Slots: 1
Deadlines
Internal Deadline: Contact RII.
LOI: October 16, 2023
External Deadline: November 15, 2023
Award Information
Award Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Award Amount: Application budgets are limited to $400,000 in direct costs in 2024 and $925,000 in direct costs in 2025-2029. Budgets need to reflect the actual needs of the proposed project.
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-23-001.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
CDMC Purpose and Research Objectives
Parkinson’s disease (PD) is the second most common and fastest growing neurodegenerative disorder, with approximately 60,000 Americans diagnosed annually. PD symptoms are not limited to motor dysfunction and more than 50% of patients who develop PD often have a history of complaints affecting nearly all parts of the gastrointestinal (GI) system. These GI symptoms often precede the onset of motor symptoms, indicating that GI dysfunction may be an early manifestation of the disease and the gut may be an unexplored diagnostic and/or therapeutic target. Few, if any, centers have sufficient information on GI dysfunction in patients with PD. Critical to moving the field forward is the collection of data and samples under a large-scale data sharing effort starting from the prodromal non-motor GI phase to the overt motor phase. Coordination of a multidisciplinary collaborative effort will provide the infrastructure needed to establish an annotated repository of biospecimens (e.g., CSF, blood, stool, and GI tissues) to allow for the identification and validation of developing innovative early-phase GI-based diagnostic tools and biomarkers for PD.
There is an acknowledged gap in our understanding of the temporal onset of GI symptoms and changes in gut-brain communication in PD that may contribute to disease pathogenesis or severity. This initiative seeks to leverage the potential role of the GI tract in the pathogenesis and progress of PD in order to improve patient diagnosis, care, and outcomes. To achieve this objective, two different types of centers will form a consortium investigating the role of the GI track in PD. This Notice of Funding Opportunity (NOFO) is to solicit new cooperative agreement applications for a single Coordinating and Data Management Center (CDMC) that will manage the Gastroenterology Neurology Research Centers (GNRCs) described in the companion NOFO, RFA-DK-22-036. The CDMC and GNRCs together will form the Gut Brain Parkinson’s Disease Consortium (GBPDC). While a major goal of the GBPDC is enrollment of PD patients and collection of biological samples relevant to gastroenterology- and neurology-based analyses, GNRC applicants are asked also to plan mechanistic studies that leverage the use of these biosamples. For example, the role of the intestinal microbiota in the pathogenesis of PD remains unclear and the GBPDC may undertake studies of the composition and activity of the intestinal microbiome, and integrate these results with clinical data and other analyses.
CDMC Organization and Management of the GNRCs of the GBPDC (additional information available at https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers)
It is essential that CDMC applicants familiarize themselves with the companion NOFO for the U01 Centers that will form the GBPDC (described fully in accompanying RFA DK-22-036). The CDMC will be the scientific and organizational nucleus and serve as the central resource for the activities of the GBPDC. As such, the administrative structure should bring strong leadership and program management skills to the GBPDC. The CDMC requires a team with a track record of academic excellence in the field of gastroenterology, neurology, or related areas, with expertise and experience in implementation of protocol harmonization and quality control and assurance. The GNRCs will be expected to conduct independent analyses (enlisting support from the CDMC, as appropriate), and also to participate in collaborative projects with other GNRCs in the GBPDC and to allocate resources and personnel for the performance of both independent and collaborative studies.
The CDMC will be responsible for the collation, management, and support of analysis of the clinical, molecular, and other data, and coordinating communication and research among the GNRCs. It will manage the processing of biospecimens, submission of clinical, cellular and molecular data to central databases, and data analysis. It will also coordinate large scale analyses (e.g., histopathology and molecular), contracting them to third-party providers of the appropriate laboratory services when this expedient is cost-effective. Inventory management, sample tracking, and publication monitoring will be essential required activities of this project.
GNRCs will be expected to share data and participant specimens with other GBPDC centers, as appropriate and consistent with program goals. The CDMC will coordinate shipment of blood and other biological samples from the GNRCs to create a repository for the GBPDC. The GBPDC will send a biological sample (when applicable) produced from each enrolled subject to the NIDDK Central Repository, an NIDDK supported resource, for eventual sharing with the broader research community, as appropriate and consistent with achieving the goals of the program. Collection of biological specimens should conform to the specimen collection protocols of the NIDDK-CR (https://repository.niddk.nih.gov/pages/for_submitters/) and NINDS BioSEND Repository (https://biosend.org/expertise.html). To further promote data sharing, the CDMC will use Global Unique Identifiers (GUIDs) to provide a secure mechanism to link research participants across disciplines. GUIDs are required for each GNRC participant and the NIDDK has joined the NIH-centralized GUID server for participant sharing across institutes and studies. GUIDs allow data to be associated with a research participant without exposing or transferring personally identifiable information (PII) and/or protected health information (PHI). To support these activities, a web-based portal for this project will need to be developed and launched within the first 2 months after award, and updated in a timely fashion to reflect growth of the project. Raw and analyzed data should be made widely available via the project website if the associated projects do not themselves host a website for this activity.
In addition, the CDMC will be expected to oversee the following activities of the GNRCs, as well as others not mentioned in this list:
- Develop study protocols, the manual of operations, data collection forms, questionnaires and monitoring of adherence to research plans and protocols, and other data formats to support secure data deposition from grantees of RFA-DK-22-036.
- Support GNRC training, implementation, and study monitoring. Work with GNRC investigators on study design, including developing statistical analysis plans, power analyses, and study budgets.
- Develop and maintain the study website, data repositories? and the data commons, including analytical tools and user-friendly web portals with the goal of enhancing dissemination, accessibility and utilization of GBPDC-generated resources across relevant research communities. Data management and web-based activities will include creating and curating a searchable database with detailed pre-analytic quality control (QC) and protocol information. All aspects of the databases and portal should conform to current NIH policies regarding encouraging compliance with FAIR principles: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792175/.
- Provide logistical support necessary to run an efficient and productive network, including videoconference support, meeting facilitation, and taking meeting minutes.
- Coordinate closely with and/or manage the GNRC single Investigational Review Board (sIRB) to obtain and maintain IRB approvals and continuing renewals for all studies and ensure all recruiting sites have appropriate reliance agreements in place.
- Conduct statistical analyses of study data for interim monitoring, final results, and secondary data analyses, and collaborating with study investigators to publish results of GBPDC studies and studies in a timely and accurate manner
- Manage GBPDC-wide reporting and data and specimen sharing requirements, to include coordination of distribution of blood, biopsies, and other biological samples to the GNRCs, the CDMC, and to third-party providers of analytic services (which may be supported by subcontracts). Oversee all aspects of the data deposition, including timeliness and completeness of data, and provide any curation needed to ensure quality of data submission.
The Principal Investigator (PI) of the CDMC is expected to have broad experience in working collaboratively with a variety of health care systems in extracting health care data for research and in managing the related regulatory, ethical, and policy issues, including the NIH single IRB policy (NOT-OD-16-094). The PI should also have experience in coordinating transdisciplinary research teams. The CDMC must demonstrate expertise and capabilities in biostatistics, computational analysis and modeling, information technology and bioinformatics, data management, protocol development, and in coordinating and providing logistical support for meetings and conferences.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.