PAR-03-033: ENDOSCOPIC CLINICAL RESEARCH IN PANCREATIC AND BILIARY DISEASES

Department of Health
and Human Services (HHS)

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ENDOSCOPIC CLINICAL RESEARCH IN PANCREATIC AND BILIARY DISEASES RELEASE DATE: November 21, 2002 PA NUMBER: PAR-03-033 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. A replacement R03 (PAR-06-171) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: After October 1, 2005, unless reissued. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Applications receipt dates o Specific Instructions for Modular Grant Applications o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Division of Digestive Diseases and Nutrition (DDDN) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Division of Cancer Prevention of the National Cancer Institute encourage innovative clinical and epidemiological research into the role of Endoscopic Retrograde Cholangiopancreatography (ERCP) and other endoscopic and imaging techniques. Acute and chronic pancreatic and biliary diseases are common in the United States and account for considerable morbidity, mortality and health care costs. The spectrum of conditions includes those due to cancer of the exocrine and endocrine pancreas, gallstones, sludge, pancreatic and biliary malignancy, trauma, anatomic problems (pancreas divisum), alcohol and drugs and idiopathic syndromes such as idiopathic pancreatitis and sphincter of Oddi dysfunction. The recently held National Institutes of Health State- of-the-Science Conference Statement on ERCP indicated that while ERCP and other advanced endoscopic and imaging techniques have gained widespread application in clinical practice, there is little evidence based on rigorous clinical trials to guide the use of advanced diagnostic and therapeutic technologies in clinical practice decisions. 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. 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 and cancer 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 endoscopic and 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. RESEARCH OBJECTIVES Background Diseases of the gallbladder, pancreas, and liver are conditions that are frequently encountered in clinical practice. Examination of the biliary and pancreatic ducts is often required for the appropriate diagnosis and management of patients with pancreatic and hepatobiliary diseases. Over the last three decades, the dramatic improvement of flexible endoscopes has established endoscopy as the primary method to diagnose and treat many pancreatic and biliary diseases. Although ERCP first came into use about 30 years ago and has been applied to the diagnosis and management of a variety of gastrointestinal disorders, the value of ERCP relative to other means for diagnosing and treating these diseases has not been firmly established. Over the last two decades, there has been the development of new diagnostic and therapeutics tools ultrasound, standard and helical computer tomography, magnetic resonance imaging (MRI), magnetic resonance cholangiography (MRCP), endoscopic ultrasound, and intraoperative cholangiography with potential usefulness in management of pancreatic and hepatobiliary diseases. Each of these tools has variable detail and accuracy. A recent State-of-the-Science Conference on ERCP in diagnosis and therapy was held at the NIH on January 14-16, 2002 (http://consensus.nih.gov/ta/020/020sos_intro.htm) Several of the recommendations of the conference included the need to improve the quality of clinical trials for the study of pancreaticobiliary diseases as well as to evaluate ERCP and other and newer technologies in assessing pancreaticobiliary diseases. 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 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 defining the role of Endoscopic Retrograde Cholangiopancreatography (ERCP) and other advanced endoscopic interventional and imaging techniques in the prevention, diagnosis and management of pancreatic and biliary diseases. This PA will encourage clinical research in a number of areas: Comparisons of interventional endoscopic procedures vs. interventional radiological approaches vs. surgery for treatment of different complications of chronic pancreatitis. Studies of the role of endoscopic interventions for acute pancreatitis, chronic pancreatitits or its complications. Studies of the role of ERCP in sphincter of Oddi dysfunction (biliary or pancreatic sphincter) Clinical studies of early detection and diagnosis, prognostication, prevention and treatment of acute and chronic pancreatitis as well as pancreatic cancer The clinical significance, natural history, and management of microlithiasis or "biliary sludge" in the pathogenesis of pancreatitis. Clinical studies of the role of endoscopic and other advanced technologies in early diagnosis, staging or treatment of biliary or pancreatic malignancy; including but not limited to the collection of pancreatic juice for the chemical analysis, cytopathology, proteomics, and gene expression microarrays. . Other studies of pancreatic and biliary diseases that compare ERCP, diagnostic imaging or surgical approaches. Studies to enhance and evaluate training for laparoscopic common bile duct exploration (and other surgical techniques) and to improve training for advanced endoscopy. Development of endoscopic and laparoscopic simulators and other new technologies to facilitate training, maintenance and objective assessment of procedural performance. 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. This PA uses just-in-time concepts. It also uses the modular budgeting format. The total project period for an application submitted in response to this PA may not exceed two years. The budget may be submitted for direct costs up to $100,000 per year, in modules of $25,000. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Only one revision is permitted. These grants may not be renewed. Replacement of the Principal Investigator on the grant is not permitted. Applications submitted in response to this PA will compete for funds with all other R03 and regular research project grant (R01) applications. The award of grants in response to this PA 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 individuals listed under scientific/research INQUIRIES. ELIGIBLE INSTITUTIONS Foreign Institutions are not eligible to submit applications in response to this PA. You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. This PA for 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Frank Hamilton M.D., M.P.H. Gastrointestinal Motility Program Director Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 669 Bethesda, MD 20817-5450 Phone: 301-594-8877 FAX: 301-480-8300 Email: fh14e@nih.gov Jose Serrano M.D., Ph.D. Liver and Biliary Diseases Program Director Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 657 BETHESDA MD 20892-5450 Phone: 301 594-8871 FAX: 301 480-8300 EMAIL: js362q@nih.gov William F. Anderson, MD MPH GI and Other Cancers Research Group National Cancer Institute, Division of Cancer Prevention EPN 2144 6130 Executive Blvd Bethesda, MD 20892-7317 Phone: 301-594-7672 FAX: 301 435-6344 EMAIL: wa31i@nih.gov o Direct your questions about peer review issues to: Francisco Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 Phone: 301-594-8897 FAX: 301-480-3505 Email: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Ms. Donna Huggins Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 711 Bethesda, MD 20892-5456 Pone: 301-594-8848 FAX: 301-480-3504 Email: dh48v@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS Instructions outlined in the PHS 398 application kit are to be followed, with the modifications noted below. o The title, "Endoscopic Clinical Research in Pancreatic and Biliary Diseases (R03)" and number of this PA must be typed on line two of the face page and the YES box must be marked. o 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. 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. o Publications may not be submitted, but color/glossy photographs and other appendix material (surveys, questionnaires, etc.) is permitted. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three 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, two additional copies of the application must be submitted to: Francisco Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 752 Bethesda, MD 20892-5452 Phone: 301-594-8897 FAX: 301-480-3505 Email: fc15y@nih.gov APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened by the NIDDK. in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection 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 o Receive a second level review by the appropriate National Institutes of Health Advisory Council or Board. 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Note: The R03 mechanism does not require that preliminary data be submitted. (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.848 and 93.395 (NCI) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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