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 NIDCR Clinical Terms of Award (CToA) policy applies to all NIDCR-funded research that meets the definition of human subjects research. 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.

NIDCR Data & Safety Monitoring of Clinical Research Policy

The NIDCR has established a process for the appropriate oversight and monitoring of the conduct of NIDCR-supported clinical research. This policy helps to ensure the safety of participants, the validity and integrity of the data, the appropriate conduct of the study, and the availability of data in a timely manner.

For more information see the NIDCR Data and Safety Monitoring Policy.

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.