Participant Engagement and Cancer Genome Sequencing (PE-CGS): Research Centers (U2C Clinical Trial Optional) | RFA CA 19 045

Opportunity Information: Apply for RFA CA 19 045

The Participant Engagement and Cancer Genome Sequencing (PE-CGS): Research Centers funding opportunity (RFA-CA-19-045) is a National Cancer Institute (NCI) cooperative agreement designed to build a multi-site network that directly involves cancer patients and post-treatment cancer survivors in research while also generating high-quality tumor genomic data. It sits under the Beau Biden Cancer Moonshot initiative and specifically responds to the Cancer Moonshot Blue Ribbon Panel recommendation to "Establish a Network for Direct Patient Engagement." The central idea is that traditional research models often struggle to reach certain patient groups or collect enough samples and clinical context for the cancers where knowledge gaps are biggest, so this program supports research centers that can engage participants more directly and effectively while carrying out rigorous genome sequencing studies.

The PE-CGS Network is structured as several U2C Research Centers funded through this announcement, plus a separate U24 Coordinating Center funded under a companion announcement (RFA-CA-19-046). The U2C mechanism means awardees are expected to work closely with NCI as partners, with substantial federal scientific and programmatic involvement typical of cooperative agreements. Rather than operating as isolated projects, funded centers are expected to function as a coordinated network, aligning methods where needed, contributing to shared goals, and participating in network-wide activities that the Coordinating Center helps organize. In practice, that network approach is meant to make it easier to compare approaches, share tools and workflows, and accelerate learning about what engagement strategies actually work across different communities and cancer types.

The program has a two-part purpose. First, it aims to promote and support research on "direct participant engagement" approaches, meaning practical, evidence-generating work on how to recruit, inform, consent, communicate with, retain, and respect participants in ways that are effective and ethically sound. Second, it aims to use those engagement approaches to enable cancer genome sequencing projects that address major gaps in tumor genomic characterization. The FOA points to several priority areas where gaps are common and where participant access is often challenging: rare cancers or rare subsets of more common cancers, highly lethal cancers, cancers diagnosed at unusually early ages, cancers with marked disparities in incidence and/or mortality, and cancers in understudied populations. The expectation is that better engagement is not just an add-on, but a core strategy to make these sequencing studies feasible, representative, and scientifically valuable.

Each proposed U2C Research Center is required to include four integrated components. An Administrative Core provides overall leadership, governance, compliance, budgeting, coordination, and day-to-day management. A Participant Engagement Unit is responsible for designing and implementing the engagement approach, which can include participant-facing communications, consent models, return of information where appropriate, partnerships with advocacy groups or community organizations, and strategies to reduce barriers to participation. A Genome Characterization Unit handles the scientific and technical work of sequencing and genomic analysis, ensuring that tumor (and potentially matched normal) data are generated with rigor, quality controls, and appropriate data handling. Finally, an Engagement Optimization Unit focuses on assessing, refining, and improving engagement methods over time, treating engagement as something to be measured and optimized rather than assumed. This structure signals that NCI wanted centers that can both produce genomic datasets and systematically learn what engagement methods work best for different participant groups and study contexts.

Eligibility for the opportunity is broad and includes many U.S.-based organizational types that commonly apply for NIH funding, such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various levels of government (state, county, city/township, special districts), as well as independent school districts and public housing authorities/Indian housing authorities. The FOA also highlights additional eligible applicant categories tied to serving specific populations or community missions, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, along with eligible federal agencies and faith-based or community-based organizations. While many domestic entities can apply, non-U.S. (non-domestic) entities and non-U.S. components of U.S. organizations are not eligible to apply directly. At the same time, the FOA allows "foreign components" as defined by NIH policy, which typically means a U.S. applicant can include certain defined international elements in the project if they are justified and compliant with NIH rules.

From a funding and administrative standpoint, this is a discretionary NIH opportunity using the cooperative agreement funding instrument, categorized under education and health activities, and associated with CFDA listings 93.353, 93.393, and 93.396. The posted award ceiling is $2,500,000, and the original closing date listed is October 30, 2020. The announcement was created July 26, 2019. Overall, the FOA is essentially a blueprint for building research centers that can (1) prove out scalable, ethically grounded participant engagement models and (2) translate those models into better genomic knowledge for cancers that have been difficult to study, particularly in populations and disease contexts where representation and data depth have historically lagged.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Participant Engagement and Cancer Genome Sequencing (PE-CGS): Research Centers (U2C Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.353, 93.393, 93.396.
• This funding opportunity was created on 2019-07-26.
• Applicants must submit their applications by 2020-10-30. (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 $2,500,000.00 in funding.
• 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.

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