Opportunity Information: Apply for RFA RM 18 015
Development of Cell and Tissue Platforms to Detect Adverse Biological Consequences of Somatic Cell Gene Editing (U01 Clinical Trial Not Allowed) is a National Institutes of Health funding opportunity from the Department of Health and Human Services focused on improving the safety evaluation of somatic cell genome editing. The core aim is to support research teams that can build and validate practical, reliable laboratory platforms using cells and tissues to detect harmful or unintended biological effects that may result when gene-editing tools are applied to non-reproductive (somatic) cells. In other words, the government is looking for well-designed experimental systems that can reveal adverse outcomes of genome editing early and clearly, before approaches move further along toward therapeutic development.
This opportunity is issued as a Cooperative Agreement (U01), which typically means the NIH expects substantial scientific involvement and coordination with funded investigators rather than operating strictly as a hands-off grant. Projects under this kind of mechanism often include milestones, shared standards, and active collaboration with NIH program staff to ensure the resulting tools, data, and validation approaches are broadly useful to the field. The announcement explicitly states "Clinical Trial Not Allowed," signaling that supported work should stay in the preclinical or translational research space and should not involve prospective assignment of human participants to interventions to evaluate health outcomes.
The scientific emphasis is on cell- and tissue-based platforms, which can include advanced in vitro models designed to mimic human biology more closely than standard cell culture. These platforms are intended to detect adverse biological consequences of somatic editing, which can cover a wide range of potential issues such as unintended edits at off-target sites, large structural changes in the genome, activation of stress or DNA damage responses, abnormal gene expression patterns, altered cell function, unexpected immune or inflammatory signaling in edited cells, clonal selection of problematic cell populations, or other harmful phenotypes that might emerge after editing. The goal is not simply to demonstrate that a gene-editing method works, but to create validated systems that sensitively and reproducibly flag negative outcomes and help researchers understand why they occur.
The program falls under the Health funding activity category and is associated with CFDA number 93.310. The Funding Opportunity Number is RFA-RM-18-015, and it was created on January 24, 2018 with an original closing date of April 3, 2018. NIH anticipated making around 8 awards under this announcement, with an award ceiling listed at $390,000. While the ceiling indicates an upper limit, actual award sizes can vary depending on the approved scope of work, the budget justification, and NIH decisions during review and negotiation.
Eligibility is broad and includes many types of organizations that can carry out biomedical research and development. Eligible applicants include federal recognized tribal governments and other tribal organizations, state and local governments (including counties, cities, townships, and special districts), public housing and Indian housing authorities, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories), for-profit organizations (including small businesses and other for-profits), and other entities as described in the announcement's eligibility details. This wide eligibility suggests NIH was aiming to draw on expertise from academia, industry, and public-sector research groups, potentially encouraging cross-sector collaboration to produce platforms that can be widely adopted.
Overall, this FOA targets the development and validation of experimental models that can serve as safety-testing workhorses for somatic cell gene-editing technologies. By funding the creation of robust cell and tissue platforms that detect adverse biological consequences, NIH is attempting to strengthen the evidence base and the methodological toolkit needed to evaluate gene-editing risks in a controlled, reproducible way, supporting safer translation of genome editing toward future clinical applications without funding clinical trials under this specific announcement.Apply for RFA RM 18 015
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Cell and Tissue Platforms to Detect Adverse Biological Consequences of Somatic Cell Gene Editing (U01 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): 93.310.
- This funding opportunity was created on Jan 24, 2018.
- Applicants must submit their applications by Apr 03, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $390,000.00 in funding.
- The number of recipients for this funding is limited to 8 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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