Ancillary Studies in Immunomodulation Clinical Trials (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Ancillary Studies in Immunomodulation Clinical Trials (R01) opportunity?

This funding opportunity, RFA-AI-10-014, is an NIH program led by the National Institute of Allergy and Infectious Diseases (NIAID). It supports ancillary (add-on) mechanistic studies that are conducted alongside ongoing or planned clinical trials, with the goal of explaining how and why an intervention works (or does not work).

What does "ancillary study" mean in this context?

An ancillary study is a companion research project that leverages the setting, participants, and/or specimens from an existing or planned parent clinical trial. The ancillary work is intended to generate mechanistic or biomarker information without slowing down or disrupting the main clinical trial.

What is the main purpose of funding ancillary mechanistic studies?

The purpose is to improve interpretation of clinical trial outcomes by investigating immune mechanisms, biomarkers, immune pathways, correlates of protection, immune signatures of response, and related biological questions. These studies can help clarify efficacy, safety, and why participants may respond differently.

What kinds of clinical trials are intended to be paired with these ancillary studies?

The opportunity is designed for studies conducted alongside ongoing or planned clinical trials, particularly those evaluating immunomodulatory interventions for immune system-mediated diseases and clinical trials of preventive or therapeutic vaccines for infectious diseases other than HIV/AIDS.

What scientific areas are within scope for immunomodulatory interventions?

The scope includes immunomodulatory interventions used in immune system-mediated diseases, including (but not limited to) asthma and allergic diseases; graft rejection in solid organ, cell, and tissue transplantation; graft-versus-host disease following hematopoietic stem cell transplantation; and a wide range of chronic inflammatory, autoimmune, immunodeficiency, and other immune-driven conditions.

What vaccine-related trials are included in the scope?

The FOA supports ancillary mechanistic work in clinical trials of preventive or therapeutic vaccines for infectious diseases other than HIV/AIDS. It specifically includes vaccines relevant to NIAID Category A, B, and C biodefense agents and to emerging or re-emerging infectious diseases.

Is HIV/AIDS vaccine research included?

No. The vaccine component described in the opportunity is for infectious diseases other than HIV/AIDS.

What types of research questions are these ancillary studies expected to address?

Applicants are expected to use the clinical trial setting to answer mechanistic immunology questions, such as identifying immune pathways involved in response, evaluating biomarkers, determining correlates of protection, characterizing immune signatures linked to outcomes, and improving understanding of variability in responses and overall trial interpretation.

What is the grant mechanism for this opportunity?

The award mechanism is the NIH Research Project Grant (R01), which typically implies a well-developed, hypothesis-driven plan with clear aims, rigorous methods, and a strong analytical strategy.

What is distinctive about the review and award timeline?

This FOA emphasizes accelerated review and award timing so ancillary studies can start in sync with trial enrollment and specimen collection. NIAID indicates that highly meritorious applications may receive awards as early as about 13 weeks after the application receipt date, though holidays or other factors may shift the schedule.

Why is rapid handling emphasized for these awards?

Ancillary studies often need to launch quickly to align with the parent trial timeline. The accelerated approach is intended to prevent delays to the parent clinical trial and allow companion mechanistic work to begin when participants are enrolling and samples are being collected.

How much funding was NIAID planning to commit, and how many awards were anticipated?

NIAID planned to commit about $2,000,000 in Fiscal Year 2010 and anticipated making five to six awards, depending on appropriations and the availability of high-quality, fundable applications.

What is the listed award ceiling?

The opportunity data lists an award ceiling of $250,000.

Are awards guaranteed if an application is submitted?

No. As with most federal funding opportunities, awards depend on available appropriations and the submission of enough high-quality, fundable proposals.

Is cost sharing or matching required?

No cost-sharing or matching requirement is stated for this opportunity.

Who is eligible to apply?

Eligibility is broad and includes many domestic and non-domestic organizations, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and multiple levels of government (state, county, city/township, and special districts), as well as tribal governments and tribal organizations.

Are specific institution types explicitly included?

Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories and possessions, and foreign organizations.

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

Yes. Foreign organizations are explicitly included in the eligibility list.

What NIH institute leads this opportunity?

The opportunity is led by the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH).

Is this funding opportunity a renewal or update of an earlier solicitation?

Yes. It is positioned as a renewal, with updates, of an earlier solicitation (RFA-AI-08-011).

What are the key dates listed for the opportunity?

The source data indicates the opportunity was posted March 18, 2010, created June 28, 2010, and had an original closing date of June 9, 2010. A later listed current closing date is March 9, 2011, with an archive date of April 9, 2011.

Where was the full announcement hosted?

The full announcement was hosted on the NIH grants site under the RFA-AI-10-014 link.

Who should be contacted for technical access issues related to the announcement?

The contact information provided directs applicants with technical access issues to the NIH Office of Extramural Research (OER) webmaster.

What research areas does this opportunity align with?

The program aligns with health-related research areas including allergy, immunology, and transplantation, and it references related NIH program listings in the source data.

What is the overall aim of the program in practical terms?

In practical terms, the grant is aimed at teams that can use clinical trial infrastructure to run tightly integrated mechanistic immune studies that add interpretive power to immunomodulation and vaccine trials, supported by an unusually fast review-to-award pathway designed to keep pace with real-world trial timelines.