Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the purpose of this funding opportunity (PAR 16-034)?

This opportunity funds ancillary studies that add new scientific value to major, already-ongoing clinical research studies. The intent is to accelerate discovery by leveraging the existing infrastructure of a large, multi-center parent study (for example, its participant population, site network, established follow-up schedule, and data systems) rather than funding an entirely new standalone clinical trial or cohort study.

What does "ancillary study" mean in this FOA?

In this FOA, an ancillary study is a research project that "rides along" with an existing major ongoing clinical research study but asks new scientific questions that are not already included in the parent study's approved protocol. It is not a continuation of the parent study's original aims, and it is not meant to replace or duplicate what the parent study is already doing.

What is the grant mechanism for this opportunity?

The mechanism is an NIH R01 discretionary grant. The FOA title is "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" and the Funding Opportunity Number is PAR 16-034.

What kinds of parent studies can an ancillary study attach to?

The FOA allows ancillary studies attached to major ongoing multi-center clinical trials and to major ongoing prospective observational studies, as long as the parent study is active/ongoing and large/multi-center in nature.

Does the parent study need to be ongoing at the time of application?

Yes. The parent study must be ongoing. The ancillary project is intended to operate within the active window of an existing major clinical research effort.

What is the central scientific requirement for the proposed ancillary work?

The proposed research must be scientifically new relative to the parent study's approved protocol. In other words, it must ask questions the parent study is not already designed to address, and it must collect new information and/or new biological samples directly from participants who are already enrolled in the parent study.

Is the ancillary study required to collect new data and/or new biospecimens?

Yes. A central requirement is that the application proposes collecting new participant-level information and/or new biological samples from enrolled participants in the parent study. The FOA emphasizes adding assessments and specimen collection that go beyond what the parent protocol already covers.

What are examples of allowable new data collection activities?

Examples described include adding additional assessments, measurements, questionnaires, imaging, physiologic testing, or new biospecimen collection. The FOA also notes that this can occur during existing study visits or at strategically planned timepoints that fit within the parent study's operational window.

What are examples of allowable biospecimens?

The FOA provides examples such as extra blood draws, urine samples, stool samples, or other specimens, collected directly from participants in the parent study.

Does the ancillary study have to use the parent study's existing visit schedule?

The FOA indicates the ancillary work will often be carried out during existing parent study visits or at strategically planned timepoints that fit within the parent study's operational window. The overall design must fit within the timeframe and structure of the parent study.

Can this FOA be used to fund a brand-new standalone clinical trial or cohort study?

No. This FOA is described as supporting projects that build onto an existing major ongoing clinical research study rather than funding an entirely new standalone clinical trial or cohort study.

Can this FOA be used to extend the duration of the parent study?

No. A key limitation is that this FOA cannot be used to extend the duration of the parent study. The ancillary award cannot be used to keep the main study running longer or to preserve core operations beyond the parent study's planned end date.

Can the ancillary award be used as bridge funding to continue the parent study's operations?

No. The FOA draws a clear boundary against using the ancillary award to operationally sustain or continue the parent study. The ancillary project must be designed so it can be completed without requiring the parent study to be prolonged.

What scientific areas are considered within NIDDK's mission for this FOA?

The ancillary study must fall within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The FOA describes this scope broadly as including diabetes, endocrinology and metabolism, digestive diseases, nutrition-related research, and kidney and urologic diseases.

What is the listed funding activity category?

The listed funding activity category for the opportunity is Food and Nutrition, Health.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.847 (Diabetes, Endocrinology and Metabolic Research) and 93.848 (Digestive Diseases and Nutrition Research).

Who is the sponsoring agency for this FOA?

The sponsoring agency is the U.S. Department of Health and Human Services under the National Institutes of Health (NIH), listed as HHS-NIH11. The participating institute highlighted in the FOA description is NIDDK.

What types of organizations are eligible to apply?

Eligibility is broad and includes standard NIH-eligible organizations, including (as listed): state, county, city/township, and 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility text.

Is this opportunity limited only to universities?

No. The eligibility list includes a wide range of organization types beyond institutions of higher education, including governments, tribal entities, nonprofits, for-profits, and small businesses.

What is the main advantage of proposing an ancillary study under this FOA?

The FOA is designed to efficiently answer additional high-value scientific questions by leveraging an existing clinical research backbone. The advantage is that recruitment, site networks, data systems, and follow-up schedules are already in place, allowing the ancillary study to broaden what can be learned without standing up a new major clinical research platform.

What date was this opportunity posted and created?

The opportunity was posted and created on November 6, 2015.

What was the listed closing date for the referenced cycle?

The listed closing date for the referenced cycle was January 7, 2019.

What is the overall "fit test" for whether a project belongs under this FOA?

Based on the description provided, a project fits when it (1) is a true ancillary study to a major ongoing multi-center clinical research study, (2) proposes new scientific questions not already covered by the parent protocol, (3) collects new participant-level data and/or new biospecimens from enrolled participants, (4) aligns with NIDDK mission areas, and (5) can be completed within the parent study's timeframe without extending or sustaining the parent study.