Opportunity Information: Apply for RFA HD 23 032

The National Institutes of Health (NIH) is soliciting R01 research grant applications under the HEAL Initiative through the funding opportunity titled "Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Basic Experimental Studies with Humans Required)" (RFA-HD-23-032). The purpose of this opportunity is to support research that clarifies how opioid exposure during pregnancy, either by itself or alongside other commonly misused substances, affects placental function and early neurodevelopment. The scientific window of interest spans pregnancy through the infant's first year of life, with an emphasis on understanding underlying biological and behavioral mechanisms rather than testing treatments or delivering near-term clinical products.

A central requirement is that proposed projects use experimental designs in human participants that prospectively assign participants to different conditions, meaning the study deliberately manipulates one or more independent variables and then measures biomedical and/or behavioral outcomes. NIH categorizes this type of work as Basic Experimental Studies with Humans (BESH): studies that fit the NIH definition of basic research but also meet the NIH definition of a clinical trial because they involve prospective assignment and an intervention or manipulation in humans. In practical terms, the FOA is aimed at mechanistic, hypothesis-driven human experiments that can reveal fundamental processes linked to prenatal opioid exposure and its downstream effects on the placenta, the developing brain, and early neurodevelopmental outcomes.

The announcement also draws a clear boundary around what should not be proposed. Applications should not be framed around achieving clinical outcomes, developing clinical products, or pursuing treatment-efficacy goals. Additionally, if a project is primarily observational in humans (for example, cohort studies without prospective experimental assignment) or relies on animal models, it does not fit this FOA and should instead be submitted to the companion announcement RFA-HD-23-030, which covers "Clinical Trials Not Allowed" projects in this scientific area.

Eligibility is broad and includes many domestic U.S. organization types. Eligible applicants include state, county, city or 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; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA further highlights a range of "other eligible applicants" such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, the FOA restricts foreign participation in specific ways. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, meaning a U.S.-based applicant organization may include certain defined foreign elements in the project when justified and compliant with NIH policy.

Administrative details included in the source information indicate this is a discretionary grant program administered by NIH, with CFDA numbers 93.213, 93.242, 93.273, 93.853, and 93.865. The opportunity was created on 2022-08-29, and the original closing date listed is 2022-12-07. The award ceiling and expected number of awards are not specified in the provided data.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Basic Experimental Studies with Humans Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.242, 93.273, 93.853, 93.865.
  • This funding opportunity was created on 2022-08-29.
  • Applicants must submit their applications by 2022-12-07. (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 RFA HD 23 032

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