Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed) | PAR 20 165

Opportunity Information: Apply for PAR 20 165

The National Institutes of Health (NIH) funding opportunity PAR-20-165, titled "Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed)," supports investigator-initiated research projects using the R01 grant mechanism. The core purpose is to expand scientific understanding of ME/CFS by funding studies that examine its causes (etiology), how it can be identified and diagnosed, the underlying biological dysfunctions (pathophysiology), and the range of symptoms and impacts (manifestations). A central theme of the announcement is improving knowledge in a way that ultimately leads to more accurate diagnosis, better approaches to care, and improved quality of life for people living with ME/CFS, while explicitly stating that clinical trials are not allowed under this specific FOA.

The FOA places strong emphasis on research that addresses major gaps in the field. In particular, NIH is looking for applications that investigate environmental and biological risk factors that may contribute to developing ME/CFS, and studies that explain why the illness can look very different from one person to another (determinants of heterogeneity). It also prioritizes work that clarifies shared mechanisms that may be affecting multiple body systems at once, reflecting the multi-system nature of ME/CFS. Another priority is research designed to span diverse groups and the full lifespan, encouraging studies that do not treat ME/CFS as a one-size-fits-all condition and that consider differences related to age, background, and other population factors.

Interdisciplinary, team-based science is a major focus of the opportunity. NIH signals particular interest in projects that bring together researchers across fields to better characterize disease processes and develop evidence-based solutions. This can include building scientific teams to study and develop biomarkers (measurable indicators that could help confirm diagnosis or stratify subgroups) and to characterize how different organ systems respond pathophysiologically in individuals with ME/CFS. The program also encourages novel, innovative ideas that either break new ground or push prior discoveries into new directions, rather than simply repeating established approaches.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments as well as tribal organizations and other tribal governments that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA also explicitly notes additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility reflects NIH's interest in expanding the research base and encouraging participation from institutions serving diverse communities.

Administratively, the opportunity is categorized as discretionary funding and uses the grant funding instrument type, with activity areas spanning education, environment, and health. Multiple CFDA numbers are associated with the announcement (93.113, 93.121, 93.213, 93.233, 93.242, 93.273, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.855, 93.879), reflecting the involvement of different NIH institutes and centers and the cross-cutting nature of ME/CFS research. The source data indicates a creation date of 2020-04-13 and an original closing date of 2023-03-05. No award ceiling or expected number of awards is specified in the provided details, which often means applicants should rely on standard NIH R01 budgeting rules, institute-specific guidance, and the FOA text for any constraints or expectations.

Overall, this FOA is aimed at strengthening the ME/CFS evidence base through rigorous, innovative, and collaborative non-clinical-trial research that can explain disease mechanisms, improve diagnostic tools (including biomarkers), and clarify why ME/CFS varies across people and across the lifespan, with an explicit push toward inclusive research that captures diverse populations and multi-system impacts.

• The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.213, 93.233, 93.242, 93.273, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.855, 93.879.
• This funding opportunity was created on 2020-04-13.
• Applicants must submit their applications by 2023-03-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 20 165

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