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)

NIDDK will support investigator-initiated, multi-center clinical studies through a two-part process: (1) an optional implementation planning (U34) cooperative agreement followed by (2) a cooperative agreement (U01) to conduct the study. Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. This policy applies to all clinical studies, interventional trials as well as observational studies, conducted at three or more centers. A study is considered to be "multi-center" if three or more sites are involved in the actual conduct of the study. A study will not be considered to involve multiple centers if participant recruitment occurs at three or more locations in a geographic area but all interventions and/or outcomes assessments are performed by a single study team.

NIDDK will not accept applications for multi-center clinical studies that are submitted as R01s, with the exception of ancillary studies to existing cooperative agreements, which can be submitted as R01s to PAR-12-265: Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) (http://grants.nih.gov/grants/guide/pa-files/PAR-12-265.html), or applications submitted in response to other/future FOAs. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 mechanism, through the appropriate program announcements: 

Potential U34 or U01 applicants are strongly encouraged to contact NIDDK program staff at least 12 weeks before the receipt date, and to read the information provided on the following pages before applying:
Applicants are reminded that NIH requires pre-approval of applications requesting $500,000 or more in direct costs (excluding consortium F&A) in any year.

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.