From owner-sci-resources@net.bio.net Sun Oct 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 32, pt. 1of1, 26 September 1997 Date: 5 Oct 1997 21:36:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 521 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <619psk$o4i@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 32 - September 26, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CENTRAL LIPID LABORATORY FOR NATIONAL HEALTH AND NUTRITION SURVEY IV (NHANES IV) (RFP NHLBI-HV-97-09) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 01/09/98 ************************************************ DIABETIC NEPHROPATHY: MECHANISMS, GENETIC DETERMINANTS, INTERVENTIONS (RFA DK-98-001) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R3 04/28/98 ************************************************ SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH (RFA HD-97-008) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** CLINICAL EPIDEMIOLOGIC STUDIES IN HEREDITARY BREAST/OVARIAN CANCER (PA-97-109) National Cancer Institute INDEX: CANCER $$INDEX P2 ********************************************************** CORE SUPPORT FOR PROGRAMS IN MENTAL HEALTH/AIDS RESEARCH (PAR-97-110) National Institute of Mental Health INDEX: MENTAL HEALTH The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the NIH gopher (gopher.nih.gov) and the NIH website (http://www.nih.gov). Alternative access is through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing grant applications submitted to the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 32, September 26, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following case: Christopher Leonhard, Dartmouth College: Based upon an investigation conducted by Dartmouth College, information obtained by the Office of Research Integrity (ORI) during its oversight review, and Mr. Leonhard~s own admission, ORI found that Mr. Leonhard, a former graduate student in the Department of Psychology, Dartmouth College, engaged in scientific misconduct arising out of certain biomedical research supported by two grants from the National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Specifically, Mr. Leonhard (1) fabricated experimental records and falsely represented them to his supervisor as being results obtained >From multiple electrophysiological screening sessions conducted on eight animals; and (2) fabricated two surgical records as evidence of experimental preparations (implantation of indwelling electrodes) on two animals, which in fact had not been done. The experimental records did not appear in any publications. Mr. Leonhard has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three (3) year period beginning September 8, 1997: (1) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which Mr. Leonhard~s participation is proposed or which uses him in any capacity on PHS supported research or that submits a report of PHS-funded research in which he is involved must concurrently submit a plan for supervision of his duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of Mr. Leonhard~s research contribution. The institution also must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NHLBI-HV-97-09 ******************************************* CENTRAL LIPID LABORATORY FOR NATIONAL HEALTH AND NUTRITION SURVEY IV (NHANES IV) NIH GUIDE, Volume 26, Number 32, September 26, 1997 RFP AVAILABLE: NHLBI-HV-97-09 P.T. National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) in cooperation with the National Center for Health Statistics (NCHS) is soliciting proposals for the establishment of a Central Lipid Laboratory in support of the NCHS National Health and Nutrition Survey (NHANES IV). The NHANES IV will involve the study of a sample population of 40,000 adults and children. The Central Lipid Laboratory will: (1) be required to be CDC standardized for lipid measurements, (2) accurately measure total cholesterol and HDL cholesterol for the entire NHANES IV sample population, (3) accurately measure triglycerides for the fasting NHANES IV population, and (4) deliver the results to NCHS. The results will be used by NCHS in its NHANES IV program to monitor current lipid levels in the United States and to determine national trends in cholesterol and other lipid values by comparing the values collected in the NHANES IV with corresponding data gathered in previous surveys. The work of the Central Lipid Laboratory will be conducted in three phases. In Phase I (5 months), the Central Lipid Laboratory will measure lipid levels in about 250 samples collected over 1-2 months and prepare a Central Lipid Laboratory manual of operations for the study. In Phase II (6 years) the Central Lipid Laboratory will measure total cholesterol and HDL cholesterol in 22,200 samples with triglyceride measurement in half (11,100)of the samples. In Phase III (7 months) the Central Lipid Laboratory will assay any remaining samples or repeat measurements as required. In addition, the Central Lipid Laboratory will work with NHLBI and NCHS in preparation of journal articles to disseminate the lipid results as well as the national trends. This is not an RFP. RFP NHLBI-HV-97-09 will be available on or about October 1, 1997, with proposals due on or about November 24, 1997. SICC is 8071. Award of a contract for this study will be made only to offerors located in the United States of America. The RFP will be available on the NIH Gopher. Access is via the NIH Website (http://www.nih.gov). At the NIH Home Page select "Grants & Contracts" then select "NIH Gopher Directory" (within the contracts page). Offerors that have access to the NIH Gopher Server can access the RFP by pointing your gopher client to Gopher://gopher.nih.gov:70/11/res/rd-rfp. All information required to submit an offer is in the electronic RFP package. INQUIRIES Organization unable to access RFP online may request a hard copy version by submitting a written request, citing "RFP NHLBI-HV-97-09," to: Douglas W. Frye HLVD Contracts Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892 Telephone: (301) 435-0340 FAX: (301) 480-3338 $$R1 END ************************************************************ $$R2 BEGIN DK-98-001 FULL-TEXT ************************************** DIABETIC NEPHROPATHY: MECHANISMS, GENETIC DETERMINANTS, INTERVENTIONS NIH GUIDE, Volume 26, Number 32, September 26, 1997 RFA AVAILABLE: DK-98-001 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 9, 1997 Application Receipt Date: January 9, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through its Division of Kidney, Urologic and Hematologic Diseases (DKUHD) invites experienced and new investigators to submit research grant applications to pursue basic and applied investigations to better the understanding of the pathophysiology of diabetic nephropathy, the genetic determinants of susceptibility, and cellular and molecular factors; mechanisms of glomerulosclerosis, interstitial fibrosis and scarring; development of experimental model systems; identification of markers of disease initiation and progression; identification of novel therapeutic interventions and gene targeted strategies to prevent, limit or reverse renal lesions due to this disorder. Applications for regular research project awards, First Independent Research and Transition Awards, Interactive Research Project Grants, and Exploratory Research Grants will be accepted under this RFA. A total of $2.5 million, in total cost will be committed by the NIDDK to fund applications of high scientific merit; it is anticipated that 10-12 awards will be made. Applicants must limit their requests to no more than the average grant size, or $160,000 Direct Costs, or provide a thorough justification if that ceiling must be exceeded. In no case will applications requesting more than $250,000 in Direct Costs, per year, be accepted in response to this RFA. 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 getting priority areas. This RFA, "Diabetic Nephropathy: Mechanisms, Genetic Determinants, Implications" is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Gladys H. Hirschman, M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS13 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: gladys_hirschman@nih.gov $$R2 END ************************************************************ $$R3 BEGIN HD-97-008 FULL-TEXT ************************************** SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH NIH GUIDE, Volume 26, Number 32, September 26, 1997 RFA AVAILABLE: HD-97-008 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 14, 1998 Application Receipt Date: April 28, 1998 PURPOSE The National Institute of Child Health and Human Development (NICHD) through the Reproductive Sciences Branch (RSB) in the Center for Population Research (CPR) provides funding for a limited number of research centers in the reproductive sciences. These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality research programs in the reproductive sciences. Applications for cooperative specialized centers (U54) are sought from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program. Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. Such a cooperative program will form a national network that fosters communication, innovation and research excellence with the ultimate goal of improving human reproductive health through accelerated transfer of basic science findings into clinical practice. It is anticipated that $2.8 million will be available to support up to three Centers in FY 1999. 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), Specialized Cooperative Centers Program in Reproduction Research, is related to the priority area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contact listed below. Louis V. DePaolo, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: depaolol@hd01.nichd.nih.gov $$R3 END ************************************************************ $$P1 BEGIN PA-97-109 FULL-TEXT ************************************** CLINICAL EPIDEMIOLOGIC STUDIES IN HEREDITARY BREAST/OVARIAN CANCER NIH GUIDE, Volume 26, Number 32, September 26, 1997 PA AVAILABLE: PA-97-109 P.T. National Cancer Institute PURPOSE The Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) invites investigator-initiated grant applications (R01s) and applications for competing supplements to existing NIH-funded research project grants (R01s, P01s) or cooperative agreements (U01s, U10s) for innovative epidemiologic studies to address clinical issues facing women with inherited predisposition for breast and/or ovarian cancer. With increasing public awareness of genetic contributions to cancer risk and the commercial availability of testing for mutations predisposing to breast and ovarian cancer, women at inherited risk for these cancers must make decisions about preventive interventions - and often cancer-directed therapy - with only limited scientific information about the natural history of disease associated with predisposing mutations, the efficacy of prophylactic surgery and other preventive measures, and the appropriateness of standard oncologic care for cancers developing in mutation carriers. While prospective studies will eventually provide definitive answers to these questions, there is an immediate need to address these issues through retrospective studies based on existing resources such as tissue banks and high- risk clinic registries and through concurrent studies added to ongoing clinical or epidemiologic research projects. This initiative seeks to enhance informed decision-making among women at hereditary cancer risk by strengthening and expanding the scientific knowledge about preventive and therapeutic options. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Title of PA, 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 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Susan G. Nayfield Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Email: nayfiels@epndce.nci.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-110 FULL-TEXT ************************************* CORE SUPPORT FOR PROGRAMS IN MENTAL HEALTH/AIDS RESEARCH NIH GUIDE, Volume 26, Number 32, September 26, 1997 PA AVAILABLE: PAR-97-110 P.T. National Institute of Mental Health Letter of Intent Receipt Date: November 1 (each year) Application Receipt Date: January 2, (each year) PURPOSE The National Institute of Mental Health Office of AIDS Research will establish Core Support for Programs in AIDS Research (CSPARs) to provide core support for multi-disciplinary research programs on the mental health aspects of HIV/AIDS. The purpose of this Program Announcement is improve and expand research by supporting infrastructure, including: subject recruitment, tracking, and retention; quality control and assurance procedures; equipment; laboratories; statistical analysis; database management; and administrative coordination. This will serve to enhance and extend the effectiveness of research related to mental health and HIV/AIDS. Some important research objectives are: 1) identify behaviors that put individuals at risk for HIV infection, and develop interventions to change those behaviors; 2) develop methods and strategies to aid HIV-infected individuals and their families in coping with HIV infection; 3) study the nervous system effects of HIV infection of the CNS; 4) identify the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction; 5) develop and test potential therapeutics to prevent or treat this CNS disease; and 6) study issues influencing adherence and non-adherence, and identify methods to improve and assure adherence and compliance to drug therapy regimens. The CSPAR will enable innovative, state-of-the- art research on HIV and mental health that could not or would not be conducted without the co re support. In addition, the CSPAR should have an overall integrating theme that is clearly described, and justifies the need for the core support to facilitate the research projects. