strategies A systematic program of research that investigates the effectiveness of environmental prevention strategies in minority settings is needed to explore interventions that are designed to change the incentives, opportunities, risks, and expectations that surround drinking. This includes examinations of the impact on African American, Hispanic, Native American, Pacific Islanders, and Asian communities (or high-risk groups within them) of national, State, or community-wide policies designed to control alcohol availability and reduce demand for such products. Policy changes might be expected to have diverse effects on minority ethnic populations because of differences in sociocultural patterns of drinking, as well as differences in the manner in which such policies are viewed in different communities and the ways they are enforced. Availability Control: Strategies that might be tested in ethnic minority contexts that attempt to control the physical, social, and economic availability of alcoholic beverages include: (1) strengthening and/or enforcing alcohol beverage control (ABC) laws regulating the hours of operation and the location and number of outlets for sales of alcoholic beverages; (2) enhancing enforcement of minimum drinking age laws; (3) implementing server training programs; and (4) raising taxes on alcoholic beverages. Examination of Media Messages: It is widely believed that the mass media have an important impact on perceptions, attitudes, and beliefs regarding alcohol although research evidence is equivocal. There has been increasing concern in the past decade about whether the alcohol industry has tailored advertising to specific ethnic communities. This suggests the need to explore the effects of focused advertising on the definitions of appropriate drinking behaviors specific to minority subcultures and to age, sex, and socioeconomic subpopulations within ethnic groups. Research is needed on reactions of ethnic groups to public service messages and fictional television and radio programming related to alcohol. Who are the most credible communicators within various ethnic groups--and which media channels (print, television, radio) have the most impact? Institutions: Within ethnic communities, institutions such as churches, business groups, schools, and local political bodies may play important roles in addressing alcohol problems. Little is known about whether and in what ways such influence is exerted in ethnic communities to address alcohol problems. To what extent have institutions such as the beverage and hospitality industries contributed to or deterred prevention efforts through; for example, server training programs or the sponsorship of cultural and athletic events? To what extent have organizations such as Mothers Against Drunk Driving (MADD) gained support in implementing prevention programs in minority communities? Server Training: Those who are responsible for serving alcohol have the opportunity to influence individuals' drinking. Recently, server training programs have been implemented to teach those who serve alcohol in bars and restaurants how to moderate patrons' drinking. The few studies to date suggest that such programs have been effective in reducing the rate and amount of consumption by patrons and the probability of patron intoxication. There is a need to test these findings among minority populations. Price Increases: Econometric studies have suggested that an increase in the prices of alcoholic beverages would result in decreases in consumption, alcohol-involved automobile crashes, and rates of cirrhosis mortality. Projections based on these studies have indicated that a tax on beer amounting to 35 percent of the retail price would halve the number of alcohol-related fatalities among 16-to 20-year-old drivers. Research is needed to determine whether these relationships and projections also apply to various ethnic minority groups. Prevention Strategies Focusing on the Individual Prevention efforts targeted at individuals, distinct from those that target changes in the environment, have attempted to change consumption practices by increasing individual knowledge of alcohol effects and by altering attitudes about the use of alcohol. These efforts usually involve the use of media campaigns and school-based instructional programs. Such programs have sometimes produced desired changes in knowledge and attitudes, but have not been able to document long-term behavior changes. School-based programs that teach youth peer pressure resistance and social competence skills for avoiding the use of alcohol and other drugs show promise but have only demonstrated moderate or short-lived effects. Even this conditional effectiveness, however, has not been established for ethnic minority students and calls for further research. The study of how ethnicity affects individual differences in drinking behavior may involve the statistical modeling of personality variables, alcohol use patterns, and prediction of prevention outcomes. In general, the most effective studies of these interrelationships are longitudinal and may monitor a wide range of variables, including income level, availability of alcohol, peer and adult influences, intention to drink, and other identified risk factors (low academic achievement, lack of prohibitions, early alcohol use, low self-esteem, psychopathology, poor family relations, lack of socialization, other drug use, etc.). These constructs allow for a more precise examination of the relationship between ethnicity and effective prevention outcomes. Identifying High-Risk Groups: Within each ethnic minority, it is important to target some intervention efforts at youth and pregnant women. This may call for creative techniques for identifying and engaging these groups in interventions. For example, since school-based programs are the most popular form of intervention, additional strategies may need to be developed to reach students who have dropped out of school. The usefulness of brief questionnaires in targeting high-risk individuals within these populations should be evaluated. Programs to prevent Fetal Alcohol Syndrome might seek to identify individuals who would participate in a support network to facilitate abstinence during pregnancy. Such a network could include peer counseling, family involvement, and community-wide interventions (i.e., a comprehensive, multiple system strategy). Identifying Protective Factors: Research on alcohol-related problems tends to focus on identifying stressful events and other factors that place individuals at high risk. A promising alternative approach is to explore coping resources and protective factors that have reduced alcohol problems among minority individuals, particularly those exposed to "high-risk" environments. Protective factors may function both at the individual level--by influencing personal decisions about engaging in risk-taking behavior--and at the social level--through the perception of social support from friends and family and through family characteristics. Strategies for Program Development One possible research strategy involves taking interventions from programs that have been successfully tested in the general community and adapting those interventions for use with ethnic minorities. Programs using the social influence model that have shown positive outcomes might be adapted for implementation with one or more ethnic minority groups (such as the Midwestern Prevention Project is attempting to do). Another possible research approach is systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but were tested on only a limited scale and/or not systematically evaluated at all. Examples of these include the community-based programs implemented by the Indian Health Service and various demonstration programs that employ social learning models and are targeted at high-risk youth. Similarly, it may be useful to design strategies for increasing awareness of health-related alcohol problems and understanding of the relationship between cultural attitudes and the social/physical environment and alcohol abuse. It may be necessary to determine how the target groups define "excessive" or "inappropriate" alcohol use, before developing educational materials about the prevention of alcohol-related health problems such as cirrhosis. Methodological Issues: Mediating Factors In the development of grant applications researchers may also choose to focus on particular cross-cutting issues concerning the design of ethnically-based programs. Recent research has focused on the methodological pitfalls of attempting to distinguish the effects of ethnicity from other demographic variables such as age, gender, and socioeconomic status and mediating processes such as acculturation. These variables may make it difficult to identify the unique importance of ethnicity in prevention outcomes. Differences in how the researcher and the subject define ethnicity may also impact the interpretation of research results. Furthermore, variations between individuals in how they define their cultural origin may mediate the effects of interventions that rely on culture specific messages. Immigration and Acculturation: The differences observed in drinking patterns of ethnic groups by residence and immigrant cohort suggest the need for further studies of the factors surrounding urbanization, immigration, and acculturation as they relate to alcohol use. To fully understand acculturation, it is also necessary to consider the effects of such factors as immigrants' economic status, social interaction patterns, employment opportunities, and access to alcoholic beverages as intervening variables in the change process. Stages of acculturation, heterogeneity of ethnic groups and individual differences in ethnic identification may confound measures of acculturation. Different ethnic groups may also experience different stresses surrounding their cultural identity. It is important that these psychological mediators and stressors be identified and examined. For example, members of ethnic minorities living in a larger society are, to varying degrees, bicultural. Bicultural membership may produce unique stresses (or provide protective advantages) affecting alcohol consumption. Research is needed to address the effect of biculturality on alcohol consumption. In particular, the possible contribution of value conflicts to alcohol-related problems in different social situations needs to be explored. Alcohol Consumption Patterns: There may be special problems associated with using measures of alcohol consumption formulated for the dominant majority culture. For example, the consistency of consumption, the standard drink equivalents, and the standard time frame referred to may be less familiar and less relevant to some ethnic groups. Moreover, the pattern of heavy drinking followed by periods of abstinence may not be captured by consumption measures based on regular recall periods, or by those that produce a volume-based measure. In general, the validity of standard tests and measuring instruments may have to be explicitly established for the relevant ethnic populations. Peer Group and Cohort Comparisons: Research is needed to determine the norms and values prevalent in specific age and generational cohorts in each of the ethnic minority populations as these norms and values relate to alcohol use and risk-taking. Without knowledge of cultural differences in the development of drinking careers, it is difficult to select appropriate interventions across different age groups. For example, cultural differences in susceptibility to peer pressure will alter the design of interventions that might impede the formation of alcohol-using "peer clusters" and encourage the formation of "peer clusters" that provide sanctions against alcohol use. These interventions may be developmentally appropriate at one age but not another within different cultures. Cultural Sensitivity, Cultural Competence: There is widespread agreement that prevention research on ethnic minorities requires an acquaintance with the culture of the target group. Concern with issues of cultural sensitivity suggests the need to consider, for example, inclusion of members of target minority groups in the planning and implementation of research programs or the use of the language of the target group in communications, data collection, or administration of standardized measures. Both cultural sensitivity and methodological considerations suggest that a clear cooperative arrangement between community organizations or agencies and researchers is an essential ingredient for the successful implementation and evaluation of an intervention strategy. Methodological