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Human Subjects Research

NIDDK funds pivotal clinical research through the activity codes outlined below. Before applying you must first determine whether NIH defines your research as human subjects research or a clinical trial. NIDDK strongly recommends that you contact the Program Director responsible for your area of research.

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.

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.

Human Subjects or Clinical Research (R01): One or Two Sites

For studies that involve up to two investigator sites, R01s may be used. View the NIH parent R01 FOA (PA-16-160) or specific FOAs issued by 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).

Three or more centers must be involved in the actual conduct of the study. A study will not be considered multi-center if participant recruitment occurs at three or more locations but all interventions or outcomes assessments are performed by a single study team.

For more information on the U34, view NIDDK’s U34 page, PAR-15-068, and NOT-DK-14-025.

For more information on the U01, view NIDDK’s U01 page, PAR-15-067, and NOT-DK-14-025.

Investigator-initiated Ancillary Studies to Major Ongoing Clinical Studies

NIDDK accepts study proposals that expand upon the scope of major ongoing clinical studies. The proposed studies may require additional data or sample collection but may not interfere with the primary objectives of the main study. View PAR-16-034.

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 support for researchers who are interested in using these resources in their clinical studies. View PAR-14-301.

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NIH Resources