Opportunity Information: Apply for RFA HD 21 005
The Genomic Predictors of Pregnancy Loss (R01 Clinical Trial Not Allowed) funding opportunity (RFA HD-21-005) is a National Institutes of Health (NIH) discretionary grant program designed to advance research on the genetic and genomic factors that may help predict the risk of pregnancy loss in future pregnancies. The central goal is to support studies that apply newer, emerging genomic technologies to identify DNA variants associated with pregnancy loss risk, specifically aiming to go beyond what standard karyotype testing can detect. In practical terms, the FOA is looking for research that can uncover more detailed or subtle genomic contributors such as smaller chromosomal changes, sequence-level variants, or other types of genomic variation that traditional karyotyping may miss, with the broader intention of improving understanding and risk prediction for subsequent pregnancies.
This opportunity uses the NIH R01 mechanism, meaning it is intended for substantial, hypothesis-driven research projects with clearly defined aims, rigorous methods, and a strong plan for generating meaningful scientific outputs. The announcement explicitly states "Clinical Trial Not Allowed," which signals that applicants should not propose studies that meet NIH’s definition of a clinical trial (for example, prospective assignment of human participants to an intervention to evaluate health-related outcomes). Instead, the FOA is oriented toward observational, laboratory, computational, and other non-interventional human studies, potentially including analyses of biospecimens and genomic datasets, as long as the work remains within the non-clinical-trial scope.
From an administrative standpoint, the award ceiling is listed at $1,000,000, indicating the maximum funding level expected per award under this announcement, though actual budgets would typically need to match the scope and justification of the proposed research. The original closing date shown is July 30, 2020, and the opportunity was created on March 19, 2020, which is important for applicants evaluating whether the FOA is still active or whether similar, more current NIH opportunities should be sought.
Eligibility is broad and includes many types of organizations that commonly apply for NIH funding. Eligible applicants include state, county, city, and 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; tribal organizations that are not federally recognized tribal governments; 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 entities. In addition, the FOA highlights a range of other eligible applicants such as 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, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities. This emphasis suggests an interest in encouraging applications from diverse institutional settings and potentially supporting research that includes varied populations and contexts.
Overall, the opportunity is focused on improving the scientific basis for predicting and understanding pregnancy loss risk by leveraging modern genomic tools beyond conventional cytogenetic methods. The expected outcome is a stronger evidence base for genomic predictors that could eventually inform better risk stratification, counseling, and future research directions, while staying firmly in the realm of non-interventional research under the R01 grant mechanism.Apply for RFA HD 21 005
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Genomic Predictors of Pregnancy Loss (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 2020-03-19.
- Applicants must submit their applications by 2020-07-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- 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.
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Frequently Asked Questions (FAQs): Genomic Predictors of Pregnancy Loss (R01 Clinical Trial Not Allowed) - RFA HD-21-005
What is the purpose of this funding opportunity?
This NIH discretionary grant opportunity supports research on genetic and genomic factors that may help predict the risk of pregnancy loss in future pregnancies. The emphasis is on studies that use newer or emerging genomic technologies to identify DNA variants associated with pregnancy loss risk, especially variants that standard karyotype testing may not detect.
What is the funding opportunity title and number?
The opportunity is titled "Genomic Predictors of Pregnancy Loss (R01 Clinical Trial Not Allowed)" and is identified as RFA HD-21-005.
Which NIH grant mechanism is used?
This opportunity uses the NIH R01 mechanism, which is intended for substantial, hypothesis-driven research projects with clearly defined aims, rigorous methods, and a strong plan for producing meaningful scientific outputs.
Are clinical trials allowed under this FOA?
No. The announcement states "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet the NIH definition of a clinical trial. For example, studies involving prospective assignment of human participants to an intervention to evaluate health-related outcomes would be out of scope.
What types of studies does the FOA appear to support instead of clinical trials?
Based on the description, the FOA is oriented toward non-interventional research such as observational studies, laboratory research, computational analyses, and other human studies that do not involve assigning participants to interventions. It may include analyses of biospecimens and genomic datasets as long as the work remains within a non-clinical-trial scope.
What research focus is NIH seeking in this opportunity?
The focus is on identifying genomic contributors to pregnancy loss risk using modern genomic tools that can go beyond standard karyotype testing. This includes the goal of detecting more detailed or subtle contributors such as smaller chromosomal changes, sequence-level variants, and other forms of genomic variation that traditional karyotyping may miss.
Why does the FOA emphasize going beyond standard karyotype testing?
Standard karyotyping can miss certain types of genetic variation. The FOA aims to support research that uses newer genomic technologies capable of detecting variants or genomic changes that are smaller, more subtle, or otherwise not captured by conventional cytogenetic methods, with the intention of improving understanding and prediction of future pregnancy loss risk.
What is the central goal of the funded research?
The central goal is to advance research on genetic and genomic predictors of pregnancy loss, strengthening the scientific basis for understanding risk in subsequent pregnancies and supporting improved risk prediction approaches grounded in genomic evidence.
What is the maximum funding level listed for this opportunity?
The award ceiling is listed at $1,000,000, indicating the maximum funding level expected per award under this announcement. Actual budgets are expected to align with the proposed scope of work and be justified accordingly.
When was this opportunity created and what is the listed closing date?
The opportunity was created on March 19, 2020. The original closing date shown is July 30, 2020.
How should applicants interpret the listed closing date?
Because the closing date shown is July 30, 2020, applicants should evaluate whether the FOA is still active or whether they should seek similar, more current NIH opportunities. The dates provided are important for assessing current applicability.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include many types of organizations commonly applying for NIH funding, including various government entities, institutions of higher education (public and private), tribal governments and tribal organizations, public housing authorities, nonprofits (with and without 501(c)(3) status, other than institutions of higher education), and for-profit organizations (including small businesses and other for-profits).
Are U.S. government entities eligible to apply?
Yes. Eligible applicants include state, county, city, and township governments, special district governments, and independent school districts. Eligible federal agencies are also highlighted as eligible applicants.
Are institutions of higher education eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are included as eligible applicants.
Are tribal entities eligible to apply?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized tribal governments are also included as eligible applicants.
Are nonprofits eligible to apply?
Yes. Nonprofits with and without 501(c)(3) status (other than institutions of higher education) are listed as eligible applicants.
Are for-profit organizations eligible to apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, as well as small businesses.
Are foreign (non-U.S.) entities eligible to apply?
Yes. The eligibility description explicitly includes non-U.S. (foreign) entities.
Does the FOA encourage applications from specific types of institutions or communities?
Yes. The FOA highlights a wide range of eligible applicants and emphasizes inclusion of diverse institutional settings, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, U.S. territories or possessions, and regional organizations.
What kinds of outcomes are expected from research funded by this opportunity?
The expected outcome is a stronger evidence base for genomic predictors of pregnancy loss risk. Over time, this could support improved risk stratification, counseling, and future research directions, while remaining within the scope of non-interventional research under an R01 mechanism.
What is the practical impact this research is aiming toward?
In practical terms, the FOA is aiming to improve the scientific understanding of pregnancy loss risk by identifying DNA variants and other genomic contributors that could help predict risk in future pregnancies, especially contributors not detectable through standard karyotyping.
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