NephCure Kidney International announces a research grant program to support investigator-initiated studies that employ CureGN resources to advance clinical and translational research in glomerular disease. The program is open to all scientists, including those within and outside of the CureGN Consortium. Proposed projects are limited to those that can be used to generate feasibility data to support additional research aimed toward advancing diagnosis, treatment or cure of human glomerular disease. NephCure will provide funding of up to $50,000 direct cost per project after a competitive process to select the TWO most meritorious projects.
Pilot project proposals will be evaluated for their compliance with the guiding principles described above. The following project characteristics will be considered meritorious if:
- The project utilizes the unique CureGN clinical data, biomaterials, infrastructure, resources and/or contributes by adding to these resources in a collaborative manner for the advancement of the work of others within the Consortium.
- The project requires and benefits from the collaboration of individuals within CureGN and/or members of the Consortium and external investigators.
- The project integrates scientific disciplines in order to advance glomerular disease research.
- The project shares new data, biological specimens, and/or infrastructure that may result from the project with the Consortium and its collaborating investigators.
CureGN participant investigators and their collaborators OR scientists presently unaffiliated with CureGN.
Applicants are required to leverage the resources provided by CureGN (infrastructure, accumulated human subjects and their associated data and materials) by bringing additional resources to conducting proposed investigations.
NephCure maintains pilot project grant programs that require the use of either CureGN or NEPTUNE consortium resources. In any one calendar year, applicants can apply for funding to either program but cannot apply to both programs simultaneously.
- Projects will be funded directly by NephCure Kidney International to the recipient institutions.
- A maximum of $50,000 per project direct costs only.
- No indirect costs allowed. NephCure Kidney International has a long-standing policy to support direct costs only.
- Projects are funded for 12 months, with a start date no earlier than January 2020.
The process of submitting applications to NephCure for this grant program occurs in 3 steps. No application can be submitted to NephCure before approval of the CureGN Ancillary studies Review Committee, which vets proposals for burden to the CureGN Consortium, CureGN subjects, and their biosamples.
- CureGN Ancillary Studies Committee Approval
This grant program is seen by CureGN as a program to fund CureGN pilot ancillary studies. CureGN will treat ancillary study proposal review for this grant program in a fashion identical to review of any CureGN ancillary study. As such, investigators should initially send CureGN ancillary study proposal requests to the CureGN Data Coordinating Center (DCC) (see timeline below). These proposals will be reviewed by the DCC for feasibility and then by the CureGN Ancillary Studies Committee to determine whether the project is compliant with the goals of the NephCure-CureGN ancillary studies grant program and to determine whether the project represents an acceptable burden to CureGN subjects, its dataset, and its infrastructure. Final approval for all CureGN ancillary studies resides with the CureGN Steering Committee prior to submission for review by NephCure.
- Grant Submission to NephCure
NephCure is responsible for funding decisions. NephCure will assemble a formal peer-review committee (with no more than two CureGN investigator participants), evaluate proposals, and assign a priority score that will be used by the NephCure Research Committee in reaching funding decisions. The goal of this process is to identify the most meritorious ancillary study proposals prioritized based on the:
- Potential value of the project to the collective mission of NephCure and CureGN;
- Scientific significance and/or novelty of the proposed hypothesis;
- Feasibility of the project;
- Impact of the project to the care of glomerular disease patients.
- Approval by Applicant’s IRB — funding will be provided when IRB approval is in place, or when IRB approval is granted pending funding.
- CureGN recognizes that projects will vary in the fashion in which they utilize or add to consortium resources and infrastructure. The resources of the CureGN consortium will mature and grow over time. Working with the CureGN DCC, applicants should understand the scope and scale of the CureGN dataset to establish study feasibility.
- Applicants are encouraged to discuss study feasibility and impact of the proposed study on the consortium with CureGN investigators or support staff. Applicants may discuss project application process with the CureGN Ancillary Program at CureGN-ASC@ArborResearch.org prior to making application.
Review Time Line
- Deadline for submission of Letter of Intent to apply: Wed., Feb. 21, 2019. Please contact the CureGN Ancillary Program at CureGN-ASC@ArborResearch.org as soon as possible for details, and please see Ancillary Study Application information on CureGN website: CureGN.org. We strongly recommend commencing this discussion as soon as possible.
- Deadline for Letter of Intent/Concept Sheet: Wednesday, Feb. 21, 2019
- Deadline for receipt of final CureGN Ancillary Study Application: March 25, 2019
- Deadline for application to NephCure Kidney International: June 21, 2019, 8 PM Eastern Time (no exceptions)
- Announcement of preliminary intent to award project: October, 2019
- Completion of Just-In-Time process (necessary IRB approval/amendment): December, 2019
- Project Start Date: January, 2020
Except where noted, applicants should use the NIH Form 398 application form and complete all items on indicated forms following 398 form instructions. (http://grants1.nih.gov/grants/funding/phs398/phs398.html)
Please use the following checklist:
|____||Face Page (signature from institutional representative required)|
|____||Abstract (398 Form Page 2)|
|____||Budget (398 Form Page 4—a modular budget should not be used)
Include description of how additional resources obtained outside the NephCure-CureGN grant, if any, will be used to leverage CureGN support (if appropriate, attach support documentation)
|____||Biographical Sketch – PI and key personnel (398 Format; please employ newly revised NIH format)|
|____||Resources (398 Format)|
Research Plan – The following format should be employed:
|____||Background and Significance|
|____||Preliminary Data, if any|
§ Include description of how resources of CureGN will be leveraged in completing the proposed studies
§ Include a discussion of how the project or the data generated might be employed/shared by other consortium investigators or how the consortium or its participating investigators might benefit from this project
§ Include description of how this “pilot” project will be parlayed into a complete project
§ If an interventional trial is being proposed, the application should discuss how the proposed trial will be integrated into the existing observational protocol
§ Include timeline
§ Include Literature Cited
§ Include one paragraph summary describing how the research design employs the “meritorious characteristics” described above
§ Page limit: 5 pages for entire Research Plan. This page limit includes figures and tables. Literature Cited is not included in these limits.
Follow Form 398 instructions for human studies (provide evidence of IRB approval as necessary; may be provided just prior to issuance of notice of award)
|____||Letters of Support:
§ From co-investigators
§ Committing to additional support (institutional or other), if any
|____||Study protocol may be included with initial application or may be provided after announcement of intent to fund and before vetting by the Ancillary Studies Committee and IRB|
|____||No other appendix of any type permitted|
Terms of Support
- Funds (direct costs only) are provided to investigator’s institution for use by the applicant; it is the applicant institution’s obligation to ensure proper use of funds and timely submission of progress reports.
- Disbursal of grant funds will be made in quarter-annual payments at the end of each fiscal quarter. Final payments will be made only after receipt of a final progress report that is due no later than 30 days following the last day of the project. NephCure does not support no-cost extensions.
- Principal investigators must comply with human institutional review board requirements and demonstrate current approval of these committees.
- Reporting requirements: Principal investigators must provide an annual report due no later than 30 days after the grant termination date describing progress made during the previous year. Failure to provide this report in a timely manner may result in reduction in payment.
- It is expected that results obtained will be shared with the consortium in a manner consistent with the ancillary studies policy of CureGN.
- It is expected that publications will be submitted in compliance with the publications policies of CureGN.
- NephCure and NIH support of CureGN ancillary studies will be acknowledged by grantees in publications, presentations, abstracts and other relevant press releases and on associated websites.
- CureGN and its associated investigators do not discriminate based on race, gender, religious, or ethnic group; applicants should assure compliance with this policy in designing and executing their studies.