U.S. Department of Health and Human Services

Human Subjects Research

NIDDK follows all NIH policies​ related to clinical and human subjects research. Additional information about NIDDK clinical research programs, associated policies, and the NIDDK Central Repository​ is provided below.

Most research involving human subjects at NIH is supported through Investigator-initiated Research Project Grants (R01), NIH Parent R01: PA-13-302.

NIDDK-Specific Funding​ Mechanisms for Clinical Research Studies

Investigator-initiated Ancillary Studies to Major Ongoing Clinical Studies (R01)

NIDDK invites investigator-initiated (R01) applications for ancillary studies to certain ongoing large-scale clinical trials, epidemiological studies and disease databases supported by the Institute.

Support for Exploratory/Developmental Grants (R21)

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

Investigator-initiated Multi-center Clinical Studies (U34/U01)

These studies are supported through a two part grant process. First an implementation planning grant (U34) is awarded followed by a cooperative agreement (U01) to conduct the study. Potential applicants are encouraged to read the information provided on the following pages before applying:

Most applicants will have had a U34 before applying for a U01. If you are seeking an exemption from the U34 requirement, please read the information on U01 Multi-center Clinical Studies.

Support for Use of NIDDK Central Repository Materials

The NIDDK invites investigators to apply for access to non-renewable samples from the NIDDK Central Repositories. Information about available samples and current funding opportunity announcements (FOAs) can be found at https://www.niddkrepository.org.

NIDDK Clinical Research Policies

The following policies apply to all grantees conducting human subjects research.

Resources for Clinical Researchers

The NIDDK Central Repository provides data and biosamples collected from current and previously funded NIDDK studies.

NIDDK Research Centers provide core services and funding for pilot and feasibility studies. View the individual centers pages below for more information and contact information for NIDDK program directors.