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Core Support for Programs in Mental Health/AIDS Research, is related to the priority area of mental health aspects of HIV/AIDS research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017- 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIMH Home Page (www.nimh.nih.gov), and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20852 Telephone: (301) 443-6100 FAX: (301) 443 9719 Email: dr89b@nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Sun Oct 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-98-001 - V26(32) 09/26/97 Date: 5 Oct 1997 21:36:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 545 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <619pt1$o5b@net.bio.net> NNTP-Posting-Host: net.bio.net DIABETIC NEPHROPATHY: MECHANISMS, GENETIC DETERMINANTS, INTERVENTIONS NIH GUIDE, Volume 26, Number 32, September 26, 1997 RFA: DK-98-001 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 9, 1997 Application Receipt Date: January 9, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through its Division of Kidney, Urologic and Hematologic Diseases (DKUHD) invites experienced and new investigators to submit research grant applications to pursue basic and applied investigations in order to better understand the pathophysiology of diabetic nephropathy, the genetic determinants of susceptibility, and cellular and molecular factors; mechanisms of glomerulosclerosis, interstitial fibrosis and renal scarring; development of experimental model systems that mimic human disease to better the understanding of the pathogenetic mechanisms and to test agents to prevent, stabilize or reverse complications; identification of sensitive and relevant markers of disease initiation and progression; identification of innovative therapeutic interventions and gene targeted strategies to prevent, limit, or reverse renal lesions due to this disorder. The intent of the Request for Applications (RFA) is to intensify investigator-initiated research, to attract new investigators to the field, and to increase interdisciplinary research to enhance the scope and effectiveness of research in this area. The ultimate aim is to encourage and facilitate diabetes nephropathy-related studies utilizing new tools and taking advantage of opportunities in other fields to increase the pace with which knowledge is accrued. 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, "Kidney Disease of Diabetes: Mechanisms, Genetics, Interventions", is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) Research Project Grants (R01), Interactive Research Project Grants (IRPG), FIRST Award (R29), and Exploratory Research Grants (R21) award mechanisms. FIRST Award applications must adhere to the R29 administrative guidelines (rev. June 1995) for eligibility, budget, and period of award. Applications from Institutions with a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under Public Health Service (PHS) grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. For R01s, the total requested project period for applications submitted in response to this RFA may not exceed 5 years. A maximum of three-years can be requested for foreign awards. In general, the maximum budget request should be limited to $160,000 in direct costs for the initial budget period. Requests for support that exceeds that amount will require a thorough justification, and in no case will a request exceeding $250,000 direct cost for the initial budget period be allowed under this solicitation. Applicants anticipating submitting Interactive Research Program Grant (IRPG) Applications should consult with the Program Official listed under "INQUIRIES" at an early opportunity. Applications for Exploratory Research Project Grant Applications (R21) awards may apply for no more than $50,000 direct costs per year, for a maximum of two years. The anticipated award date is July 1, 1998. FUNDS AVAILABLE A total of $ 2.5 million in total cost will be committed by the NIDDK to fund applications of high scientific merit submitted in response to this RFA. It is anticipated that 10-12 awards will be made. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background: Diabetic nephropathy has emerged as the largest single cause of end stage renal failure in the United States. It accounts for nearly 40% of the 60,000 to 70,000 new patients who need dialysis each year. Diabetic patients do poorly on dialysis, with high rates of infection, access failure, and cardiovascular complications. Of all long-term complications of diabetes, nephropathy imposes the highest costs, both in dollars and in terms of human suffering. Concerning the genetic implications, diabetic nephropathy does not necessarily develop in all diabetic patients, the incidence of end stage renal failure being about 30% in patients with insulin-dependent diabetes mellitus (IDDM) and approximately 4-20% in patients with non-insulin-dependent diabetes mellitus (NIDDM). There is now strong evidence that genetic factors influence susceptibility to this condition. A variety of new strategies are available to characterize the genetic determinants for the development and progression of diabetic nephropathy. Included are the identification of new candidate susceptibility genes using methods of molecular genetics such as differential display or others; examination of the role of putative candidate genes in the onset and progression of diabetic nephropathy using family studies and transmission disequilibrium testing (TDT); identification of chromosomal regions containing genes responsible for susceptibility through family (linkage) studies and, potentially, once such regions are identified, positional cloning of the putative genes, etc. Concerning the pathophysiology of the disease, new insights also suggest new productive avenues for research. In virtually all patients, diabetes mellitus initially leads to diffuse renal hypertrophy and basement membrane thickening. Much early investigation focused on the pathogenesis of these lesions. Progression of these early markers is highly variable, however. In many patients, the early lesions are not followed by the development of glomerular scarring. Much of the available evidence suggests that scarring of the glomerulus arises from interactions between the microvasculature and the surrounding cell types. Specific topics needing further study include the mechanism by which hemodynamic factors potentiate injury, the role of cytokines and growth factors in regulation of scarring, particular stress responses, role of the renin-angiotensin system and aldosterone, the role of epithelial cells in the genesis of glomerular injury, the elucidation and characterization of the biochemical composition of the expanded matrix in diabetic nephropathy, the role of the polyol pathway activity, non-enzymatic glycation, advanced glycosylation end-products (AGES), redox changes, formation of reactive oxygen species, and the possible interrelationship of the mechanisms listed above in different cell types and tissues and in the different stages of the natural history and progression of diabetic nephropathy. Further work is needed in the development of animal models which mimic human disease, as well as models using genetically modified mice in which the effect of over- or underexpression of candidate susceptibility genes is examined. This may permit direct examination of genetic factors which determine the development and progression of the renal injury. Concerning the need to identify markers which will permit early identification of patients at risk of developing renal disease, the best currently available clinical tool for early identification of diabetic nephropathy remains the quantitative assessment of urinary albumin excretion. Prospective epidemiological information is needed to assess the predictive value of this measure, together with other clinical parameters in various population groups. Scientific Objectives: (1) To identify genes whose altered function predispose to diabetic nephropathy and to understand the mechanisms by which these genetic alterations enhance susceptibility. (2) To understand the underlying mechanisms leading to progressive renal scarring in diabetic nephropathy. (3) To identify markers which will permit early identification of patients at increased risk for diabetic nephropathy. Research Scope: It is the intent of this solicitation to invite applications from investigators with diverse scientific interests, who wish to apply their expertise to basic and applied research to enhance the understanding of the pathophysiology and pathogenesis of diabetic nephropathy; the genetic determinants and genetic factors influencing susceptibility, and cellular and molecular mechanisms and interplay that lead to the development of glomerulosclerosis and tubulointerstitial fibrosis and scarring; the development of experimental model systems in which the expression of susceptibility genes is examined; the identification of markers to ascertain when the process starts and when disease progresses; the identification of therapeutic opportunities and potentially gene targeted strategies to prevent or control scarring and progressive renal insufficiency in diabetic nephropathy. Examples which illustrate areas to be considered within the intent of this solicitation are presented in the following paragraphs. These examples are meant only to provide a broad direction and should be considered illustrative, and not restrictive. Examples, include the following: 1. Pathogenetic Mechanisms o Role, mechanisms of action and interplay of growth factors and other cytokines in regulating glomerular and interstitial sclerosis and scarring; studies addressing molecular elements of relevant signaling pathways. o Definition of the sequence of events in the pathophysiology of diabetic nephropathy, at the molecular and cellular levels and characterization of the molecular elements of relevance in signaling pathways. o Pathobiology of glomerular epithelial cells as well as role of glomerular endothelial cells, in-vivo, as players in the injury process. o Interaction between the microvasculature and the surrounding cell types in glomerulosclerosis, tubulo-interstitial fibrosis and scarring, in diabetic nephropathy. o Effect of insulin therapy and counter regulatory hormones on glomerular and interstitial sclerosis and extracellular matrix synthesis, composition, and response. o Interrelationship of biochemical mechanisms leading to matrix expansion and the development of scarring in diabetic nephropathy, including, but not limited to the polyol pathway activity, advanced glycosylation end-products (AGES), redox changes and formation of reactive oxygen species in different cell types and tissues in the different stages of diabetic nephropathy. o Role of hemodynamic and vasoactive factors, renin-angiotensin system, aldosterone and inhibitors, with an effect either over vascular tone or as trophic factors affecting mRNA expression for extracellular matrix components and vascular smooth muscle proliferation. o Identification and characterization of susceptibility factors for renal sclerosis and of putative risk factors for the onset of microalbuminuria and progression of diabetic nephropathy. 2. Genetic Considerations o Identification and characterization of genetic determinants for the development and progression of human diabetic nephropathy. o Identification of new candidate susceptibility genes using methods of molecular genetics such as differential display or others. o Role of putative candidate genes in the onset and progression of diabetic nephropathy using family studies and transmission disequilibrium testing. o Identification of chromosomal regions containing genes responsible for susceptibility through family (linkage) studies and potentially, once such regions are identified, positional cloning of the putative genes, etc. 3. Therapeutic Strategies o Identification of early quantitative markers of disease and sensitive markers of progression, and identification of adequate outcome measures to judge the effect of clinical interventions in early stages of the disease. o Identification of novel interventions and new targets for prevention and treatment of renal fibrosis in diabetic nephropathy. Mesangial deposition seems to be reversible and glycosylated proteins remain biodegradable, offering hopes for future therapy. o Gene therapy and sequence-specific methods for modifying gene expression in the kidney; development of techniques suitable for modifying expression of gene products that accelerate progression of diabetic nephropathy. o Trial of agents that prevent, stabilize or reverse complications in animal models of diabetic nephropathy. 4. Markers o Identification of markers for early recognition of diabetic renal disease in patients at increased risk for diabetic nephropathy. o Identification of sensitive and specific surrogate end-points for the development of diabetic nephropathy, other than GFR and albumin excretion which, are either non-specific or not sensitive enough. o Formulation of prospective epidemiologic strategies to assess the predictive value of quantitative markers, together with other relevant clinical parameters in various population groups. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 9, 1997, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@od.nih.gov. Applicants for FIRST (R29) awards must submit at least three letters of reference, with the application. FIRST (R29) award applications received without the three reference letters will be returned to the applicant. The RFA label available in the PHS 398 (rev. 5/95) 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 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, plus three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by January 9, 1998. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by DRG and responsiveness by the NIDDK. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?" o Appropriateness of the proposed budget and duration in relation to the proposed research. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. For applications awarded to foreign institutions: o Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. AWARD CRITERIA Applications recommended for funding will considered on the basis of the following: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Gladys H. Hirschman, M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS13 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: gladys_hirschman@nih.gov Inquiries regarding fiscal and administrative matters may be directed to: Aretina D. Perry-Jones Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Building 45 Room 6AN-38 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8862 FAX: (301) 480-3504 SCHEDULE Application receipt dates, initial review, and award cycles will be: Letter of Intent Receipt Date: December 9, 1997 Application Receipt Date: January 9, 1998 Initial Review Date: March-April 1998 Advisory Council Review: May 1998 Anticipated Date of Award: July 1, 1998 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-97-008 - V26(32) 09/26/97 Date: 5 Oct 1997 21:37:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1025 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <619ptf$o63@net.bio.net> NNTP-Posting-Host: net.bio.net SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH NIH GUIDE, Volume 26, Number 32, September 26, 1997 RFA: HD-97-008 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 14, 1998 Application Receipt Date: April 28, 1998 PURPOSE The National Institute of Child Health and Human Development (NICHD) through the Reproductive Sciences Branch (RSB) in the Center for Population Research (CPR) provides funding for a limited number of research centers in the reproductive sciences. These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality research programs in the reproductive sciences. Applications for these centers are sought from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program. Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. Such a cooperative program will form a national network that fosters communication, innovation and research excellence with the ultimate goal of improving human reproductive health through accelerated transfer of basic science findings into clinical practice. 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), Specialized Cooperative Centers Program in Reproduction Research, is related to the priority area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, that meet the requirements stated in this RFA. Minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators. The need for continuous and active communications and interactions among the awarded sites dictates that only domestic institutions in the United States will be eligible for these Center grant awards. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in participating in this Centers Program will be the National Institutes of Health (NIH) cooperative specialized center (U54) mechanism. Funding will be provided by means of cooperative agreements established between the participating Centers and the NICHD. A cooperative agreement is not an "acquisition" mechanism. It is an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities conducted by the awardee. Under a cooperative agreement, the NIH purpose is to support, stimulate, and expedite the recipient's activities by jointly being involved with them. NIH staff work cooperatively with the award recipients in a partner role and do not assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the activities to be funded under the cooperative agreements awarded for this Program are discussed later in this document under the section "Terms and Conditions." The total project period for an application submitted in response to this RFA is five years. The anticipated award date is April 1, 1999. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available (see Description of a Center). It is expected that NICHD will solicit additional new or continuation center applications through annual issuance of an RFA. It is anticipated that at least three Centers will be funded in each subsequent annual competition contingent upon the availability of funds. FUNDS AVAILABLE Although this solicitation is included in the fiscal plans for FY 1999, support for these center grants is contingent upon the availability of funds for this purpose. The number of grants to be awarded is also contingent upon a sufficient number of applications deemed meritorious enough to be considered for an award. It is anticipated that an estimated total of $2,800,000 (including indirect and direct costs) will be available for the first year of the Program, which will support up to three Centers in FY 1999. RESEARCH OBJECTIVES Background The ultimate goals of biomedical research supported by the RSB are to develop new knowledge leading to clinical applications that will enable men and women to control their own fertility choices with methods that are safe, effective, inexpensive, reversible and acceptable to various population groups. Such research aims to develop new leads for contraception, procedures for alleviating infertility, and fertility preserving treatments for reproductive disorders that threaten fertility. The present day need for the availability of contraception options acceptable to diverse populations remains globally unmet. Among the 600 million women of reproductive age in today's world, as many as 228 million women are at risk of unintended pregnancy from the 39 trillion acts of intercourse that occur annually. Up to 64 percent of all worldwide pregnancies are unintended (mistimed or completely unwanted). Over 50 million abortions occur worldwide each year with minimal estimates of at least 100,000 abortion-related deaths annually. In the U.S., 3 million unintended pregnancies--57 percent of all pregnancies--occur annually with half resulting in abortion as an outcome. In half of the 1.3 million abortions occurring in the U.S. each year, a contraception method being used failed to prevent a pregnancy. Families, family values, and family planning form the cultural essence and cohesiveness of our existence as human societies. One of the most basic of human rights--the right to procreate--is frustrated or denied by the occurrence of infertility in a couple desiring children. It has been estimated that infertility affects between 37 and 70 million married couples around the world. In U.S. studies described nearly 50 years ago, it was stated that up to 10 percent of married couples were 'sterile' with the remaining 90 percent having varying degrees of fertility. More recent and technically rigorous U.S. survey studies have conservatively identified that there are about 2.3 million infertile couples, which is about 9 percent of the domestic married couple population base with wives aged 15-44. In addition, such studies found that about 4.9 million U.S. women in this age range had an impaired ability to have children. At least 30-50 percent of infertility is attributable to male factor infertility for which the pathophysiology is either not understood at all or, at best, poorly understood. The prognosis for male infertility treatment outcomes is extremely poor at present. While analyses of the U.S. population base has not found alarming annual increases in the overall number of infertile couples or the overall prevalence of infertility, significant age-related increases in infertility coupled with delayed childbearing in the contemporary couple population base have been found in such studies. Physician office visits reflecting current societal life style requirements for infertility services have markedly increased from 1968 (600,000) to 1988 (1,350,000) with a projected U.S. peak estimated for 1995 approaching 1,800,000. Of the infertile couples seeking treatment for infertility, it has been estimated that up to one-half will be unsuccessful in achieving their desired outcome. In concert with the increased medical assistance sought, U.S. infertility service costs have risen to exceed a billion dollar annual medico-economic impact in the U.S. Reproductive disorders affecting fertility are associated with significant morbidity and a degree of mortality in some specific instances that cannot be ignored. During the past two decades, the incidence of ectopic pregnancy has increased from 4.5 to 16.1 per 10,000 pregnancies. The rate appears to be particularly increasing in young women aged 15-19, perhaps in relationship to the U.S. factors of earlier age of menarche and initiating sexual activity leading to encountering tubal disease factors earlier. In 1989, it was reported that 88,400 women experienced an ectopic pregnancy and 34 of them died as a direct consequence. While improved diagnostic procedures and early intervention protocols have resulted in markedly reducing mortality, surviving women are left with an 8-fold risk of reoccurrence and a 20 percent lowered chance of ever conceiving again. Accompanying the human costs of morbidities of reproductive tract disorders, as noted above, are the attendant substantial costs of the U.S. health care system involving the diagnosis, treatment, and follow-up services provided the patients, as well as the added costs to the patient and the U.S. economy of lost employment and family service hours. In reproductive aged couples, the obstructive sequelae of male accessory gland infections account for 8-12 percent of male partner diagnostic costs for fertility impairment. In reproductive aged females, it has been estimated that the general incidence of endometriosis is 5 to 15 percent. The incidence of endometriosis in females being surgically treated for infertility is known to be 30 to 50 percent. Among infertile females with no other known cause of their infertility, the incidence of endometriosis has been reported at 40 to 70 percent. A diagnosis of severe endometriosis often leads to hysterectomy-associated treatment. While the causative role of endometriosis in infertility remains poorly understood and its optimal diagnosis and treatment remain a goal--not an accomplishment--of contemporary medicine, the morbid impact of the associated pelvic pain has significant human cost and national economic costs. The etiology of polycystic ovary syndrome (PCOS), while identified more than 60 years ago by Stein and Leventhal, remains misunderstood despite 60 years of research. This insidious disease is currently the most common endocrine disorder of women of reproductive age. Recent prevalence rate estimates suggest at least 10 percent of the reproductive aged population of U.S. women suffer the full blown syndrome of hyperandrogenism, chronic anovulation and polycystic ovaries. While PCOS has been recognized to have a familial tendency consistent with a genetic factor in its etiology, few compelling studies clarifying this aspect have been forthcoming prior to this year. PCOS is a major cause of infertility, other reproductive system, and other tissue and organ system morbidities. Hysterectomy is a common patient outcome. PCOS is a major medical economic cost component in U.S. reproductive health care costs. Similarly, the role of dysfunctional uterine bleeding, either in the presence or the absence of uterine leiomyomata (fibroids), is not well understood despite its common occurrence and decades of research. It is a significant factor in noncompliant contraceptive use or discontinuance and, therefore, in the unintended pregnancy problem. Uterine myomata occur in nearly 20 percent of all reproductive aged women, are the single most common diagnosis from gynecological hospital admissions, may be the only abnormality observed in an infertile couple, and represent the most common medical indication for an unintended and often unwanted hysterectomy that prematurely ends a female's reproductive options. Hysterectomy to treat the morbidity of certain reproductive disorders is the second most common major surgery performed in the U.S., with greater than 500,000 hysterectomies reported each year prior to 1995, the year signifying the peak of 'baby boom' women in the population. If current hysterectomy rates had remained at the same pre-1995 prevalence level in the U.S., it is estimated that up to one- third of all women in the U.S. will have had a hysterectomy before the age of 60. The annual performance rate is not constant, however, with a projected level estimated at more than 800,000 annually beyond the 1995 marker year. Recognizing that the interactive needs of basic and clinical research necessary to address the above and related problems may be so complex that they cannot be solved by individual investigators working alone without the intellectual and fiscal resources of a cooperative specialized center program, it is the intention of the RSB, contingent upon the availability of funds, to initiate and maintain organized, multi-component reproductive extramural research programs of high quality that focus on topics deemed to be of high priority and significance because of their critically important relationship to the mission of the RSB. Objectives The objectives of this Centers Program are to support specialized reproductive research programs of high quality, and to facilitate and accelerate the translation of promising new preclinical or clinical leads into clinical practice. The RSB believes that the partnership developed between program staff and the award recipients through use of the cooperative agreement mechanism maximizes the ability of the RSB to promote, facilitate, and assist the research conducted by the awarded centers. This RFA is specifically designed to stimulate the reproductive sciences research community to organize and maintain research- based centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation and high quality reproductive research. Such networking as afforded by the cooperative nature of this Centers Program will ensure that the reproductive research community remains in the forefront of the development and utilization of new technologies which can be used to treat and ameliorate reproductive disorders, as well as to identify novel leads for fertility regulation. Research Scope The Specialized Cooperative Centers Program in Reproduction Research (SCCPRR) is composed of research-based center grants designed to support interactive groups of research projects and supporting core service facilities. The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas announced in this RFA (see below). These centers may have more than one theme, focus, or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of reproduction supported by the RSB. Furthermore, the translational objective of this Program requires that one of the subprojects be entirely or predominantly clinical. The following is a list of topics that are considered to be responsive to the research mission areas of the RSB. Additionally, these topics identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to fertility control, as well as of diagnostic tools and procedures for the detection, treatment and effective management of reproductive disorders that impact on reproductive competence. Reproductive Biology and Physiology - gametogenesis, including nuclear and cytoplasmic mechanisms