U.S. Department of Health and Human Services

Human Subjects Research

The NIDDK is committed to the support of pivotal clinical studies and provides funding ranging from individual awards for career development and novel, exploratory studies to large multi-center trials. The NIDDK also offers access to research resources for the conduct of clinical studies. NIDDK-funded clinical investigators must follow both NIH and NIDDK policies for human subjects research.

Most research involving human subjects at NIH is supported through Investigator-initiated Research Project Grants (R01), NIH Parent R01: PA-13-302. Additional NIDDK-sponsored funding opportunities are described below.

Career Development Awards (K)

K awards support mentored career development for researchers. Researchers should have preliminary data on which to base their hypothesis-driven 3 to 5 year research projects in areas of interest to the NIDDK.

Support for Exploratory/Developmental Grants (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.

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

The NIDDK invites investigator-initiated (R01) applications for ancillary studies to certain ongoing large-scale clinical trials and epidemiological studies. See NIH Parent R01: PAR-12-265.

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

The NIDDK supports investigator-initiated, multi-center clinical studies through a two-part process: (1) an 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.

The 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 that specifically invite multi-center clinical studies. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 mechanism described above through the following disease-specific 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.