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 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.
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.
Investigator-initiated Ancillary Studies to Major Ongoing Clinical Studies
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.
Research involving human subjects at NIH.
Allows researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands.
Helps NIH applicants and grantees understand their roles and responsibilities in relation to the Food and Drug Administration Amendments Act (FDAAA) of 2007.
Easy access to information on publicly and privately supported clinical studies.
OHRP provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by HHS.