Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01 Clinical Trial Optional) | PAR 18 042

Opportunity Information: Apply for PAR 18 042

The grant opportunity "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01 Clinical Trial Optional)" is a National Institutes of Health (NIH) funding announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Its central purpose is to speed up and broaden research progress on diseases and conditions that fall within NIDDKs mission, especially work focused on understanding clinical course, improving prevention strategies, and developing or refining treatments. Rather than funding an entirely new, standalone clinical study, this program is built around the idea of adding high-value, scientifically distinct sub-studies onto large, already-running, multi-center clinical research efforts. In practical terms, it is meant to help investigators get more scientific mileage out of major existing clinical trials and prospective observational cohorts by asking new questions that the parent study was not originally designed to answer.

The mechanism for this opportunity is an R01 research project grant, and it is labeled "Clinical Trial Optional," meaning an application may or may not propose a clinical trial component depending on what the ancillary work requires. What makes an application eligible under this FOA is that it must be an ancillary study tied to a specific, active parent study that is already underway. The proposed ancillary project must involve collecting new information and/or new biological specimens directly from participants enrolled in that parent study. Importantly, the ancillary study has to go beyond the aims of the parent protocol: it must address research questions that are new, not simply add more data collection to complete the parent studies original objectives. At the same time, the new questions still need to fit squarely within NIDDKs scientific mission areas.

A key boundary in the announcement is that the FOA cannot be used to extend the duration of the parent study. In other words, applicants cannot use this award as a way to keep the main trial or cohort running longer than planned. The ancillary work should be designed to operate within the timeframe and structure of the existing study, leveraging its established recruitment, infrastructure, and follow-up procedures. Conceptually, NIDDK is prioritizing efficient research that takes advantage of the substantial investments already made in large clinical networks and cohorts, while allowing investigators to pursue additional hypotheses, add novel measurements, or obtain biospecimens that can open up new scientific directions.

Eligibility is broad and includes many types of institutions and organizations. Standard eligible applicants listed include state, county, 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; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Indian/Native American Tribal Governments that are not federally recognized. It further allows eligible federal agencies to apply, as well as faith-based and community-based organizations, regional organizations, non-U.S. entities (foreign organizations), and applicants located in a U.S. territory or possession. This wide eligibility reflects an intent to encourage participation from diverse research settings and communities, including groups and regions that are often underrepresented in clinical research leadership.

Administratively, the opportunity is categorized as discretionary grant funding, with activity areas spanning health and food and nutrition, and it is associated with CFDA number 93.847. The funding opportunity number is PAR 18 042, and the posting indicates an original closing date of 2019-01-07, with a creation date of 2017-11-01. While the source text does not specify an award ceiling or the expected number of awards, the overall structure suggests NIDDK is looking for well-justified, scientifically compelling add-on projects that can be executed efficiently because the participant population and study operations already exist.

In summary, this FOA is designed for investigators who have access to an ongoing large clinical trial or prospective observational study and who want to propose a distinct, NIDDK-relevant set of questions that require collecting new participant data and/or biosamples. The program is essentially a way to capitalize on existing study cohorts to generate new knowledge faster, without restarting recruitment from scratch, and without turning the award into a backdoor extension of the parent studies timeline.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2017-11-01.
• Applicants must submit their applications by 2019-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 042

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