From owner-sci-resources@net.bio.net Sun Nov 07 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 7 November 1993 Message-ID: Date: 8 Nov 93 22:54:25 GMT Sender: kristoff@net.bio.net Lines: 65 Approved: biosci-moderator@net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 92040 STIS Filename: phnalpha Title: NSF Alpha Telephone Directory File size (bytes): 92040 STIS Filename: phnalpha Document Type: Program Guideline Title: NSF 93-150 Postdoctoral Research Associates in Computational Science and Engineering File size (bytes): 16295 STIS Filename: nsf93150 ------------------------------------------------------------------------ ** 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 nsf93150, the text of your message should be as follows: get nsf93150 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf93150, you would enter: ftp> get nsf93150 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 Mon Nov 15 22:00:00 1993 Path: biosci!nsf.gov From: parzberg@nsf.gov (Peter Arzberger) Newsgroups: bionet.sci-resources Subject: nsf93141 - NSF 93-141 - Research on Digital Libraries Message-ID: Date: 15 Nov 93 12:14:42 GMT Sender: kristoff@net.bio.net Lines: 76 Approved: biosci-moderator@net.bio.net The following is extracted from the new program announcement on the NSF-ARPA-NASA Research on Digital Libraries. Complete copies of the program announcement should be attainable at local Sponsored Project Offices or over the network on STIS or the NSF gopher (under CISE, program announcements). Title : NSF 93-141 - Research on Digital Libraries Type : Program Guideline NSF Org: CISE / IRI Date : September 16, 1993 File : nsf93141 RESEARCH ON DIGITAL LIBRARIES A JOINT INITIATIVE OF: NATIONAL SCIENCE FOUNDATION COMPUTER AND INFORMATION SCIENCE AND ENGINEERING DIRECTORATE ADVANCED RESEARCH PROJECTS AGENCY COMPUTING SYSTEMS TECHNOLOGY OFFICE and the SOFTWARE AND INTELLIGENT SYSTEMS TECHNOLOGY OFFICE National Aeronautics and Space Administration PROPOSALS MUST BE RECEIVED AT NSF NO LATER THAN FEBRUARY 4, 1994 Digital Library Initiative, FY 1994 INTRODUCTION The past decade has seen a remarkable expansion in digital networks within the U.S. research and education community from a state where networking was the purview of the privileged few to one where it is considered an essential tool by millions of researcher and educators. Since the mid-1980's with the advent of NSFNET the volume of traffic, the number of interconnected networks and the functionality of the networks has grown and continues to grow exponentially. The entire assemblage of linked networks using the IP communications protocol throughout the world is now referred to as the Internet. It is a network of networks, which within the U.S., links one third of all two year and four year colleges and universities, many primary and secondary schools, public and private institutions, commercial enterprises, individuals in their homes, and foreign institutions in sixty countries. Information sources accessed via the Internet are the ingredients of a digital library. Today, the network connects some information sources that are a mixture of publicly available (with or without charge) information and private information shared by collaborators. They include reference volumes, books, journals, newspapers, national phone directories, sound and voice recordings, images, video clips, scientific data (raw data streams from instruments and processed information), and private information services such as stock market reports and private newsletters. These information sources, when connected electronically through a network, represent important components of an emerging,universally accessable, digital library. To explore the full benefits of such digital libraries, the problem for research and development is not merely how to connect everyone and everything together in the network. Rather, it is to achieve an economically feasible capability to digitize massive corpora of extant and new information from heterogeneous and distributed sources; then store, search, process and retrieve information from them in a user friendly way. Among other things, this will require both fundamental research and the development of ~intelligent~ software. It is the purpose of this announcement to support such research and development by combining the complementary strengths of the participating agencies in basic research, advanced development and applications, and academic/industry linkage. NSF 93-141 (new) From owner-sci-resources@net.bio.net Mon Nov 15 22:00:00 1993 Path: biosci!nsf.gov From: parzberg@nsf.gov (Peter Arzberger) Newsgroups: bionet.sci-resources Subject: NSF-Sloan Postdoctoral Research Fellowships in Molecular Evolution Message-ID: Date: 13 Nov 93 14:42:20 GMT Sender: kristoff@net.bio.net Lines: 73 Approved: biosci-moderator@net.bio.net The following is extracted from the new program announcement on the NSF-Sloan Postdoctoral Research Fellowships in Molecular Evolution. Complete copies of the program announcement should be attainable at local Sponsored Project Offices or over the network on STIS or the NSF gopher. Please note the deadline and eligibility requirements. Title : NSF 93-151 -- Postdoctoral Research Fellowships in Molecular Evolution Type : Program Guideline NATIONAL SCIENCE FOUNDATION ALFRED P. SLOAN FOUNDATION 1994 ANNOUNCEMENT DEADLINE FOR APPLICATIONS: JANUARY 17, 1994 The National Science Foundation and the Alfred P. Sloan Foundation announce a special program of Postdoctoral Research Fellowships in Molecular Evolution as part of an effort by both foundations to increase support for basic research in Molecular Evolution. Within the NSF, both the Directorates for Biological Sciences and for Social, Behavioral and Economic Sciences are participating in this program. In this first year of the joint program, approximately 18 two-year awards of $80,000 will be offered. The deadline for submission of application materials is January 17, 1994, with awards to be announced in April, 1994. Contingent upon availability of funds, a competition for approximately the same number of fellowships will be held in each of the next 4 years. Molecular evolutionary studies involve the theoretical, comparative, computational, and/or experimental analyses of biological patterns and processes at the molecular level, within the framework of organismic evolutionary change and adaptation. The NSF and the Sloan Foundation believe that the experimental tools and intellectual discoveries of molecular biology have generated exciting possibilities for expanding the scientific understanding of evolution. Moreover, NSF and the Sloan Foundation envision molecular evolution studies involving the biological sciences in concert with other disciplines, both in concepts and techniques, and encourage applications that reflect a broad scientific spectrum. The NSF/Sloan Postdoctoral Research Fellowship in Molecular Evolution will provide recipients the freedom to define and pursue their own research programs while developing relevant interdisciplinary knowledge and skills in a host laboratory or field station. Applicants are expected to take full advantage of this important feature of the award by identifying opportunities to broaden their scientific training and experience, both conceptually and technically, so that they may approach problems in molecular evolution with sound concepts and the most appropriate tools. Because of this essential aspect of the program, applicants are expected to submit research and training plans that differ from the plans followed during their doctoral training or, for applicants who have been postdoctoral fellows for more than one year at the time of award initiation, plans that differ from their current postdoctoral research. Eligibility Applicants for a National Science Foundation/Alfred P.Sloan Foundation Molecular Evolution Postdoctoral Research Fellowship must have earned the Ph.D. after January 1, 1989, or must expect to receive it no later than June 30, 1994. Applicants can be considered only from nationals or permanent resident aliens of the United States. The term "national of the United States" denotes a citizen of the United States or a native resident of the possesion of the United States such as American Samoa. Only one application per applicant will be considered. From owner-sci-resources@net.bio.net Mon Nov 15 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 14 November 1993 Message-ID: Date: 16 Nov 93 01:02:30 GMT Sender: kristoff@net.bio.net Lines: 110 Approved: biosci-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Antarctic EAM Title: Automated surface observing systems File size (bytes): 2206 STIS Filename: opp94004 Title: Berthing at McMurdo for Williams FIeld File size (bytes): 44200 STIS Filename: opp94005 Title: Conservation of Antarctic Animals and Plants; Waste Regulation; Enforcement and Hearing Procedures File size (bytes): 34155 STIS Filename: opp94006 Title: Ice core drilling at Vostok File size (bytes): 16609 STIS Filename: opp94007 Document Type: Bulletin Title: NSF Bulletin November 1993, Vol. 21; No.3 File size (bytes): 43935 STIS Filename: bul9311 Document Type: Program Guideline Title: NSF 93-149 - Grant Opportunities for Academic Liaison with Industry (GOALI) File size (bytes): 22994 STIS Filename: nsf93149 Title: NSF 93-151 -- Postdoctoral Research Fellowships in Molecular Evolution File size (bytes): 29416 STIS Filename: nsf93151 Title: NSF 93-155 -- Research Equipment Grant Program File size (bytes): 28515 STIS Filename: nsf93155 Document Type: Recruit Title: Contract Specialist File size (bytes): 5385 STIS Filename: vgs9415 Title: Secretary (Office Automation) File size (bytes): 4906 STIS Filename: vgs9418 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Antarctic EAM Title: USAP environmental documents list File size (bytes): 14223 STIS Filename: opp93000 Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 100809 STIS Filename: phnalpha ------------------------------------------------------------------------ ** 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 phnalpha, the text of your message should be as follows: get phnalpha Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha, you would enter: ftp> get phnalpha 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 Thu Nov 18 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: Three NIH Guides coming! Message-ID: Date: 19 Nov 93 04:29:52 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 12 Approved: sci-resources-moderator@net.bio.net After returning from my trip to DC earlier this month I had several new items dropped in my lap which I had not anticipated last month. I'm finally getting caught up on BIOSCI this evening, and my apologies for the late postings of the Guide. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Thu Nov 18 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 40, pt. 3, 5 November 1993 Message-ID: Date: 19 Nov 93 04:44:29 GMT Sender: kristoff@net.bio.net Lines: 837 Approved: biosci-moderator@net.bio.net $$XID RFA CA94006 CA-94-006 P1O1 *************************************** PATTERNS OF CARE IN RADIATION ONCOLOGY NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA: CA-94-006 P.T. 34; K.W. 0785140, 0725015, 0730050 National Cancer Institute Letter of Intent Receipt Date: December 1, 1993 Application Receipt Date: January 24, 1994 PURPOSE The Radiation Research Program (RRP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites applications for Patterns of Care Studies in Radiation Oncology. The objective of this Request for Applications (RFA) is to focus on those factors in radiation oncology that are most likely to affect patient outcome, such as failure to control local-regional neoplastic disease, treatment related morbidity that negatively impacts a patient's quality of life, or failure to implement new methods and new treatment strategies that have been shown to be advantageous for the patient. While patterns of care studies in the past have focused on retrospective data, the new concept should address prospective studies that document patterns of diagnostic methodology, treatment workup and followup for a variety of tumors. The purpose of this research is to identify those variables associated with maximizing local control, with the goal of increasing survival and minimizing complications of normal tissues. An interdisciplinary activity involving diagnostic imaging, pathology, medical oncology, surgery and radiation oncology is essential to the goals of this RFA. New research projects are likely to result from these studies, such as new findings that are useful in the design of therapeutic protocols and in the formulation of clinical and reimbursement policy. 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 RFA, Patterns of Care in Radiation Oncology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. In order to participate in this program, applicant institutions must demonstrate or meet the following requirements: Requirements 1. Expertise in the design and coordination of multi-disciplinary, multi-modality clinical studies. 2. Capacity to develop and implement a methodology for investigating patterns of care studies that respond to the objectives of this RFA. 3. Demonstrated experience and expertise in the appropriate statistical methodology and design of clinical studies so that statistically valid results are obtained that accurately represent radiation oncology practice throughout the U.S. 4. Availability of facilities and professional personnel with expertise in data collection, management and analysis and the ability to participate in patterns of care studies to provide centralized statistical services. 5. Demonstrated capabilities for monitoring the quality assurance of the data collection procedures. 6. Demonstrated capabilities for developing reports, presentations, scientific manuscripts, workshops, short courses, newsletters and other methods for the educational and informational objectives of this RFA. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the investigator-initiated research project grant (R01). The NCI anticipates awarding one to two grants, with total costs not to exceed $650,000 for the first year. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, if there is sufficient programmatic need, the NCI will invite recipients of awards under this RFA to submit competitive continuation grant applications for review according to the procedures of the DRG. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-05,000, revised October 1, 1990. FUNDS AVAILABLE Approximately $650,000 in total costs per year for three years will be committed specifically to fund applications that are submitted in response to this RFA. The NCI anticipates that one or two awards will be made. Although this program is provided for in the financial plans of the NCI, the award of a grant in response to this RFA is also contingent upon the availability of funds for this purpose. The earliest feasible start date for the initial award will be September 30, 1994. RESEARCH OBJECTIVES The major goal of this research initiative is to support clinical investigations that (1) document and evaluate patient survival and outcome as a function of radiation oncology practice and methodology, (2) coordinate with the leadership of the Cooperative Groups conducting clinical trials for the optimal design of protocols and clinical research based on data received from patterns of care studies, (3) examine the patterns of care for minorities vs non-minorities, and (4) present the findings of the patterns of care studies to the radiation oncology community to achieve both the goals of information and education. The evaluation and documentation of the acceptance and implementation of new treatment strategies in the radiation oncology community where a benefit for the cancer patients has been shown is also of interest. New studies of interest are prospective patterns of care and/or patterns of fractionation that will support and enhance on-going protocols for cancers of the prostate and cervix. Prospective studies that show patterns of total care for breast cancer are of special interest. Background The National Cancer Institute has supported patterns of care studies in radiation oncology since 1973. The first Patterns of Care Study (PCS) was accomplished through a grant to the American College of Radiology (ACR) and was the first nationwide evaluation of a medical specialty. A pioneering effort, the PCS has served as a model for other oncology-related disciplines. The PCS was again funded as a grant in 1978 and 1983. Data from these earlier studies provided the foundation for long-term follow-up of patients treated for cancer of the prostate, cervix, and Hodgkin's disease. Significantly, these studies have shown that the quality of care and the survival of cancer patients treated with radiation therapy was statistically related to the treatment "process" (e.g., equipment, personnel, and diagnostic workup). By identifying those pretreatment and treatment factors that are significant to patient survival and outcome in disease sites where local control and patient outcome could be improved, previous patterns of care studies have facilitated a gradual, but significant, improvement in the management of several cancers, including prostate and cervical cancer and Hodgkin's disease. New Study The objective of this RFA is to focus on those factors that are most likely to affect patient outcome and quality of life, such as failure to treat and control local-regional neoplastic disease and the incidence of treatment related morbidity. Although studies in the past have focused on retrospective data, prospective studies that document patterns of diagnostic methodology, treatment workup, and followup for a variety of anatomical sites with neoplastic disease are of interest, with a goal of identifying those variables associated with maximizing local control and minimizing complications of normal tissues. Specific projects of interest include prospective patterns of care studies that coordinate with active protocols of the cooperative groups in cancers of the prostate and cervix, as well as studies that show patterns of total care for early stage breast cancer. Patterns of care that document differences between minorities and non-minorities are also of interest, as well as documentation of the penetration of the results of clinical trials into routine clinical practice. Applicants should describe how they plan to coordinate with active protocols and how they will assess the impact of results of clinical trials on routine clinical practice. 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 applications for NIH clinical research grants are 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 must 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 inadequately represented in the clinical research of this RFA, particularly in proposed population-based studies, a clear and compelling rationale must be provided. The composition of the proposed study population must be described in terms of the racial/ethnic group, together with a rationale for its choice. In addition, racial/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 (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 should be provided. For the purpose of this policy, clinical research includes 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 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 tissue from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of minorities and women in the study design is inadequate to answer the scientific question 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 that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Sandra Zink at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). Application kits are available from most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, MD 20892** At the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by January 24, 1994. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed (initially) by the Division of Research Grants (DRG) for completeness and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated in the RFA for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. Review Criteria 1. Extent to which the application addresses the goals and objectives of this RFA; 2. scientific, technical or clinical significance and originality of the proposed research; 3. appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; 4. the leadership ability of the Principal Investigator and documented experience in clinical studies; 5. documented ability of the staff to carry out all the procedures of data collection, evaluation of evaluability, and quality assurance; 6. statistical support necessary to design, monitor, analyze and report on the patterns of care studies; and 7. adequacy of appropriate facilities and resources to support the research objectives of this RFA. Reviewers will examine the budget request critically and recommend an appropriate budget. AWARD CRITERIA The earliest feasible start date for the initial award will be September 30, 1994, and will be made solely on the basis of peer review. Only the most meritorious will be considered, contingent upon the availability of funds. Although this program is provided for in the financial plans of the NCI, a grant award pursuant to this RFA is contingent upon the availability of funds for this purpose. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged. The NCI welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Dr. Sandra Zink Radiation Research Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9360 FAX: (301) 480-5785 Direct inquiries regarding fiscal matters to: Ms. Barbara Fisher Grants Administration Branch Executive Plaza South, Room 242 6120 Executive Boulevard Bethesda, MD 20852 Telephone: (301) 496-7800, Ext. 29 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395 (Cancer Treatment Research). Awards are made under the authorization of Public Health Service Act, Title IV, Sections 301, 410 and 411, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285 (a.)) and administered under the PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA AI94002 AI-94-002 P1O1 *************************************** MECHANISM OF RESPIRATORY SYNCYTIAL VIRUS VACCINE IMMUNOPOTENTIATION NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA: AI-94-002 P.T. 34; K.W. 0705048, 0740075, 0710070 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 14, 1994 Application Receipt Date: March 17, 1994 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications to conduct basic research on the immunology of Respiratory Syncytial Virus (RSV) protection and disease. Specifically, the NIAID is interested in addressing the immune responses associated with the exacerbation of disease in children who had previously received formalin-inactivated RSV vaccine. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Mechanism of RSV Vaccine Immunopotentiation, is related to the priority area of immunization and 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 domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Successful applications from foreign institutions, however, are limited to three years of support without indirect costs. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards made under this RFA will use the National Institutes of Health (NIH) individual research grant (R01) award mechanism. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted by domestic institutions may not exceed four years; the total project period for applications submitted by foreign institutions may not exceed three years. The anticipated earliest possible award date is September 1994. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations to accelerate technical progress and clinical development of promising prophylactics. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the amounts awarded will also vary. This RFA is a one-time solicitation. Future competing continuation applications will compete with all unsolicited investigator-initiated applications and be reviewed by an appropriate Study Section according to the customary NIH referral and peer review procedures. FUNDS AVAILABLE The funds available for the total (direct and indirect) first year cost of all awards under this RFA is $1.0 million. Foreign applications that may be funded under this RFA are not eligible for indirect costs. The NIAID anticipates making a minimum of three new awards. RESEARCH OBJECTIVES Background Acute respiratory infections represent a significant cause of death, worldwide. The most serious acute respiratory condition, pneumonia, is the cause of four million deaths per year in children under the age of five. The etiology of pneumonia has been assessed in both developed and developing countries and has been found to be strikingly similar. Worldwide, it has been estimated that, for children under the age of five, over half of pneumonia deaths are of viral or bacterial/viral origin. Of all the respiratory viruses associated with death due to childhood pneumonia, over 62 percent were associated with RSV. Within the U.S., the impact of RSV infection is primarily through increased morbidity (hospitalization due to pneumonia) in both normal and high risk children including low birth weight infants and children with bronchopulmonary dysplasia (BPD), congenital heart disease (CHD) and immunodeficiencies. For example, in a prospective study conducted at the University of Colorado Hospital, BPD infants infected with RSV accounted for 10 percent of total pediatric hospital days. Thus, the development of successful vaccines for RSV could significantly alleviate the excess infant morbidity and mortality. Presently, there are no licensed RSV vaccines and only limited efforts in the development of vaccine candidates because attempts to develop a safe and effective vaccine have met with continued frustration. In the mid-1960's, a formalin inactivated RSV vaccine was evaluated in previously unprimed (seronegative) infants. When these children were subsequently exposed during an RSV outbreak, the resulting illnesses were very severe. Specifically, children under two years of age who received the vaccine had a much higher incidence of pneumonia (60 percent) and hospitalization (21 percent) compared to the children who received placebo (8 percent and 1.5 percent, respectively). Attempts to understand the nature of this immunopotentiation event have relied primarily on data generated using the cotton-rat model. In this system, RSV challenge of animals immunized with a formalin-inactivated RSV vaccine has been associated with changes in lung histology. The equation of this altered histology in animals with the exacerbated disease in humans has been widely debated. Nonetheless, in the absence of definitive data to the contrary, the cotton-rat model has been widely used to define the preclinical safety of potential new vaccine candidates. At a recent NIAID/WHO/CDC RSV Workshop (May 1993) use of alternative animal model systems for detailed studies of the immunologic mechanism of immunopotentiation (eg., mouse model) and development of animal models with clinical disease patterns/immunologic responses similar to those seen in humans (eg., lamb/bovine models) were encouraged. It was also clear that continued use of the cotton-rat model to define safety of new experimental vaccines requires additional knowledge as to the basis of the histologic changes observed following challenge. Until then, a significant barrier would remain in the development of RSV vaccines. Scope of Research The long-term goal of the NIAID is to facilitate the development of an effective RSV vaccine. However, interim objectives must be met before candidate vaccines can be entered into clinical trials involving seronegative infants and children. The goal of this RFA is to stimulate innovative new research on the complex immunology associated with RSV disease immunopotentiation and within that context to develop in vitro and/or in vivo assays that accurately reflect the potential safety of RSV vaccine candidates. Examples of projects that might be responsive to this RFA include, but are not limited to: 1. Detailed analysis of the immune pathways stimulated following: o immunization with experimental RSV vaccines that have been previously associated with immunopotentiation; o immunization with experimental RSV vaccines that have been associated with protection but not immunopotentiation; o natural infection; 2. Development of in vivo models that closely mimic the clinical disease/immunopotentiation event seen in humans; 3. Development of immunologically defined reagents for valid in vivo models; 4. Development of in vitro models to assess the immunopotentiation effect of candidate RSV vaccines; 5. Definition of the properties of vaccine preparations which have been associated with immunopotentiation. SPECIAL REQUIREMENTS NIAID Program Staff will organize annual meetings in Bethesda that Principal Investigators and other key members (as designated by the Principal Investigators) of the projects will be requested to attend to discuss progress. At the discretion of the Program Staff, clinical researchers and members of the vaccine industry may also be invited to attend. Funds for travel to these meetings should be included in the budget. 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 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 must 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 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, gender and racial/ethnic issues must 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 should 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 women and 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 application will be returned. 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 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. NOTE: Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID advises that, as a minimum, the application should contain demographic data about the clinic and/or in-patient population from which study subjects will be drawn: average hospital admission per year; percentage distribution of Black/Hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. LETTER OF INTENT Prospective applicants are asked to submit, by January 14, 1994, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAID Staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI-94-002 and the title "MECHANISM of RSV VACCINE IMMUNOPOTENTIATION." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by March 17, 1994. Applications not received by the receipt date will be considered non-responsive and will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of essentially identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group, before or during the initial review meeting, to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIH will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The factors to be considered in scientific review of the application are: 1. Scientific merit of the proposed research approach, design, and methodology as well as the potential scientific, technical, or medical significance of the proposed research. 2. Research experience and competence of the Principal Investigator(s) and other staff to conduct the proposed studies. 3. Adequacy of the time (effort) that the Principal Investigator(s) and staff would devote to the proposed studies. 4. Adequacy of facilities, including, if relevant to the proposed research, adequacy of the clinical facilities and patient availability for clinical studies. AWARD CRITERIA In selecting applications for funding, while scientific merit is of primary consideration, applications will also be evaluated for programmatic relevance and potential for impact on the clinical development of RSV vaccines. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Carole Heilman Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3B-06 Bethesda, MD 20892 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-mail: hck@exec.niaid.pc.niaid.nih.gov Address the letter of intent, two copies of the completed application, and direct any questions regarding review procedures to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C19 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-35 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: January 14, 1993 Application Receipt Date: March 17, 1994 Scientific Review Date: June 1994 Council Meeting Date: September 1994 Earliest Award Date: September 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease 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. From owner-sci-resources@net.bio.net Thu Nov 18 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 40, pt. 2, 5 November 1993 Message-ID: Date: 19 Nov 93 04:43:36 GMT Sender: kristoff@net.bio.net Lines: 837 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19931105 V22N40 P2O2 ************************************ Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301 and administered under PHS grants policies and Federal Regulations of Title 42 CFR 52 "Grants for Research Projects", Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may be applicable to these awards. Title 42 Part 241(d) "Certificates of Confidentiality and Communicable Disease Reporting" will also apply. Program is not subject to the intergovernmental review requirements of Executive Order 12372. $$P1 END ************************************************************ $$P2 BEGIN PA-94-011 ************************************************ ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE NIH GUIDE, Volume 22, Number 40, November 5, 1993 PA NUMBER: PA-94-011 P.T. 34; K.W. 0408006, 0715035, 0745027, 0730050 National Cancer Institute Agency for Health Care Policy and Research PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) and the Agency for Health Care Policy and Research (AHCPR) invite investigator-initiated grant applications for research directed at increasing the knowledge base in the area of the economic aspects of cancer prevention, screening and care. The goal of this program announcement is to generate new economic knowledge that will promote the optimal design of cancer prevention and control trial studies and interventions and will facilitate the formulation of effective health care policy related to cancer prevention and control. This initiative requests research applications on new methods development, the synthesis and extension of existing methods, and innovative data gathering strategies. Applications that propose to implement actual data collection on a pilot or full-scale basis as well as analytical studies that use existing data and methodology will be entertained. The focus of this Program Announcement (PA) relates to the general health services and medical treatment effectiveness research supported by the AHCPR for a wide range of clinical conditions, including cancer. For example, AHCPR is presently supporting, and continues to be interested in, research on the analysis of health care costs, the measurement of patient outcomes, the cost effectiveness of health care services and procedures, and the development of methods used in studies of the quality and outcomes of care. Related research priorities for AHCPR are described in: PA-93-045 "Cost and Financing Issues in Health Care Reform", PA-93-063 "Primary Care and Health Care Reform", and RFA HS-94-002 "Medical Treatment Effectiveness Research." 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, Economic Studies in Cancer Prevention, Screening, and Care, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this PA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000. Because the nature and scope of research proposed in response to this PA may vary, it is anticipated that the size of award will vary also. The anticipated amount of the direct costs per award will vary from $50,000 to $500,000 per year. Expenses incurred in development and implementation of the proposed research, including baseline and follow-up surveys, design of materials, and professional education are allowable costs. RESEARCH OBJECTIVES This initiative supports research directed at increasing our understanding of economic aspects of cancer prevention, screening and care. Cancer is a heterogeneous chronic disease characterized by innovation in treatment and care approaches. Studies that cover the national population of all ages on an episodic basis fail to capture an adequate sample of cancer patients or the full scope and duration of cancer costs. Studies that focus on a convenience sample of cancer patients in a single health care delivery setting or community can be criticized as lacking external validity. Studies proposed in response to this PA will be expected to address these issues and propose innovative methods of overcoming these limitations. Three broad topics are included in this PA: o The cost of cancer treatment and care in various organizational settings. o Collection of economic data in the context of clinical trials and the use of economic data and analysis in the design of trials. o Cost-effectiveness of cancer prevention and screening trials and cancer prevention and control interventions. The purpose of this PA is to solicit collaborative research between academics in the fields of health economics and health services research and clinical researchers in cancer. The specific research goals of this PA are: 1. The cost of cancer treatment and care in various organizational settings To develop and validate methods for collecting reliable and representative data on longitudinal patterns of health care resource use, expenditures and costs for cancer prevention, screening, diagnostic, treatment, and care in various organizational settings. To develop and validate methods for collecting reliable and representative data on the cost of continuing care for cancer patients. These costs include not only out-of-pocket costs for medical treatment and related expenses but also other monetary and non-monetary disease and treatment costs to the cancer patient and the family of the cancer patient. To explore alternative proposed and existing models of out-patient and home-based continuing care for cancer patients in order to determine efficient modes of organization that provide access to and meet the continuing care needs of cancer patients and their families. 2. Collection of economic data in the context of clinical trials and the use of economic data and analysis in the design of trials To determine the cost of the health care intervention (e.g., cancer prevention, control, treatment or rehabilitation) in NCI sponsored trial settings compared to standard cancer control and treatment settings. To determine the feasibility of collecting data on direct and indirect lifetime costs in the context of clinical trials. To collect data on direct and/or indirect lifetime cost in the context of a clinical trial. 3. Cost-effectiveness of cancer prevention and screening trials and cancer prevention and control interventions To review and evaluate the existing conceptual basis, methodology and application of cost effectiveness analysis to cancer related interventions. Studies should identify conceptual, methodological and data collection problems unique to cancer related interventions and propose solutions to these problems. Studies should also include an evaluation of the appropriate role of cost effectiveness analysis in policy formulation related to cancer and how this role relates, or should relate, to medical ethics, equity and fairness, and community values. To determine the cost effectiveness of NCI sponsored cancer prevention and screening trials. Studies should include an analysis of the important determinates of cost effectiveness, the level of uncertainty of these determinates, and how these determinates might be effected by alternative trial designs. To determine the cost effectiveness of cancer prevention and control interventions as implemented through the health care system. Studies should include an analysis of the important determinates of cost effectiveness, the level of uncertainty of these determinates, and how these determinates might be effected by alternative health care delivery settings and health care policies. The relevance of cost effectiveness analysis for the particular question studied should be demonstrated by showing that it contributes additional information to the health care decision making process than would be available from clinical trial efficacy information alone. 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 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 must 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 inadequately represented in clinical research, particularly in proposed population-based studies, a clear and 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, gender and racial/ethnic issues must 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 (revised 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, the 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 should 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 women and 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 application will be returned. 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. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. In cases where the proposed study involves collaboration with an ongoing NCI sponsored trial the application must include a letter from the principal investigators of that trial indicating the latter's endorsement of the proposed study and willingness to collaborate. Any grant proposing association with an existing NCI trial would, of course, have to be approved by NCI grants or contracts administration and by the project officer to the existing trial before submission. All regulations involving human subjects and release of data applicable to the original trial would apply to the supplemental grant. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The application package is available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the announcement must be typed in line 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 CONSIDERATIONS Applications will be assigned to the appropriate PHS study section, by the Division of Research Grants on the basis of established Public Health Service referral guidelines. Applications will be reviewed by the study section for scientific and technical merit in accordance with standard PHS peer review procedures. The following criteria will be considered when assessing the merit of a research grant application: o scientific, technical or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary for the research; o appropriateness of the proposed budget and timetable in relation to the scope of the proposed research; o adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, vertebrate animals, and/or the environment; and o for studies involving minorities and both genders subjects in research, the adequacy of plans to include minorities and both genders in the study design, and the potential of that design to address the scientific question(s) addressed. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. 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 concerning the objectives and scope of this PA, or inquiries about whether or not specific proposed research would be responsive, are encouraged. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Martin L. Brown Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8500 FAX: (301) 496-8667 Michael Hagen Program Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: 301/594-1354 Direct inquiries regarding budgetary, administrative, and/or policy issues to: Mrs. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800 FAX: (301) 496-8601 Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research. Awards are made under the 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 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$XID RFA HS94004 HS-94-004 P1O1 *************************************** FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION AWARD NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA: HS-94-004 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research Application Receipt Date: March 11, 1994 PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the availability of the First Independent Research Support and Transition (FIRST) Award (R29) in health services research. The purpose of the FIRST Award is to provide a sufficient period of research support for newly independent health services researchers to initiate their own research and demonstrate independent investigative efforts; to provide a reasonable opportunity to demonstrate creativity, productivity, and further promise; and to help in the transition to traditional types of AHCPR research project grants. The award is not intended for established investigators who may be in transition to another endeavor. A FIRST Award is for a distinct research endeavor and may not be used merely to supplement or broaden an ongoing project at the applicant institution. FIRST Awards are intended to provide funds for newly independent investigators for five years during which time they can establish their own research program and make significant and innovative contributions to health services research. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202/783-3238). ELIGIBILITY To be eligible for a FIRST Award, the proposed Principal Investigator (PI) must be genuinely independent of a mentor yet at the same time must be at the beginning stages of his or her research career with, in most instances, no more than five years research experience since completing postdoctoral research training or its equivalent. If the applicant is in the final stages of such training, it is permissible to apply, but no FIRST Award will be made to persons in training status. In addition, the proposed PI must otherwise be eligible to serve in the same capacity on a traditional research project grant (R01) awarded to the applicant institution. Only non-profit domestic institutions and organizations are eligible to receive FIRST Awards. The applicant investigator must never have been designated previously as PI on any PHS-supported research project OTHER THAN a PHS small grant (R03), an Academic Research Enhancement Award (R15), or certain career development awards (K series) directed principally to physicians, dentists, or other clinicians with little research experience. (Current or past Research Career Development Awardees are not eligible.) Subproject leaders on multicomponent PHS awards such as Program Project grants (P01), Center grants (P50), or Minority Biomedical Research Support grants (S06) may also be eligible, depending on their stage of career development; however, potential applicants in these categories are urged to contact AHCPR prior to filing an application. MECHANISM OF SUPPORT This Request for Applications (RFA) represents the initial use of the First Independent Research Support and Transition (FIRST) Award (R29) by AHCPR. See SPECIAL REQUIREMENTS, below, for details of this mechanism. FUNDS AVAILABLE The AHCPR expects to fund approximately three FIRST Awards in Fiscal Year (FY) 1994. The actual number awarded in FY 94 will depend on availability of funds as will the number in future years. RESEARCH OBJECTIVES The AHCPR conducts and supports research on the quality, appropriateness, efficiency, and effectiveness of health care services and the systems for delivery of these services. Research areas of interest for FIRST applications are as follows: o Health care reform issues; o Health care costs and financing; o Relationship between primary care and health care costs, access, and quality; o Rural health including access to services, supply of health professionals, delivery systems issues, primary health care, health promotion and disease prevention, technology diffusion, and special populations; o Health care quality improvement and quality assurance including methods and measures; o Information technologies and factors affecting their use; o Costs and quality of alternative delivery systems and managed care; o Health care technologies, facilities, and equipment; o Medical effectiveness and patient outcomes research; o Medical liability and malpractice; o Access, medical effectiveness, and patient outcomes research in low-income, minority, elderly, and other underserved populations; o Dissemination of health and clinical information and research findings to practitioners, consumers, and patients for use in improved health care decisionmaking; o Services for persons with human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS); and o Evaluation of outcomes associated with the use of clinical practice guidelines. The following announcements, which were published in the NIH Guide for Grants and Contracts, provide more detailed information on selected areas of interest: "Health Services for Persons with HIV Infection" (PA-93-110), Vol. 22, No. 33, September 17, 1993; "Health Care Quality Improvement and Quality Assurance Research" (PA-93-084), Vol. 22, No. 19, May 21, 1993; "Primary Care and Health Care Reform" (PA-93-063), Vol. 22, No. 10, March 12, 1993; "Cost and Financing Issues in Health Care Reform" (PA-93-45), Vol. 22, No. 4, Jan. 29, 1993; "Health Services Research on Rural Health" (PA-92-71), Vol. 21, No. 16, May 1, 1992; and "Effective Dissemination of Health and Clinical Information and Research Findings" (PA-92-51), Vol 21, No. 10, March 13, 1992. STUDY POPULATIONS SPECIAL INSTRUCTION TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS The AHCPR requires all applicants for research grants 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 must be placed on the need to include 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 research, a clear and compelling rationale should be provided. AHCPR will not award grants for applications which do not comply. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing the 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 to 4 of the Research Plan and summarized in section 5, Human Subjects (or in the Program Narrative section of form PHS 5161 for State and local governments). Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, AHCPR recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations (i.e., Native Americans, Asian/Pacific Islanders, African Americans, and Hispanics). Where appropriate, the applicant must provide the rationale for studies on single minority population groups. 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. This policy applies to all AHCPR research grants. The AHCPR will not award grants for applications that do not comply. If the application does not contain the required information, it will be returned without review. SPECIAL REQUIREMENTS An individual may submit only one FIRST Award application to the Public Health Service (PHS) for the receipt date and may not submit any other type of research grant application (including research career applications), to the PHS during the applicable review cycle. However, applications for an R03 and an R15 may be submitted to the PHS simultaneously with a FIRST application provided they are on separate topics. Applications for other projects may be submitted during the FIRST Award period, if the time and effort on the FIRST Award are less than 100 percent. FIRST Award applications must request five years of research support. Applications submitted to AHCPR in which the request is for fewer than five years of support will be designated R01s and so reviewed unless the applicant withdraws the application. The Principal Investigator must make a commitment of no less than 50 percent effort to the proposed project. Up to 100 percent effort may be requested if a greater commitment of the principal investigator is required to do the research. The request for effort of the applicant investigator will be reviewed and modifications may be recommended. The total direct cost award for the five-year period may not exceed $350,000. The direct cost award in any yearly budget period should not exceed $100,000. Indirect costs will be paid to the grantee institution in accord with applicable policy of the Department of Health and Human Services (DHHS). FIRST Awards are not renewable. Replacement of the PI on a FIRST Award will not be approved. Transfer of the FIRST Award with the Principal Investigator to another institution for the remaining performance period may be requested. APPLICATION PROCEDURES The application receipt date is March 11, 1994. The research grant application form PHS 398 (rev. 9/91) is to be used, and the applicants must provide relevant information on eligibility. These forms are available at most institutional offices of sponsored research and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Application page limitations apply to the Research Plan section of the PHS 398 application form. Sections 1-4 of the Research Plan, as described on page 20 of the instructions for the PHS 398 (rev. 9/91), are limited to a total of 25 pages, including tables and figures. Applications exceeding the 25-page limitation will be returned. If appendix material is submitted, five collated sets must be included with the application package. Identify each of the five sets with the name of the principal investigator and the project title. This material will not be routinely duplicated and will be used in a limited way by members of the initial review group. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box in 2a must be marked. Special care should be taken to thoroughly understand and carefully address the matters of human subject certifications and assurances, including issues related to gender and minority representation, as described in the application form PHS 398 (especially pages 11-13, 21-23, and 25-26). In the instructions for the PHS 398, "human subject" is defined by regulations as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The human subject regulations encompass graphic, written, or recorded information derived from individually identifiable human subjects. The following is to be addressed in a letter or memorandum from a suitable department head or dean and submitted with the application: (1) eligibility of the proposed Principal Investigator to independently lead a research project at the applicant institution, is this person otherwise qualified to be the PI on a traditional research project grant (R01)?; and (2) details of the intended commitment of the institution to the project for the five-year period. In addition, three letters of reference for the proposed PI are needed. Reference letters must be submitted with the application. Such letters are critically important and should reflect the investigator's research originality and potential for independent investigation. When the application is from the institution where the proposed PI received postdoctoral research training, it must be made absolutely clear that the FIRST Award would be to support a research endeavor independent of that conducted in the former training environment. FIRST applicants are to request the letters of reference well in advance of the application submission, advising the referees to return the reference letters to the applicant in sealed envelopes as soon as possible. To protect the utility and confidentiality of reference letters, applicants should not open envelopes. The sealed envelopes must be attached to the front of the original applications. Applications received without the three reference letters will be returned to the applicant. A list of individuals providing letters of reference must be included in Section 10 of the Research Plan. Provide the name, title, and institutional affiliation for each person. The completed, signed, original application and five legible copies of form PHS 398; the letter or memorandum from the department head or dean; and the three letters of reference must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Completed applications must be received by the Division of Research Grants by March 11, 1994. If an application is received after that date, it will be returned to the applicant. The following is the review schedule for FIRST applications: Application Receipt Date: March 11, 1994 Initial Review Date: May/June 1994 Council Review Date: September 1994 Earliest Possible Start Date: September 30, 1994 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants, NIH, for completeness and by AHCPR staff for responsiveness to the RFA. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Applications may be subject to triage to determine their scientific merit relative to other applications received in response to this RFA. The AHCPR will withdraw from further competition those applications judged by triage to be noncompetitive for award and notify the Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Review results and funding decisions will be announced approximately six months after the submission date. Review criteria are described below. Review Criteria Applications will be evaluated by an appropriate peer review group convened by AHCPR in accordance with the criteria for scientific and technical merit stated below, taking into consideration the investigator's stage of development, merit of the proposed research, the resources and environment, and the appropriateness of the proposed budget. Applications may be reviewed by the National Advisory Council for Health Care Policy, Research, and Evaluation for policy relevance and research value. For a FIRST application, it is recognized that an investigator with limited experience is less likely to be able to submit an application with the breadth and depth of that submitted by an experienced investigator. Reviewers are expected to recognize that, in general, less detail will be expected with regard to work planned for the later years of the project, but the Principal Investigator should outline the general plans for these years. A FIRST application must provide clear evidence of the investigator's ability to develop a plan for the research project. The following criteria will be used in evaluating the application for scientific and technical merit: Principal Investigator o Potential to carry out independent research; o Quality and extent of education, scientific training, and research experience; o Evidence of research productivity, appropriate to the level of experience; o Quality of any research publications; and o Commitment to a research career. Research Design o Originality and significance of the research goals; o Appropriateness and significance of the research hypotheses; o Feasibility and adequacy of design and methodology; and o Availability of data and appropriateness of plans for organizing the project and carrying out the data collection and analysis. Resources and Environment o Availability of essential facilities and equipment, subject populations, computer time, or other resources, as appropriate; and o Evidence of institutional commitment to the project. Budget Appropriateness o Appropriateness of budget estimates in relation to aims and methods; and o Appropriateness of period of support for carrying out the research and for demonstrating the investigator's scientific abilities. AWARD CRITERIA The decision to fund an application will depend on the overall scientific and technical merit of the proposal as determined by peer review, program balance and relevance, and availability of funds. In very unusual circumstances, FIRST awards may be recommended by the initial review group or the awarding component for periods of fewer than five years. INQUIRIES Inquiries regarding programmatic issues may be directed to the appropriate office listed below: For applied dissemination research: Center for Research Dissemination and Liaison Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 501 Rockville, MD 20852 Telephone: (301) 594-1362 For medical effectiveness and outcomes research: Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852 Telephone: (301) 594-1485 For other AHCPR health services research: Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852 Telephone: (301) 594-1349, Ext. 104 Direct inquiries regarding fiscal/administrative matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.180 and 93.226. Awards are authorized under the Public Health Service Act, Title IX, as amended by Public Laws 101-239 and 102-410, (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372. From owner-sci-resources@net.bio.net Thu Nov 18 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 40, pt. 1, 5 November 1993 Message-ID: Date: 19 Nov 93 04:42:47 GMT Sender: kristoff@net.bio.net Lines: 1505 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19931105 V22N40 P1O2 ************************************ X-comment: RFAs described: CA-94-006, HS-94-004, AI-94-002 NIH GUIDE - Vol. 22, No. 40 - November 5, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N2 ********************************************************** WORLD AIDS FOUNDATION Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 01/24/94 ************************************************* PATTERNS OF CARE IN RADIATION ONCOLOGY (RFA CA-94-006) National Cancer Institute INDEX: CANCER $$INDEX R2 03/11/94 ************************************************* FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION AWARD (RFA HS-94-004) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R3 03/17/94 ************************************************* MECHANISM of RESPIRATORY SYNCYTIAL VIRUS VACCINE IMMUNOPOTENTIATION (RFA AI-94-002) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH ON NEEDLE HYGIENE AND NEEDLE EXCHANGE PROGRAMS (PA-94-010) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE (PA-94-011) National Cancer Institute Agency for Health Care Policy and Research INDEX: CANCER; HEALTH CARE POLICY, RESEARCH This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 22, Number 40, November 5, 1993 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human persons and those currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: WESTERN WORKSHOP DATES: November 4-5, 1993 LOCATION Radisson Hotel Denver South, Denver, CO SPONSORS University of Colorado Health Sciences Center, Denver, CO University of Southern Colorado, Pueblo, CO REGISTRATION Ms. Mary Peratt, Secretary IRB University of Colorado Health Sciences Center 4200 East Ninth Avenue (Box C-290) Denver, CO 80262 Telephone: (303) 270-7960 TITLE: Medical Research: Protection of Vulnerable Subjects DESCRIPTION: IRBs are confronted with a complexity of questions and ethical issues that seldom have defined answers or ready resolve. Some of the more perplexing clinical research protocols presented for review are studies involving human subjects in overt, at-risk groups. This human subjects workshop will address protections of highly vulnerable and protected human populations. Discussions will focus on the ethical principles, protective measures, and definitions of criteria for informed consent that are tantamount for IRB reviews when members of these vulnerable groups are subjects of research studies. Subject groups and protocols to be covered will be focused on prisoners, children, mentally compromised, AIDS and HIV-infected, geriatric, and emergency room. The conference program is designed to be of value to physicians, nurses, pharmacists, scientific investigators, pharmaceutical and medical device company representatives, and other health care professionals. All IRB members, faculty, and students in health care areas and administrators will benefit from the conference. Critical attention will be given to Federal regulations governing these special groups, professional judgment, real and perceived elements of "implied," "second," and "third" party consents. Conference emphasis will be placed on the assessment of risks and protection of the vulnerable subject with the application of medical, legal, psychosocial and ethical standards and principles. The conference format is structured to promote the optimum exchange of ideas and discussion through small and large group, topic-defined, informal, and provocative sessions. WEST COAST WORKSHOP DATES: January 23-24, 1994 LOCATION Doubletree Hotel, Pasadena, CA SPONSORS City of Hope National Medical Center, Duarte, CA Charles R. Drew University of Medicine and Science, Los Angeles, CA REGISTRATION Ms. Donna Pearce Administrative Secretary, IRB City of Hope National Medical Center Beckman Research Institute Duarte, CA 91010 Telephone: (818) 359-8111, ext. 2700 TITLE: Ethical Issues in Human Subject Research: Catastrophic Diseases and Minorities DESCRIPTION: This workshop is intended for physicians, nurses, pharmacists, and other health care professionals as well as administrators, members of Institutional Review Boards, students, ethicists and legal experts, and lay persons with interest and concern for human subject research. The program will address the following issues: (1) new governmental policies on human subject research; (2) resolving ethical principles in clinical research on AIDS, gene transfer, and cancer prevention trials involving catastrophic illnesses; (3) drug trials and parallel track protocols; (4) minorities as research subjects; and (5) the uncertain fate of clinical research in the current era of health care reform. SOUTH COAST CENTRAL WORKSHOP DATES: February 17-18, 1994 LOCATION Fairmont Hotel, New Orleans, LA SPONSORS University of New Orleans - Lakefront, New Orleans, LA Xavier University of Louisiana, New Orleans, LA REGISTRATION Ms. Anne O'Hearn Jakob Office of Conference Services University of New Orleans - Lakefront New Orleans, LA 70148 Telephone: (504) 286-7118 TITLE: Recent Trends in Human Subjects Research DESCRIPTION: The purpose of this conference is to explore recent issues and trends related to the protection of human subjects in research. It will provide discussions and opportunities among participants to share views on NIH's new guidelines on fetal research, the inclusion of women and minorities in research, and FDA's recent policy on enrolling women of childbearing age in drug trials. Workshops and meetings will be conducted by faculty of more than 25 national experts whose research interests include alzheimer's disease, environmental research, women's health, human genome