Considerations Studies concerning the prevention of alcohol-related problems among ethnic minorities must be conceived and executed so as to satisfy the usual criteria of scientific merit. Careful attention should be paid to the specific design requirements for adequate statistical power, particularly if comparisons between or within ethnic minority groups are planned. Research designs that require comparison groups should carefully consider the selection of appropriate control groups, the possibility of differential influence of psychiatric and other drug use patterns, and the effects of possible differential attrition at outcome. Evaluation of Prevention Interventions: Prevention research involving interventions must include comprehensive evaluation components that are conceptually and procedurally integrated into the overall research program. The three areas of evaluation (formative, procedural-or process, and outcome) provide information relevant to the interpretation of the research findings. Evaluation bears directly upon the verification of the research hypotheses connecting interventions to outcomes. Formative evaluation involves community members in the identification of critical issues that should be researched and in the evaluation of instruments and procedures for appropriateness to the particular community. Procedural evaluation refers to the periodic monitoring of the implementation of interventions during the course of the research to assure adherence to protocol and to document what actually was being done or delivered. Outcome evaluation is concerned with determining whether the program achieved its objectives, i.e., whether the outcomes hypothesized to be caused or produced by the interventions did in fact occur. This phase of the evaluation process requires the specification of a verifiable causal linkage between the interventions and the events or behaviors whose encouragement or avoidance is the ultimate target of the interventions. Cross-Institute or Center Areas of Interest Projects may be submitted under this announcement that address issues in common with other agencies. For example, the Center for Substance Abuse Prevention (CSAP), which was an original co-funding agency for the earlier Request for Applications in this area, may be interested in funding the intervention component of an NIAAA prevention research grant responsive to this announcement. CSAP has initiated many prevention service demonstration projects focused on high-risk youth and their families, including prevention projects targeted at ethnic minority groups. It is conceivable that an applicant could carry out the research in the context of a CSAP Community Partnership grant, High Risk Youth grant or other initiative. This would have the benefit of providing a potential applicant with a pool of clients from an ongoing community intervention. Preapplication consultation with the appropriate individual listed below is strongly encouraged. Applications are considered for acceptance and assigned according to standing PHS referral guidelines. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study: special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials and applies to men and women of all ages. If one gender and/or minority group are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear, compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design or sample size appropriate for the scientific objectives of the study. Applications for support of research involving human subjects must use a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypotheses under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minority group is impossible or inappropriate with respect to the purpose of the research because of the health of the subjects, or other reasons or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements, or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. Protection of Human Subjects The Department of Health and Human Services (DHHS) has regulations for the protection of human subjects which include additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects), including those pertaining specifically to children, are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B47, Bethesda, Maryland 20892, telephone 301-496-7041. Specific questions concerning protection of human subjects in research may be directed to the staff members listed under INQUIRIES. An applicant organization proposing to conduct nonexempt research involving human subjects must file an Assurance of Compliance with the Office for Protection from Research Risks (OPRR). As part of this assurance, which commits the applicant organization to comply with the DHHS regulations, the applicant organization must appoint an institutional review board (IRB) which is required to review and approve all nonexempt research activities involving human subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. Second level review of small grants (R03s) is by NIH staff. REVIEW CRITERIA Criteria for scientific/technical merit review of applications for regular research grants (R01) will include: 1. The overall scientific and technical merit and significance of the proposed research. 2. The appropriateness and adequacy of the research design, including the adequacy of mechanisms for the implementation of any intervention and the methodology proposed for collection and analysis of data. 3. The adequacy of the qualifications and relevant research experience of the principal investigator and key research personnel. 4. The availability and adequacy of facilities, general environment for the conduct of the proposed research, other resources, and any collaborative arrangements necessary for the research. 5. The appropriateness of budget estimates for the proposed research activities. 6. Where applicable, the adequacy of procedures to protect human subjects. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03) and FIRST awards (R29) are contained in the respective program announcements, available from: National Clearinghouse for Alcohol and Drug Information (NCADI) P.O. Box 2345 Rockville, MD 20892 Telephone: (301) 468-2600 or 1-800-729-6686 AWARD CRITERIA Applications recommended for approval by the appropriate advisory council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, program needs and balance, and the availability of funds. Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to carry out research projects, including both direct costs, which can be specifically identified with the project, and allowable indirect costs of the institution. Research grant support may not be used to establish, add a component to, or operate a prevention, rehabilitation, or treatment service program. Support for research-related prevention, rehabilitation, or treatment services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grants will be administered in accordance with the PHS Grants Policy Statement (rev 10/90) which should be available from your office of sponsored research. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elsie Taylor or Kendall Bryant, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 Inquires relating to prevention service demonstration projects and evaluation may be directed to: Armando Pollack Special Assistant to the Director of Community Prevention and Training Center for Substance Abuse Prevention Rockwall II Building, 9th floor 5600 Fishers Lane Rockville MD 20857 Telephone: (301) 443-0369 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, Sections 301 and 405, and administered under the PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 2, 5 February 1993 Message-ID: Date: 6 Feb 93 00:56:14 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1499 $$XID NIHGUIDE 19930205 V22N05 P2O3 ************************************ larger societal factors upon the onset, casual use, escalation to use, maintenance, development of dependence, cessation of use, and relapse of drugs among ethnic/racial minority groups and other underserved populations. These studies should be based upon a multidimensional and multidisciplinary perspective where the exploration of drug use will be grounded within a person-in-situation-environment configuration with reciprocal interactions existing among and within the various systems an individual interacts. Especially encouraged is research that investigates resiliency and protective factors among minority children who may otherwise be at high risk of using drugs but do not. Studies that help in the development of information which can lead to the early identification of those at risk of drug use and abuse among the various ethnic/racial groups and underserved populations are particularly needed. Studies that provide data on identifying the motivating factors responsible for the cessation of drug use among school dropouts, children of drug users, longtime drug addicts, young African-American, Asian American and Hispanic male and female adults are also invited. Projects are encouraged to utilize qualitative and quantitative methods in combination; a reliance on retrospective data is discouraged. Community-based studies with matched control groups where feasible are encouraged; longitudinal efforts and secondary analysis of existing data studies also are supported as appropriate. Also encouraged are studies that critically validate the cultural relevance of current methodological approaches and those that utilize rigorous research designs within the context of their data collection activities. Epidemiologic studies Patterns and prevalence of drug use related studies: Research in this area seeks to evaluate whether the patterns, including the sequencing and multiple use and abuse of drugs of ethnic/racial minority youth, school dropouts, gang members, children of drug users, and homeless youth differs from non-minority youth as reported by drug abuse researchers. Also encouraged are studies that gather information on the prevalence of drug use among Asian American, Hispanic individuals of South, Central American, and Caribbean extraction, migrant workers, and U.S.-Mexican border populations. Consequences related studies: Research in this area concentrates on providing information on the impact that drug use has upon the emotional and economic well-being of minority individuals, their families, and communities. Research on the interrelationship between drug abuse and violence, including domestic violence among ethnic/racial minority youth, school dropouts, gang members is particularly encouraged. Research in this program component may include studies on the effects that drug abuse and related criminality has upon the social and economic well-being of minority neighborhoods. Encouraged also are studies that investigate to what extent drug use and drug dealing is responsible for violence reported among ethnic/racial minority groups and other underserved populations. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated below and in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional business offices or offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, Maryland 20892, telephone 301/496-7441. The title and number of this announcement must be typed in item 2a on the face page of the application for PHS 398. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five legible copies of the application form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCESS The Division of Research Grants, NIH, serves as a central point for receipt of applications. Applications will be assigned in accordance with established Public Health Service referral guidelines and will be reviewed by an initial review group (IRG) for scientific and technical merit in accordance with the standard NIH peer review procedures. AWARD CRITERIA Applications will compete for available funds with all other applications recommended for further consideration and assigned to the appropriate institute. R03 applications do not receive a second level review. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mario R. De La Rosa, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse Rockwall II, Suite 615 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2974 Direct inquiries regarding fiscal matters to: Mrs. Shirley Denney Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under the authority of Section 301 of the Public Health Service Act (42 USC 241). