NIH and NIDCR Human Subjects Research & Clinical Trial Policies and Expectations
Am I Conducting Human Subjects Research?
The NIH Office of Extramural Research (OER) has developed a quick decision tool that can assist investigators with determining whether research involves human subjects, may be considered exempt from federal regulations, or is not considered human subjects research.
If you have questions about whether your application involves human subjects, consult with your NIH Program Official or ask your institutional review board (IRB) or independent ethics committee (IEC).
Resources for NIH- and NIDCR-funded Human Subjects Research
In addition to NIDCR-specific policies and terms described on this page, NIDCR adheres to NIH-wide policies for investigators conducting clinical research. To learn about NIH initiatives, policies, and resources related to clinical research, see the information provided by the NIH Office of Extramural Research and the NIH Office of Science Policy. In addition, the Office of Research on Women’s Health provides an NIH Inclusion Outreach Toolkit.
The National Institute of Dental and Craniofacial Research (NIDCR) Clinical Terms of Award policy applies to all grants and cooperative agreements conducting human subjects research that have been determined by NIDCR to need additional oversight. This includes studies that will enroll human subjects to collect new data, and studies that use previously collected data or specimens that can still be linked to living individuals.
NIH has a longstanding commitment to scientific data sharing. Responsible data management and sharing have many benefits, including accelerating the pace of biomedical research, enabling validation of research results, and providing accessibility to high-value datasets. NIDCR prioritizes the public sharing of scientific data and promotes the secondary use of data to drive advances in dental, oral, and craniofacial research areas. Read more about the scientific data sharing policies that may be applicable to your research.
In addition to study preparedness and data and safety monitoring, NIDCR sets the expectation for human subjects accrual and retention monitoring. For extramural studies, the institute’s implementation of standardized accrual and retention monitoring is communicated through the NIDCR Clinical Terms of Award.
Additional Resources for NIH- and NIDCR-funded Clinical Trials
NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. These interventions include drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
See the NIH Definition of a Clinical Trial for further details, including case studies and frequently asked questions (FAQs).
NIDCR adheres to NIH-wide policies for investigators conducting clinical trials. To learn about new NIH initiatives, policies, and resources related to clinical trials, see the information posted by the NIH Office of Extramural Research and the NIH Office of Science Policy.
The NIH clinical trial policies are applicable to social and behavioral studies that meet the NIH definition of a clinical trial. Please visit the Office of Behavioral and Social Sciences Research for more information.