Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional) | PAR 18 511

FAQs: NIH R01 Opportunity - Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Therapeutics (Clinical Trial Optional)

1) What is the title of this NIH grant opportunity?

The opportunity is titled "Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional)."

2) What is the main purpose of this funding opportunity?

The central purpose is to support research that improves prevention and treatment of conditions that arise during pregnancy or are triggered by pregnancy by identifying specific molecular targets that drive those disorders and using that knowledge to lay the groundwork for safer, more effective therapeutics for pregnant people.

3) What kind of projects is NIH trying to encourage through this FOA?

Projects are expected to move beyond describing symptoms, associations, or risk factors and instead pinpoint actionable molecular pathways or targets. Competitive projects would typically also show that modifying the target could plausibly prevent disease onset, reduce severity, or treat an established pregnancy-related/induced disease, and present a credible strategy toward therapeutic development.

4) What does it mean that the mechanism is an NIH R01?

This opportunity uses the NIH R01 mechanism, which generally supports substantial, hypothesis-driven research projects and can fund multi-year research programs.

5) What does "Clinical Trial Optional" mean in this opportunity?

"Clinical Trial Optional" means a clinical trial may be proposed if it is scientifically justified, but a clinical trial is not required. Proposed work can range from basic and translational studies (for example, target discovery, pathway mapping, validation in model systems, and early therapeutic development) through later-stage work that could include human testing, as long as the approach aligns with NIH rules for clinical research and safety oversight.

6) Does this FOA require a clinical trial?

No. A clinical trial is optional, not required.

7) What types of research activities are in-scope based on the description provided?

Based on the description, in-scope activities may include molecular target discovery, mechanistic pathway mapping, target validation in relevant model systems, translational studies that connect mechanisms to intervention strategies, and early therapeutic development. The description also indicates later-stage efforts may be appropriate, potentially including human testing when scientifically justified and compliant with NIH clinical research oversight requirements.

8) What scientific area does this opportunity focus on?

The focus is pregnancy-associated or pregnancy-induced disorders, especially where pregnancy biology creates unique safety constraints, limits drug choices, or contributes causally to disease, and where current treatments are inadequate or pose maternal or fetal risk.

9) Does the excerpt list specific pregnancy-related diseases?

No. The excerpt does not list specific diseases. It describes a broad theme covering disorders that arise during pregnancy or are triggered by pregnancy.

10) What is NIH expecting applicants to deliver conceptually?

The expectation is that applicants will identify specific molecular targets that drive pregnancy-related/induced disorders and demonstrate a plausible link between modulating those targets and preventing or treating disease during pregnancy, with a clear path toward developing pregnancy-appropriate therapeutics.

11) Why does this FOA emphasize pregnancy-specific therapeutics?

The description highlights that pregnancy presents unique biological constraints and safety considerations that often limit available drug choices. The program aims to generate interventions that are safer for pregnant people and more effective than current options.

12) Who is eligible to apply?

Eligibility is described as broad and includes many U.S.-based organizations and governmental units, including:

• State, county, and municipal 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 governments
• Public housing authorities/Indian housing authorities
• Nonprofits with or without 501(c)(3) status (excluding institutions of higher education where relevant)
• For-profit organizations (other than small businesses)
• Small businesses

13) Are minority-serving institutions and community-based organizations included in the eligibility language?

Yes. The FOA explicitly highlights additional eligible applicant categories, 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

14) Can a non-U.S. organization apply as the applicant institution?

No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization under the rules described in the excerpt.

15) Can a U.S. organization apply using a non-U.S. component as the applicant?

No. The excerpt states that non-domestic components of U.S. organizations are not eligible to apply.

16) Is any foreign involvement allowed at all?

Yes. The excerpt states that "foreign components" are allowed as defined by the NIH Grants Policy Statement. This means a U.S. applicant may include certain substantive foreign involvement (for example, specialized expertise, resources, or study populations abroad) if it meets NIH definitions, is justified, and is approved under NIH policy.

17) Which agency is issuing this opportunity?

The opportunity is issued by the National Institutes of Health (NIH).

18) What is the funding opportunity number (FOA number)?

The funding opportunity number is PAR-18-511.

19) What is the CFDA number and activity area listed in the excerpt?

The excerpt lists CFDA number 93.865 and categorizes the opportunity as a discretionary grant in the Health, Income Security and Social Services activity area.

20) What is the record creation date shown in the excerpt?

The record shows a creation date of December 19, 2017.

21) What closing date is mentioned, and should applicants verify it?

The excerpt lists an original closing date of January 7, 2021. It also notes that applicants would typically need to confirm whether the FOA has been reissued, extended, or replaced, because NIH announcements may have multiple receipt dates over time or may be superseded by newer versions.

22) What is the overall gap this program is trying to address?

The program is designed to address a long-standing gap in pregnancy therapeutics by funding rigorous research that links mechanistic molecular insights to practical therapeutic development, aiming to enable safer, pregnancy-appropriate interventions for disorders that arise during or are triggered by pregnancy.