Ancillary Studies in Clinical Trials (R01) | Apply Online

Frequently Asked Questions (FAQs): Ancillary Studies in Clinical Trials (R01) - RFA-HL-09-001

What is this funding opportunity?

This NIH funding opportunity, titled "Ancillary Studies in Clinical Trials (R01)" (Funding Opportunity Number RFA-HL-09-001), supports time-sensitive ancillary research that can be conducted alongside an existing clinical trial. The intent is to use an active NIH- or non-NIH-supported clinical trial as a platform to address additional, closely related scientific questions without starting a brand-new trial.

What is meant by an "ancillary study" in this program?

In this program, an ancillary study is additional research that leverages the participants, infrastructure, and follow-up schedule of an ongoing clinical trial to collect extra measurements, conduct sub-studies, perform additional analyses, or obtain specimens. The ancillary work is meant to complement the parent trial and increase the scientific value of the existing trial platform.

Is this grant intended to fund a clinical trial itself?

No. The FOA is not intended to fund the parent clinical trial. It is specifically designed to support ancillary measurements, sub-studies, analyses, or specimen collection that are added onto an existing clinical trial.

Why does the FOA emphasize that studies must be "time-sensitive"?

The program is geared toward projects that need to be initiated while the parent trial is still enrolling participants, delivering an intervention, or collecting outcomes. This timing matters because ancillary data or specimens often must be collected at specific moments during trial operations in order to be valid and useful.

What scientific areas are within scope for this FOA?

The ancillary research must align with the mission areas described in the FOA: heart, lung, and blood diseases, as well as sleep disorders. The scope is associated with the NHLBI mission areas and the National Center on Sleep Disorders Research.

What NIH grant mechanism is used for this opportunity?

The mechanism of support is the NIH Research Project Grant (R01).

What kind of project is expected under an R01 for this FOA?

Applicants are expected to propose a well-developed, hypothesis-driven research plan with clear aims, strong methods, and a feasible approach for integrating the ancillary study into the operations of the ongoing (parent) clinical trial.

Do ancillary studies have to be tied to an existing clinical trial?

Yes. The central design of this opportunity is to conduct the ancillary research alongside an existing clinical trial that is already active and supported by NIH or by a non-NIH source.

What kinds of activities might the grant support?

Based on the FOA description, supported activities may include additional measurements, sub-studies, analyses, and/or specimen collection that complement the parent trial and extend the scientific value of the trial cohort and infrastructure.

How much funding did NHLBI plan to commit, and how many awards were expected?

NHLBI indicated an intent (contingent on appropriations and application quality) to commit about $1.6 million in FY 2009 to support an estimated 4 to 5 new grants, and about $3.2 million in FY 2010 to support an estimated 8 to 9 new grants.

Are those funding levels guaranteed?

No. The FOA notes that these figures reflect plans rather than guarantees. Awards depend on the availability of funds and the receipt of a sufficient number of strong, meritorious applications.

Who is eligible to apply?

Eligibility is broad. The FOA lists eligible applicants across many organization types, including public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (including small businesses); local and state governments; U.S. territories or possessions; and other public entities such as independent school districts and housing authorities.

Are community-based and faith-based organizations eligible?

Yes. The eligibility list explicitly highlights community-based and faith-based organizations among eligible applicant types.

Are tribal governments and tribal organizations eligible?

Yes. The FOA includes federally recognized tribal governments and also other tribal governments and organizations, as well as tribally controlled colleges and universities.

Are minority-serving institutions included in the eligibility list?

Yes. The FOA highlights several categories of minority-serving institutions, including HBCUs, Hispanic-serving institutions, and Alaska Native and Native Hawaiian-serving institutions.

Can foreign (non-U.S.) organizations apply?

Yes. Foreign (non-U.S.) entities are included among eligible applicants, indicating that international organizations may apply when appropriate, presumably in collaboration with or in relation to qualifying clinical trials.

Is there a cost sharing or matching requirement?

No. The FOA specifies that there is no cost sharing or matching requirement.

What are the key dates for this funding opportunity?

The posted date is October 3, 2008. The original and current closing date is September 30, 2009. The archive date is October 31, 2009.

What is the funding activity category?

The funding activity category is health.

Which CFDA numbers are associated with this opportunity?

The FOA lists CFDA 93.233 (sleep disorders research) and CFDA 93.837, 93.838, and 93.839 (cardiovascular, lung, and blood research programs).

Which agency sponsors this FOA?

The sponsoring agency is the National Institutes of Health (NIH).

Where was the full announcement made available?

The FOA states that the full announcement was made available through the NIH grants guide at the provided link.

Who should be contacted for technical issues with accessing or linking to the announcement?

For technical issues accessing or linking to the announcement, the FOA lists the NIH Office of Extramural Research webmaster as the contact: FBOWebmaster@OD.NIH.GOV.