Defining A Comprehensive Reference Profile of Circulating Human Extracellular RNA (U01) | Apply Online

Opportunity Summary:

This grant opportunity, titled "Defining A Comprehensive Reference Profile of Circulating Human Extracellular RNA (U01)" (Funding Opportunity Number RFA-RM-13-014), was issued by the National Institutes of Health as a discretionary funding announcement using the cooperative agreement mechanism (U01). In practical terms, a U01 means NIH is not only providing funds but is also likely to have substantial scientific or programmatic involvement in the work as it progresses, which is typical for projects that aim to build community resources, standard reference datasets, or coordinated multi-investigator efforts.

The central goal of the FOA is to fund projects that create high-quality reference profiles of extracellular RNA (exRNA) found in circulating or cell-free form in human body fluids. The focus is specifically on noncoding regulatory RNAs, and it explicitly includes both short and long noncoding RNA species. The announcement also highlights interest in environmentally derived exRNA, such as RNA originating from diet or the microbiome, reflecting an intent to capture not only human-derived RNA signals but also exogenous RNA signatures that may routinely appear in healthy people. The word "reference" is important here: the intent is to define what "normal" looks like across different fluids and across healthy individuals, so that future research can compare disease states or exposures against a well-characterized baseline.

Another defining feature of the FOA is the breadth of specimen types it targets. Rather than limiting the work to blood or plasma, NIH calls for profiling a diverse set of healthy human body fluids, specifically listing blood, saliva, urine, breast milk, semen, amniotic fluid, cerebrospinal fluid, ascites, and pleural effusions. This wide scope suggests the program is trying to map exRNA biology across many physiological compartments, including fluids associated with neurological systems (cerebrospinal fluid), pregnancy (amniotic fluid), lactation (breast milk), reproductive biology (semen), and clinical effusions (ascites and pleural effusions). Building reference profiles for these fluids would support later biomarker discovery, diagnostics development, and basic research into how RNA is packaged, transported, and stabilized outside cells in different biological contexts.

The announcement strongly encourages applicants to use existing human biospecimen collections, which signals a preference for leveraging established repositories, cohort studies, or previously collected samples where appropriate consent and metadata already exist. Using existing collections can speed up the creation of reference datasets, increase statistical power through larger sample availability, and improve the ability to analyze how exRNA profiles vary with common covariates such as age, sex, or other demographic factors, depending on what metadata are available. It also implies that applicants should think carefully about sample handling, storage conditions, and pre-analytical variables, since those factors are especially influential for extracellular RNA measurements and can affect how comparable different samples are.

A key responsiveness rule is that this FOA is strictly limited to studies involving human samples. The text is explicit that animal studies and other non-human disease model studies are not responsive. That means projects proposing mouse models, in vitro disease models without direct human sample profiling, or any non-human experimental systems as the primary basis would not fit the intent of this call. The program is clearly designed to produce human reference resources rather than mechanistic insights from model organisms.

From an administrative and funding standpoint, the FOA was posted on September 19, 2013, with an original and current closing date of November 22, 2013, and an archive date of December 23, 2013, indicating it is no longer open for applications. The estimated total funding level listed is $3.8 million, with an award ceiling of $700,000, which gives a rough sense of the anticipated scale of individual awards and the likely number of funded projects under the program. The CFDA number associated with the opportunity is 93.310 (Trans-NIH Research Support), reinforcing that this initiative is positioned as a cross-NIH effort rather than being confined to a single disease institute.

Eligibility is broad and includes a wide range of organization types: for-profit organizations (including those other than small businesses), small businesses, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, special districts, and other categories. The eligibility section also explicitly includes a variety of minority-serving institutions (such as HBCUs, Hispanic-serving institutions, AANAPISIs, and tribally controlled colleges and universities), as well as faith-based and community-based organizations where relevant. Foreign participation is permitted: non-U.S. entities and foreign institutions can apply, foreign components of U.S. organizations are allowed, and foreign components as defined by NIH policy are acceptable. The opportunity does not require cost sharing or matching.

Overall, this FOA is best understood as an NIH resource-building effort aimed at establishing robust, baseline extracellular RNA profiles in many different healthy human body fluids, including both endogenous human regulatory noncoding RNAs and exogenous RNAs associated with environment, diet, or microbial sources. By emphasizing reference profiling, healthy samples, and the use of existing biospecimen collections, the program is geared toward producing standardized datasets that can serve as a foundation for later translational and clinical research, especially in areas like biomarker development and noninvasive diagnostics where extracellular RNA has become a major area of interest.

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