Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed) | PAR 25 044

Opportunity Information: Apply for PAR 25 044

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is soliciting applications under PAR-25-044 for an R21 grant opportunity titled "Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed)." The focus is on investigator-initiated, early-stage research that digs into the biological, behavioral, or physiological mechanisms through which bariatric surgery may change a persons risk of developing cancer. A key theme is that NCI wants to broaden the bariatric surgery research lens beyond the typical near-term endpoints (such as weight loss, glycemic control, or diabetes remission) and encourage scientists who already work in bariatric surgery to directly study downstream cancer-related effects and pathways.

This NOFO is designed specifically as a proof-of-concept and exploratory development mechanism. In practice, that means the NCI is looking for projects that test new ideas, generate early feasibility evidence, and open up novel lines of inquiry about how bariatric procedures influence cancer initiation, promotion, progression, or protective processes. A crucial boundary is that the feasibility of the proposed approach should not already be established either in the published literature or through preliminary data. In other words, the R21 here is meant for genuinely exploratory work rather than incremental extensions of well-demonstrated feasibility.

The opportunity also sets clear expectations about preliminary evidence and what can be cited. Unpublished data are not permitted as support for feasibility in the application. However, applicants may cite and use information from widely available preprints as long as those preprints have a Digital Object Identifier (DOI). If an investigator already has generated unpublished preliminary data that would underpin a stronger, more mature application, the NOFO explicitly nudges them toward a companion R01 mechanism instead of this R21, since the R01 is more appropriate for projects that are beyond early feasibility and exploratory development.

As indicated by the title and the explicit statement "Clinical Trial Not Allowed," applicants must propose research that does not meet the NIH definition of a clinical trial. That generally means the work should not prospectively assign human participants to an intervention to evaluate health-related outcomes. Mechanistic studies can still involve human data or biospecimens, observational designs, secondary analyses, and other non-trial approaches, but applicants need to ensure the proposed aims do not cross into clinical trial territory.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed include state, county, city or 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; tribal organizations (including those other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); small businesses; and other organizations. The NOFO also highlights additional applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Foreign eligibility is limited in a way that matters for planning collaborations. Non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components are allowed under NIH policy definitions, meaning a U.S. applicant can include certain foreign elements in the project if they meet NIH requirements and are appropriately justified, but the primary applicant organization must be domestic.

Administrative details provided in the source include that this is a discretionary grant program in the education and health activity space, associated with CFDA numbers 93.393, 93.396, and 93.399. The opportunity was created on 2024-09-05, and the original closing date listed is 2028-01-07. The award ceiling and expected number of awards are not specified in the provided extract, which typically means applicants should consult the full NOFO text and NIH guidance for budget and project period expectations standard to R21 mechanisms, as well as any institute-specific constraints.

Overall, PAR-25-044 is aimed at sparking new mechanistic insights into why bariatric surgery may alter cancer risk, using a strictly non-clinical-trial R21 framework that prioritizes exploratory, not-yet-established feasibility work, and invites a wide range of U.S.-based institutions and organizations to contribute to this cancer-focused bariatric research niche.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.396, 93.399.
• This funding opportunity was created on 2024-09-05.
• Applicants must submit their applications by 2028-01-07.
• 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 25 044

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