Human Subjects Research

Research and Human Subjects

According to UIS HRP policy, it is the investigator’s responsibility to determine whether or not their activity meets the definition of human subjects research and therefore subject to the regulation of the IRB.

Definitions

[45 CFR 46.102(e)]

“Human subject

means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the

individual, and, uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

 

Research

means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.”

Decision Tree

See the HHS OHRP webpage for a graphical and textual decision tree.

Decision Process

Investigators who proceed with human subjects research without approval will be held liable. When in doubt, investigators should contact the HSRO for a determination on whether or not their activity is research. For a formal determination,* use the Decision Request form. (doc)

 

*Note: some journals require a formal determination before they accept research for publication.