that direct germ cell mitosis and meiosis, and somatic cell-germ cell interactions which support gametogenesis; folliculogenesis, including studies addressing intraovarian control of follicle selection and atresia by growth factors, cytokines and their respective binding proteins and receptor antagonists; luteogenesis and luteolysis, including intraovarian mechanisms which control luteal lifespan; fertilization; early embryogenesis during the pre- to peri-implantation period; implantation, including cell-to-cell interactions regulating implantation. Reproductive Endocrinology - fundamental mechanisms of hormone synthesis, secretion, regulation and action in the context of reproduction, including intrapituitary mechanisms governing gonadotropin secretion, and intraneuronal mechanisms and glial-neuron interactions controlling pulsatile GnRH secretion; identification of elements and factors controlling gene transcription, and identification of signaling molecules and pathways mediating hormone action; interaction of the immune and neuroendocrine systems in controlling fertility; mechanisms by which nutritional modification alters the hypothalamo-pituitary- gonadal endocrine axis. Reproductive Medicine - pathophysiology, diagnosis and treatment of male or female infertility; relation of endometriosis to infertility, treatment of benign gynecologic diseases; improvement of existing and development of new approaches for assisted reproduction. Since this list is not meant to be all-inclusive, prospective applicants preparing either a competing new or continuation center grant application are encouraged to discuss program relevancy issues with the program staff contact cited under INQUIRIES in this RFA. However, applicants should note that the research scope of this RFA does not include studies in the area of reproductive oncology or reproductive epidemiology or studies dealing with post-implantation pregnancy and parturition. These topic areas are outside the purview of research areas supported by the RSB, and, therefore, will be deemed nonresponsive to this RFA. In addition, research proposals for projects or cores directly involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes. It is also not intended for the Centers to conduct large clinical trials. Guidance and Management Structures Overall coordination of the Centers Program consistent with the stated objectives set forth in the RFA (see Objectives) will be done by a Steering Committee consisting of all Center Principal Investigators and an NICHD staff Research Coordinator from the RSB, CPR. The Steering Committee will employ a consensus decision process to guide the Centers Program in evaluating the progress of member Center programs, their proposed new research initiatives within the general scope of the approved program, the need for collaborations either within or outside the Center network, and the need to redirect certain efforts of member Centers due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience proving that the proposed research is no longer feasible. In addition to the Steering Committee, smaller cooperative groups will be formed that consist of research components of member centers having common research interests addressing a specific basic and/or clinical research problem. These research focus groups will perform coordinated research activities as recommended by the Steering Committee. In turn, progress of the focus groups will further guide the Steering Committee in decision-making regarding changes in specific research directions, translational activities, and new research initiatives. The research focus group will consist of an NICHD staff Research Coordinator from the RSB, CPR, and Key Investigators of the relevant subproject and/or Core Directors. Further details of the guidance and management structures and processes may be found in the 'Terms and Conditions' section below. Description of a Center The minimal requirements for a Center described in this RFA are as follows (see sections on Review Criteria and Procedures and Award Criteria below): o Each center will propose a research plan that is responsive to the objectives of the Centers Program set forth in the RFA (see RESEARCH OBJECTIVES). o Each center will support at least three research subprojects that thematically address one or more research areas listed under Research Scope. It is required that one subproject be entirely or predominantly clinical in nature. For this Centers Program, the definition of clinical can involve patient studies or use of cultured human cells or tissue. Although not required, it is strongly encouraged that at least one basic science subproject be in a similar scientific area as the clinical subproject in order to facilitate transfer of information from bench to bedside. Alternatively, a project may be proposed that incorporates both basic and clinical approaches to a particular problem. o An administrative core unit which provides oversight to the Center that is located at the grantee institution, and is accessed only by budgeted center subprojects and cores; o A competent and experienced principal investigator who is committed to and directly involved in research dealing with mammalian reproduction; o Availability of competent and experienced scientific experts to direct individual research projects or cores associated with the proposed Center; o Availability of the technical resources and facilities necessary for the conduct of the experiments; o Access to properly managed animal facilities for projects conducting animal studies; o As appropriate, access to inpatient and outpatient reproductive health care units providing adequate numbers of patients for clinical research projects that require patient participation [Applications >From institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application]. Optional components of the Center organization include the mix of subprojects and cores to be included in the Center. o The Principal Investigator may choose to organize the Center using collaborations of projects within the same institution. Alternatively, Centers may seek to maximize their scientific expertise and research capabilities by including in the application a subproject and/or a technical service core to be supported at other institutions through subcontracted consortium arrangements. No more than one consortium subproject and one consortium core service facility will be permissible in each Center. o The Principal Investigator may choose one of two center structure options regarding access to technical service core facilities. Closed Access Structure - In this center structure, administrative and all technical service cores will be utilized by budgeted center subprojects only. Consistent with NICHD guidelines for establishment of core facilities, utilization by three subprojects is required to justify a core technical service facility. Percent utilization by any one of the three subprojects justifying the core cannot exceed 50 percent or be less than 5 percent. The percent utilization of additional subprojects requiring core services can be less than 5 percent. Costs necessary to use a particular core facility can be incorporated into the budget of the core unit, and not in the budgets of the research subprojects per se. No internal chargeback system would be required. Open Access Structure - In this center structure, budgeted center subprojects as well as research projects external to the center (e.g., R01, R29, R03, P01 subproject) may have access to technical service cores. However, special consideration must be given to justification of a technical service core facility and the formal establishment of an effective chargeback system for all technical service cores. For each core service facility, at least one of the three projects used to justify a core must be a budgeted center subproject while the remaining project(s) used in justifying the core must be externally funded NICHD projects administered by the RSB. Percent utilization by any internally budgeted center subproject or externally-funded RSB project used to justify a particular core facility cannot exceed 50 percent or be less than 5 percent. An additional seven federally-funded, peer-reviewed external research projects addressing program-relevant research areas of the RSB can access the core up to 100 percent of its service capacity. The 50/5 percent utilization requirement applies to this group of external projects. Centers must establish an internal management policy for evaluating the acceptability of proposed RSB program relevant external projects to access the core facilities. Approval of requests for core access privileges for external projects which would replace those described above must be made to RSB Program Staff who then will evaluate the extent to which the project is relevant to RSB mission research areas (see Research Scope), and render a decision accordingly. If centers choose to operate in an open access format, costs necessary to utilize a particular core facility by budgeted center subprojects must be incorporated into the budget of the subproject and not the core budget in order to accommodate participation in the required chargeback system. Core budgets will be justified and evaluated based on its access by budgeted center subprojects and external, program-relevant research projects as described above. Above and beyond this arrangement, technology-based core units can offer services to additional external projects addressing any area of research regardless of funding source only on a full payback (fee-for-service or in kind) basis. However, additional funds necessary to provide services to these external projects (e.g., technical support, supplies, etc.) must come from sources other than the center funding, such as the supply budgets of the external projects wishing to access the core facilities. In choosing to configure a center in an open-access center structure, the Principal Investigator must have in place and adequately described in the application management policies which ensure that budgeted center subprojects are given highest priority in receiving services provided by the core. Centers choosing to configure in an open-access center format may propose one or more technical service cores that will be utilized exclusively by budgeted center subprojects. These centers may, therefore, have a mix of open or restricted access technical service cores. On the other hand, administrative cores in open center structures may be accessed only by budgeted center subprojects. Once an award is made, centers configured as a closed-access center structure may, at a later time, choose to convert to an open access center structure by requesting such conversion in writing to the NICHD. Irrespective of the organizational mix selected by the Principal Investigator, each research subproject or core proposed for inclusion in the Center must be described independently using the PHS 398 application format as described in the document "Suggested Format for NICHD U54 Grant Applications," which is available from the program staff listed under INQUIRIES. For the individual projects or cores, the page limits stated in the PHS 398 instructions must be followed. The overall Center application must also use the PHS 398 format to provide at the beginning of the application an overall summary of the Center's organization and cumulative aggregate budgeting for the various budgetary categories. In both instances, all essential information for the evaluation of the application must appear in the body of the application rather than in an appendix. SPECIAL REQUIREMENTS Terms and Conditions of Award Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 45 CFR Part 74 and 92. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS, PHS, and NIH grant administration requirements. 1. The purpose of these cooperative agreements is to support a coordinated research program of specialized centers pursuing high quality reproductive research with the ultimate goal of facilitating and accelerating translation of basic science knowledge into clinical applications which can be used to regulate fertility or diagnose and treat infertility or reproductive disorders that impact on fertility. The primary authorities and responsibilities of the awardees are to participate cooperatively with the Steering Committee in the following activities: o Pursuit of research objectives consistent with the research scope of the RFA and research approved during the initial peer review; o Conduct experiments and collect the resulting data; o Analyze, interpret and present results and plans to the Steering Committee for approved activities; o Publish results, conclusions, and interpretation of the studies. The awardees will agree to: 1)accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores focused on a particular reproductive research topic area. Awardees will retain custody of and primary rights to their data developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies. 2. The degree of programmatic involvement of the Research Coordinator is as follows: o Participating in the overall coordination of the Centers Program with the Steering Committee. This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers, particularly as it pertains to translational research activities within and between centers. As a means of improving inter-center cooperation, the Research Coordinator will directly participate in the activities of the smaller collaborative groups established by the Steering Committee comprised of subprojects and/or cores focused on a particular reproductive research topic area. The Research Coordinator will also assist the research efforts of the Centers Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists. The Research Coordinator will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Centers Program and NICHD. In the event of disagreements among the Program participants, the Research Coordinator will assist in forming an arbitration panel as discussed below. o Interacting with each individual center awardee evaluating objectives and research goals of that particular center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Research Coordinator will assist and facilitate this process and not direct it. The Research Coordinator will also provide assistance in reviewing and commenting on all major transitional changes of an individual center's activities prior to implementation to assure consistency with required goals of the Centers Program. o Retaining the option to recommend the withholding of support from a Center subproject or core materially failing to meet the technical performance requirements established by the Centers Program. This includes identifying jointly with participants of the Steering Committee the need to add additional research subprojects or service cores to Centers or to phase out a Center subproject or core when performance standards have not been met; and o Participating, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co- authorship of the publication of results of studies conducted by the Centers. 