research, biomedical research, and others. INQUIRIES For further information regarding these workshop and future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** WORLD AIDS FOUNDATION NIH GUIDE, Volume 22, Number 40, November 5, 1993 P.T. 34, 42; K.W. 0715008, 0502017 Fogarty International Center The World AIDS Foundation (WAF) announces its intent to support research and education relating to Acquired Immunodeficiency Syndrome (AIDS) in the developing world. The goal of the WAF is to facilitate information exchange and assist developing countries in responding to the AIDS pandemic. The WAF is particularly interested in projects that are catalytic and once in place could have a multiplicative effect. Projects that involve collaboration with the WHO Global Programme on AIDS are of particular interest. The WAF is also interested in supporting applications that originate from developing countries and that emphasize collaboration between and among scientists, physicians, and public health workers from developed and developing countries. Of special interest are projects that respond to the anticipated increase in HIV infection in South-East Asia and the Western Pacific. The limit of any single funding request to the WAF is $200,000. APPLICATION PROCEDURES Concept letters and applications may be prepared in either English or French. Applicants should submit concept letters for initial consideration. Following review of concept letters, applicants may be invited to submit complete proposals. The annual deadline for receipt of concept letters is February 1. INQUIRIES Concept letters and inquiries concerning the programs of the World AIDS Foundation may be directed by mail or by FAX to: World AIDS Foundation Assistant Secretary for Health c/o Director, Fogarty International Center National Institutes of Health Building 31, Room B2C02 Bethesda, MD 20892, U.S.A. FAX: (301) 402-2056 or Fondation Mondiale SIDA c/o Directeur de l'Institut Pasteur 28 rue du Docteur Roux 75724 Paris, Cedex 15, FRANCE FAX: 0033-1-45688938 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN CA-94-006 FULL-TEXT ************************************** PATTERNS OF CARE IN RADIATION ONCOLOGY NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA AVAILABLE: CA-94-006 P.T. 34; K.W. 0785140, 0725015, 0730050 National Cancer Institute Letter of Intent Receipt Date: December 1, 1993 Application Receipt Date: January 24, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Radiation Research Program (RRP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites applications for Patterns of Care Studies in Radiation Oncology. The objective of this RFA is to focus on those factors in radiation oncology that are most likely to affect patient outcome, such as failure to control local-regional neoplastic disease, treatment related morbidity that negatively impacts a patient's quality of life, or failure to implement new methods and treatment strategies that have been shown to be advantageous for the patient. 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 RFA, Patterns of Care in Radiation Oncology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the investigator-initiated research project grant (R01). The NCI anticipates awarding one to two grants, with total costs not to exceed $650,000 for the first year. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, if it is determined that there is sufficient programmatic need, the NCI will invite recipients of awards under this RFA to submit competitive continuation grant applications for review according to the procedures of the DRG. FUNDS AVAILABLE Approximately $650,000 in total costs per year for three years will be committed specifically to fund grants that are awarded in response to this RFA. The NCI anticipates that one to two awards will be made. Although this program is provided for in the financial plans of the NCI, the award of a grant in response to this RFA is also contingent upon the availability of funds for this purpose. The earliest feasible start date for the initial award will be September 30, 1994. RESEARCH OBJECTIVES The major goal of this research initiative is to support clinical investigations that (1) document and evaluate patient survival and outcome as a function of radiation oncology practice and methodology, (2) coordinate with the leadership of the Cooperative Groups for the optimal design of protocols and clinical trials based on data received from patterns of care studies, (3) examine the patterns of care for minorities vs non-minorities, and (4) present the findings of the patterns of care studies to the radiation oncology community to achieve both the goals of information and education. The evaluation and documentation of the acceptance and implementation of new treatment strategies in the radiation oncology community where a benefit for the cancer patients has been shown is also of interest. New studies of interest are prospective patterns of care and/or patterns of fractionation studies that will support and enhance on-going protocols for cancers of the prostate and cervix. Prospective studies that show patterns of total care for breast cancer are of special interest. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES NIH policy is that applications for NIH clinical research grants 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 must 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 persons of all ages. If minorities and women are excluded or inadequately represented in the clinical research of this RFA, a clear and compelling rationale must be provided. NIH funding components will not award grants that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. A letter of intent is not required, is not binding and does not enter into the review of subsequent applications. The letter of intent is to be sent to the Program Director at the address listed under INQUIRIES. APPLICATION PROCEDURES Application are to be submitted on form PHS 398 (rev. 9/91). Application kits are available from most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NCI in accordance with the usual NIH peer review procedures. See RFA for review criteria to be used in initial review. Following initial review, applications will be given a secondary review by the National Cancer Advisory Board unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant. Questions concerning the responsiveness of proposed research to the RFA may be directed to program staff listed under INQUIRIES. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged. The NCI welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Sandra Zink Radiation Research Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9360 FAX: (301) 480-5785 Direct inquiries regarding fiscal matters to: Ms. Barbara Fisher Grants Administration Branch Executive Plaza South, Room 242 6120 Executive Boulevard Rockville, MD 20852 Telephone: (301) 496-7800, Ext. 29 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395 (Cancer Treatment Research). Awards are made under the authorization of Public Health Service Act, Title IV, Sections 301, 410 and 411, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285 (a.)) and administered under the PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN HS-94-004 FULL-TEXT ************************************** FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION AWARD NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA AVAILABLE: HS-94-004 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research Application Receipt Date: March 11, 1994 THIS IS A NOTICE OF THE AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the availability of the First Independent Research Support and Transition (FIRST) Award (R29) in health services research. The purpose of the FIRST Award is to provide a sufficient period of research support for newly independent health services researchers to initiate their own research and demonstrate independent investigative efforts; provide a reasonable opportunity to demonstrate creativity, productivity, and further promise; and to help in the transition to traditional types of AHCPR research project grants. The award is not intended for established investigators who may be in transition to another endeavor. A FIRST Award is for a distinct research endeavor and may not be used merely to supplement or broaden an ongoing project at the applicant institution. FIRST Awards are intended to provide funds for newly independent investigators for five years during which time they can establish their own research program and make significant and innovative contributions to health services research. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY To be eligible for a FIRST Award, the proposed Principal Investigator (PI) must be genuinely independent of a mentor, yet at the beginning stages of his or her research career with, in most instances, no more than five years research experience since completing postdoctoral research training or its equivalent. If the applicant is in the final stages of such training, it is permissible to apply, but no FIRST Award will be made to persons in training status. In addition, the proposed PI must otherwise be eligible to serve in the same capacity on a traditional research project grant (R01) awarded to the applicant institution. Only non-profit domestic institutions and organizations are eligible to receive FIRST Awards. Further information on eligibility is contained in the RFA. MECHANISM OF SUPPORT This RFA represents the initial use of the First Independent Research Support and Transition (FIRST) Award (R29) by AHCPR. See SPECIAL REQUIREMENTS, below, for details of this mechanism. FUNDS AVAILABLE The AHCPR expects to fund approximately three FIRST Awards in Fiscal Year (FY) 1994. The actual number awarded in FY 94 will depend on availability of funds as will the number in future years. RESEARCH OBJECTIVES The AHCPR conducts and supports research on the quality, appropriateness, efficiency, and effectiveness of health care services and the systems for delivery of these services. Research areas of interest for FIRST applications are as follows: o Health care reform issues; o Health care costs and financing; o Relationship between primary care and health care costs, access, and quality; o Rural health including access to services, supply of health professionals, delivery systems issues, primary health care, health promotion and disease prevention, technology diffusion, and special populations; o Health care quality improvement and quality assurance including methods and measures; o Information technologies and factors affecting their use; o Costs and quality of alternative delivery systems and managed care; o Health care technologies, facilities, and equipment; o Medical effectiveness and patient outcomes research; o Medical liability and malpractice; o Access, medical effectiveness, and patient outcomes research in low-income, minority, elderly, and other underserved populations; o Dissemination of health and clinical information and research findings to practitioners, consumers, and