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).

Analysis of Existing Data or Specimens

If you're using private information, data, or specimens, your research may be exempt from the Code of Federal Regulations 45 Part 46. You may refer to the NIH Office of Extramural Research (OER) decision tool or consult with your institutional review board (IRB) or independent ethics committee (IEC).

The NIH expects broad data-sharing for funded research that produces large-scale human or non-human genomic data, as described in the supplemental information to the Genomic Data Sharing (GDS) Policy. Examples of data types within the scope of this policy include genomics such as genotyping, whole genome or exome sequencing, epigenomics, transcriptomics, and metagenomics.

The Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46 defines a human subject as: a living individual about whom an investigator (whether professional or student) conducting research:

For more information about the clinical researcher toolkit & educational materials, contact the Office of Clinical Trials Operations and Management at NIDCR-OCTOM@nidcr.nih.gov.

Potential applicants should contact the appropriate NIDCR Program Official prior to submitting grant applications that involve human subjects research.

Clinical Trial Definition

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.