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PAR-23-289: Diagnostic Centers of Excellence for the Undiagnosed Diseases Network (U01 – Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: October 3, 2023

External Deadline: November 3, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Anticipated Award Amount: Application budgets may not exceed $500,000 Direct Costs per year and must reflect the actual needs of the proposed project.  Budgets may be administratively reduced before award based on program priorities and the amount of NIH appropriations.

Who May Serve as PI: Applications for this DCoE U01 NOFO (RFA-NS-24-008) may be submitted by individuals located at the same institution(s) as the DMCC award (see RFA-NS-22-051), but an individual may not be the PD/PI of both the DMCC award and a DCoE application.  Institutions/organizations and PD/PIs are allowed only one DCoE award that is active at the same time [e.g., under this NOFO (i.e., RFA-NS-24-008), PAR-NS-23-171 or RFA-NS-23-004]. Therefore, recipients and PD/PIs of an approved X01 access award under PAR-23-171 may submit an application under this NOFO but will be required to relinquish the X01 access award if this U01 is awarded.  Likewise, if recipients of a U01 award under RFA-NS-23-004 submit a New application under this NOFO, versus a Renewal application, they will be required to relinquish the original grant if a new U01 is awarded.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-289.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

Purpose and Research Objectives

The purpose of this NOFO is to solicit proposals from highly qualified clinical sites in the US to join the Phase III Network as DCoEs through a U01 Cooperative Agreement award. Awarded DCoEs will have access to DMCC resources and infrastructure including high-quality phenotypic and genotypic data and collaboration with highly skilled physicians, researchers, and bioinformaticians. Successful applicants will demonstrate that they have the appropriate expertise, resources and infrastructure needed to conduct advanced diagnostic evaluations at their site and propose a research plan that meets the following Phase III priorities:

  1. Scale clinical capacity to engage more participants across the US by increasing diagnostic efficiencies and incorporating community and third-party payer support for patient services. To achieve this goal, DCoEs are expected to:
    • Provide a plan to enroll an achievable number of participants based on the site’s experience, outreach capabilities, community needs, and budget. Awarded DCoEs are expected to work with the DMCC to develop an enrollment plan that utilizes a tiered evaluation approach and is based on the specific diagnostic needs of each participant (e.g., Tier 1: initial screening/record review; Tier 2: telemedicine visits; Tier 3: comprehensive on-site clinical evaluations for a subset of participants; Tier 4: research activities) with plans to scale up enrollment as diagnostic efficiencies are established.
    • Work closely with the DMCC and other DCoEs to improve the efficiency and cost-effectiveness of the clinical evaluation (e.g., Artificial Intelligence (AI)/machine learning and other innovative tools for record review and data analysis, tiered evaluation strategies and remote visits as described above, etc.), while still providing a comprehensive and expeditious clinical evaluation of participants.
    • Although DCoEs are encouraged to enroll and evaluate participants with disorders in any clinical specialty, applicants have the option to specialize in one or more areas of clinical practice including but not limited to pediatrics, neurology, ophthalmology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.
    • Seek reimbursement when possible from non-NIH sources for patient services, for example, by billing insurance, utilizing support from their institutions, outside partnerships, foundations, or private donors.
    • Collaborate with the DMCC and other DCoEs to incorporate health economics approaches into network operations and establish additional outside funding partnerships including institutional and philanthropic support, and private donations to support the expansion and sustainability of the UDN in Phase III.
  2. Expand access to the UDN for individuals and groups who historically have not benefited from modern diagnostic investigations due to race, ethnicity, socioeconomic status, geographic location, sex/gender, linguistic or other systemic barriers. To achieve this goal, DCoEs are expected to:
    • Collaborate with the DMCC to recruit and enroll individuals from populations defined by the NIH to experience health disparities in the US.
    • Partner with community collaborators that serve populations defined by the NIH to experience health disparities, including but not limited to academic institutions, local healthcare systems and hospitals, state and local public health agencies, community-based organizations, faith-based organizations, and rural or urban community health centers including those that serve economically disadvantaged individuals. At least one of the partnerships must be a community healthcare organization that provides services for economically disadvantaged individuals who are under/uninsured. Applicants are expected to establish cooperative and mutually beneficial partnerships with the community collaborators beyond simply providing patient referrals to the DCoE (e.g., opportunities for the community collaborators to partner with the DCoE in the clinical evaluation, gain clinical and research expertise in undiagnosed diseases, engage fully in UDN activities, and participate in DCoE decisions that impact the partnership) and provide appropriate reimbursement for research performed by the community collaborator. Note: the partnerships with community collaborators may also comprise a component of the applicant’s Plan for Enhancing Diverse Perspectives (PEDP), as described below.
    • Prioritize NIH funds to cover the patient costs of under/uninsured participants along with research studies that facilitate a diagnosis.
  3. In addition to continuing the fruitful genomic approaches established in Phase I/II of the UDN, Phase III DCoEs are expected to propose and develop innovative strategies to investigate other potential causal factors in undiagnosed diseases such as environmental insults, infectious, oncologic, immunologic, or complex genetic disorders.
  4. Ensure that participants consistently receive a high-quality experience, for example, by collaborating with the DMCC to survey and incorporate input from patients, caregivers and family members into the practice of the UDN.

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