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-47 FULL-TEXT *************************************** PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA AVAILABLE: PA-93-47 P.T. 34, FF; K.W. 0404003, 0414014, 0411005 National Institute on Alcohol Abuse and Alcoholism THE PROGRAM ANNOUNCEMENT ANNOUNCED (PA) IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE PA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications related to the prevention of alcohol-related problems among ethnic minority groups of African Americans, Hispanic Americans, Native Americans, Asian Americans, and Pacific Islanders. Most of these groups are at elevated risk for specific alcohol problems or may have changing patterns of increased alcohol consumption. All of these minority groups require the development and evaluation of culturally relevant programs of alcohol abuse prevention. NIAAA promotes innovative prevention research within a broad range of populations and is particularly interested in receiving methodologically sound and conceptually grounded outcome-oriented research applications. The primary objective of this program announcement is to expand the limited information available about the prevention of alcohol-related problems among ethnic minorities. While differential rates of alcohol problems have been well documented within minority communities, the link between ethnic identity and successful alcohol abuse prevention interventions has not. Research proposed within the domain of this program announcement should address factors that facilitate or impede the development, implementation, and evaluation of prevention strategies among diverse sociocultural populations. Attention should be focused on (1) the culturally-appropriate development or adaptation of interventions within these minority settings and (2) how ethnic minority identity relates to prevention research outcomes. In general, the impact of ethnicity on alcohol use and prevention of its abuse should be studied within a particular context such as, alcohol availability control, server training, price increases, media messages, or psychosocial antecedents of high-risk behavior. 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 PA, Preventing Alcohol-Related Problems Among Ethnic Minorities, is related to the priority area of alcohol abuse reduction. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign public and private non-profit and for-profit organizations, such as, universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01), small grant (R03), or FIRST award (R29). Applicants for R01s may request support for up to five years. The average direct cost per year for R01s is approximately $220,000. Small grants (R03) are limited to two years for up to $50,000 per year for direct costs. FIRST award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST award and small grants cannot be renewed but grantees may apply for R01 support to continue research on the same topics. RESEARCH OBJECTIVES Background Information on Alcohol-Related Problems and Use Among Ethnic Minorities In the United States, alcohol use is involved in nearly 100,000 deaths annually, including approximately one-half of the nearly 45,000 fatalities in traffic crashes; 27,000 deaths due to cirrhosis of the liver; and a high proportion of the deaths due to homicide, suicide, drowning, falls, burns, and other accidents. Alcohol abuse results in alcohol-related injuries and violence, marital discord, job loss, and serious medical consequences including birth defects. Alcohol-related problems and costs are unevenly distributed across racial and ethnic groups. This uneven distribution may be related to cultural differences in drinking patterns. Surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among African Americans, Hispanic Americans, and Native Americans. In contrast, Asian Americans and Pacific Islanders have been found to have lower levels of alcohol use. However, recent evidence indicates that consumption may be increasing among these two groups. Areas of Research Interest Despite the relatively large number of findings describing broad ethnic differences in drinking behaviors and alcohol-related problems, the nature of the linkage between ethnic identity and alcohol use or abuse has not been established. There are few theoretical paradigms to guide research into these variations. However, there is a need to understand the relationships in order to increase the potential effectiveness of prevention strategies within communities. The paucity of rigorous research on the prevention of alcohol-related problems indicates a need for a variety of prevention and pre-prevention studies directed specifically to these populations. Environmental Prevention Strategies A systematic program of research that investigates the effectiveness of environmental prevention strategies in minority settings is needed to explore interventions that are designed to change the incentives, opportunities, risks, and expectations that surround drinking. This includes examinations of the impact on African American, Hispanic, Native American, Pacific Islanders, and Asian communities (or high-risk groups within them) of national, State, or community-wide policies designed to control alcohol availability (e.g., server training) and reduce demand for such products (e.g., price increases). Policy changes might be expected to have diverse effects on minority ethnic populations because of differences in sociocultural patterns of drinking, as well as differences in the manner in which such policies are viewed in different communities and the ways they are enforced. Prevention Strategies Focusing on the Individual Prevention efforts targeted at individuals, distinct from those that target changes in the environment, have attempted to change consumption practices by increasing individual knowledge of alcohol effects and by altering attitudes about the use of alcohol. These efforts usually involve the use of media campaigns and school-based instructional programs. Such programs have sometimes produced desired changes in knowledge and attitudes, but have not been able to document long-term behavior changes. School-based programs that teach youth peer pressure resistance and social competence skills for avoiding the use of alcohol and other drugs show promise but have only demonstrated moderate or short-lived effects. Even this conditional effectiveness, however, has not been established for ethnic minority students and calls for further research. The study of how ethnicity affects individual differences in drinking behavior may involve the statistical modeling of personality variables, alcohol use