Full Text DK-92-16 PHYSIOLOGY AND PATHOPHYSIOLOGY OF THE PANCREATIC DUCTS NIH GUIDE, Volume 21, Number 6, February 14, 1992 RFA: DK-92-16 P.T. 34 Keywords: Physiology, Human Pathophysiology Digestive Diseases & Disorders National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 15, 1992 Application Receipt Date: July 15, 1992 PURPOSE The Division of Digestive Diseases and Nutrition and the Division of Diabetes, Endocrinology and Metabolism of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) wish to encourage applications that conduct basic and clinical studies into the physiology and pathophysiology of the pancreatic ducts. 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), Basic and Clinical Studies on the Physiology and Pathophysiology of the Pancreatic Ducts, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Minority individuals and women are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH grant-in-aid research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. The total requested project period for applications submitted in response to this RFA may not exceed five years. A maximum of three years may be requested for foreign awards. The earliest possible award date will be April 1, 1993. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review process. FUNDS AVAILABLE For FY 1993, $1.0 million will be committed to fund applications submitted in response to this RFA. It is anticipated that five to seven awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. In order to help meet NIDDK goals for managing the costs of biomedical research, applicants more than $160,000 direct costs for the initial budget period. 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 A neglected but very important component of the pancreas, the pancreatic ductules and duct system, was the subject of a three-day conference held in September 1991. Because duct cells represent only about 10 percent of the adult exocrine pancreas, it has been difficult to study. Recently, investigators have been able to use tissue culture and microdissection techniques to study duct cells in vitro. The ion transport, neural and hormonal regulation, and other electrophysiological measurements of these cells can now be made in health and disease. Some of the common diseases of pancreatic ducts are pancreatitis, cystic fibrosis and adenocarcinoma. All of these basic and clinical areas offer opportunities to expand our knowledge of the physiology and pathophysiology of the pancreatic duct system. Examples of potential interest, which are not meant to be directive or inclusive, are listed below. Studies may examine normal duct cell development and function and the alterations that occur in disease. o Assessment of pancreatic duct cell development using biochemical markers. When during development do protodifferentiated cells acquire adult duct cell markers? Do different size classes of duct cells exhibit different biochemical markers, suggestive of different functions? Is duct cell development altered in disorders such as cystic fibrosis? o Development of the functional capacity of the duct epithelium to secrete fluid, electrolytes, and mucin. When does this capability appear? What are the controlling growth factors, hormones, stromal interactions, receptors? When do the various components of the stimulus-secretion coupling system appear? When and how do disorders such as pancreatitis and cystic fibrosis manifest? o Developmental potential of adult duct epithelium. Does the duct cell have the capacity to give rise to new acinar and/or endocrine cells? What circumstances unleash or preclude such a capacity? o Detailed characterization of primary duct cell cultures, the first several subcultures, and putative duct cell lines. To what extent are primary cell cultures and cell lines good models for duct cells in vivo? o Establishment of a confluent monolayer culture of duct cells on which functional measurements can be made, as in Ussing chambers. o Development of integrative approaches to the study of function in living cells, e.g., by fluorescent probes, electron microscopy. Such approaches can be applied to normal duct cells and cells affected by disorders of the pancreatic ducts. o Understand processes at the molecular level. Are the secretin receptors (already cloned on brain neuroblastomas) the same on pancreatic ducts? o Subsets of chronic pancreatitis that are regarded as "idiopathic" should be evaluated to test the hypothesis that autoimmune mechanisms directed toward ductal cells play a role in the pathogenesis. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by June 15, 1992, 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 is being 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 is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 APPLICATION PROCEDURES The research grant application form PHS 398 (revised 9/91)is to be used in applying for these grants. The form is available from most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and four signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 605 Bethesda, MD 20892 Applications must be received by July 15, 1992. If an application is received after that date, it will be returned to the applicant. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant. The application either may be returned to the applicant, or held until the next receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, the NIDDK may conduct a preliminary scientific peer review (triage) and withdraw applications from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an NIDDK initial review group specifically convened for this RFA. Following study section review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and AWARD CRITERIA Awards in connection with this announcement will be made to foreign institutions only for research that is unique and can only be performed outside of the United States. Public Health Service policy will govern such awards. The anticipated date of award is April 1, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues and requests for copies of the workshop program with summaries of the presentations and abstracts of poster presentations, are available to those considering responding to this RFA. Such inquiries should be directed to: Sarah C. Kalser, Ph.D. Pancreatic Diseases Program Director Division Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 3A-17 Bethesda, MD 20892 Telephone: (301) 496-7858 Inquiries relating to proposed research on cystic fibrosis should be directed to: Judith Fradkin, M.D. Chief, Endocrinology and Metabolic Diseases Program Branch Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 621 Bethesda, MD 20892 Telephone: (301) 496-7791 Inquiries regarding fiscal matters should be directed to: Ms. Thelma Jones Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 Schedule Letter of Intent: June 15, 1992 Application Receipt: July 15, 1992 Initial Review: Oct/Nov 1992 Second Level Review: February 1993 Anticipated Award: April 1, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847 and No. 93.848. Awards are 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. .
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