Analysis of Existing Data or Specimens - Planning & Startup


The NIH defines clinical research as research with human subjects that is:

  • Patient-oriented research: research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.
  • Epidemiological and behavioral studies.
  • Outcomes research and health services research. 1

The 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.

The NIDCR evaluates each project independently to determine oversight needs.

Clinical Terms of Award

Resources Description
Clinical Terms of Award The NIDCR policy that applies to grants involving human subject research.

Definition and Tools

Resources Description
Definition of Human Subjects Research This provides a link to the Office of Extramural Research, Human Subjects Research resources and includes the definition of Human Subjects research as codified by 45 CFR part 46.
Decision Tool: Am I Doing Human Subjects Research? This decision tool is used to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research. This tool should not be used as the sole determination of exemption.
Last Reviewed
June 2021