3. Overall Coordination of the Centers Program consistent with the stated intent of the RFA will be done by a Steering Committee consisting of the Principal Investigators from each of the participating Centers and one NICHD staff member from the RSB, CPR, NICHD, who will be the Research Coordinator. A member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee. A chairperson for the Steering Committee will be chosen by a majority vote of the Principal Investigators. The Steering Committee meetings will be convened at least once per year. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct the business of the cooperative research program. In anticipation that some centers will have common research interests that address a specific basic and/or clinical research problem, it is envisioned that research focus groups will be formed to conduct coordinated research activities recommended by the Steering Committee. The Steering Committee will approve multicenter protocols on specific research activities. As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts. 4. Arbitration When agreement between an awardee and NICHD staff cannot be reached on scientific/ programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigator, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by January 14, 1998, a letter of intent that includes: 1) a descriptive title of the proposed research; 2) the name, address, and telephone number of the Principal Investigator; 3) the identities of other key personnel and participating institutions along with the tentative titles of the respective subprojects; and 4) 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 NICHD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Louis V. DePaolo at the address listed under INQUIRIES. APPLICATION PROCEDURES Contents of Applications A response to this RFA should consist of an application that includes: o A description of a Specialized Center in Reproduction Research consisting of multiple individual research subprojects, an Administrative Core and, if applicable, one or more technology- based core service facilities. For suggested formatting instructions see the document, "Suggested Format for NICHD U54 Grant Applications," available from the program staff listed under INQUIRIES. o A description of the capabilities of the Center to meet or exceed the minimal requirements stated below (see Description of a Center). o A proposed five-year research plan that presents the applicant's perception of the Center's organization and component functions. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multiproject research infrastructure for conducting basic and clinical studies in the reproductive sciences. The research plan for the Center and all component subprojects must address the "Research Scope" described earlier. o The stated willingness of the Principal Investigator to cooperate in a coordinated cooperative program involving multiple Centers with the objective of developing research project and/or service core interactions between Centers. o Substantive evidence of departmental and institutional support for and commitment to the proposed Center. All applicants must document their ability to meet or exceed the minimum requirements as set forth in the 'Description of a Center.' This specifically includes understanding of and commitment to the cooperative nature of this Program. Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research, if appropriate. If so, a letter of agreement >From either the GCRC program director or principal investigator could be included with the application. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these awards. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@od.nih.gov. Additional suggestions for formatting the application into a Center grant application are provided in the document "Suggested Format for NICHD U54 Grant Applications," which is available from the program staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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, SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH, and number, RFA HD-97-008, must be typed on line 2 of the face page of the application form and the YES box must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by April 28, 1998. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The NICHD will not accept for review competing new or continuation applications that have been revised more than one time. If a revised competing continuation application is not selected for funding, the applicant institution may then only submit a new, substantially different application. Schedule Letter of Intent Receipt Date: January 14, 1998 Application Receipt Date: April 28, 1998 Initial Review Group Peer Review: October/November 1998 NACHHD Council Review: January 1999 Earliest Award Date: April 1, 1999 Budgets Applications from new center sites may not request more than $750,000 in direct costs for the first year, with incremental increases not exceeding three percent in each subsequent year. For currently existing RSB-supported center sites, direct costs requested for the first year can be either $750,000 or 120 percent of the direct costs awarded for the final competitive segment year of the preceding project period as stated in the Notice of Grant Award whichever is higher. A submitted application exceeding the budgetary limits specified above will be returned to the applicant unreviewed. In the event that an application submitted in response to this RFA is not funded, one revision of the application will be accepted in response to a subsequent RFA. Budgets for revised applications must be submitted in accord with the recommendations of the peer review group who evaluated the initial submission unless a different budget has been approved in advance by the NICHD. If a revised competing continuation application is not selected for funding, the applicant institution may then submit only a new, substantially different application that will be subject to the direct cost limit of $750,000. Principal Investigators should request travel funds to support their participation in the annual Steering Committee Meeting, and Key Investigators of budgeted center subprojects should request travel funds to support participation in either the Steering Committee Meeting or a research focus group meeting. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness to the RFA by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements as set forth in the 'Description of a Center' section of this RFA will be considered unresponsive to the RFA and returned to the applicant. This includes, but is not limited to, an evaluation by NICHD staff of the program relevancy of the proposed research subprojects and external projects being proposed to access core facilities. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the review committee will be withdrawn from further consideration, and the principal investigator will receive a summary statement reflecting the reviewers' evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. They will then receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). Applications submitted in response to this RFA and judged to be competitive may also receive a site visit as part of the review process. However, applicants should assure that their applications are complete and can stand on their own. Review Criteria The scientific and technical merit peer review focuses on three areas: (1) review of the component research subprojects; (2) review of the core units, and (3) review of the overall center as an integrated effort. 1. Component Research Subproject Criteria: The review criteria for the component research subprojects are: o The scientific merit of each individual project which evaluates the research plan, significance, approach and innovativeness when appropriate; o Accomplishments and progress to date of the component research subprojects in the case of competing renewal applications; o Qualifications, experience and commitment of the Key Investigators and their ability to devote the required time and effort to the subproject and the Center; o Willingness of the Key Investigators to work and collaborate with other Center Programs as appropriate and with NICHD assistance in the manner summarized in this RFA; o Appropriateness of the budget for each component research subproject; o Adequacy of animal facilities and appropriateness of animal care management where animal work is proposed; o Adequacy of clinical facilities and appropriateness of patient care management where clinical work is proposed; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS). 2. Core Unit Criteria: The criteria for reviewing the Core Units are: o Qualifications, experience and commitment of key personnel in the services provided by the core unit, as well as their ability to devote the required time and effort in providing services to the Center; o Accomplishments of the Core Unit in the case of competing renewal applications; o Appropriateness of the budget for each core unit that considers cost effectiveness and quality control for core units; o Appropriateness of the use of core services by the budgeted center subprojects, and, if applicable, by external projects. o Adequate plans for chargeback and priority management procedures for technical core units offering services to external projects. 3. Overall Center Criteria: The criteria for reviewing the Center as an integrated effort are: o Overall strength of the Center in terms of the combined strength of the research subprojects and core units, and the significance of the application to the objectives of the Program outlined in this RFA; o Leadership ability and scientific stature of the Principal Investigator particularly, but not exclusively in the area of the proposed research, and his/her ability to meet the Center's demands of time and effort; o Specifically stated and described willingness of the Principal Investigator to work and cooperate with other Center Programs as appropriate, and with NICHD assistance in the manner summarized in this RFA; o An appropriate organizational and administrative structure for effective attainment of Center objectives that considers arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication among Center investigators; o The institutional environment in which the research will be conducted, including the availability of space, equipment, and subjects, if proposed; adequacy of administrative, clinical and technical capabilities to conduct the research proposed; physical proximity of investigators; and the potential for interaction with scientists from other areas; o Appropriateness of policies to ensure the protection of human subjects, the humane care and use of laboratory animals, and the environment; and o Demonstrated commitment of the Institution to the Center and its objectives in terms of providing research facilities and management support. 4. Budgeting Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is April 1, 1999. Applications approved by the NACHHD Council will be considered for award based on scientific and technical merit; program balance; and availability of funds. The NICHD will not support more than one SCCPRR center award involving departments or specialty units of a single grantee institution. In order to receive funding, an individual domestic institution's application for a Specialized Cooperative Center Grant must have three or more related, interactive, and high quality research subprojects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. At least one of the subprojects must be clinically oriented. Awards will not be made for applications with research activities focused exclusively on clinical research or exclusively on basic research or for applications or components thereof proposing epidemiological or large scale clinical trial research. 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 and address the letter of intent to: Louis V. DePaolo, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: depaolol@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: nelsonm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the PHS Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285). These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-109 - V26(32) 09/26/97 Date: 5 Oct 1997 21:37:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 527 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <619ptu$o75@net.bio.net> NNTP-Posting-Host: net.bio.net CLINICAL EPIDEMIOLOGIC STUDIES IN HEREDITARY BREAST/OVARIAN CANCER NIH GUIDE, Volume 26, Number 32, September 26, 1997 PA NUMBER: PA-97-109 P.T. National Cancer Institute PURPOSE The Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) invites investigator-initiated grant applications (R01s) and applications for competing supplements to existing NIH-funded research project grants (R01s, P01s) or cooperative agreements (U01s, U10s) for innovative epidemiologic studies to address clinical issues facing women with inherited predisposition for breast and/or ovarian cancer. With increasing public awareness of genetic contributions to cancer risk and the commercial availability of testing for mutations predisposing to breast and ovarian cancer, women at inherited risk for these cancers must make decisions about preventive interventions - and often cancer-directed therapy - with only limited scientific information about the natural history of disease associated with predisposing mutations, the efficacy of prophylactic surgery and other preventive measures, and the appropriateness of standard oncologic care for cancers developing in mutation carriers. While prospective studies will eventually provide definitive answers to these questions, there is an immediate need to address these issues through retrospective studies based on existing resources such as tissue banks and high- risk clinic registries and through concurrent studies added to ongoing clinical or epidemiologic research projects. This initiative seeks to enhance informed decision-making among women at hereditary cancer risk by strengthening and expanding the scientific knowledge about preventive and therapeutic options. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA 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. 017-001-10473- 1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign institutions for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local government, and eligible agencies of the Federal government. The total requested project period for an application submitted in response to this PA may not exceed five years. Competing supplements should not extend beyond the funding period of the parent grant; the parent grant must have at least one year remaining in its project period after award of the supplement. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01) and competing supplements to existing NIH-funded research project grants and cooperative agreements. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background The identification of numerous genes that contribute to inherited predisposition to cancer has generated cautious enthusiasm for presymptomatic genetic testing within both scientific and lay communities. While the cloning of each new cancer susceptibility gene brings hope that mutation carriers can ultimately decrease their cancer risk through preventive interventions, the potential for psychosocial complications and discrimination against mutation carriers has led numerous professional organizations to recommend that predictive genetic testing should be limited to the research setting (1-4). However, the recent identification of an increased prevalence of specific mutations of BRCA1 and BRCA2 among defined population subgroups (5,6) has made presymptomatic testing clinically relevant and commercially attractive, and several laboratory companies now offer predictive genetic testing for BRCA1 and BRCA2 mutations. Progress in genetic technology and molecular diagnostics has rapidly outpaced scientific information about cancer prevention and management in individuals with a genetic predisposition to cancer. This knowledge gap translates into significant decision- making dilemmas for unaffected individuals found to be carriers of predisposing mutations and for cancer patients with germline mutations of these genes: risks for developing primary and second primary cancers may be extremely high; options for cancer prevention are limited, with most involving radical surgical procedures for which preventive efficacy is unknown; recommendations for preventive measures are variable and may conflict with each other; and optimal treatment and post-treatment management for mutation carriers who develop cancer has not been well explored. Specific examples for BRCA1/2 mutations include: Cumulative risks of breast cancer may approach 85% and of ovarian cancer, 60%, by age 70 years (7) for BRCA1 mutation carriers from strictly-defined breast/ovarian kindreds; while risk associated with specific alleles may be lower, it is still markedly elevated (8). Investigations of penetrance are just beginning for other high risk or general population groups toward which commercial testing is marketed. Methods for more accurately assessing individual risk for mutation carriers are largely unexplored. Molecular markers such as ploidy and ER/EGFR over-expression (9) or altered breast DNA patterns on infrared spectroscopy (10), potentially useful in assessing individual breast cancer risk for women in general, have not been systematically studied for mutation carriers. Recognized risk factors for sporadic cancers may modify susceptibility differently for mutation carriers. For example, in contrast to sporadic ovarian cancer, the risk of ovarian cancer in BRCA1 mutation carriers is reported to increase significantly with increasing parity (11). Clinical and histologic patterns of carcinogenesis may differ for sporadic and hereditary breast cancers. Recent studies suggest that ductal carcinoma in situ (DCIS) may not be a usual component of the BRCA1 spectrum of disease (12, 13) and that cytogenetic changes may occur without histologic atypia (14); the implications of this finding for surveillance technologies and interpretation of breast biopsies have not been studied. The preventive efficacy of prophylactic mastectomy is poorly defined and may vary according to surgical procedure (15). While case series report cancer rates as low as 0.5% following subcutaneous procedures among women at "high risk," surgical complications (e.g., skin flap necrosis, nipple loss) are reported in as many as 25% of procedures (16). A 1994 NIH Consensus Statement recommends prophylactic oophorectomy for women in ovarian cancer families (17), despite failure of this procedure to prevent intra-abdominal carcinomatosis in mutation carriers (18). The Task Force on Follow-Up Recommendations of the NIH-funded Cancer Genetics Studies Consortium concluded that evidence is insufficient to recommend prophylactic oophorectomy at this time (19). Surgical Oncologists may empirically advise against breast- conserving surgical procedures for known or suspected mutation carriers with early stage breast cancer, while breast conservation is encouraged for women with early stage sporadic cancers. While definitive answers to these problems will eventually become available from prospective follow-up studies of persons currently undergoing predictive testing, there is an immediate need to address these issues through existing resources such as tissue banks, high-risk clinic registries, and ongoing clinical research projects. This PA requests applications for innovative retrospective epidemiologic studies that utilize existing clinical and pathology resources or for concurrent research projects that supplement ongoing studies in related scientific areas (e.g., cancer prevention/treatment clinical trials), to provide information for decision-making about predictive testing, preventive strategies, and treatment options for persons at inherited risk for breast/ovarian cancer. Research Scope and Goals The goal of this PA is to enhance informed clinical decision- making among (1) individuals with gene mutations predisposing for breast and ovarian cancer risk and (2) individuals from high- risk families who do not wish to be tested for predisposing mutations. Its major objective is to provide scientific information about efficacy of cancer prevention and treatment measures among untested members of high risk families, and known mutation carriers, that will serve as a knowledge base for medical decisions by persons who are, or may be, at genetic risk for these cancers. This PA requests applications which use innovative epidemiologic approaches to address clinical issues critical to informed decision- making by persons in the groups described above. Applications should address at least one question from either A or B below: A. Options for Cancer Prevention among Mutation Carriers 1) Do women with mutations predisposing to breast cancer have the same patterns of preinvasive disease (atypical hyperplasia, LCIS, DCIS) as women without mutations? 2) Can the use of histologic findings, molecular changes, or serum markers more accurately predict individual risk of developing breast or ovarian cancer for carriers of predisposing mutations? 3) Does use of hormonal or other therapy (e.g., oral contraceptive use, hormone replacement therapy, antiestrogens, calcium/vitamin D supplementation) or differences in reproductive behavior (e.g., delaying birth of first child, forgoing childbearing) impact risk of breast and/or ovarian cancer for women with predisposing mutations? 4) Can retrospective natural history data be used to mathematically model optimal screening methodologies and intervals for women with mutations predisposing to breast and/or ovarian cancer? 5)What are the acceptability, efficacy, and complication rates of bilateral prophylactic mastectomy procedures among women with gene mutations predisposing to breast cancer? 6) What are the acceptability, efficacy, and long-term effects of prophylactic oophorectomy procedures among women with gene mutations predisposing to breast/ovarian or ovarian cancer? Does prophylactic oophorectomy decrease breast cancer risk among women with gene mutations predisposing to both breast and ovarian cancer? B) Clinical Management of Cancer Patients with Germline Mutations 1) Is breast-conserving therapy of equivalent efficacy to mastectomy for women with germline mutations who develop early stage breast cancers with respect to traditional (e.g., disease- free survival, overall survival) and non-traditional (e.g., quality of life) outcomes? 2) What is the efficacy of post-surgical adjuvant therapy among mutation carriers with early stage breast cancer compared to patients without germline mutations? 3)What is the risk of bilateral and contralateral breast cancer among mutation carriers who develop an invasive breast neoplasm? Does systemic adjuvant therapy impact this risk? Does prophylactic mastectomy or oophorectomy decrease this risk? Applications should be based on retrospective or concurrent methodologies: Retrospective studies. Applications for retrospective studies should build upon existing resources (e.g., pathology specimens, tissue repositories, cancer registration/tracking systems) or clinical facilities (e.g., high-risk clinic registration logs, ongoing predictive testing projects or programs, prevention/treatment clinical trial cohorts). Concurrent studies. Applicants may propose supplemental studies of targeted individuals participating in ongoing NCI-funded clinical trials or epidemiologic studies by submitting applications for competing supplements to the parent projects. The research proposed in competing supplements must not extend beyond the funding period of the parent project. Support for initiation of prospective studies or clinical trials testing preventive or therapeutic interventions in the target populations is beyond the scope of this initiative. Investigators are encouraged to incorporate innovative epidemiologic approaches, laboratory procedures, and statistical methods as appropriate to the study question. An interdisciplinary research team, including expertise in basic sciences (e.g., human genomics, carcinogenesis), clinical cancer research (cancer and/or genetic epidemiology, preventive and therapeutic oncology), social and behavioral sciences, and biomedical ethics is strongly recommended. Multi-site collaborations are encouraged as appropriate to study hypothesis and/or design. Applications may include genetic counseling and predictive testing of participants, as appropriate to study design. For applications in which results of genetic studies are made available to participants, investigators must demonstrate that genetic counseling protocols meet established standards/guidelines and that testing procedures are performed in a certified clinical laboratory by appropriately trained personnel. Applications in which results of genetic studies are not made available to participants may utilize research laboratory facilities but must describe procedures to assure accuracy and reliability of laboratory results. Applications which rely on previously collected tissue specimens must assure that study procedures are consistent with published guidelines for the use of stored tissue samples. Because of the sensitive nature of genetic data, applications must include a clear description of methods for securing research records and protecting confidentiality and privacy of study data. Procedures for informed consent must conform to federal requirements for protection of human research subjects (45 CFR 64), with special attention to ethical, legal, and social implications for participants and their family members. The proposed R01 research projects should not exceed five years duration, and competing supplements should not extend beyond the funding period of the parent grant. All studies must be completed within the specified grant period; the PA will not support establishment of disease or risk registry systems or participant contact beyond the specified study period. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714. The title and number of the program announcement must be typed in Item 2 on the face page of the application and the "YES" box marked. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD, 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged, particularly during the planning phase of the grant applications. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susan G. Nayfield Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: 301-496-9600 FAX: 301-402-4279 Email: nayfiels@epndce.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Kelli Oster Grants Administration Branch National Cancer Institute Executive Plaza South 6120 Executive Boulevard, Suite 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: 301-496-7800, EXT. 261 FAX: 301-496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and No. 93.856. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42 USC 241 and 285) and administered under PHS policies and Federal regulations 42 CFR 52 and 45 CFR Part 74 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non- use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American People. References 1. Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition. Am J Hum Genet 55:i-iv, 1994 2. National Advisory Council for Human Genome Research. Statement on the use of DNA testing for presymptomatic identification of cancer risk. JAMA 271:785, 1994 3. Presymptomatic Genetic Testing for Heritable Cancer Risk. Press release of the National Breast Cancer Coalition, Washington, DC, September 28, 1995 4. Statement of the American Society of Clinical Oncology: Genetic testing for cancer susceptibility. J Clin Oncol14:1730-1736, 1996 5. Fitzgerald MG, MacDonald DJ, Krainer M, et al. Germ- line BRCA1 mutations in Jewish and non-Jewish women with early-onset breast cancer. N Engl J Med 334:143-9, 1996 6. Neuhausen S, Gilewski T, Norton L, et al. Recurrent BRCA2 617delIT mutations in Ashkenazi Jewish women affected by breast cancer. Nature Genetics 13:126-128, 1996 7. Easton DF, Bishop DT, Ford D, et al. Genetic linkage analysis in familial breast and ovarian cancer: Results from 214 families. Am J Human Genet 52:678-701, 1993. 