Fertility and Fertility Preservation for Patients with Diseases that Previously Precluded Reproduction (R21 Clinical Trial Optional) | RFA HD 20 021

Opportunity Information: Apply for RFA HD 20 021

This funding opportunity, titled "Fertility and Fertility Preservation for Patients with Diseases that Previously Precluded Reproduction (R21 Clinical Trial Optional)" (RFA-HD-20-021), is a National Institutes of Health (NIH) research grant from the Department of Health and Human Services. It is designed to support early-stage, exploratory projects that focus on reproductive health in people who were born with serious chronic diseases that historically limited life expectancy, but who now commonly survive into adulthood and are well enough to think about having children. As medical care has improved for conditions like sickle cell anemia, thalassemia, and cystic fibrosis (among others), a growing number of patients are reaching reproductive age, and their fertility and reproductive well-being have become important, sometimes unmet, health needs.

The central goal of the RFA is to encourage research that clarifies how these chronic diseases, and the treatments used to manage them over many years, affect reproductive function. The opportunity recognizes that fertility problems may arise from the underlying disease process itself (for example, chronic inflammation, organ damage, endocrine disruption, or other disease-related biological pathways) and/or from cumulative treatment effects (such as chemotherapy exposure, repeated transfusions and iron overload, long-term medication use, radiation, or other interventions). The NIH is specifically encouraging studies that examine measurable parameters of reproductive health, which can include factors related to gonadal function, hormonal regulation, pubertal development, menstrual and ovulatory function, sperm quality, ovarian reserve, sexual health, pregnancy-related risks, and broader reproductive system outcomes that influence the ability to conceive or safely carry a pregnancy.

A major emphasis of the RFA is collaboration between disease-area experts and reproductive health specialists. The intent is to bring together teams that understand the chronic condition in depth with investigators who can rigorously assess fertility, reproduction, and fertility preservation. Through that kind of partnership, the NIH is seeking projects that not only describe or quantify reproductive deficits, but also identify practical ways to preserve fertility, protect reproductive potential during treatment, or treat fertility impairments after they occur. Because the mechanism is an R21 and clinical trials are optional, the scope can include foundational or pilot human studies, feasibility work, development of new approaches, and early testing of interventions when appropriate, without requiring that every application be a full-scale clinical trial.

From an administrative and funding standpoint, this is a discretionary grant opportunity in the health domain (CFDA 93.865). The award ceiling is listed as $200,000, and the agency anticipated making about 8 awards. Eligibility is broad and includes many types of organizations that typically apply for NIH funding: public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses) as well as small businesses, and a range of governmental entities (state, county, city/township, special districts), including federally recognized Native American tribal governments and other Native American tribal organizations, and public housing authorities/Indian housing authorities. The opportunity was created on September 12, 2019, with an original closing date of November 26, 2019.

Overall, the opportunity targets an emerging and important gap in care: understanding and addressing fertility and reproductive health in patient populations who now live long enough to want reproductive options, but whose disease biology and life-long treatments can make reproduction difficult. The NIH is signaling interest in research that generates actionable knowledge, whether that means mapping specific mechanisms of reproductive harm, developing screening and monitoring approaches for reproductive risk, improving counseling and decision-making around fertility preservation, or testing strategies that preserve or restore reproductive function in these medically complex populations.

• The Department of Health and Human Services, National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Fertility and Fertility Preservation for Patients with Diseases that Previously Precluded Reproduction (R21 Clinical Trial Optional)" 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 Sep 12, 2019.
• Applicants must submit their applications by Nov 26, 2019. (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 $200,000.00 in funding.
• The number of recipients for this funding is limited to 8 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA HD 20 021

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