and Human Services (HHS)
EXPIRED
SMALL CLINICAL RESEARCH GRANTS IN DIGESTIVE DISEASES AND NUTRITION Release Date: February 22, 2001 PA NUMBER: PAR-01-056 (see replacement PAR-04-082) National Institute of Diabetes and Digestive and Kidney Diseases THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PAR. This Program Announcement replaces Program Announcement, PAR-98-071 (Small Grants In Digestive and Nutritional Disorders), which was published in the NIH Guide May 15, 1998. PURPOSE The Division of Digestive Diseases and Nutrition (DDDN) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages applications using the small grant (R03) mechanism in an attempt to encourage innovative clinical and epidemiological research into new therapies or means of prevention of digestive diseases and nutritional disorders. The DDDN began using the R03 mechanism in 1995 to support short-term clinical studies and help stimulate the translation of promising and potentially relevant new developments from the laboratory into the clinical setting. The current program announcement (PA) supersedes and expands upon the PAR-98-071, which was published in the NIH Guide, May 15, 1998. This PAR specifically encourages the submission of applications for pilot studies leading to full- scale clinical trials and epidemiological studies relating to digestive diseases and nutritional disorders. These R03 projects should focus on research that is particularly innovative and/or potentially of high impact. High impact research involves feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks an historical precedent or sufficient preliminary data, but whose successful outcome would have a major effect on a scientific area. The small grants (R03) may be used as planning grants for full-scale multi- center clinical trials or for pilot studies that could lead to full-scale multi-center clinical trials designed to provide evidence for or against changes in the current standard of care. Such trials may use pharmacological, dietary, surgical, or behavioral interventions given for disease therapy or prevention. Pilot epidemiological studies are encouraged that could lead to more extended research that would provide evidence for or against changes in health policy, especially as related to disease prevention. It is expected that these R03 grants will serve as a basis for planning future multi-center research project grant applications (R01) or cooperative agreement (U01) awards. New and experienced investigators in relevant fields and disciplines may apply for these small grants. Investigators are encouraged to take advantage of recent laboratory developments. In addition, the small grant is a good mechanism for new and experienced investigators to become better equipped to perform clinical and epidemiological research. Areas of special interest in this PAR include but are not limited to: inflammatory bowel disease in children and adults, motility disorders of children, celiac disease, functional bowel disease, non-ulcer dyspepsia, Barrett’s esophagus, peptic ulcer disease caused by nonsteroidal anti- inflammatory agents, endoscopic management of biliary disorders, acute and chronic diverticulitis, acute and chronic pancreatitis including hereditary pancreatitis, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, Wilson’s disease, biliary atresia, neonatal hepatitis, chronic hepatitis B and C, hepatotoxicity, prevention and treatment of complications of liver transplantation, living donor liver transplantation, small bowel transplantation, nutritional support of patients with intestinal failure, surgical therapy of obesity, binge eating disorders, anorexia nervosa and bulimia. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," in a PHS-led national activity for setting priority areas. This Program Announcement (PA), Small Clinical Research Grants in Digestive Diseases and Nutrition (R03), is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applications may be from a single institution or several institutions (collaborating institutions or consortia), if appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. This NIDDK small grant support is for new projects only, competing continuation applications will not be accepted. Submission of an application under this PAR precludes concurrent submission of any other Public Health Service application containing substantially the same research proposal. In addition, these R03 awards may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Public Health Service. To be eligible for this award, the proposed Principal Investigator must be an independent researcher. New investigators are eligible, but they must be independent of a mentor and have strong institutional support. Small grant support may not be requested for thesis or dissertation research. Investigators who have questions about eligibility should contact one of the officials listed under INQUIRIES. MECHANISM OF SUPPORT This PA will use the NIH small grant (R03) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PAR may not exceed two years. The budget may be submitted for direct costs up to four modules of $25,000 each ($100,000 direct costs per year). These grants may not be renewed. Facilities and Administrative (F & A) costs will be awarded based on the negotiated rate at the time of each award. Replacement of the Principal Investigator on this award is not permitted. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applications submitted in response to this PAR will compete for funds with all other R03 and regular research project grant (R01) applications assigned to NIDDK. The award of grants in response to this PAR is also contingent upon the availability of funds. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the 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. Applicants are encouraged to collaborate with the Directors of the Silvio O. Conte Digestive Diseases Centers, Clinical Nutrition Research Centers, and Obesity/Nutrition Research Centers for consultation in experimental design, intervention, and methodology, as well as usage of core facilities appropriate for carrying out their projects. Information describing the centers and their cores can be requested from the person listed in INQUIRIES. RESEARCH OBJECTIVES Background This PAR supersedes PAR-98-071 published in 1998. The major changes in this PAR are an increase in the maximum direct costs available from $50,000 to $100,000 and a refocus on different priority areas for clinical research in digestive diseases and nutrition. The goal of this small grants program is to provide flexibility for initiating preliminary, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage experienced investigators as well as new investigators to pursue new approaches, underdeveloped topics, or more risky avenues of research. If successful, these awards should lead to significant scientific advances in digestive disease and nutrition research. New areas of special interest in this PAR are motility disorders and liver diseases of children, chronic hepatitis B and C, surgical therapy of digestive and nutritional disorders, and endoscopic research. A major focus of this PAR is on diseases that ordinarily have little research support because they are rare, or difficult to manage, or are not the focus of pharmacological therapy. There are several rare digestive diseases that may, nevertheless, have lasting and major consequences for the patients who have these conditions. These conditions are particularly challenging when they occur in children and have life-long consequences. These diseases are often too rare to be adequately investigated by a single individual or at a single medical research institution. For these reasons, applications for study of these conditions might be best performed by a consortium of investigators that come together with a common protocol to focus on natural history and clinical investigation rather than a specific therapeutic intervention. Examples of these rare digestive and liver diseases that are of particular focus in this PAR include gastrointestinal motility disorders of children, biliary atresia and neonatal hepatitis, Wilson’s disease, sclerosing cholangitis in children, and familial pancreatitis. Many digestive diseases and nutritional disorders are diagnosed, monitored or treated using endoscopic or surgical techniques. These techniques are often the consequence of years of study and development by a talented and innovative investigator or group of investigators. Once the final technique is developed and reported in the medical literature, however, there is often little independent analysis of its efficacy and risk-benefit ratio. Thus, endoscopic management of gastrointestinal bleeding, Barrett’s esophagus, retained biliary stones, pancreatitis and colonic ectasia may be widely practiced but have not been subjected to careful, large-scale, prospective randomized controlled trials. Among surgical procedures in digestive and nutritional disorders, there is also often little controlled evidence for efficacy and safety. Thus, small bowel transplantation, the use of living donor liver transplantation, the surgical therapy of obesity are a few areas in which surgical techniques have been introduced and widely used without controlled observations on the efficacy and relative safety of these approaches. This PAR is meant to provide a means for investigators to develop prospective randomized controlled trials of endoscopic and surgical therapies. Also included as areas of special focus of this PAR are chronic hepatitis B and C. These two diseases are major causes of morbidity and mortality from liver disease in the United States. Current estimates suggest that chronic hepatitis B affects 1 million and hepatitis C approximately 2.5 million Americans. Hepatitis C accounts for at least 30% of liver transplants done in the United States, while hepatitis B and its complications account for 5- 10% of transplants. While there are many industry sponsored studies of new and innovative therapies of these diseases, many important approaches to the management, prevention and treatment of chronic hepatitis B and C are outside of the usual interest of industry-sponsors of clinical trials. Thus, use of cytokines, innovative combination therapies, iron depletion, and complementary and alternative medical (CAM) treatments of hepatitis B and C might be the focus of a small grant application. In addition, approaches to management and therapy of hepatitis B and C in special populations might be the focus of a small grant application, such populations might include children, patients with hemophilia, patients with renal failure, solid-organ transplant patients, patients with human immunodeficiency virus co-infection, injection drug users, patients with continuing problems with alcohol or substance abuse, and patients with significant psychiatric disease, such as schizophrenia and bipolar disorders. Other areas of importance in digestive disease research that would be appropriate for R03 applications are the hepatic and gastrointestinal adverse effects of medication use. As an increasing number of the U.S. population is exposed to a greater number of pharmacological agents, hepatotoxicity and gastrointestinal toxicity have become increasingly more common causes of digestive disease morbidity and mortality. It is difficult to study mechanisms of hepatic and gastrointestinal toxicity, as these adverse events are uncommon, unexpected and sporadic. Of particular interest in this area would be the establishment of prospective epidemiological databases on hepatotoxicity or gastrointestinal toxicity with careful collection of clinical information, outcome and laboratory tests, as well as, creation of serum and tissue banks to aide in studies of the mechanisms and genetics of adverse reactions to medications. The NIDDK is currently sponsoring several large, multi-center studies of specific digestive diseases and nutritional disorders. These studies include prospective studies in chronic hepatitis B and C, liver transplantation, acute liver failure, primary biliary cirrhosis, non-alcoholic steatohepatitis, functional bowel disease, helicobacter pylori associated peptic ulcer disease, portal hypertension, ascites, bleeding esophageal varices, gastrointestinal endoscopy, and both behavioral and pharmacological therapy of obesity. Small grant applications for clinical studies that overlap with ongoing studies sponsored by NIDDK may be denied funding because of overlap. Persons interested in applying for an R03 grant under this PAR are encouraged to contact NIDDK (as outlined below under INQUIRES) and discuss the planned application. 