8. Easton DF, Ford D, Bishop TD, and the Breast Cancer Linkage Consortium. Breast and ovarian cancer incidence in BRCA1 mutation carriers. Am J Human Genetics56:265-271, 1995 9. Fabian CJ, Exiles C, Kame S, et al. Prevalence of aneuploidy, overexpressed ER, and overexpressed EGFR in random breast aspirates of women at high and low risk for breast cancer. Breast Cancer Res Treat 30(3):263-74, 1994 10. Malins DC, Polissar NL, Nishikida K, et al. The etiology and prediction of breast cancer. Fourier transform-infrared spectroscopy reveals progressive alterations in breast DNA leading to a cancel-like phenotype in a high proportion of normal women. Cancer 75(2):5003-17, 1995. 11. Narod SA, Goldgar D, Cannon-Albright L, et al. Risk modifiers in carriers of BRCA1 mutations. Int J Cancer64(6):39944--8, 1995. 12. Sun CC, Lenoir G, Lynch H, Nard SA. Lancet 348:408, 1996 13. Liotta, L (personal communication) 14. Teixeira MR, Pandis N, Gerdes A-M, et al. Cytogenetic abnormalities in an in situ ductal carcinoma and five prophylactically removed breasts from members of a family with hereditary breast cancer. Breast Cancer Res Treat38:177-182, 1996 15. Wapnir IL, Rabinowitz B, Greco RS. A reappraisal of prophylactic mastectomy. Surg Gynecol Obstet 171:171- 184, 1990 16. Danforth DN Jr. Prophylactic mastectomy to prevent cancer of the breast in high-risk patients. In: DeVita VT Jr, Hellman S, Rosenberg SA (eds). Cancer Prevention. JB Lippincott, Philadelphia, 1990 17. Ovarian cancer: screening, treatment, and follow-up. NIH Consensus Statement 1994 Apr 5-7; 12(3):11-30 18. Struewing JP, Watson P, Easton DF, et al. Prophylactic oophorectomy in inherited breast/ovarian cancer families. Monogr Natl Cancer Inst 17:33-35, 1995 19. Burke W, Daly M, Garber J, et al. Follow-up recommendations for individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. JAMA277:997-1003, 1997. From owner-sci-resources@net.bio.net Sun Oct 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-110 - V26(32) 09/26/97 Date: 5 Oct 1997 21:37:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 578 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <619pug$o7s@net.bio.net> NNTP-Posting-Host: net.bio.net CORE SUPPORT FOR PROGRAMS IN MENTAL HEALTH/AIDS RESEARCH NIH GUIDE, Volume 26, Number 32, September 26, 1997 PA NUMBER: PAR-97-110 P.T. National Institute of Mental Health Letter of Intent Receipt Date: November 1 (each year) Application Receipt Date: January 2, (each year) PURPOSE The National Institute of Mental Health Office of AIDS Research will establish Core Support for Programs in AIDS Research (CSPARs) to provide core support for multi- disciplinary research programs on the mental health aspects of HIV/AIDS. The purpose of this Program Announcement is improve and expand research by supporting infrastructure, including: subject recruitment, tracking, and retention; quality control and assurance procedures; equipment; laboratories; statistical analysis; database management; and administrative coordination. This will serve to enhance and extend the effectiveness of research related to mental health and HIV/AIDS. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Core Support for Programs in AIDS Research, is related to the priority area of mental health aspects of HIV/AIDS research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017- 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign organizations are not eligible to apply. Domestic organizations may not include international components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. MECHANISM OF SUPPORT The mechanism of support for the CSPAR is the core center grant (P30). The applicant may propose pooling existing resources and request additional support for research infrastructure to be shared by investigators with existing related funded research. This research infrastructure support may include, e.g., subject recruitment, equipment, laboratories, statistical analysis, database management, developmental cores, and administrative coordination. Applicants must demonstrate the potential for continuing funding for projects proposed to be supported by the core. Core Support Center Grant applicants may apply for up to five (5) years of support and the grants are renewable until further notice. Construction costs are not allowable. FUNDS AVAILABLE NIMH will provide up to a maximum of $850,000 total costs for CSPAR grants. Applicants must demonstrate a funded research base of at least six peer-reviewed AIDS and AIDS-related research awards active at the time that the CSPAR is funded and throughout the award period. Sixty percent of this funded research base must be from NIMH-funded grants and 40% may be from other NIH Institutes or appropriate peer-reviewed funding from alternate sources. This research base must demonstrate synergy and collaboration for all aspects of AIDS-related behavior research, including research investigating the neurological and neurobehavioral complications of HIV infection. The research base includes grants and contracts utilizing the following mechanisms: P01, R01, R03, R21, R29, R35, R37, U01, U10, U19, and K series awards. Applicants planning to submit center application requesting $500,000 or more in direct costs in any year are advised that they must contact program staff prior to submission of the grant. Applications in this category received without prior staff contact may be delayed in the review process or returned to the applicant without review (NIH GUIDE, Volume 25, Number 14, May 3, 1996). RESEARCH OBJECTIVES The NIMH seeks to foster a synergistic approach to research on mental health issues of HIV infection. The goal of the CSPAR is to encourage the application of multiple scientific perspectives and approaches to stimulate inter- and multi-disciplinary collaboration and coordination. NIMH CSPARs are broadly based investigative endeavors, encompassing or supporting research in a variety of areas including biological, biomedical, behavioral, neuroscience, prevention, clinical sciences and services research. Some important research objectives are: 1) identify behaviors that put individuals at risk for HIV infection, and develop interventions to change those behaviors; 2) develop methods and strategies to aid HIV-infected individuals and their families in coping with HIV infection; 3) study the nervous system effects of HIV infection of the CNS; 4) identify the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction; 5) develop and test potential therapeutics to prevent or treat this CNS disease; and 6) study issues influencing adherence and non- adherence, and identify methods to improve and assure adherence and compliance to drug therapy regimens. The CSPAR will enable innovative, state-of-the-art research on HIV and mental health that could not or would not be conducted without the co re support. In addition, the CSPAR should have an overall integrating theme which is clearly described, and which justifies the need for the core support to facilitate the research projects. Applicants are strongly encouraged to consult with NIMH program staff with regard to questions concerning program-specific requirements. Although the specific structure and organization of individual research core centers will vary, the following characteristics must be apparent in each application. Applicants should carefully review these characteristics because they are important factors in the evaluation and scoring of the application by peer reviewers. NIMH CSPAR applications must describe in detail the essential function of each core of the center, how each core will contribute to the overall theme and organization of the center, and how each core will be used by the participating research projects. Specific aims of the proposed components should be defined, and a time line for addressing those aims should be presented. This focus of the proposal should be clearly addressed in the Introductory section prefacing the application. Research Environment Each center must provide an environment that promotes and enhances the conduct of the highest quality, state-of-the-art research, exhibiting leadership and innovation in its particular area(s) of investigation. CSPARs are expected to serve as regional or national research resources for established and promising investigators, and provide opportunities for research training, career development, and mentoring. Applicants should be specific in describing the advantages of the overall center structure, how it will be beneficial, and how it will contribute to achieving the identified research goals. The application of multiple scientific perspectives and a synergistic approach as well as thematic integration should be defining features of the CSPAR. For competitive renewals, applicants should identify original specific aims and progress made on each specific aim as well as evidence of relevant publications produced in the previous funding period. CSPAR Director The CSPAR director must be scientifically and administratively qualified to direct the center, and able to provide leadership for the scientific program. The director will have final responsibility for the scientific, administrative, and operational aspects of the center. The center director is responsible for overall coordination and for the development of the CSPAR as a significant local, regional, or national resource. Because of the role and importance of the center director to the success of the center, the commitment of time and effort to be devoted to the center must be described and adequately justified, and an individual may not serve as director of more than one research core center grant. Training As a leader in its particular area of investigation, the CSPAR should attract new investigators and provide for mentoring and career development. The applicant institution must demonstrate that it has the capacity to train predoctoral and/or postdoctoral students for careers in HIV/mental health research, and the capacity to provide career development and mentoring opportunities for potential researchers. CSPAR grant funds may not be used to pay stipends or other trainee costs, however, the center staff are encouraged to participate in the development of training programs, and center resources may be made available for use of trainees. In addition, as regional or national resources, center applicants should also facilitate the sharing of data and methodologies as well as training in such methodologies with the scientific community. Travel Limited support is available to cover travel of the CSPAR director and other investigators to scientific meetings, justified as essential to the conduct of research under the center. Travel of technical staff for training justified as essential to enhancing the quality of the research projects is also allowed. Organization NIMH core center grants are expected to be multidisciplinary in scope, applying multiple scientific perspectives and approaches, to foster inter- and multi-disciplinary collaboration and coordination, and include a depth of expertise and experience not ordinarily present in an individual research project grant. The mechanisms to foster interactions and collaborations among center investigators should be described in detail, clearly and specifically explaining how this will result in enhanced quality, productivity and overall progress in mental health research in the center. An effective center provides an environment that encourages cross-fertilization of ideas, provides an interactive research environment, and encourages creativity and innovation. Through interactions and collaborations, participating investigators should enhance the development and productivity of their research efforts, benefiting from shared resources, formal and informal planning activities and developmental or pilot support provided through the NIMH core center grant. The CSPAR should be organized to include an administrative core, a minimum of two research cores, and a developmental core as described below. Core directors should be senior-level investigators with a history of research support. ---Administrative Core The center must have an appropriate and adequate administrative structure with an internal organization capable of planning and evaluating center activities. This should include a structure that has clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among and between programmatic elements of the center in an efficient and cost-effective manner. A mechanism for internal advisory, review, decision-making, and priority setting processes appropriate to conduct the activities of the center must be defined. Appropriate criteria and review processes must be established and described to sustain individual participation in the center based on productivity, research direction, and overall contribution. The administrative structure must include a standing outside advisory structure(s) charged to provide appropriate and objective advice and evaluation as needed to the center director. Administrative cores may provide support for a limited number of administrative and clerical personnel. However, salary and support for central administrative personnel usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel are not allowed. Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment are allowed when not covered by institutional overhead charges. Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowed. ---Research Cores The structure of the CSPAR will include the establishment of a minimum of two research cores to support shared resources that will enhance the ongoing research grants. Research cores can be developed around any research activity that can provide resources to basic and clinical investigators, such as behavioral intervention development, neurobehavioral/neurological assessment, information dissemination, statistical analysis, etc. Shared resources and services are intended to provide access to technology that enhances the research productivity of the center, scientific interaction and consultation. Shared resources also provide access to services that facilitate the research and strengthen the administrative and organizational cohesion of the center. The costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies are also allowed. A table should be presented indicating how the current projects will be served by the proposed cores, and a clear and detailed description of this should be included in the narrative of each appropriate research core. CSPARs may request funds for use of inpatient, residential, or outpatient facilities which are essential to the conduct of the research and must be adequately justified. CSPAR funds can also support subject recruitment and incentive costs, as well as community sanction efforts where relevant. ---Developmental Core Developmental core money may be used as start-up funds for new, innovative pilot projects by independent investigators. Developmental support may be for investigators new to AIDS research and for feasibility studies. Generally, the total amount of money allocated to pilot projects should not exceed 10% of the center grant's total annual direct costs (exceptions should be strongly justified). These projects should have the potential for developing into larger projects that could compete for funds on their own. The support of pilot projects or feasibility studies should be of relatively short duration (e.g., 1-2 years), depending upon the nature of the research. A process by which high-quality, innovative pilot proposals are identified or solicited from investigators must be developed and clearly described. The mechanism to review potential projects, make funding decisions and awards, and the manner in which projects will be monitored to ensure effective use of pilot project funds must be described. As with all research to be conducted under the center, pilot projects must comply with applicable NIH policies and the necessary human subject and animal welfare assurances must be submitted. CSPAR grantees are to provide the NIMH program officer with written notification of the initiation of new pilot projects. The notification should contain a brief description of and rationale for the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, a statement that the project will comply with applicable NIH policies and that the necessary human subject and animal welfare assurances have been submitted and obtained. Competing continuation center applications should supply information about the progress, accomplishments and relevant publications of all projects supported by the center through the pilot project mechanism. This information should also include the current funding status of completed pilot projects, and whether data generated from pilot projects provided a basis for projects with independent funding. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by November 1, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this announcement. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443 9719 Email: dr89b@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714; fax: (301) 480-0525; Email: ASKNIH@OD.NIH.GOV. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The receipt date for all new and competitive renewal center grant applications will be once per year on January 2. The letter of intent should be submitted by November 1. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) The application should include an overview summarizing the overall organization of the proposed CSPAR, including the cores, and is limited to 5 pages. The RESEARCH PLAN should describe the CSPAR in detail, and is limited to 25 pages, including tables, graphs, figures, diagrams, and charts. In addition, a detailed description of each core is required, limited to 10 pages each. Applications must be complete and must not exceed these page limits or they will not be accepted. Potential applicants are strongly encouraged to contact NIMH program staff early in the planning process. NIMH staff will provide preapplication consultation to all applicants for NIMH CSPAR grants. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Applications recommended for further consideration by the review committee will receive a second-level review by the National Institute of Mental Health Advisory Council. After Council consideration, applications will be considered for funding decisions by the relevant program staff and the Institute Director. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The following aspects of the application will be evaluated in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Applicants should ensure that their applications are responsive to the research goals of NIMH and to the essential organizational and administrative characteristics of an NIMH core center as described below. Overall CSPAR Program Review Criteria o Scientific significance of the center's research program with regard to furthering research on mental health and HIV o Specific goals of the cores and a clear description of the plans and time frame to achieve those goals o Synergy of approach and cohesiveness of objectives o Impact of the existing research base, and unique contributions of the proposed center to innovation, scientific productivity, and recognition, including publications, new research grants, honors and awards o Multi-disciplinary scope, breadth, and overall quality of the center's program, and provisions for coordinating the research projects and core units o Quality of the administrative functions and overall infrastructure in promoting the center themes and research projects o Extent of collaboration among investigators within the center o Quality of plans for internal peer review of papers, chapters, and grant applications o Track record and quality of plans for mentoring and career development of promising investigators o Quality of plans for sponsoring workshops, seminars, and other educational activities for center investigators and research staff o Institutional commitment to the program CSPAR Director o Scientific and administrative qualifications of the center director o Appropriateness of the level of time and commitment to the center grant o Quality of scientific expertise and track record o Quality of administrative skills and institutional authority o Ability to participate in the development of research training programs, career development and mentoring opportunities Core Units o Evidence of cost-effectiveness and document of quality control of core units o Quality of the data analytic functions and procedures for database management, including quality assessment and control procedures, extent of use of the data for analysis, publication, and development of additional hypotheses o Quality of the core laboratories o Quality and innovation of pilot studies and quality of the procedures for evaluation and selection of new pilot study proposals o Relationship to existing grants and appropriateness of planned activities for ongoing research Research Activities o Scientific and technical merit of each component research activity and the relation of the activity to the CSPAR's overall theme o Quality and productivity of research projects using core units, and description of how the core units will increase the effectiveness of the research o Accomplishments and progress of the component research projects and core units (for competing continuations) o Accomplishments and progress of pilot studies (for competing continuations) o Qualifications, experience, and commitment to the CSPAR mission of the investigators responsible for the core units and research projects and their ability to devote the required time and effort to the program o As appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment o As appropriate, the adequate representation of women and minorities in study populations Personnel o Scientific qualifications and productivity of center investigators o Quality and extent of the research expertise o Quality of plans for personnel recruitment, training, and supervision o Quality and degree of synergistic potential among the research groups Resources and Environment o Availability and accessibility of appropriate research laboratories, equipment, and subjects o Availability and accessibility of appropriate clinical facilities (if applicable) o Quality of institutional resources o Quality and degree of institutional support and commitment o Academic and physical environment as it bears on the potential for interaction with scientists from other departments and institutions Budget o Appropriateness of budget and time frame for the proposed activities o Appropriateness of procedures for making allocations to core units and, reviewing and selecting pilot projects for support Information Dissemination o Quality of plans to participate in scientific, professional, and public meetings and present research findings and, where concrete findings exist, plans for publishing the findings o Quality of plans for making data and methodologies available to the scientific community and for providing training in such methodologies o The quality of plans for participating in workshops and conferences, as well as disseminating information to other investigators and the local community when applicable AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIMH. The following will be considered in making funding decisions: quality of the application as determined by peer review, availability of funds, and program priority. INQUIRIES: Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443 9719 Email: dr89b@nih.gov Direct inquiring regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Oct 08 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: Termination of E-Guide Date: 9 Oct 1997 13:03:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 56 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <61jdbf$45n@net.bio.net> NNTP-Posting-Host: net.bio.net NOTICE TO USERS OF THE NIH GUIDE FOR GRANTS AND CONTRACTS Dear Colleagues: You are likely aware that, as of October 1, 1997, the NIH Guide for Grants and Contracts was moved off Gopher and onto the World Wide Web. The final printed version and the final LISTSERV version were for Volume 26, Number 32, September 26, 1997. The full text of all Requests for Applications (RFAs), Program Announcements (PAs), as well as Notices, will be available on the NIH Office of Extramural Research Homepage . Archived issues of the NIH Guide are also retrievable at this URL. The NIHTOC-L, which contains the Table of Contents for each week's issue of the NIH Guide will continue to be made available. For each of the titles listed there will be a URL that will enable investigators to link to the full text of each announcement that is of interest to them. Therefore we encourage investigators to subscribe to this LISTSERV by sending an e-mail request to: LISTSERV@LIST.NIH.GOV. The text of the message should read ONLY : SUBSCRIBE NIHTOC-L First-name Last-name e.g. SUBSCRIBE NIHTOC-L John Smith INQUIRIES Inquiries regarding these procedures may be directed to : James O'Donnell, Ph.D. Office of Extramural Programs National Institutes of Health 6701 Rockledge Drive, Room 6182 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2768 Email: odonnelj@od.nih.gov Myra Brockett Office of Extramural Programs National Institutes of Health 6701 Rockledge Drive, Room 6202 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2694 Email: mb36t@nih.gov ---------------------------------------------------------------- William K. Jones Chief, Database Systems Section Phone: 301-402-1241 NIH Computer Center Fax: 301-480-8263 wkj@nih.gov ---------------------------------------------------------------- From owner-sci-resources@net.bio.net Sun Oct 19 23:00:00 1997 Path: biosci!biosci!not-for-mail From: prismx@earthlink.net (Claire Haller) Newsgroups: bionet.sci-resources Subject: SCIENCE-WEEK: This Week's Headlines (17 Oct 97) Date: 20 Oct 1997 12:32:34 -0700 Organization: SCIENCE-WEEK Lines: 23 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <62gbki$bu8@net.bio.net> Reply-To: prismx@earthlink.net NNTP-Posting-Host: net.bio.net Headlines in This Week's SCIENCE-WEEK (October 17, 1997) For free Email subscription to complete news reports, send SUB SW to prismx@earthlink.net 1. A Conflict Between Seismologists and Defense Analysts 2. An Essay on the Confusion Over Cloning 3. Revelations Concerning Lisa Meitner and the Nobel Prize 4. A Postulate of Possible Sub-Surface Planetary Life Habitats 5. Squeezed Light Experiments Reveal Non-Classical Correlations 6. New Satellite Data Maps the Ocean Floor 7. Gravito-Optical Surface Trap for Super-Cooled Atoms 8. Reversible Metallic State Tuning of Quantum Dot Monolayers 9. Method for Controlled Elaboration of Macromolecular Dendrimers 10. An Unusual Idea Concerning Honeybees and Quarks The Editors SCIENCE-WEEK A Free Weekly Digest of the News of Science prismx@earthlink.net http://members.aol.com/sciweek From owner-sci-resources@net.bio.net Sun Oct 19 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 20 Oct 1997 12:35:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 234 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199710200900.CAA23223@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. From owner-sci-resources@net.bio.net Tue Oct 21 23:00:00 1997 Path: biosci!biosci!not-for-mail From: prismx@earthlink.net (Claire Haller) Newsgroups: bionet.sci-resources Subject: SCIENCE-WEEK: This Week's Headlines (24 Oct 97) Date: 22 Oct 1997 10:36:28 -0700 Organization: SCIENCE-WEEK Lines: 23 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <62jdkk$gb3@suriname.earthlink.net> Reply-To: prismx@earthlink.net NNTP-Posting-Host: net.bio.net Headlines For the Next Issue of SCIENCE-WEEK (October 24, 1997) For free Email subscription to complete news reports, send SUB SW to prismx@earthlink.net 1. Irish Activist Group Sabotages Genetically Engineered Crop 2. National Cancer Institute Releases Nuclear Fallout Report 3. A Workshop on Chondrite Meteorites 4. Fractional Electrons in Condensed Matter Physics 5. Long Range Order in Stacks of Fluid Monolayers 6. A New Approach to the De Novo Design of Proteins 7. Specification of Cell Affinities by an Intercellular Signal 8. New Data Against Important Telomerase Role in Cancer 9. Role of Kainate Receptors in Synaptic Transmission 10. Increasing U.S. Prevalence of Herpes Simplex Viral Disease The Editors SCIENCE-WEEK A Free Weekly Digest of the News of Science prismx@earthlink.net http://members.aol.com/sciweek