Mechanistic Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed) | RFA AR 19 006

Frequently Asked Questions (FAQs)

What is this NIH/NIAMS funding opportunity about?

This opportunity from the National Institutes of Health (NIH), through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is intended to fund mechanistic ancillary studies that can be added onto clinical projects that are already underway. The goal is to support focused, time-sensitive research that uses the existing participants, samples, data, and operational infrastructure of an active clinical study to answer additional biological or disease-mechanism questions.

What does "mechanistic ancillary study" mean in this context?

In this FOA, a mechanistic ancillary study is a set of experiments or analyses designed to explain biological or disease mechanisms by building on an ongoing clinical effort. Rather than creating a new clinical project from scratch, the ancillary study "piggybacks" on a parent clinical project to add mechanistic endpoints or deeper laboratory and biomarker-oriented investigations.

What is the funding mechanism for this opportunity?

The award uses the NIH R01 mechanism.

Does this funding opportunity allow clinical trials?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed." The funded work is intended to be mechanistic and ancillary to an existing clinical project, not to initiate a new clinical trial under this application.

What kind of parent clinical project is required?

The ancillary study must attach to a parent clinical project that is already up and running and is either actively enrolling participants or actively collecting clinical data and/or biospecimens.

Can the parent project be an interventional clinical trial?

Yes. The parent project can be an interventional clinical trial, as long as it is already ongoing and provides the needed participants and infrastructure for the proposed ancillary mechanistic work.

Can the parent project be an observational or non-interventional clinical study?

Yes. The parent project can also be a non-interventional clinical study (for example, an observational cohort), as long as it provides a well-characterized participant group and the necessary infrastructure to support the ancillary study.

What infrastructure does the parent study need to have in place?

The parent project should already have established operational capabilities such as consent procedures, clinical assessments, data management systems, biospecimen collection and storage, and established workflows. The ancillary study is expected to leverage these existing resources rather than recreate them.

Why does the FOA emphasize time-sensitive research?

Ancillary studies can depend on narrow windows of opportunity. Examples include cohorts that are only available for a limited period, trials nearing completion, treatment exposure windows that are ending, or samples that can only be collected at specific visits. This FOA emphasized speed because missing those windows can make the ancillary science impossible or much less informative.

What is meant by an accelerated review and award process?

Applications under this FOA were intended to go through an accelerated review and award process to better match the time-sensitive nature of ancillary mechanistic studies that depend on ongoing clinical timelines.

What is the overall scientific goal of funding these ancillary studies?

The scientific goal is to increase the value of ongoing investments by extracting deeper mechanistic insight from clinical studies that are already funded (publicly or privately). By adding mechanistic analyses to an existing clinical framework, the work is meant to strengthen the parent study and produce findings that can help point toward better diagnostics, new treatment targets, improved prevention strategies, or more precise ways to classify disease.

What research areas are in scope for NIAMS under this opportunity?

The proposed mechanistic work should align with the NIAMS mission areas described in the FOA: arthritis and rheumatic diseases, musculoskeletal biology and diseases, and skin biology and diseases.

What types of mechanistic approaches are envisioned?

The FOA describes adding mechanistic endpoints or deeper laboratory, molecular, cellular, genetic, immunologic, or biomarker-oriented analyses within the existing clinical framework of the parent study.

Is the intent to fund a brand-new standalone clinical project?

No. The overarching intent is not to fund a new standalone clinical project. The intent is to add targeted mechanistic depth to an existing clinical effort to increase scientific return and advance understanding of NIAMS-relevant diseases and organ systems.

Who is eligible to apply?

The eligible applicant pool described in the FOA is broad and includes many U.S.-based organizations and governments. Eligible applicants include state, county, and city or 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 other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education institutions where applicable); for-profit organizations other than small businesses; and small businesses.

Are certain institution types specifically highlighted as eligible?

Yes. The FOA explicitly highlights additional eligible applicant categories, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can a foreign (non-U.S.) organization apply as the applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations/institutions) are not eligible to apply as the applicant organization under this FOA.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are not eligible to apply under this announcement.

Are collaborations or activities outside the U.S. allowed at all?

Yes, in a limited way. While foreign organizations cannot be the applicant, "foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This means a U.S. applicant could include certain foreign activities or collaborations if they meet NIH's definition and requirements for a foreign component.

What is the funding opportunity number?

The funding opportunity number is RFA-AR-19-006.

What is the CFDA number associated with this program?

The FOA is categorized under health research (CFDA 93.846).

What was the original closing date for this opportunity?

The original closing date listed for this FOA was April 2, 2019.

What is the award ceiling mentioned in the FOA?

The listed award ceiling was $300,000, indicating the upper bound on the amount NIH expected to provide per award under this announcement.

What does it mean that this is a discretionary grant program?

The FOA describes this as a discretionary grant program under NIH, within the health research category.

Why does NIH/NIAMS want applicants to leverage existing participants, samples, and data?

The FOA is designed to increase scientific return by using the existing people, samples, data, and operational setup already created by an ongoing clinical study. This allows the ancillary research to be more efficient, faster to launch, and feasible within narrow clinical timelines.