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 are 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). A complete copy of the updated Guidelines is available at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. The PHS 398 grant application form (rev. 4/98) is to be used to submit the R03 grant at the standard application deadlines indicated in the application kit. The form may be downloaded from the NIH web site at: http://grants.nih.gov/grants/forms.htm. Application kits are also 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 301/710-0267, email: [email protected]. BUDGET INSTRUCTIONS R03 Modular Grant applications will request Direct Costs in $25,000 modules, up to a Total Direct Cost request of $100,000 per year, with the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE - The title, Small Clinical Research Grants in Digestive Diseases and Nutrition (R03)" and number of this PAR must be typed on line two of the face page and the YES box must be marked. Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) Costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative Page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the Total Direct Costs requested for each year. This is not a Form Page. o Personnel - List all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct plus F&A Costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o OTHER SUPPORT -- Do not complete this section. It is not required and will not be accepted with the application. o RESEARCH PLAN -- Items a - d of the Research Plan [Specific Aims, Background and Significance, Preliminary Studies (not required), and Research Design and Methods] may not exceed a total of ten pages. Detailed descriptions of protocols for the proposed involvement of human subjects and/or vertebrate animals, literature cited, consortium/contractual arrangements and consultant letters are not included in the ten-page limit. Describe the particularly innovative/high impact aspects of the proposed study in an introductory paragraph at the beginning of the research plan. Include a description of how the outcome of this project would provide a foundation for important new research in digestive diseases and nutritional disorders. Label this paragraph, "Justification as Innovative/High Impact Research." The significance of this section is to demonstrate the following as briefly as possible. o Professional credentials of the organizers indicating experience in such areas as: o The problem under study o Clinical trial administration o Methodology o Adequate and similar participant recruitment o Methods for monitoring safety and efficacy of research o The proposed procedures. o Professional credentials of the participating center investigators in the clinical problem and in clinical trial participation. Verification of the cooperating investigators and their institutions will be required later if considered for funding. For revised applications, an Introduction (not to exceed one page) in addition to the Research Plan is required. This Introduction should respond to the comments and concerns of the initial review group delineated in the summary statement. o APPENDIX -- Appendix material will be limited to color/glossy figures, tables and manual of procedures or data collection forms. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A Costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW 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, one additional copy of the application must be sent to: Francisco Calvo, Ph.D. Chief, Review Branch NIDDK 6707 Democracy Blvd Room 655, MSC 5452 Bethesda, MD 20892 (For FedEx and UPS: use 20817) Telephone: 301-594-8897 Fax: 301-480-3505 [email protected] REVIEW CONSIDERATIONS Applications will be reviewed by the Center for Scientific Review (CSR) for completeness. NIDDK staff will carry out an administrative review of all submissions. Applications that lack the introductory justification, are incomplete, do not conform to the required format, or exceed the ten-page limit will not be reviewed and will be returned to the investigator. Applications will be evaluated for scientific and technical merit in accordance with the standard NIH procedures by an appropriate scientific review group convened by the NIDDK. 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 and assigned a priority score. All applications also receive a second level review by the National Diabetes, Digestive and Kidney Disease 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 comments reviewers will be asked to discuss the following aspects of the application 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 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 major scientific impact and thus deserve a high priority score. (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? Will a successful outcome from this pilot study lead directly to more extensive studies that would likely advance the digestive disease research? (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? Will the project generate a new body of data that provides a foundation for important new research directions? (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)? Is the Principal Investigator an independent researcher? (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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional considerations pertinent to the review of these NIDDK Small Research Grants (R03) applications: o Because the research plan is limited to ten pages, these R03 small grant applications may not have the same level of detail or extensive discussion normally found in a regular R01 research project grant application. Review emphasis will be placed on the conceptual framework and general approach to the problem, with less emphasis on methodological details. o Since pilot/feasibility studies may not include preliminary data, the review will focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to additional studies that could potentially be funded as a regular research project grant (R01). AWARD CRITERIA Applications will compete for available funds with all other recommended applications. 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. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Patricia Robuck, Ph.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, 6707 Democracy Blvd., Room 675 Bethesda, MD 20817 Telephone: (301) 594-8879 Email: [email protected] Direct inquiries regarding specific epidemiological 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 2 Democracy Plaza, 6707 Democracy Blvd., Room 673 Bethesda, MD 20817 Telephone: (301) 594-8878 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Sharon Bourque Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 612 6707 Democracy Blvd. Bethesda, MD 20817 Telephone: (301) 594-8860 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.867. 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, a 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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