RFA-DK-19-010: Polycystic Kidney Disease (PKD) Research and Translation Core Centers (U54 Clinical Trial Not Allowed)

Slots:                                                     1

Internal Deadline:                           Contact the Office of Research if interested.

LOI:                                                        October 21, 2019

External Deadline:                          November 21, 2019

Award Information:                        Type: Cooperative Agreement

Estimated Number of Awards: 4

Anticipated Amount: $600,000 in direct costs per year for up to 5 years

Cost Sharing:                                     N/A

Submission Process:                     PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants

Materials to submit:

• Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
• CV – (5 pages maximum)

Link to Award:                                  https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-19-010.html

Who May Serve as PI:                   

The RTCC (Research and Translation Core Center) Director must be an established investigator with demonstrated research accomplishments in PKD and who can provide effective administrative and scientific leadership. RTCC Director should demonstrate prior success in obtaining external funding. The RTCC Director is expected to work closely with the CCS, other RTCCs and the NIDDK, including through participation on the PKD Research Consortium Steering Committee, regular teleconference calls and at relevant meetings and workshops supporting the PKD Research Consortium goals. One or more Associate Directors may be named. The RTCC Director will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:

• Maintaining the RTCC’s vision and ensuring the relevance of the RTCC’s goals to NIDDK mission interests in PKD.
• Oversight of the Administrative Core and the Biomedical Research Cores.
• Ensuring productivity, internal communication and cooperation among RTCC investigators, including performance of all personnel.
• Ensuring equitable access to RTCC resources across the PKD Research Consortium and the wider research community
• Communicating with the larger PKD Research Consortium, NIDDK Program Staff and the outside research community.

Purpose:

This Funding Opportunity Announcement (FOA) requests applications for Polycystic Kidney Disease (PKD) Research and Translation Core Centers (RTCC). The RTCCs are expected to work collaboratively with the Central Coordinating Site (CCS) as part of a PKD Research Consortium and serve as a national resource for the larger research community. The RTCCs should develop and share research resources (e.g. reagents, tools etc.), services and expertise that would be difficult or impractical to support in individual labs.

The goal of the PKD Research Consortium is to create a framework for collaboration that develops and broadly shares research resources, core services and expertise to support innovation in research related to PKD. The RTCCs will develop and share research resources (e.g. data, samples, tissues, reagents, technologies, tools, software, animal models, etc.), core services (e.g. genotyping) and expertise that would be difficult or impractical to support in individual labs. All activities within the PKD Research Consortium are expected to address the overall goal of improving our understanding of the pathogenesis, progression, prevention and clinical management of PKD through enhanced sharing of research resources, core services and expertise to ensure the establishment of a robust research community. The RTCCs will be awarded to institutions with a strong track record of funded research in PKD that demonstrate a plan to engage new and established investigators including those from outside the traditional areas of PKD research. An RTCC may be located at a single institution or may span multiple institutions with complementary research bases. All RTCCs are expected to work collaboratively with other RTCCs within the PKD Research Consortium, the Central Coordinating Site and NIDDK program staff to achieve the goals of the program. It is expected that all resources developed by the RTCCS will be made available as soon as quality control procedures have been completed at the local institution and be rapidly shared with the broader research community. RTCCs which include a Clinical/Translational Biomedical Research Core will work with other sites in the PKD Research Consortium to devise a unified approach to PKD patient evaluation, novel phenotyping, data collection, and data and image sharing to make the best use of participants.

Project Organization: The PKD Research Consortium will consist of up to four RTCCs and a Central Coordinating Site (CCS). Individual RTCCs, directed by the RTCC Director must include an Administrative core and at least two Biomedical Research Cores. An RTCC must be an identifiable organizational unit within a university or a defined consortium of cooperating institutions. The CCS will coordinate communications between the PKD Research Consortium and the greater research community, organize and facilitate the education and outreach activities of the Consortium and support and administer the Pilot and Feasibility Program. Applications for CCS are solicited through a separate, companion FOA (RFA-DK-19-011). Investigators with appropriate expertise may apply to both RFA-DK-19-010 and RFA-DK-19-011.   Potential applicants are encouraged to contact the Program Official named in Section VII to discuss their potential applications.

The coordinated efforts of the RTCCs and the CCS will be overseen by PKD Research Consortium Steering Committee composed of RTCC Directors, the CCS Director, and NIDDK program staff. The PKD Research Consortium will meet at minimum once yearly for a face-to-face meeting in the Bethesda, MD area that will be coordinated by the CCS. The first meeting will be held September 14, 2020 and all RTCC Directors, Biomedical Research Core Directors and the CCS Director are required to attend.  The NIDDK will utilize an External Experts Panel (EEP) to monitor research efforts and advise the Institute on the progress of the PKD Research Consortium.

Administrative Core: The Administrative Core will serve as the primary managerial component for all activities of the RTCC, including communication with the CCS. It will be responsible for the management of resources within the RTCC to ensure success in the integrated activities of the RTCC and to collaborate with the CCS in meeting the goals of the PKD Research Consortium.

Key responsibilities of the Administrative Core are to:

• Establish access to and monitor use of each Biomedical Research Core.
• Create mechanisms for internal monitoring and planning, including for RTCC budget and personnel considerations.
• Establish and maintain internal communication and cooperation among all RTCC investigators, the larger PKD Research Consortium, the CCS, outside research community, and the NIDDK.
• Work with the CCS to execute Material Transfer Agreements (MTA) between the CCS, other RTCCs and investigators outside of the PKD Research Consortium.
• Administer the Summer Student Enrichment Program.
• Develop reports on RTCC activities and progress for external review.
• Identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subawards/subcontractors (i.e. clinical/research laboratories, biospecimen repositories, etc.) with involvement of NIDDK Technology Advancement Office, and develop processes to efficiently administer and manage same throughout the project.

Biomedical Research Core: The Biomedical Research Cores are defined as highly innovative, shared resources that provide specialized and essential services, techniques, or instrumentation to PKD Research Consortium investigators and the outside community, allowing studies to be conducted more efficiently and effectively. The Biomedical Research Cores thus must demonstrate utility as a national resource for supporting PKD research within and outside the PKD Research Consortium. Biomedical Research Cores headed by investigators from outside the PKD research community are strongly encouraged.

Examples of types of Biomedical Research Core resources may include, but are not limited to:

• Provision of specialized tools and technologies or access to specialized expertise
• Development, standardization and distribution of antibodies, cells, organoids, animal models and/or protocols
• Development, beta-testing and dissemination of specialty assays, methods, and services
• Provision of models for high throughput screening of promising new therapeutic targets for PKD
• Development of mathematical models to identify novel pathways in the pathogenesis of PKD
• Recruitment, retention and evaluation of PKD patients using novel methods of phenotyping and a unified, consortium-wide approach
• Collection and sharing of clinical data, protocols, biological samples and imaging.
• The National Center for Advancing Translational Sciences (NCATS) currently supports a national network of medical research institutions, i.e. hubs, via Clinical and Translational Science Awards (CTSA), which provide services and resources to enhance clinical research (https://ncats.nih.gov/ctsa). The Biomedical Research Cores supported by the NIDDK are encouraged to collaborate with CTSAs and should not overlap effort or services.

Visit our Institutionally Limited Submission webpage for updates and other announcements.