NIH and NIDCR-Funded Human Subjects Research

NIH Human Subjects Research Policies and Terms

In addition to NIDCR-specific policies and terms described on this page, the 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 posted by the NIH Office of Extramural Research (OER) and the NIH Office of Science Policy (OSP).

NIDCR Clinical Terms of Award Policy

The National Institute of Dental and Craniofacial Research (NIDCR) Clinical Terms of Award (CToA) 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.

For information on determining whether a study involves human subjects, see Overview of Human Subjects Research.

Genomic Data Sharing (GDS) Policy

The NIH Genomic Data Sharing (GDS) Policy applies to all NIH-funded research (e.g., grants, contracts, and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. The NIDCR extends this expectation for certain projects producing genomic data, regardless of the number of specimens or participants.