Full Text PA-95-088 ETIOLOGY AND PREVENTION OF GALLSTONES DURING PERIODS OF HIGH RISK NIH GUIDE, Volume 24, Number 32, September 1, 1995 PA NUMBER: PA-95-088 P.T. 34 Keywords: Digestive Diseases & Disorders Etiology Disease Prevention+ National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this Program Announcement (PA) is to encourage research into the etiology and prevention of gallstone formation during periods of high risk. Applications are encouraged that range from careful prospective studies of the mechanisms of gallstone formation in humans to clinical trials aimed at the prevention of gallstones. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," in a PHS-led national activity for setting priority areas. This PA, Etiology and Prevention of Gallstones During Periods of High Risk, is related to the priority areas of chronic disabling conditions and nutrition. 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 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH research project grant (R01) and FIRST awards (R29). RESEARCH OBJECTIVES Gallstones are a highly prevalent condition, responsible for over half a million cholecystectomies in the U.S. each year. It has been suggested that persons with recently formed gallstones are at more risk of symptomatic illness than persons who have had gallstones for years. The following are among the situations that acutely increase the risk of gallstones: (1) substantial, rapid weight loss, (2) pregnancy, (3) total parenteral nutrition, (4) major abdominal surgery, (5) treatment with the somatostatin analogue octreotide, and (6) the period following dissolution of gallstones. Prevention of gallstone formation in these situations could eliminate a substantial portion of symptomatic gallstone disease. Despite the general acceptance that gallstone formation is caused by defects in hepatic cholesterol processing, nucleation in the gallbladder, and gallbladder motility, these and other factors have not been systematically and prospectively evaluated in humans. Situations in which the risk of gallstone formation is high and well-defined lend themselves to the prospective study of gallstone pathophysiology. It is likely that the study of the process of gallstone formation in humans at high risk would lead to effective prevention strategies, and thus, eliminate the substantial morbidity associated with the formation of gallstones. Studies that would better define the risk of gallstones in high risk populations are also encouraged. In addition, clinical trials that address safe and cost-effective measures for the prevention of gallstones are encouraged. For clinical trials, administrative suggestions for preparing an R01 clinical trial grant application are available (see INQUIRIES). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy 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 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) 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 applications proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical Research" that were published in the Federal Register of March 28, 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. 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 Grants Information, Division of Research Grants, 6701 Rockledge Drive Suite 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267. The title and number of this program announcement must be typed in Section 2 on the face page of the application. For investigators applying for support through the FIRST award mechanisms (R29), three letters of references must be submitted with the application. An applicant submitting a revised application in response to this RFA must again submit reference letters. Applications will be accepted at the regular application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are also found in the PHS 398 instructions. The completed original application and five legible copies must be sent or delivered to: OFFICE OF GRANTS INFORMATION DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (For express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both sexes 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. AWARD CRITERIA For other than clinical trials, applicants must limit their R01 requests to not more than $150,000 in direct costs for the first year budget period. For clinical trials the direct cost may not exceed $500,000 for the first budget period. Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For clinical trials, administrative suggestions for preparing an R01 clinical trial grant application are available. Direct inquiries regarding programmatic issues to: James Everhart, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN-12J 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8878 FAX: (301) 480-8300 Email: vjy@cu.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Thelma Jones Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-44B 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8853 FAX: (301) 480-3504 Email: jonest@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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. .
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