Diabetes, Digestive, and Kidney Diseases Extramural Research

(1) To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmat

To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved prevention, diagnosis, and treatment of diabetes, digestive, and kidney diseases. NIDDK programmatic areas include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. Specific programs areas of interest include: (a) For diabetes, endocrine, and metabolic diseases: Fundamental and clinical studies on etiology, pathogenesis, prevention, diagnosis, treatment and cure of diabetes mellitus and its complications; Normal and abnormal function of the pituitary, thyroid, parathyroid, adrenal, and other hormone secreting glands; Hormonal regulation of bone, adipose tissue, and liver; fundamental aspects of signal transduction, including action of hormones, coregulators, and chromatin remodeling proteins; Hormone biosynthesis, secretion, metabolism, and binding; hormonal regulation of gene expression and the role(s) of selective receptor modulators as partial agonists/antagonists of hormone action; Fundamental studies relevant to metabolic disorders including membrane structure, function, and transport phenomena and enzyme biosynthesis; basic and clinical studies on etiology, pathogenesis, prevention, and treatment of inherited metabolic disorders (e.g. cystic fibrosis). (b) For digestive disease and nutrition: Genetics and genomics of the GI tract and its diseases; Genetics and genomics of liver/pancreas and diseases; Genetics and genomics of nutrition and obesity; Bariatric surgery; Clinical nutrition and obesity research; Liver disease complications; Fatty liver disease; Genetic liver disease; HIV and liver; Cell injury, repair, fibrosis and inflammation in the liver; Liver cancer; Liver transplantation; Pediatric liver disease; Viral hepatitis and infectious diseases; Gastrointestinal and nutrition effects of AIDS; Gastrointestinal mucosal and immunology; Gastrointestinal motility; Basic neurogastroenterology; Gastrointestinal development; Gastrointestinal epithelial biology; Gastrointestinal inflammation; Digestive diseases epidemiology and data systems; Nutritional epidemiology and data systems; Autoimmune liver disease; Bile, Bilirubin and cholestasis; Bioengineering and biotechnology related to digestive diseases, liver, nutrition and obesity; Liver cell and molecular biology; Developmental biology and regeneration; Drug-induced liver disease; Gallbladder disease and biliary diseases; Exocrine pancreas biology and diseases; Gastrointestinal neuroendocrinology; Gastrointestinal transport and absorption; Nutrient metabolism; Pediatric clinical obesity; Digestive diseases clinical trials; Liver clinical trials; Obesity prevention and treatment; Obesity and eating disorders. (c) For kidney, urologic and hematologic diseases: Kidney cell biology, development, physiology, and pathophysiology studies; Genetics of kidney disorders; Immune mechanisms of kidney disease; Kidney disease as a complication of diabetes; Effects of drugs, nephrotoxins and environmental toxins on the kidney; Mechanisms of kidney injury repair; Improved diagnosis, prevention and treatment of chronic kidney disease and end-stage renal disease; Improved approaches to maintenance dialysis therapies; Basic studies of lower urinary tract cell biology, development, physiology, and pathophysiology; Clinical studies of bladder dysfunction, incontinence, pyelonephritis, interstitial cystitis, benign prostatic hyperplasia, urolithiasis, and vesicoureteral reflux; Development of novel diagnostic tools and improved therapies, including tissue engineering strategies for urologic disorders; Research on hematopoietic cell differentiation; metabolism of iron overload and deficiency; Structure, biosynthesis and genetic regulation of hemoglobin; Research on etiology, pathogenesis, and therapeutic modalities for the anemia of inflammation and chronic diseases.

Project Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both non-profit and for-profit, and individuals who propose to establish, expand, and improve research activities in health sciences and related fields. NRSAs: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Individuals must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. Nonprofit domestic organizations may apply for the Institutional NRSA. SBIR and STTR grants can be awarded only to domestic small businesses that meet the following criteria: 1) Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit; 2) Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States. 3) Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. STTR grants which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Health professionals, graduate students, health professional students, scientists, and researchers, any nonprofit or for-profit organization, company, or institution engaged in biomedical research. Project Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. NRSAs: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.

Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. NRSAs are made directly to individuals for research training in specified biomedical shortage areas, or, to institutions to enable them to make NRSAs to individuals selected by them. Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.

Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.

Research Grant and Training Program applications are reviewed initially for scientific merit by an appropriate review panel, composed of scientific authorities, and by the National Diabetes and Digestive and Kidney Diseases Advisory Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. The successful applicant is sent a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Project Grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months.

Project Grants: Renewals are determined by competitive application and review. Extensions considered upon request. Individual NRSAs: Awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html.