patients for use in improved health care decisionmaking; o Services for persons with human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS); and o Evaluation of outcomes associated with the use of clinical practice guidelines. The following program announcements, which were published in the NIH Guide for Grants and Contracts, provide more detailed information on selected areas of interest: "Health Services for Persons with HIV Infection" (PA-93-110), Vol. 22, No. 33, September 17, 1993; "Health Care Quality Improvement and Quality Assurance Research" (PA-93-084), Vol. 22, No. 19, May 21, 1993; "Primary Care and Health Care Reform" (PA-93-063), Vol. 22, No. 10, March 12, 1993; "Cost and Financing Issues in Health Care Reform" (PA-93-45), Vol. 22, No. 4, Jan. 29, 1993; "Health Services Research on Rural Health" (PA-92-71), Vol. 21, No. 16, May 1, 1992; and "Effective Dissemination of Health and Clinical Information and Research Findings" (PA-92-51), Vol 21, No. 10, March 13, 1992. SPECIAL REQUIREMENTS An individual may submit only one FIRST Award application to the Public Health Service for this receipt date. FIRST Award applications must request five years of research support. Applications submitted to AHCPR in which the request is for fewer than five years of support will be returned to the applicant. The PI must make a commitment of no less than 50 percent effort to the proposed project. Up to 100 percent effort may be requested if a greater commitment of the PI is required to do the research. The request for effort of the applicant investigator will be reviewed and modifications may be recommended. The total direct cost award for the five-year period may not exceed $350,000. The direct cost award in any yearly budget period should not exceed $100,000. Indirect costs will be paid to the grantee institution in accord with applicable policy of the Department of Health and Human Services (DHHS). FIRST Awards are not renewable. Further special requirements are provided in the RFA. STUDY POPULATIONS SPECIAL INSTRUCTION TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS The AHCPR requires applicants to include minorities and women in study populations so that research findings can be of benefit to all persons. If women or minorities are excluded or inadequately represented in research, a clear and compelling rationale must be provided. All applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The RFA contains important information for applicants, including the application and review schedule for FIRST Awards, and may be obtained from the Center for Research and Dissemination Liaison, see INQUIRIES. The application receipt date is March 11, 1994. The research grant application form PHS 398 (rev. 9/91) is to be used. These forms are available at most institutional offices of sponsored research and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. In addition, a letter or memorandum from a suitable department head or dean is to be submitted with the application, that addresses: (1) eligibility of proposed Principal Investigator to independently lead a research project at the applicant institution (i.e., is this person otherwise qualified to be the PI on a traditional research project grant (R01)?) and (2) details of the intended commitment of the institution to the project for the five-year period. Also, three letters of reference for the proposed PI are to be submitted with the application. Further details on letters of reference are provided in the RFA. REVIEW CONSIDERATIONS Applications will be reviewed initially by the Division of Research Grants, NIH, for completeness and by AHCPR staff for responsiveness to the RFA. Incomplete and nonresponsive applications will be returned to applicants without further consideration. Applications will be evaluated in accordance with the criteria stated in the RFA for scientific/technical merit by an appropriate AHCPR peer review group. Further review considerations and review criteria are listed in the RFA. Review results and funding decisions will be announced approximately six months after the submission date. INQUIRIES A copy of the RFA may be obtained from the Center for Research Dissemination and Liaison at the address below. In addition, inquiries regarding programmatic issues may be directed to the appropriate office listed below: Applied Dissemination Research: Center for Research Dissemination and Liaison Suite 501, telephone (301) 594-1362 Medical Effectiveness and Outcomes Research: Center for Medical Effectiveness Research Suite 605, telephone (301) 594-1485 Other AHCPR Health Services Research: Center for General Health Services Extramural Research Suite 502, telephone (301) 594-1349, Ext. 104 Direct inquiries regarding fiscal/administrative matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.180 and 93.226. Awards are authorized under the Public Health Service Act, Title IX, as amended by Public Laws 101-239 and 102-410, (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372. $$R2 END ************************************************************ $$R3 BEGIN AI-94-002 FULL-TEXT ************************************** MECHANISM of RESPIRATORY SYNCYTIAL VIRUS VACCINE IMMUNOPOTENTIATION NIH GUIDE, Volume 22, Number 40, November 5, 1993 RFA AVAILABLE: AI-94-002 P.T. 34; K.W. 0705048, 0740075, 0710070 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 14, 1994 Application Receipt Date: March 17, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) announces the availability of an RFA for research on the immunology of Respiratory Syncytial Virus (RSV) protection and disease. Specifically, the NIAID is interested in addressing the immune responses associated with the exacerbation of disease in children who had previously received formalin-inactivated RSV vaccine. 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 RFA, Mechanism of Respiratory Syncytial Virus (RSV) Vaccine Immunopotentiation, is related to the priority area of immunization and 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 domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards made under this RFA will use the National Institutes of Health (NIH) individual research grant (R01) award mechanism. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted by domestic institutions may not exceed four years; the total project period for applications submitted by foreign institutions may not exceed three years. The anticipated earliest possible award date is September, 1994. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations so as to accelerate technical progress and clinical development of promising prophylactics. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the amounts of the awards will vary also. This RFA is a one-time solicitation. Future competing continuation applications will compete with all unsolicited investigator-initiated applications and be reviewed by an appropriate Study Section according to the customary NIH referral and peer review procedures. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first year cost of all awards under this RFA is $ 1.0 million. The NIAID anticipates making a minimum of three new awards. RESEARCH OBJECTIVES Presently, there are no licensed Respiratory Syncytial Virus (RSV) vaccines and only limited efforts in the development of vaccine candidates because attempts to develop a safe and effective vaccine have met with continued frustration. In the mid-1960s, a formalin inactivated RSV vaccine was evaluated in previously unprimed (seronegative) infants. When these children were subsequently exposed during an RSV outbreak, the resulting illnesses were very severe. Specifically, children under two years of age who received the vaccine had a much higher incidence of pneumonia (60 percent) and hospitalization (21 percent) compared to the children who received placebo (8 percent and 1.5 percent, respectively). Attempts to understand the nature of this immunopotentiation event have relied primarily on data generated using the cotton-rat model. In this system, RSV challenge of animals immunized with a formalin-inactivated RSV vaccine has been associated with changes in lung histology. The equation of this altered histology in animals with the exacerbated disease in humans has been widely debated. Nonetheless, in the absence of definitive data to the contrary, the cotton-rat model has been widely used to define the preclinical safety of potential new vaccine candidates. At a recent NIAID/WHO/CDC RSV Workshop (May 1993) use of alternative animal model systems for detailed studies of the immunologic mechanism of immunopotentiation (eg., mouse model) and development of animal models with clinical disease patterns/immunologic responses similar to those seen in humans (eg., lamb/bovine models) were encouraged. It was also clear that continued use of the cotton rat model to define safety of new experimental vaccines requires additional knowledge as to the basis of the histologic changes observed following challenge. Until then, a significant barrier would remain in the development of RSV vaccines. The long-term goal of the NIAID is to facilitate the development of an effective RSV vaccine. However, interim objectives must be met before candidate vaccines can be entered into clinical trials involving seronegative infants and children. The goal of this RFA is to stimulate innovative new research on the complex immunology associated with RSV disease immunopotentiation and within that context to develop in vitro and/or in vivo assays that accurately reflect the potential safety of RSV vaccine candidates. Examples of projects that might be responsive to this RFA include, but are not limited to: 1. Detailed analysis of the immune pathways stimulated following: o immunization with experimental RSV vaccines that have been previously associated with immunopotentiation; o immunization with experimental RSV vaccines that have been associated with protection but not immunopotentiation; o natural infection; 2. Development of in vivo models that closely mimic the clinical disease/immunopotentiation event seen in humans; 3. Development of immunologically defined reagents for valid in vivo models; 4. Development of in vitro models to assess the immunopotentiation effect of candidate RSV vaccines; 5. Definition of the properties of vaccine preparations which have been associated with immunopotentiation. SPECIAL REQUIREMENTS NIAID Program Staff will organize annual meetings in Bethesda that Principal Investigators and other key members (as designated by the Principal Investigators) of the projects will be requested to attend to discuss progress. At the discretion of the Program Staff, clinical researchers and members of the vaccine industry may also be invited to attend. Funds for travel to these meetings should be included in the budget. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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. LETTER OF INTENT Prospective applicants are asked to submit, by January 14, 1994, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains