Human Subjects Research
NIDDK funds human subjects research—including clinical studies and trials—through various funding mechanisms. Before you apply to a funding opportunity announcement (FOA), take the following steps.
- NIDDK strongly recommends that you contact the Program Director responsible for your area of research before you submit an application. We recommend this contact occur at least 12 weeks prior to any planned submission.
- Determine if your research is appropriate for NIDDK or another NIH Institute or Center. Prospective applicants may find the RePORTer matchmaker tool useful.
- Determine if your research involves human subjects with the help of NIH’s Am I Doing Human Subjects Decision Tool or Private Information or Biological Specimens Decision Chart (PDF, 26 KB) , or your Institutional Review Board or Independent Ethics Committee. Your research may involve human subjects even if you are not working directly with human participants.
Determine if your research is a clinical trial. In January 2018, NIH instituted new policies regarding applications for clinical trials. The NIH definition of a clinical trial is broadly interpreted to encompass both therapeutic clinical trials, as well as mechanistic trials. Studies that have previously been considered physiologic studies or basic behavioral and experimental studies may now be considered clinical trials. Additional information about the NIH definition of a clinical trial, including case studies and FAQs, is available on the NIH website.
One of the most important policy changes is that FOAs now specify whether applications involving clinical trials are allowed. If your proposed clinical trial falls within the research areas and mission of NIDDK, you may be able to submit your application to either PA-20-183 (for therapeutic and mechanistic clinical trials) or PA-20-184 (for basic experimental studies with humans).
Additional NIH policies to keep in mind include
- Select an appropriate FOA and read it carefully. Many FOAs have unique requirements.
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.
Funding Mechanisms for Human Subjects Research
Pilot & Feasibility Clinical Studies (Small R01s)
NIDDK supports small R01s for pilot and feasibility clinical trials within the mission of NIDDK through PAS-20-160. Applications to this Funding Opportunity Announcement are limited to three years and $200,000 in direct costs per year. Proposed studies should be designed to acquire preliminary data regarding the effects of the intervention, as well as feasibility data related to recruitment and retention, and study conduct. Preliminary data regarding intervention efficacy are not required.
Clinical Research Considered Low-Risk (R01)
For clinical studies that involve only one center, or involve low-risk studies at more than one center, R01s may be used. A single clinical research center may encompass one or more physical locations where the clinical trial is being conducted—i.e., where study participants are recruited, intervened upon, or have outcomes assessed under a single protocol—as long as all locations are under the overall direction of a single investigator. A multi-center study is classified as “high risk” if it utilizes either a high-risk intervention and/or invasive measures or has high operational risk, or both. Please review NOT-DK-20-051 for additional information on what is considered a low-risk versus a high-risk study.
High-Risk Multi-center Clinical Studies (U34/U01)
For high-risk clinical studies (see NOT-DK-051) that involve more than one research centers, NIDDK uses a two-part process that usually requires use of a U34 planning grant followed by a separate application for the clinical trial or study (U01). A single clinical research center may encompass one or more physical locations where the clinical trial is being conducted—i.e., where study participants are recruited, intervened upon, or have outcomes assessed under a single protocol—as long as all locations are under the overall direction of a single investigator.
Investigator-initiated Ancillary Studies to Major Ongoing Clinical Studies
NIDDK encourages ancillary studies to its large multi-center clinical trials and clinical studies. These major studies offer unique opportunities to conduct additional investigations that are not part of the parent protocol. These new studies must be within the mission of NIDDK. Applications for ancillary studies must have the approval of the parent study and may be submitted to PA-20-185 or other appropriate FOAs.
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 access for researchers who are interested in using these biosample resources in their clinical studies. View PAR-19-319.
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.