on or before May 1, 2003
on or before July 1, 2003
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, Urology and Hematology (KUH) Division of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces the availability of funds in FY2003 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 (KDCSI) Initiative, is intended to support activities such as data analysis, protocol development, and formation of consortia necessary to plan clinical studies. The KDCSI Steering Committee has been established to provide expert advice to KUH on the implementation of this initiative. The roster of the KDCSI Steering committee can be viewed at KDCSI Steering Committee roster (pdf - 91kb).
The scope of this KDCSI 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 KDCSI is to foster the development of high quality research on the prevention, treatment, and clinical management of kidney disease. Another goal of this Initiative is to foster public-private partnerships in renal research
Eligibility Requirements and Other Administrative Aspects:
The funds provided for each Concept Development Administrative Supplement will not exceed the maximum of $50,000 direct costs. The period of support will be limited to one year. Eligible projects for these Supplements will be limited to studies performed in collaboration with a currently funded NIDDK/KUH Division grantee. As a consequence, proposals need to be within the overall scope of a funded NIDDK parent award. The funded grants should have at least one year of remaining funding at the time of the award of the supplemental funds.
We are inviting applications from investigators who wish to propose projects within the scope of their current funding. Investigators who are not the PI of an NIDDK grant may also submit supplement applications, if they have identified an eligible collaborator. Individuals who wish to propose projects that do not fall within the scope of their own current funding or who do not currently 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 funded collaborator to serve as Principal Investigator on their project.
For administrative purposes, the Principal Investigator (PI) of each Concept Development Supplement must be the PI of a currently active KUH- NIDDK grant with appropriate scope of work. Investigators who are not the PI of an NIDDK grant may also submit supplement applications, if they have identified an eligible collaborator. In this case, the interested investigator ("Lead Investigator") will serve as a co-investigator and the PI of the collaborating NIDDK funded grant will serve as the PI of the Concept Development Administrative Supplement. For this arrangement, there must be evidence that the work proposed by the Lead Investigator will be performed in collaboration with the NIDDK grant supported investigator.
Eligibility is limited to individuals with the skills, knowledge, resources, and institutional environment necessary to carry out the proposed research. In addition, eligibility is limited to projects where there is a NIDDK/KUH Division-funded investigator who is willing to collaborate and whose funded grant has an appropriate scope of work.
Submission of requests for administrative supplemental funds:
The Concept Development Administrative Supplement request should be prepared using the face page of PHS 398 as the first page. For administrative purposes, the Principal Investigator of an NIDDK-funded parent proposal needs to be the PI on the supplement request, with the Lead Investigator on the Concept Development Supplement serving as co-investigator. Any individual may be the lead investigator on no more than one Concept Development Supplement per submission cycle.
In addition to the face page (PHS 398) and NIH biosketches of the Key Personnel, four additional text pages are allowed. Other supplemental material is not permitted.
The proposal text should include the following elements:
A) Project Title
B) List of investigators
C)A description of the proposed study with study hypotheses and pertinent references from the literature
D)A description of the funding needs for concept development. Although detailed budgets are not requested, the proposals should provide estimates of the personnel effort needed for concept development. KUH anticipates that a typical project might provide support of 5-10 % effort for initiating investigators and a biostatistician and as much as 20 % time for programmers or other support staff. Travel for meeting of collaborating investigators may also be supported.
The proposal should not include a detailed budget. The budgets will be modular, with increments of $25,000 direct costs, with the maximum of $50,000. When the "Lead Investigator" is not a member of the institution where the Principal Investigator is located, a consortium agreement will need to be entered into. In such cases, the facilities and administrative (F&A) costs for the consortium institution must be displayed as a direct cost to the primary grantee. Accordingly, the award may exceed the $50,000 limit by the F&A cost amount to be awarded to the consortium grantee. In all cases where consortia agreements are anticipated, the applicants should consult with KUH program staff for guidance in development of the budget request. The first receipt date will be May 1, 2003, and the second will be July 1, 2003. The proposal and 15 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 to determine completeness of the proposal and eligibility. Projects will then undergo administrative review to verify the relevance of the project to the overall goals of the Kidney Disease Clinical Studies Initiative . In addition, the following specific criteria will be applied:
1) Practicability: Is the proposed work achievable within the time and effort constraints? Will the Concept Development Supplement allow clear assessment of the overall study feasibility or design of an appropriate feasibility study?
2) Value of Concept Development Supplementary funds. : Is there a need for Concept Development funds to develop the ideas for the proposed project?