Exploring the Scientific Value of Existing or New Sepsis Human Biospecimen Collections (R21/R33 - Clinical Trial Not Allowed) | PAR 21 077

Frequently Asked Questions (FAQs)

What is the focus of this NIH funding opportunity?

This opportunity supports projects that improve how human sepsis biospecimens and associated clinical information are collected, stored, shared, and used to enable mechanistic discoveries in sepsis. The emphasis is on creating or strengthening high-quality biospecimen resources that can act as reliable research "testbeds" for studying the biology of sepsis.

What is the official title and identifier for the opportunity?

The opportunity is titled Exploring the Scientific Value of Existing or New Sepsis Human Biospecimen Collections (R21/R33 - Clinical Trial Not Allowed). It is identified as PAR-21-077 with CFDA 93.859.

Is this a clinical trial funding announcement?

No. The announcement is explicitly Clinical Trial Not Allowed. The core intent is not to fund a clinical trial or test an intervention in patients.

If clinical trials are not allowed, what kinds of work are supported?

Supported work centers on building, improving, and evaluating human sepsis biospecimen collections and the clinical datasets needed to interpret and reuse those specimens. This includes practical biobanking operations, specimen handling workflows, quality considerations, and producing well-annotated clinical variables that make specimens scientifically valuable for downstream mechanistic analyses.

What is meant by “scientific value” in this FOA?

Applicants are expected to demonstrate and/or rigorously assess how valuable an existing or new sepsis biospecimen collection is for answering real mechanistic questions in human sepsis. The intent is to ensure collections are not only gathered, but are demonstrably useful for producing interpretable, reproducible insights.

Does this FOA support using existing sepsis biospecimen collections, creating new collections, or both?

Both. The FOA expects applicants to either leverage existing sepsis biospecimen collections or create new ones, and then evaluate their utility for mechanistic sepsis research.

Why does the FOA emphasize efficiency and usefulness to the broader research community?

A central theme is maximizing the long-term scientific return of each sample by ensuring collections are high quality, well annotated, and reusable. Projects are expected to support biospecimen banking and sharing in ways that benefit not only the applicant team, but also other investigators.

What is the purpose of pairing biospecimens with clinical data?

The FOA stresses that specimens must be interpretable and reusable, which depends on having robust, standardized clinical variables and metadata. Pairing specimens with clinical context helps researchers relate samples to clinical events, severity measures, treatments, and outcomes.

What aspects of sepsis make biospecimen collection and annotation especially important?

Sepsis is described as heterogeneous and time-sensitive. As a result, the FOA implicitly prioritizes careful attention to timing of collection, consistency of processing, and the ability to link specimens to key clinical time points and outcomes.

What kinds of scientific questions or downstream uses are these collections intended to support?

The collections are intended to support modern mechanistic work in human sepsis, including immunologic profiling, host response characterization, biomarker development, and stratification of sepsis subphenotypes, as well as research into differences in immune responses, organ dysfunction, trajectories, and outcomes.

What does the R21/R33 structure mean for applicants?

The activity code indicates a phased approach: an initial exploratory/feasibility phase (R21) followed by a second phase (R33) that supports an expanded effort after predefined milestones are met.

What is typically done in the R21 (early) phase for this program?

Based on the FOA description, the early phase would generally be used to establish or validate operating procedures, demonstrate recruitment and sampling workflows in critical care settings, confirm specimen quality and clinical data completeness, and show the collection can support meaningful mechanistic analyses.

What is typically done in the R33 (later) phase for this program?

After milestones are met, the later phase would scale up collection efforts, expand sharing capacity, and more fully establish the biospecimen resource as a platform for ongoing studies by the applicant team and other investigators.

Does the FOA include expectations around biospecimen sharing?

Yes. The announcement highlights the importance of making biospecimen resources broadly useful, including an emphasis on sharing capacity and enabling use by other investigators.

Are projects expected to produce community-facing guidance or best practices?

Yes. In parallel with building collections, the program seeks to generate clear guidance on best practices for collecting, using, and analyzing sepsis biospecimens to help future studies be more comparable across sites and more reproducible.

What types of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, federally recognized Native American tribal governments, tribal organizations (other than federally recognized tribal governments), public housing authorities/Indian housing authorities, nonprofits (with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

Are specific institution types explicitly highlighted as eligible?

Yes. The FOA explicitly highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

Can foreign institutions apply?

No. Foreign institutions are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed under NIH definitions?

No. The FOA states that foreign components (as NIH defines them) are not allowed, reinforcing that supported collection and infrastructure must be domestically based.

What is the sponsoring agency and grant category?

The sponsoring agency is the National Institutes of Health (NIH), and it is described as an NIH discretionary grant opportunity.

What are the key dates included in the provided summary?

The FOA was created on 2020-11-13, and the original closing date listed is 2022-11-16.

Does the provided summary include an award ceiling or expected number of awards?

No. The summary provided does not include a stated award ceiling or the number of expected awards.

What is the overall intended impact of the funded projects?

The intent is to build and evaluate high-quality sepsis biospecimen resources and to raise standards across human sepsis research by enabling more comparable, reproducible, and generalizable mechanistic findings.