Ancillary Studies to Large Ongoing Clinical Projects (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Ancillary Studies to Large Ongoing Clinical Projects (R01) opportunity?

This is a National Institutes of Health (NIH) funding announcement (RFA-AR-10-010) that supports ancillary (add-on) research that can be embedded within an already active, large clinical effort. The ancillary work must align with the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and is intended to leverage existing clinical investments that are already underway.

What does "ancillary study" mean in this funding opportunity?

An ancillary study is a focused add-on project that "plugs into" a suitable ongoing clinical trial, observational cohort study, or disease registry. Instead of starting a new study from scratch, the ancillary study uses the parent project's established participant cohort, operational infrastructure, existing data streams, and (when available) stored or prospectively collected biological samples.

What kinds of parent projects can an ancillary study be attached to?

The parent project should be an already active, large clinical effort such as an ongoing clinical trial, an observational cohort study, or a disease registry that can support additional rigorous scientific questions relevant to NIAMS disease areas.

What is the main goal of this FOA?

The goal is to maximize the scientific return on investment from major clinical projects that are already in progress. NIAMS is looking for ancillary studies that strengthen and extend the scientific yield of the parent effort and deepen understanding of diseases or organ systems within the NIAMS portfolio, with potential to inform future diagnosis, treatment, and prevention approaches.

Why does the announcement emphasize speed and timing?

A defining feature of this FOA is that the proposed ancillary research must be genuinely time sensitive. This means there is a limited window of opportunity to collect key measurements, connect outcomes to a particular follow-up phase, capture transient exposures, or add specimen collection while participants are still being seen under the parent protocol.

What makes an ancillary study "time sensitive" under this opportunity?

Time sensitive studies are those where waiting would make the research infeasible or reduce its value because the needed data or samples can only be collected during a specific period while the parent project is ongoing (for example, during a particular phase of follow-up or while certain visits are still occurring).

Does NIH indicate anything about review and award speed?

Yes. Because of the time-sensitive nature of these ancillary studies, NIH indicates that submissions under this announcement will be handled through an accelerated review and award process.

How important is the remaining duration of the parent project?

It is critical. Since the parent study is already in motion, the application must clearly show that the parent project has enough remaining duration and active operations to accommodate the ancillary work. The ancillary activities need to fit within the parent project's schedule and milestones.

Is a timeline required in the application?

Yes. Every application must include a concrete timeline showing when the ancillary activities will occur relative to the parent project’s schedule and milestones.

What permissions or documentation are required from the parent project?

Applicants must document explicit permission from the parent project leadership to access and use the cohort, associated clinical data, and any relevant biological materials. The expectation is that access is clearly authorized, not implied.

What operational considerations does NIAMS expect applicants to address?

The ancillary study must fit the parent project's real-world constraints, including participant burden, visit schedules, consenting constraints, data governance, specimen handling, and oversight arrangements. The application should show the ancillary work can be executed cleanly without disrupting the parent project.

Is scientific merit the only evaluation focus?

No. The FOA emphasizes both scientific merit and operational feasibility, including whether the ancillary study can be carried out without disrupting the parent study while still producing meaningful additional value.

What types of activities or data additions are examples of a strong ancillary study?

The FOA highlights examples such as adding new assays, substudies, mechanistic measures, biomarkers, imaging, patient-reported outcomes, genetics or other omics, or other high-value data. The intent is to collect information that would be difficult or impossible to gather later.

Does the ancillary study need to be more than a minor add-on?

Yes. The ancillary study is expected to materially enhance what can be learned from the parent project, not serve as a minimal or low-impact addition.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 mechanism.

What is the program area or category for this grant?

It is a health-related grant opportunity associated with NIAMS and CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).

How much funding is available and what is the award ceiling?

The estimated total funding is $1.5 million, and the award ceiling is $250,000.

Is cost sharing or matching required?

No. The opportunity states that no cost sharing or matching is required.

When was this opportunity posted and when does it close?

The opportunity was posted on April 29, 2009. The original and current closing date is April 1, 2010. The archive date is May 2, 2010.

Who is eligible to apply?

Eligibility is broad and includes many organization types, including public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities other than institutions of higher education); for-profit organizations (including small businesses and for-profits other than small businesses); independent school districts; and multiple levels of government (state, county, city/township, and special district governments), as well as public housing authorities/Indian housing authorities.

Are minority-serving institutions and tribal entities included in eligibility?

Yes. The eligible applicant categories listed include Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, and tribal governments (including federally recognized tribes and other tribal entities as specified). The list also includes regional organizations and U.S. territories or possessions.

Are faith-based or community-based organizations eligible?

Yes. The eligibility list includes faith-based or community-based organizations.

Are federal agencies eligible applicants?

Yes. The announcement includes eligible federal agencies among the eligible applicant categories.

What does NIAMS expect investigators to demonstrate in their application?

The FOA is intended for investigators who can show urgency and readiness: a strong and well-justified scientific question, a clear rationale for why the work must be done now, a workable plan aligned with the parent study’s remaining timeline, and documented access to the needed participants, data, and specimens through permission from the parent project leadership.

What is the core advantage of this funding model compared to starting a new clinical study?

The core advantage is efficiency and feasibility: rather than building a new recruitment pipeline and study infrastructure, the ancillary study leverages an existing cohort, established operations, and existing data and samples, allowing investigators to answer high-value questions within a limited time window.