Full Text PA-97-108 STUDIES OF MOLECULAR MECHANISMS OF RENAL INJURY AND RECOVERY NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA NUMBER: PA-97-108 P.T. Keywords: National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The Division of Kidney, Urologic and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases announces a continuing interest in receiving research project applications on the above subject. The need for this initiative was recognized, in part, as a result of the recommendations emanating from the conference held at the NIH in May, 1996, organized and sponsored by the DKUHD, titled "Acute Renal Failure in the 21st Century." A report from the meeting summarized recommendations from the participants, which included a set of published recommendations for patient management and outcomes assessment (AJKD, Vol. 29, # 5, 793-799, 1997). Also advocated was the development and establishment of a multi-center database as one mechanism to facilitate cooperative multi-center studies. It was further recommended that research initiatives be undertaken to enhance the transfer of new body of knowledge derived from basic studies and laboratory investigation (including cellular and molecular aspects of tissue injury, changes in cell differentiation, cell repair mechanisms, cell death and organ recovery) to the clinical management of ARF. With a more complete understanding of these fundamental aspects of the pathophysiological response by the kidney to ARF, it is anticipated that new therapies and potentially novel uses of replacement therapies may emerge. Additional insight in this field will likely emerge from another conference convened by the American Society of Nephrology, with support from the NIDDK ("Mechanisms of Tissue Injury and Repair") that will be convened November 1997. 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. 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, D.C. 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal Government. Although applications from foreign laboratories are excluded, collaborative efforts with foreign laboratories may be expedited as subcomponents (subcontracts) of applications submitted through domestic institutions. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the grant-in-aid and will be governed by the current policies of grant programs of the National Institutes of Health. New applications may be submitted for the traditional, investigator-initiated research project grant (R01), First Independent Research Support and Transition [FIRST (R29)] awards. On a limited basis, and only following extensive consultation with NIDDK Program Staff will program project (P01) and the NIH Investigator-Initiated Interactive Research Project Grants (IRPG) submissions be entertained. Within the framework of the above support mechanisms, the applicants are expected to plan, direct, and conduct the research programs. The project periods during which the research will be conducted should adequately reflect the time required to accomplish the stated goals and be consistent with the policies for the respective support mechanisms. Support will be provided for up to 5 years (renewal for subsequent periods) subject to the availability of funds and progress achieved. FUNDS AVAILABLE There are no set aside funds for this solicitation and therefore all applications submitted in response to this PA compete for the dollars available during any current or subsequent fiscal year. New applications in response to this announcement are to be submitted at the regularly published receipt dates of February 1, June 1 and October 1 (exceptions are IRPGs, which have receipt dates of February 15, June 15 and October 15). RESEARCH OBJECTIVES The purpose of this initiative is to stimulate research into the pathophysiological response by the kidney to acute renal failure (ARF), which can lead to new therapies and novel uses of replacement therapies in the clinical setting. To that end, the following are some of the objectives of this solicitation that are being encouraged, which are examples only and should not be viewed as all inclusive: o Studies addressing the effect on function of renal cells of ischemia/hypoxia induced alterations in cytoskeletal proteins and ATP depletion; o Studies to determine the role of integrins and protein kinases in the cascade of events leading to acute tubular obstruction/necrosis; o Studies to evaluate the role of blood pressure maintenance in recovery from ARF; o Studies on nephrotoxins, including antibiotics, heavy metals, oxidants, and halogenated hydrocarbons; o Clinical studies to evaluate the effects of hormones (e.g., ANP, a-MSH, prostaglandins, nitric oxide, endothelin) and growth factors or their inhibitors on prevention and recovery from ARF; o Post-transplantation ARF: Studies to protect renal allografts and to evaluate the relationship between delayed graft function and long- term outcome; o Studies that will identify the regulatory mechanism(s) in regeneration of the kidney following ischemic or toxic insults and identify regeneration-specific gene pathways; o Studies to evaluate the effects of intermittent hemodialysis (IHD) and continuous hemodialysis on residual kidney function in critically ill patients with ARF; o Studies to ascertain the role of ARF in multiorgan dysfunction syndrome (MOD); o Studies that will determine appropriate nutritional support in the ARF patient; o Studies to identify appropriate characteristics of dialysis membranes for renal replacement in ARF; o Proposals that will lead to the development of a cooperative multicenter database for coordination of studies in ARF; o Studies that will identify methods to enhance endogenous pathways within the kidney that protect against injury or stimulate repair; o Studies that will lead to the development and validation of severity of illness scores in ARF patients; o Studies that will lead to markers for early detection of renal injury. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Whenever human subjects may be used in research proposed in applications in response to this PA, the following language is required: 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 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. 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, or 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 301-710-0267, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Prospective applicants considering the submission of a program project applications should contact the program official listed under INQUIRIES to obtain the booklet "Guidelines for NIDDK Program Project Grants." Those considering the submission of Interactive Investigator- Initiated Research Project Grants should refer to the publication "Guidelines: NIH Investigator-Initiated Interactive Research Project Grant" (NIH Guide for Grants and Contracts, Volume 24, Number 35, October 6, 1995, PA-96-001). Mail the signed, original, single-sided application, along with five exact, single-sided copies and five collated sets of appendix materials 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened 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, 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. Review Criteria 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. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. 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. Inquiries regarding programmatic issues may be directed to: M. James Scherbenske, Ph.D. Division of Kidney, Urologic and Hematologic Diseases NIDDK Natcher Building, Room 6AS.19E 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-7719 FAX: (301) 480-3510 E-mail: scherbensk@extra.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Mrs. Helen Y.S. Ling Grants Management Specialist Division of Extramural Activities NIDDK Natcher Building, Room 6AN.44F 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8857 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.XXX (insert 93.847 for DEM, 93.848 for DDN and 93.849 for KUH). 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. 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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