Studies at Periviable Gestation (R03 Clinical Trial Optional) | PA 18 053

Frequently Asked Questions (FAQs)

What is the "Studies at Periviable Gestation (R03 Clinical Trial Optional)" funding opportunity?

This is a National Institutes of Health (NIH) discretionary grant opportunity intended to support small, focused research projects that strengthen the evidence base for medical care at periviable gestational ages, often described as the earliest edge of fetal viability where outcomes are highly uncertain and clinical decisions are especially complex.

What is the main goal of this FOA?

The central aim is to generate practical, data-driven guidance to improve therapies, treatment strategies, and decision-making for pregnant people and their infants when birth is imminent or occurs at extremely early gestational ages.

What does "periviable gestation" mean in this context?

In this opportunity, periviable gestation refers to the earliest edge of fetal viability, a period when outcomes are highly uncertain and clinicians and families often face difficult decisions about maternal and neonatal care.

Is a clinical trial required under this announcement?

No. The FOA is labeled "Clinical Trial Optional," meaning projects may involve clinical trials, but a clinical trial is not required.

What is the Funding Opportunity Number (FOA number) for this announcement?

The Funding Opportunity Number is PA 18 053.

What NIH grant mechanism does this opportunity use?

This opportunity uses the NIH R03 mechanism, which typically supports short-duration, limited-scope studies such as pilot studies, feasibility studies, secondary analyses, or early-stage investigations that can prepare for larger projects.

What is the maximum award amount mentioned for this opportunity?

The listed award ceiling is $50,000, suggesting applicants should propose tightly scoped aims with clear deliverables that can be completed efficiently.

What types of projects are a good fit for an R03 under this FOA?

Based on the description provided, well-aligned projects commonly include small, clinically grounded studies such as pilot or feasibility work, secondary analyses of existing datasets, or early-stage investigations that produce interpretable and actionable evidence to guide periviable care.

What general topic areas are responsive to the FOA?

The FOA emphasizes building an evidence base to guide therapies and treatment at periviable gestation for both the mother and the infant. Examples of responsive research areas mentioned include comparing management strategies, evaluating maternal and neonatal outcomes tied to specific interventions, examining timing and dosing questions for commonly used therapies, assessing neonatal resuscitation and stabilization approaches, studying counseling and shared decision-making practices, and analyzing existing datasets to identify factors linked to better outcomes.

Does the FOA focus on outcomes for the pregnant person, the infant, or both?

Both. A stated feature of the FOA is its emphasis on periviable care for both the mother and the infant, reflecting that interventions near the threshold of viability involve balancing maternal health, neonatal survival, and risks of severe long-term morbidity.

What kind of results is NIH looking for from projects under this FOA?

The FOA stresses practical, data-driven guidance that can directly inform clinical practice. Strong applications would typically focus on clinically relevant endpoints, clear definitions of periviability and gestational-age windows, and methods that can produce interpretable results despite small sample sizes and heterogeneous clinical scenarios.

Are secondary data analyses allowed or encouraged?

Yes. The R03 mechanism commonly supports secondary analyses, and the FOA description explicitly notes analyzing existing datasets as an example of work that may be responsive and useful for identifying factors linked to better outcomes.

Who is eligible to apply?

Eligibility is broad and includes many U.S. public and private organizations as well as certain non-U.S. entities. The FOA lists eligible applicants such as state, county, and city or township 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; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations.

Are institutions that serve specific communities explicitly mentioned as eligible?

Yes. The FOA explicitly highlights applicant types including 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), and faith-based or community-based organizations.

Can federal agencies apply?

Yes. Eligible applicant types include eligible federal agencies.

Can organizations in U.S. territories apply?

Yes. The FOA notes eligibility for U.S. territories or possessions.

Can non-U.S. (foreign) organizations apply?

Yes. The opportunity notes that certain non-U.S. entities are eligible and explicitly includes non-domestic (non-U.S.) entities or foreign organizations.

What is the CFDA number associated with this program?

The CFDA number listed is 93.865.

What activity category is associated with this opportunity?

The activity category listed is Health, Income Security and Social Services.

When was this opportunity posted, and what was the original closing date?

The posting (creation) date provided is November 2, 2017, and the original closing date provided is September 7, 2018.

Is this FOA likely still open for applications today?

Based on the provided dates, this appears to have been a time-bounded solicitation with a closing date of September 7, 2018. Anyone interested now would typically look for a reissued or related active FOA, or confirm whether NIH still accepts applications under PA 18 053.

How does the small-grant structure affect project scope?

The R03 mechanism and the $50,000 award ceiling indicate NIH expects tightly scoped aims, clear deliverables, and efficient completion, such as feasibility testing, generating preliminary data, or producing targeted evidence that can guide clinical care.

What kinds of clinical questions might be addressed under this FOA?

Questions mentioned or implied by the FOA description include how different management strategies compare, which interventions are associated with improved maternal and neonatal outcomes, what timing or dosing is most effective for commonly used therapies, what resuscitation or stabilization approaches work best for extremely early births, and how counseling and shared decision-making practices influence care and outcomes.

Why does the FOA emphasize decision-making and counseling?

Periviable situations often require balancing maternal health, fetal or neonatal survival, and the risk of severe long-term morbidity. The FOA indicates that evidence to support counseling and shared decision-making is part of the broader goal of producing clinically useful guidance.

What makes a project "clinically grounded" under this FOA?

From the description provided, clinically grounded work is research designed to directly inform clinical practice in periviable care, using clinically relevant endpoints and clearly defined gestational-age windows, and producing results that can guide therapies, treatment strategies, and decision-making.

Is this opportunity intended for large, multi-year studies?

No. The R03 mechanism is described as supporting short-duration, limited-scope studies, and the $50,000 ceiling points toward smaller projects rather than large, multi-year efforts.

What is the overall purpose of funding these small studies in periviable care?

The overall purpose is to quickly add clarity to a challenging area of obstetric and neonatal care by strengthening the evidence base for treatment and decision-making at extremely early gestational ages, including groundwork that may support larger future studies.