Internal Deadline: Friday, August 27, 2021, noon PT
LOI: September 20, 2021
External Deadline: October 20, 2021
Award Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: $1.5 million in FY 2022
Who May Serve as PI: The PD/PI must have experience with obtaining post-mortem tissue
for research purposes from Organ Procurement Organizations.
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.
Materials to submit include:
- (1) 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.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs and Co-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.
This Funding Opportunity Announcement (FOA) invites a single cooperative agreement application for a Data Coordinating Center (DCC) to first establish a biorepository of human cardiovascular (CV) tissue and then serve as the coordinating center resource for discovery and mechanistic research to increase knowledge of the CV complications of type 1 diabetes (T1D).
The research under this FOA would have two phases. The goal of the first phase is to establish a biorepository over the initial two years through 1) the collection and storage of donated human tissue; 2) the performance of quality control and basic histopathologic examination; and 3) the creation of a process for distribution of the samples to qualified investigators. The goal of the second phase is to serve as the Data Coordinating Center for investigators that would perform a thorough and comprehensive analysis of the biosamples using a broad range of state-of-the-art technologies. The second phase would take place over the final three years of funding.
Specific activities starting in the first phase, initiating the biorepository, include:
- Establish tissue collection, processing, and storage protocols that preserve the quality of the biosamples for multiple analytical paradigms.
- Create methods and data entry procedures to obtain and record a comprehensive clinical history of each donor.
- Work with Organ Procurement Organizations to obtain the proper consent for the use of donated tissue for research through the biorepository for tissue from organ donors that cannot be used for transplantation.
- Collect tissue from at least 60 donors with an even distribution among donors with T1D, T2D or no diabetes during the first two years. The donors with T2D and no diabetes should roughly match the ages and disease severity of the T1D donors with attention paid to matching sex and racial diversity, if possible.
- Obtain from each donor, if possible, a complete tissue panel that includes heart (myocardium, coronary arteries, and autonomic nerves), kidney, aorta, common carotid arteries, peripheral arteries of the lower extremities and blood (serum, plasma and cellular components).
- Determine tissue quality and establish minimum requirements for inclusion in the biorepository.
- Perform a histopathological examination of the collected tissue with an assessment of CVD.
- Develop a public data portal with easily accessible information on the tissues, histopathology, quality measures and clinical history, as well as information on obtaining access to the biosamples.
- Establish and initiate procedures for the incorporation of high quality T1D tissue and the associated medical history from other sources into the biorepository including procedures for privacy issues related to genomic data.
- Distribute biosamples and data to investigators qualified through an evaluation process and establish a chain of custody to monitor the distribution.
- Administer the evaluation and funding of pilot studies using biorepository tissue and data.
Specific activities starting in the second phase, serving as a coordinating center resource for the biorepository, include:
- Support research projects that use multimodal approaches to obtain a systematic, comprehensive, unbiased and standardized deep phenotyping of CV tissue at various stages of disease development in T1D, T2D and no diabetes tissue.
- Organize and integrate all the anatomical, cellular, and molecular data and metadata generated into a comprehensive and searchable community database that conforms to the FAIR (findability, accessibility, interoperability, and reusability) principles of big data and NIH policy.
- Continue to obtain donor tissue for the biorepository with the possible expansion to specific requests based on the research direction of investigators.
- Organize annual in-person meetings at the NIH for investigators who are recipients of the CV biorepository tissue.
- Coordinate regular steering committee meetings of investigators for operational and scientific discussions.
- Advertise the existence and value of the CV biorepository with an efficient outreach strategy.
- Additional information on NIDDK regulatory policies and guidance can be found at Policies for Clinical Researchers | NIDDK (nih.gov).
Visit our Institutionally Limited Submission webpage for more updates and other announcements.