Advancing Methods for Safe, Noninvasive, Real Time Assessment of Placenta Development and Function Across Pregnancy (R01 Clinical Trial Not Allowed) | PAR 22 237

Opportunity Information: Apply for PAR 22 237

This grant opportunity, titled "Advancing Methods for Safe, Noninvasive, Real Time Assessment of Placenta Development and Function Across Pregnancy (R01 Clinical Trial Not Allowed)," is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) that supports research aimed at improving how clinicians and researchers monitor the human placenta throughout pregnancy. The central goal is to move beyond current limitations in placental assessment by pushing forward new or emerging approaches that can evaluate placental development and function in real time, while being safe for pregnant patients and fetuses. The FOA emphasizes methods that are non-invasive, or at most minimally invasive, reflecting a clear priority for techniques that can be used repeatedly over the course of pregnancy without adding meaningful risk.

The scientific focus is on advancing or clinically validating novel tools and approaches that can measure placental health and performance across gestation. In practice, that means proposals are expected to address how a method can capture dynamic changes in placental structure, physiology, perfusion, transport, metabolism, or related functional markers as pregnancy progresses. The language of the announcement highlights two broad pathways: (1) further development of promising emerging methods and (2) clinical validation of those methods, meaning the work should build convincing evidence that a new assessment approach is accurate, reliable, and relevant in human pregnancy settings. Because the FOA specifies "real-time" assessment, strong applications will typically frame how the technology or methodology can deliver timely information that could plausibly inform monitoring, risk assessment, or future clinical decision-making, even if the project itself is not testing clinical interventions.

The mechanism is an NIH R01 research project grant, indicating support for substantial, hypothesis-driven or milestone-driven research programs rather than small pilot studies alone. At the same time, the label "Clinical Trial Not Allowed" clarifies an important boundary: applicants must design studies that do not meet the NIH definition of a clinical trial. In other words, the funded work can involve human participants and can include clinical validation activities, but it cannot be structured as a prospective assignment of participants to an intervention with the intent to evaluate health-related outcomes. Applicants typically need to be careful in how they describe study design, especially when working in clinical environments, so that projects remain observational, measurement-focused, or otherwise outside the clinical trial definition while still producing clinically meaningful validation evidence.

From an administrative standpoint, the FOA is listed as PAR-22-237 and falls under the discretionary grant category, with the funding activity aligned to Health, Income Security and Social Services. The CFDA (now often referenced through Assistance Listing) number provided is 93.865. The opportunity is sponsored by the NIH, and the original closing date shown is November 5, 2024. The source data does not specify an award ceiling or the expected number of awards, which usually means applicants should consult the full FOA text or NIH Institute/Center guidance for budgeting expectations, typical award sizes, and any institute-specific considerations.

Eligibility is broad and includes many types of domestic organizations that commonly apply for NIH research funding. Eligible applicants include state, county, and local governments; 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant categories, reflecting an interest in broad participation and inclusion across institution types. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This wide eligibility framework supports diverse applicant pools and encourages innovation that may come from many different research settings and communities.

Overall, the opportunity is designed to accelerate the pipeline of placental monitoring methods that are safe, practical, and informative across pregnancy, with a particular emphasis on real-time and non-invasive measurement. The expectation is that funded projects will strengthen the technical and clinical evidence base for new assessment approaches, making it more feasible to understand placental function as it changes over time and to identify placental dysfunction earlier or more accurately than is possible with current standard tools, all while staying within a non-clinical-trial research design.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Advancing Methods for Safe, Noninvasive, Real Time Assessment of Placenta Development and Function Across Pregnancy (R01 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): 93.865.
• This funding opportunity was created on 2022-09-22.
• Applicants must submit their applications by 2024-11-05. (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 22 237

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