Reproductive Medicine Collaborative Clinical Trials Program (Collaborative R01 Clinical Trial Required) | RFA HD 19 022

Opportunity Information: Apply for RFA HD 19 022

The Reproductive Medicine Collaborative Clinical Trials Program (Collaborative R01 Clinical Trial Required) is a funding opportunity from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH). Listed under concept CONCEPT-19-000 and published as RFA-HD-19-022, it is designed to support multi-site, collaborative clinical trials focused on key problems in reproductive medicine. The central emphasis is on infertility and fertility-impairing conditions, including both female and male infertility as well as gynecologic and male reproductive system diseases and disorders that can reduce or prevent fertility.

The core purpose of the program is to move infertility care forward by generating stronger, faster clinical evidence than a single research site could typically produce on its own. The FOA is specifically aimed at large-scale human studies that test the safety and efficacy of new medications, treatments, and technologies relevant to infertility. By using shared, common research protocols across multiple locations, the program seeks to answer important clinical questions more quickly, increase the reliability of findings, and improve the ability to enroll enough participants to detect meaningful effects. A practical advantage of this approach is that multi-site trials can also broaden participant representation, improving the generalizability of results across diverse populations and clinical settings.

A defining feature of this opportunity is that it requires participation by at least two collaborating sites to complete the proposed study. The trial is expected to run under a single, shared protocol used across the consortium, with each site contributing to recruitment, intervention delivery, and data collection under the same study rules. Each collaborating site must have its own Program Director/Principal Investigator (PD/PI), reflecting the expectation that each location carries real scientific and operational responsibility rather than serving as a minor affiliate. Because this is a coordinated, multi-site effort, the consortium must also include clear structures for day-to-day coordination and oversight, including trial implementation, protocol adherence monitoring, quality control, database management, statistical analysis, and study reporting. In other words, the FOA is not only about proposing an interesting clinical question, but also about demonstrating the infrastructure and governance needed to run a rigorous clinical trial across institutions.

The intended beneficiaries are infertile couples, individuals with reproductive disorders that affect fertility, and the clinicians and health systems that care for them. The program is built around the idea that collaborative clinical trials can produce actionable evidence that directly informs diagnostic approaches and treatment decisions, ultimately improving reproductive health outcomes and patient care.

Eligibility is broad and includes many types of U.S.-based organizations that can lead or participate in NIH-funded clinical research. Eligible applicants include state, county, and local 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses, as well as other entities. The FOA explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments other than federally recognized, and U.S. territories or possessions.

At the same time, the opportunity sets important limits related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed if they meet the NIH Grants Policy Statement definition, meaning certain types of international collaboration may be included when justified, even though the main applicant and core components must remain eligible under the FOA rules.

Administratively, this is a discretionary grant funding opportunity using the NIH grant mechanism, categorized under Health, Income Security and Social Services, with CFDA number 93.865. The opportunity was created on 2018-10-24, with an original closing date of 2019-01-18. While the provided listing does not specify an award ceiling or the expected number of awards, the structure and requirements make clear that NICHD is seeking well-organized, multi-site consortia capable of running clinical trials to a high standard, with strong coordination, data systems, and statistical support to deliver publishable, practice-informing results in reproductive medicine and infertility care.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Reproductive Medicine Collaborative Clinical Trials Program (Collaborative R01 Clinical Trial Required)" 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 2018-10-24.
• Applicants must submit their applications by 2019-01-18. (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 19 022

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