Key Dates
NOT-DK-23-006 - Notice of Intent to Publish a Funding Opportunity Announcement for A Consortium for Gut-Brain Communication in Parkinson’s Disease (U01 Clinical Trial Not Allowed)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for a Coordinating and Data Management Center (CDMC) that will manage collaborations among the Gastroenterology Neurology Research Centers (GNRCs) that will form the Gut Brain Parkinson's Disease Consortium (GBPDC). The responsibilities of the CDMC include, but are not limited to: (1) coordination of enrollment of subjects into the study; (2) management of consortium-wide meetings and conferences, and cross-consortium collaborative activities; (3) provision of statistical and computational analysis support; and (4) establishing a central data hub for data capture, curation and management, and protocol development and registration.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and strong responsive projects. The FOA is expected to be published in Spring, 2023 with an expected application due date in Fall, 2023.
This FOA will utilize the U24 mechanism “Resource-Related Research Projects—Cooperative Agreements". Details of the planned FOA are provided below.
This Notice encourages clinical investigators with expertise in gastroenterology and neurology and interests in the area of gut brain communication in PD to consider applying for this new FOA.
The CDMC will act as the scientific and organizational nucleus and serve as a central resource for the activities of the Gut Brain Parkinson's Disease Consortium (GBPDC). It will coordinate submission of data and other biological samples to central repositories, processing of biospecimens, submission of clinical, cellular and molecular data to central databases, and data analysis. In addition, the CDMC will manage the operations of the GBPDC Steering Committee and other committees and provide the infrastructure for the efficient design and conduct of multicenter clinical studies and establish a repository of patient samples that may be used for ancillary studies.
The CDMC must have 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. It is essential that the CDMC applicants familiarize themselves with the companion FOA for the U01 Centers that will form the GBPDC.
The Program Director/Principal Investigator(s) (PI) of the CMDC 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 (
TBD
TBD
1
TBD
93.847
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Terez Shea-Donohue, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301 825-2314
Email: terez.shea-donohue@nih.gov
and Human Services (HHS)
