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Human Subjects Research

The NIH has instituted new policies regarding applications for clinical trials. The NIH definition of a clinical trial is being broadly interpreted to encompass both therapeutic clinical trials, as well as mechanistic trials. Studies that have previously been considered physiologic studies or basic behavioral studies may now be considered clinical trials.

Additional information about the NIH definition of a clinical trial, including case studies and FAQs, is available on the NIH website.

One of the most important policy changes is that, starting Jan. 25, 2018, the parent NIH R01 FOA will no longer accept clinical trial applications. If your proposed clinical trial falls within the mission of NIDDK, you may be able to submit your application to PA-18-330 (see below). Additional policies include:

NIDDK strongly recommends that you contact the Program Director responsible for your area of research before submitting an application proposal.

If you are applying for or have already received a clinical research grant you must follow both NIH and NIDDK policies for clinical research. You can also review the wide range of NIDDK Research Resources to help clinical researchers work more efficiently, lower costs, and improve effectiveness.

NIDDK funds pivotal clinical research through the application mechanisms outlined below.

Pilot/Feasibility Clinical Studies (R21)

The R21 mechanism provides support for exploratory, short-term clinical studies that investigate new ideas and novel approaches with less stringent requirements for preliminary data. Short-term studies should focus on research questions that are likely to have high clinical impact. Funding is provided through a series of disease-specific Funding Opportunity Announcements (FOAs). View open R21 FOAs from NIDDK.

Clinical Research (R01): One or Two Sites

For studies that involve up to two investigator sites, R01s may be used.  

Clinical trials within the mission of NIDDK that involve one or two sites may use PA-18-330 or other appropriate FOAs from NIDDK.

Observational studies or other types of human subjects work that is not a clinical trial that involve one or two sites may use the parent NIH R01 FOA or specific FOAs from NIDDK

Multi-center Clinical Studies: Three or More Sites (U34/U01)

For studies that involve three or more investigator sites, NIDDK uses a two-part process that usually requires use of a U34 planning grant followed by a separate application for the clinical trial (U01).

For more information on the U34, view NIDDK’s U34 page, PAR-18-423, and NOT-DK-14-025.

For more information on the U01, view NIDDK’s U01 page, PAR-18-414, PA-18-415, and NOT-DK-14-025.

Investigator-initiated Ancillary Studies to Major Ongoing Clinical Studies

NIDDK encourages ancillary studies to its large multi-center clinical trials and clinical studies. These major studies offer unique opportunities to conduct additional investigations that are not part of the parent protocol. These new studies must be within the mission of NIDDK. Applications for ancillary studies must have the approval of the parent study and may be submitted to PA-19-056 or other appropriate FOAs. 

Biosamples for Use in Research (X01)

Many of the large clinical studies funded by the NIDDK collect non- renewable biosamples, such as plasma and urine, and associated data for analysis and future study. Biosamples are stored in the NIDDK Central Repository. The X01 mechanism provides access for researchers who are interested in using these resources in their clinical studies. View PAR-17-270.

Related Links

NIH Resources