Studies at Periviable Gestation (R01 Clinical Trial Optional) | PA 18 036

Opportunity Information: Apply for PA 18 036

The Studies at Periviable Gestation (R01 Clinical Trial Optional) funding opportunity (PA 18 036) is a National Institutes of Health (NIH) discretionary grant program designed to strengthen the scientific evidence base for medical care at periviable gestational ages, meaning the threshold period when a fetus is on the edge of viability and clinical decisions are especially complex. The central aim is to support research that can directly inform therapies, treatment strategies, and clinical management for both pregnant patients and their infants during this high-risk window, where outcomes can vary widely and practice is often shaped by limited or inconsistent data. Because the FOA is labeled "Clinical Trial Optional," applicants may propose either clinical trial work or non-trial research, as long as the project meaningfully contributes evidence that can guide care at periviable gestation.

The mechanism is the NIH R01, which generally supports substantial, hypothesis-driven research projects and can accommodate a wide range of study designs. In this context, the FOA is geared toward studies that clarify what interventions work best, for whom they work, and under what circumstances, including maternal and neonatal treatments, timing decisions, and approaches to reduce morbidity and mortality. Projects might include prospective or retrospective clinical studies, comparative effectiveness work, pragmatic trials, implementation-oriented research in real-world clinical settings, or other rigorous methods that can produce actionable findings for clinicians and health systems caring for mothers and infants at the limits of viability. The emphasis is on generating high-quality evidence that can guide therapies and treatment, rather than purely descriptive work that does not translate into clinical decision-making.

Eligibility is intentionally broad and includes most standard domestic applicant types, such as 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly welcomes additional applicant categories that NIH highlights to encourage inclusive participation and diverse institutional perspectives. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility is intended to support research capacity across varied clinical environments and communities, including those disproportionately affected by adverse perinatal outcomes.

From an administrative standpoint, the opportunity is listed under CFDA 93.865 and is administered by NIH. The posted original closing date in the provided record is 2018-09-07, and the record does not specify an award ceiling or expected number of awards. The FOA was created on 2017-11-02. In practical terms, applicants would be expected to propose a scientifically rigorous project with clear relevance to periviable care, articulate how the results will improve clinical decision-making for mothers and infants, and use methods appropriate to the ethical and clinical realities of research at very early gestational ages, where outcomes, consent considerations, and standard-of-care practices can differ across institutions.

Overall, this grant opportunity is aimed at moving periviable obstetric and neonatal care toward stronger, more consistent evidence, helping clinicians and families make decisions grounded in data rather than uncertainty. It supports research that can translate into better treatment pathways, clearer guidance on interventions, and improved outcomes during one of the most medically and ethically challenging periods in perinatal medicine.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Studies at Periviable Gestation (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2017-11-02.
• Applicants must submit their applications by 2018-09-07. (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 PA 18 036

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