Receipt dates:
On or before April 1, 2004
On or before July 15, 2004
This document provides the following information regarding the Concept Development Administrative Supplements for the Kidney Disease Clinical Studies Initiative:
- Purpose and background
- Eligibility requirements and other administrative aspects
- Procedures for submission of supplement requests
- Evaluation criteria
Purpose and Background:
The Kidney, Urologic and Hematologic (KUH) Division of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces the availability of funds in FY2004 to provide Concept Development Administrative Supplements to on-going research projects for clinical studies in kidney disease. This effort, part of the Kidney Clinical Studies Initiative (KCSI), is intended to support activities such as data analysis, protocol development, and formation of consortia necessary to plan clinical studies. The KCSI Steering Committee has been established to provide expert advice to KUH on the implementation of this initiative. The roster of the KCSI Steering committee can be viewed at www.niddk.nih.gov/fund/divisions/KUH/kdcsi
The scope of this KCSI includes clinical trials, both single site and multi-center, epidemiological studies, ancillary studies to on-going or completed clinical trials, and meta-analyses of existing study data bases.
A major goal of the KCSI is to foster the generation of data to serve as the bases of investigator-initiated grant applications that will then undergo competitive peer review. Another goal of this Initiative is to foster public-private partnerships in renal research. It is anticipated that subsequent grant applications fostered by this KCSI will likely be relevant to the research scope described in the following two program announcements from the KUH Division of NIDDK:
PAR-03-105: Research Grants for Clinical Studies in Kidney Disease http://grants.nih.gov/grants/guide/pa-files/PAR-03-105.html
PA-03-091: Ancillary Studies of Kidney Disease Accessing Clinical Trials, Epidemiological Studies and Public Access Databases http://grants.nih.gov/grants/guide/pa-files/PA-03-091.html
Eligibility Requirements and Other Administrative Aspects:
Eligibility is limited to individuals with the skills, knowledge, resources, and an institutional environment necessary to carry out the proposed research. Eligible projects for these Supplements will be limited to studies performed in collaboration with a currently funded NIDDK/KUH Division grant. As a consequence, proposals need to be within the overall scope of a funded NIDDK/KUH grant. The funded grants should have at least one year of funding remaining at the time of the award of the supplemental funds. The funds provided for each Concept Development Supplement will not exceed the maximum of $50,000 direct costs. The period of support will be limited to one year.
Two categories of investigators have been defined for administrative purposes: 1) Investigators with currently funded NIDDK/KUH grants may submit a Concept Development Supplement application that is within the scope of their funded project, and 2) Investigators who are not the Principal Investigator (PI) of a NIDDK/KUH grant may also submit a supplement application if they have identified an eligible NIDDK/KUH supported collaborator. Investigators who do not have NIDDK/KUH funding should contact one of the KUH Program Officers (pdf-73kb) to discuss their ideas and for assistance in identification, if possible, of an appropriate NIDDK/KUH funded collaborator. Individuals who wish to propose projects that do not fall within the scope of their own currently funded NIDDK/KUH grant should contact Dr. Thomas Hostetter (hostettert@extra.niddk.nih.gov) or Dr. Catherine Meyers (meyersc@extra.niddk.nih.gov) for assistance.
As stated above, the Principal Investigator (PI) of each Concept Development Supplement must be the PI of a currently active NIDDK/KUH grant. In the case where a Researcher is not the PI of a NIDDK/KUH funded grant, but who has identified an eligible funded NIDDK Investigator, the NIDDK funded Investigator will serve as the Principal Investigator of the Concept Development Supplement and the non-NIDDK funded Researcher will serve as the Collaborating-Investigator of the Concept Development Supplement. In this latter arrangement, there must be evidence that the work proposed will be performed in collaboration with the NIDDK grant supported investigator.
Submission of requests for administrative supplemental funds:
The Concept Development Supplement application should be no more than four (4) pages in total length, with the face page of PHS 398 as the first page. The application should include the following:
- The Concept Development Project Title, and the Title of the funded NIDDK parent grant
- A List of Investigators
- A description of the proposed study with the study hypotheses and pertinent references from the literature
- A proposal outlining how the concept development funds are to be used, and why they are needed to develop the proposal. The proposal should include estimates of personnel needs. The NIH biosketch of Key personnel may be appended in addition to the four pages. Other supplemental material is discouraged.
The proposal should not contain a detailed budget. The awards will be modular, with either one or two $25,000 direct cost modules. However, the proposals should provide estimates of the personnel effort needed for concept development. KUH anticipates that typical project might provide support of 5-10 % effort for initiating investigators and a biostatistician, and as much as 20 % for programmers or other support staff. Travel for meeting of collaborating investigators may also be supported.
The first receipt date will be April 1, 2004, and the second will be July 15, 2004. The proposal and 5 copies should be sent to the address below:
Dr. Thomas Hostetter
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 645
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Evaluation Criteria:
Concept Development Administrative Supplements will undergo administrative review by KUH staff and the KCSI Steering Committee. A major goal of this initiative is to promote the development of high quality investigator-initiated grant proposals that will undergo subsequent successful competitive peer review. Concept Development Projects will, therefore, be evaluated with the review criteria used in the NIH peer review process for R01 grant applications: Significance, Approach, Innovation, Investigator, and Environment. These criteria are described at: http://www.csr.nih.gov/guidelines/R01.htm
In addition the following specific criteria will be applied:
- Feasibility: Is the proposed study feasible? If feasibility is not easily established, will the Concept Development Supplement allow clear assessment of the study feasibility or design of an appropriate feasibility study?
- Value of Concept Development Supplementary Funds: Is there a need for Concept Development funds to develop the ideas for the proposed project?
INQUIRIES
Investigators who are interested in applying for a supplement request are encouraged to contact:
Thomas Hostetter, M.D.
Senior Scientific Advisor, National Kidney Disease Education Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 645
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Phone: (301) 594-8864
Fax: (301) 480-3510
Or
Catherine M. Meyers, M.D.
Director, Inflammatory Renal Diseases Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza., Room 641
6707 Democracy Boulevard
Bethesda, MD 20892
Phone: (301) 451-4901
Fax: (301) 480-3510
