Reissued Funding Opportunity Centers on ME/CFS

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The lives of an estimated 800,000 to 2 million Americans are severely impacted by Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a debilitating and complex disorder.

Investigators, if your research interests include ME/CFS, consider applying to the reissued notice of funding opportunity (NOFO) ME/CFS Collaborative Research Centers (CRCs) (U54, Clinical Trial Optional), which seeks to support a network of Centers that will work collaboratively to define the cause(s) of and discover improved treatments for ME/CFS.

If after reading this article and the NOFO, you decide to apply, then consult with the scientific/research contact as an initial step toward preparing your application. For NIAID, that person is Dr. Joseph Breen; you may reach him at jbreen@niaid.nih.gov or 240-292-4123.

What Is Expected

The expectation is that the ME/CFS CRCs will help provide the foundation and infrastructure to complete basic, translational, and mechanistic clinical trials. ME/CFS CRC applicants at an institution with a Clinical and Translational Science Awards site (CTSA) are strongly encouraged to partner with and include the investigators and resources available at their CTSA.

Each Center will participate in a network with other funded ME/CFS CRCs and a Data Management and Coordinating Center (DMCC), which will be supported by the NOFO: RFA-NS-22-020.

Each ME/CFS CRC may consist of a collaborative, multi-disciplinary group of basic and clinical investigators; investigators from the NIH-funded Clinical and Translational Science Awards sites (CTSAs), where applicable; institutions; and relevant organizations, including patient advocacy group organizations; and will focus on research on ME/CFS.

ME/CFS CRC Focus

The ME/CFS CRC should be focused on the etiology, pathogenesis, and/or identification of targets for the treatment of ME/CFS and may include studies on the various manifestations of the disease.

An immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as local resources and national leaders in ME/CFS research.

Successful CRC research programs will facilitate research in ME/CFS through 1) conducting collaborative basic and/or clinical research on ME/CFS; 2) conducting longitudinal studies of individuals with ME/CFS within each ME/CFS CRC and across CRCs within the network; and 3) enabling access to information related to ME/CFS for basic and clinical researchers, academic and practicing physicians, healthcare professionals, patients, and the lay public.

The DMCC will 1) provide the data management and support necessary for the network of ME/CFS CRCs to function optimally and 2) work with the ME/CFS CRCs to integrate and utilize research tools into their research, including continued support for and use of data-sharing tools and query tools to identify available biospecimens for research.

The overall theme, proposed research projects, and associated cores must inform the etiology, pathogenesis, or treatment of ME/CFS, as noted above.

For studies proposed under this NOFO, it is recommended that the investigators use the Canadian Consensus Criteria for ME/CFS as proposed by Carruthers and colleagues in 2003 and revised by Jason and colleagues in 2010, and the case definition from the Institute of Medicine Report on ME/CFS. See the Background section of the NOFO for additional details.

Data Sharing

Data sharing will be required through the DMCC and biospecimens will be required to be deposited, stored, and shared through NIH-supported biorepositories. Funding decisions will focus on those applications most likely to make highly impactful contributions to ME/CFS research, as well as on those with the greatest potential to collaborate effectively across the ME/CFS CRC program.

Required Elements

Each ME/CFS CRC application must include:

  1. A minimum of two and a maximum of three research projects
  2. An Administrative Core
  3. A plan for community outreach and engagement with other ME/CFS stakeholders (patients, advocacy organizations, etc.)

Each ME/CFS CRC director must be an established leader in scientific research with visionary leadership skills and proven experience in the stewardship of large-scale research programs.

Use of a single IRB for multi-site clinical studies proposed in the application is required. See Reminder of Guidance on Requirement for NIH Single Institutional Review Board (IRB) Plan.

NIAID’s Research Areas of Interest Include:

  • Studies on infectious etiology of ME/CFS, including post infectious sequelae of ME/CFS.
  • Identification of potential triggers or modifiers of immune responses or immune cell metabolism that contribute to ME/CFS; application of current methodologies (e.g., immune phenotyping) or computational modeling to better characterize human immune responses triggered in ME/CFS.

See the NOFO for additional examples as well as overall research areas of interest.

Award Information

NIAID will commit $750,000 total costs per year over 5 years to support components that align with the mission of the Institute.

Award Budget

Application budgets are limited to $1,200,000 annual direct costs and need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

Application Due Date

This NOFO has a single application deadline for both new and renewal applications: June 15, 2023.

For Questions

Again, direct any inquiries related to this initiative to Dr. Joseph Breen at jbreen@niaid.nih.gov or 240-292-4123. For peer-review related matters, contact a scientific review officer at the National Institute of Neurological Disorders and Stroke at nindsreview@nih.gov or 301-496-9223.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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