Is My Study Human Subject Research?

Human Subject Research

A research project must fulfill BOTH definitions of research and human subjects to require IRB review. If, after reading the definition of human subjects research (HSR), you are not sure if you need IRB review, please complete the Human Subjects Research (HSR) Determination Form for determination. Nonetheless, DU investigators are encouraged to submit their proposed research to the ORIE for determination of ethical and regulatory review requirements. The ORIE will provide the necessary documentation by issuing a formal letter for professional and academic endeavors.

Is My Study Human Subjects Research?

Research is defined in the Code of Federal Regulations, 45 CFR 46.102(d), as a systematic investigation designed to develop or contribute to generalizable knowledge.

Human subject is defined in the Code of Federal Regulations as "a living individual about whom an investigator conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

The project must meet the definition of both Research and Human subject to constitute Human Subjects Research.

All human subjects research must obtain IRB approval prior to study activities (that includes emailing participants, displaying or distributing recruitment materials, and obtaining participant consent).

If you assess your project as NOT human subjects research, or if you are unsure whether your project needs IRB review, you are strongly encouraged to complete the Human Subjects Research (HSR) Determination Form.