patterns, and prediction of prevention outcomes. In general, the most effective studies of these interrelationships are longitudinal and may monitor a wide range of variables, including income level, availability of alcohol, peer and adult influences, intention to drink, and other identified risk factors (low academic achievement, lack of prohibitions, early alcohol use, low self-esteem, psychopathology, poor family relations, lack of socialization, other drug use, etc.). These constructs allow for a more precise examination of the relationship between ethnicity and effective prevention outcomes. Strategies for Program Development One possible research strategy involves taking interventions from programs that have been successfully tested in the general community and adapting those interventions for use with ethnic minorities. Programs using the social influence model that have shown positive outcomes might be adapted for implementation with one or more ethnic minority groups. Another possible research approach is systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but were tested on only a limited scale and/or not systematically evaluated at all. Examples of these include the community-based programs implemented by the Indian Health Service and various demonstration programs that employ social learning models and are targeted at high-risk youth. Similarly, it may be useful to design strategies for increasing awareness of health-related alcohol problems and understanding of the relationship between cultural attitudes and the social/physical environment and alcohol abuse. It may be necessary to determine how the target groups define "excessive" or "inappropriate" alcohol use, before developing educational materials about the prevention of alcohol-related health problems such as cirrhosis. Cross-Institute or Center Areas of Interest Projects may be submitted under this announcement that address issues in common with other agencies. For example, the Center for Substance Abuse Prevention (CSAP), which was an original co-funding agency for the earlier Request for Applications in this area, may be interested in funding the intervention component of a NIAAA prevention research grant responsive to this announcement. CSAP has initiated many prevention service demonstration projects focused on high-risk youth and their families, including prevention projects targeted at ethnic minority groups. It is conceivable that an applicant could carry out the research in the context of a CSAP Community Partnership grant, High Risk Youth grant or other initiative. This would have the benefit of providing a potential applicant with a pool of clients from an ongoing community intervention. Preapplication consultation with the appropriate individual listed below is strongly encouraged. Applications are considered for acceptance and assigned according to standing PHS referral guidelines. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. The second level review of small grants (R03s) is by NIH staff. REVIEW CRITERIA Criteria for scientific/technical merit review of applications for research project grants (R01) will include: 1. The overall scientific and technical merit and significance of the proposed research. 2. The appropriateness and adequacy of the research design, including the adequacy of mechanisms for the implementation of any intervention and the methodology proposed for collection and analysis of data. 3. The adequacy of the qualifications and relevant research experience of the principal investigator and key research personnel. 4. The availability and adequacy of facilities, general environment for the conduct of the proposed research, other resources, and any collaborative arrangements necessary for the research. 5. The appropriateness of budget estimates for the proposed research activities. 6. Where applicable, the adequacy of procedures to protect human subjects. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03) and FIRST awards (R29) are contained in the respective program announcements, available from: National Clearinghouse for Alcohol and Drug Information (NCADI) P.O. Box 2345 Rockville, MD 20892 Telephone: (301) 468-2600 or 1-800-729-6686 AWARD CRITERIA Applications recommended for approval by the appropriate advisory council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and request for the Program Announcement to: Elsie Taylor or Kendall Bryant, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 Inquires relating to prevention service demonstration projects and evaluation may be directed to: Armando Pollack Special Assistant to the Director of Community Prevention and Training Center for Substance Abuse Prevention Rockwall II Building, 9th floor 5600 Fishers Lane Rockville MD 20857 Telephone: (301) 443-0369 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, Sections 301 and 405, and administered under the PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. $$P2 END ************************************************************ $$P3 BEGIN PA-93-48 ************************************************* BASIC AND APPLIED STUDIES ON ANTIPROGESTINS NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-48 P.T. 34; K.W. 0413002, 0760025, 0750020, 0710110 National Institute of Child Health and Human Development PURPOSE The National Institute of Child Health and Human Development (NICHD) invites investigator-initiated research grant applications to conduct basic research on antiprogestins and to explore the potential clinical utilization of antiprogestins in the treatment of a variety of reproductive disorders as well as for contraception. 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 (PA), Basic and Applied Studies on Antiprogestins, is related to the priority areas of family planning, prevention of teenage pregnancies and unintended pregnancies. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications for research grants may be made by public and private, for-profit and non-profit organizations, such as universities, colleges, hospitals, and laboratories. Women and minority investigators, in particular, are encouraged to apply. Applicants for First Independent Research Support and Transition (FIRST) Awards (R29) must meet specific eligibility requirements. In addition, foreign applicants are not eligible for the FIRST Award. MECHANISM OF SUPPORT Mechanisms available for the support of this program are the traditional research project grant (RO1), and the FIRST Award (R29). RESEARCH OBJECTIVES Summary The purpose of this initiative is to stimulate research that will attempt to further characterize and define the mechanism(s) of action of antiprogestins, their use for treatment of disorders of the reproductive system, and their utility for application as contraceptive agents or in facilitating parturition. It is recognized that this class of compounds may act through a variety of mechanisms, some of which may not involve antagonism of the progesterone receptor system. Background Progesterone plays a crucial role in female reproduction. Some of the important reproductive events attributable to progesterone influence include: (1) regulation of cellular function via control of synthesis of specific proteins, (2) ovulation induction, (3) regulation of tubal transport of fertilized ova, (4) transformation of the endometrium for implantation, and (5) maintenance of pregnancy. Because these reproductive events physiologically involve progesterone mediated regulatory events, antiprogestins can be utilized to antagonize progesterone actions in a manner regulating or blocking gonadal, uterine or cervical functions associated with the menstrual, conception, and parturition processes. These effects offer promise for molecular, preclinical and clinical applications in the fields of veterinary and human medicine. In addition to interfering with the effects of progesterone on normal physiological events, antiprogestins could be utilized therapeutically when the presence of progesterone is contraindicated. It has been suggested, but not fully documented, that antiprogestins could be utilized for treatment of endometriosis, breast cancer, meningiomas and other disorders. Existing evidence indicates that certain antiprogestins can inhibit estrogenic, glucocorticoid and androgenic actions. These activities may be differential among various antiprogestins. The molecular basis of antiprogestin action is not fully known. Whether antiprogestins bind solely to progesterone receptors or to other functionally related sites is not clear. Displacement of bound progesterone from its receptor sites indicates that the antiprogestin enters the target cells and interacts with specific progesterone-binding sites without exhibiting agonistic activity. Scope Some examples of research topics that would be considered responsive to this solicitation include, but are not limited to, the following: o Clarification of the intracellular mode of progesterone action. o Understanding ovulatory function and dysfunction. Pituitary gonadotropin secretion appears to be modulated in part by progesterone. Antiprogestins could help to determine the effects of this and other regulatory factors in normal and aberrant gonadotropin secretion and the relationship of the mechanism to some forms of ovulatory dysfunction. o Studies on implantation. Information could be gained to further the understanding of: (a) uterine receptivity for blastocyst implantation, (b) decidualization of the endometrium, (c) significance of the morphological parameters that are used for "dating" of endometrial maturation and (d) clarification of mechanisms by which progesterone may render the uterus an immunologically privileged site. o Clarification of the roles of progesterone accumulating neurons in reproductive neuroendocrinological phenomena, such as sexual behavior, ovulation, and feedback mechanisms in the hypothalamo-pituitary-gonadal axis. o Studies on gamete maturation, interaction, fertilization and activation of development. o Effects on sperm. There is preliminary evidence that progesterone is involved in sperm capacitation and changes in sperm motility in the female tract. Whether antiprogestins could affect male fertility by altering sperm maturation or the fertilizing capacity of spermatozoa is not known. o Studies on blocking ovulation. o Post-coital emergency contraception (morning-after pill). o Mini-pill or sequential contraceptive pill regimen. o Cervical dilatation and induction of parturition. o Treatment of endometriosis. Antiprogestins may have a beneficial effect in the medical treatment of endometriosis through suppression of pituitary gonadotropin secretion and the resulting inhibition of follicular development and ovulation, as well as noncompetitive antiestrogenic actions that inhibit endometrial proliferation. o Medical treatment of uterine fibroids. o Ovarian hyperstimulation syndrome treatment. These areas of interest are not listed by priority and they are only suggested examples of areas of research that could be undertaken under this program announcement. Applicants are encouraged to propose other areas that are related to the objectives and the scope described above. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, such issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. The NICHD has received assurance from the pharmaceutical manufacturers of mifepristone and onapristone that they will assist in this research effort by making supplies of the antiprogestin available for funded projects. Applicants are encouraged to contact NICHD staff, who will facilitate access and referral to the appropriate industry officials to discuss the proposed research and the compounds available. Direct inquiries regarding programmatic issues regarding contraceptive development, basic and reproductive disorder research, or gestational and pregnancy research, respectively, to: Nancy J. Alexander, Ph.D. Contraceptive Development Branch Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, MD 20892 Telephone: (301) 496-1661 Michael E. McClure, Ph.D. Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B91A Bethesda, MD 20892 Telephone: (301) 496-6515 Donald McNellis, M.D. Pregnancy and Perinatology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Direct inquiries regarding fiscal matters to: Melinda Nelson Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07 Bethesda, MD 20892 Telephone: (301) 496-5001 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-93-49 ************************************************* NEUROLOGICAL ASPECTS OF LYME DISEASE NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-49 P.T. 34; K.W. 0715125, 0715038, 0785055, 0755020, 0765033, 0710070 National Institute of Neurological Disorders and Stroke National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Allergy and Infectious Diseases (NIAID) invite research grant applications seeking support of a wide spectrum of research directed at generating improved knowledge concerning Lyme disease of the nervous system. Lyme borreliosis is a multi-system disease caused by the spirochete Borrelia burgdorferi. It may affect skin, joints, heart, eye, and the nervous system. Reported neurological consequences of Lyme borreliosis may range from minor to serious. The infectious vector is a tick commonly harbored by many sylvatic and domestic animals, but the principal reservoirs of the adult infective tick are deer and field mice. Well described neurological disorders, meningoradiculitis and chronic neuropathy in patients with acrodermatitis chronica atrophicans, and an array of central and peripheral nervous system complications of Lyme disease have all been found to result from borrelia infection. Between 1982 and 1990 over 30,000 Lyme borreliosis cases were reported in the U.S. Reported neurological manifestations of the disease include one or more of the following: meningitis, cranial neuritis, radiculoneuritis, peripheral neuropathy, meningoencephalitis, myelitis, ataxia, psychoses, encephalopathy, cognitive abnormalities, pain, fatigue, and sleep disorder. It has been reported that up to half of patients with late Lyme neuroborreliosis (LNB) may exhibit encephalopathy evidenced by impairment of memory and intellect. Encephalopathy is probably caused by subacute infection of the central nervous system. Some patients may display small white matter lesions visualized by magnetic resonance imaging. Cerebrospinal fluid abnormalities may include lymphocytic pleocytosis, intrathecal IgA, IgG, and IgM synthesis, anti-myelin basic protein antibodies, oligoclonal bands, and increased total protein. CSF anti -B. burgdorferi specific antibody is helpful in diagnosing the disease but may only be indicative of exposure, not necessarily of active disease. Peripheral blood may have B. burgdorferi specific antibody and reactive T cells. None of the laboratory diagnostic tests is totally reliable because of false negative and positive readings. The cause of damage to the nervous system is unknown. It may be due to direct damage from spirochetes, tissue inflammation, or immune response, separately or in combination. Diagnosis of Lyme neuroborreliosis is a major challenge because neurological signs and symptoms may imitate those of multiple sclerosis, peripheral neuropathy, Guillain-Barre syndrome, neurosyphilis, and many other diseases of the nervous system. 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 PA, Neurological Aspects of Lyme Disease, is related to the priority area of infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, 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. Applications from minority institutions, minority individuals, and women are particularly encouraged. Foreign institutions are not eligible for FIRST Independent Research Support and Transition Awards (R29) or Research Program Projects (P01). MECHANISM OF SUPPORT Research support may be requested through application for an individual investigator-initiated research project grant (R01). Applications from new investigators who have not received previous PHS research grant support may apply for a First Independent Research Support and Transition (FIRST) award (R29). FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. To apply for the support of a more broadly based multidisciplinary research program, the Research Program Project (P01) mechanism is suggested. NINDS also provides support for the career development of clinical investigators (K08) and support for clinical investigators through individual fellowships (F32) and institutional national research service awards (T32). RESEARCH OBJECTIVES Neurological involvement is a frequent clinical manifestation of Lyme disease. In addition, it has been suggested that the CNS may serve as a reservoir for persistent infection. Central issues about neurological aspects of Lyme disease are unresolved, including the definition of the neurological disease in adults and children in the U.S., the appropriate criteria to use for diagnosis, and the optimal choice and duration of therapy. The pathogenetic mechanisms which produce central and peripheral nervous system syndromes are unknown; in particular, the etiology of persistent post-infectious symptoms and their optimal management is unclear. Examples of research goals, many of which could be studied in humans as well as animal models and tissue cultures and are appropriate for pursuing an application in response to this PA, include, but are not limited to: o The epidemiology of the neurological aspects of Lyme disease, especially in endemic areas. Identification of neurological syndromes in children and adults that can be reliably attributed to this disorder, including both primary and post-infectious syndromes. o Studies of diagnostic laboratory abnormalities which correlate with the various syndromes, including cerebrospinal fluid, serum, neurophysiological, and neuroimaging testing. o Studies of mechanisms of pathogenesis in development of encephalopathy, encephalomyelitis, and neuropathies. o Characterization of the severity and frequency of cognitive impairments in LNB, and studies of correlated laboratory parameters, and their response to therapy. o Studies of immune-mediated and other pathogenic mechanisms role in injury to the nervous system. This may involve spirochete interactions with the immune system, and definition of immune and inflammatory abnormalities, including studies of auto-antibodies, cytokines, cellular immune responses, and immune complexes. o Development of effective treatment regimen(s). Optimization of antibiotics, drug dosage, and treatment duration. Development of therapeutic approaches for patients who have persistent neurological symptoms. This could be accomplished by controlled clinical trials. o Studies of the molecular basis for B. burgdorferi neurotropism and the role of strain differences in pathogenesis. o Development of reliable animal models for studies of the nervous system infection and studies of viral latency neuropathogenicity. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequate