NephCure Kidney International-NEPTUNE Ancillary Studies Grant Program

Objectives:

NephCure Kidney International (NKI) in cooperation with the NIH-sponsored NEPTUNE Consortium announces a research grant program to support investigator-initiated studies that employ NEPTUNE resources to advance clinical and translational research in glomerular disease. The program is open to all scientists, whether a participant in the NEPTUNE Consortium or not. Proposed projects can include but are not limited to those that can be used to generate feasibility data to support advancement of promising future studies and projects to develop clinical assays, or protocols, or early phase clinical trials. NKI will provide funding of up to $150,000 direct cost per project after a competitive process to select the most meritorious project. Wherever possible, proposals should adhere to the guiding principles of the Consortium that include:

Collaboration among participants within the NEPTUNE Consortium, and between NEPTUNE and external investigators conducting pilot or ancillary studies using Consortium resources, is essential to the success of the program.
 

Integration: NKI and NEPTUNE understand—and will take advantage of—the dramatic benefits to advancing glomerular disease science inherent in employing a multi-disciplinary approach.
 

Sharing: NEPTUNE will serve as a resource to the community of scientists and lay persons interested in studying FSGS, MN, or MCD. The Consortium's ability to share its systematically collected data, biological specimens, and infrastructure for future ancillary studies is as important to advancing this field as studies conducted directly by NEPTUNE.
 

Networking: The existence and experience of maintaining a network of investigators and clinical study sites with experience in glomerular disease research will dramatically facilitate organizing and conducting future clinical studies by investigators in the public and private sectors.

Meritorious Characteristics:

Pilot project proposals will be evaluated for their compliance with the guiding principles described above. The following project characteristics will be considered meritorious if:

  1. The project utilizes the unique Consortium infrastructure, resources and materials and/or contributes by adding to these resources in a collaborative manner for the advancement of the work of others within the Consortium.
  2. The project requires and benefits from the collaboration of individuals within NEPTUNE and or members of the Consortium and external investigators.
  3. The project integrates scientific disciplines in order to advance glomerular disease research.
  4. The project shares new data, biological specimens, and/or infrastructure that may result from the project with the Consortium and its collaborating investigators.

Eligibility:

NEPTUNE participant investigators and their collaborators OR scientists presently unaffiliated with NEPTUNE.

Applicants are strongly encouraged to leverage the resources provided by NEPTUNE (infrastructure, accumulated human subjects and their associated data and materials) by bringing additional resources to conducting proposed investigations.

Funding:

Projects will be funded directly by NephCure Kidney International to the recipient institutions.

A maximum of $150,000 per project direct costs only.

No indirect costs. NephCure Kidney International has a long standing policy to support direct costs only.

Projects are funded for 12 months, beginning as early as January, 2018

A maximum of $150,000 will be awarded. The number of projects funded during will be dictated by the size of project budgets requested and awarded. NKI makes this determination at the time of review.

Application Review Process:

Pilot project applications will proceed through these general stages:

1.  NEPTUNE Ancillary Studies Committee Approval. NEPTUNE will treat these proposals in a fashion identical to any NEPTUNE ancillary study. As such, investigators should initially send NEPTUNE ancillary study proposal requests to the NEPTUNE Data Analysis and Coordinating Center (DACC) (see timeline below). These proposals will be reviewed by the DACC for feasibility and then by the NEPTUNE Ancillary studies Review Committee (ARC) for the purpose of determining whether the project is compliant with the goals of the NKI-NEPTUNE ancillary studies grant program and whether the project represents an acceptable burden to NEPTUNE subjects, its dataset, and its infrastructure. Final approval for all NEPTUNE ancillary studies resides with the Steering Committee prior to submission for external funding.

 

2.  Grant Submission to NKI. NKI is responsible for funding decisions. NKI will assemble a formal peer-review committee (with no more than two NEPTUNE investigator participants), evaluate proposals, and assign a priority score that will be used by the NKI Research Committee in reaching funding decisions. The goal of this process is to identify the most meritorious ancillary study proposals prioritized based on: a) the potential value of the project to the collective mission of NKI and NEPTUNE; b) the scientific significance and/or novelty of the proposed hypothesis; c) the feasibility of the project; and d) the impact of the project to the care of glomerular disease patients.

 

3.  Approval by NKI Research Committee

 

4.  ​Approval by Applicant’s IRB or animal use committee (funding will be provided when IRB approval is in place, or when IRB approval is granted pending funding)

 

NEPTUNE recognizes that projects will vary in the fashion in which they utilize or add to consortium resources and infrastructure.  The resources of the NEPTUNE consortium will mature and grow over time. Working with the NEPTUNE DACC, applicants should understand the scope and scale of the NEPTUNE dataset to establish study feasibility. 

Applicants may discuss project applications ideas with Dr. Larry Holzman (lholzman@upenn.edu) prior to making application, or to discuss study feasibility and impact of the proposed study on the consortium with appropriate NEPTUNE investigators and support staff. 

 

Review Timeline:

FEB 24 2017:  Deadline to submit a letter of intent /NEPTUNE Ancillary Study Concept Sheet 

APR 07 2017:  Deadline for receipt of final NEPTUNE Ancillary Study Application

JUN 30 2017:  Deadline for application to NephCure Kidney International

OCTOBER 2017:  Announcement of preliminary intent to award project

DECEMBER 2017:  Completion of Just-In-Time process (necessary IRB approval/amendment)

Notice of Award

JANUARY 2018:  Project Start Date 

Please see the NEPTUNE Ancillary Studies webpage for more information on ancillary study application process and materials.

Please see NKI website for Application Format details. 

Contact Tina Mainieri, NEPTUNE Consortium Project Manager for details: NEPTUNE-STUDY@umich.edu.  

Review Timeline:  

PLEASE NOTE: The process of submitting applications to NKI for this grant program occurs in 3 steps. No application can be submitted to NKI before approval of the NEPTUNE ancillary studies committee, which vets proposals for scientific burden to the NEPTUNE consortium, NEPTUNE subjects, and their biosamples.

FEB 24 2017:  Deadline to submit a letter of intent /NEPTUNE Ancillary Study Concept Sheet

APR 07 2017:  Deadline for receipt of final NEPTUNE Ancillary Study Application


2017 Nephcure Kidney International NEPTUNE Pilot Program RFA

Concept Sheet

NEPTUNE ancillary study process and requirements.

Applicants must follow the NEPTUNE Ancillary Study Policy and Process. Please visit this page for details.


Questions?

Please contact Tina Mainieri, NEPTUNE Consortium Project Manager for questions and details: NEPTUNE-STUDY@umich.edu