Definitions for IRB Review
The following are definitions to determine if IRB review is required, pulled from [45 CFR 46.102(e)].
- Determine if your project meets the definition of “Research”: “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.”
- If your project is “Research”, then determine if it will involve data collection from any “Human subject”: “a living individual about whom an investigator (whether professional or student) conducting research that:
- Obtains information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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. Investigators who proceed with human subjects research without approval will be held liable. Investigators should review the decision tools below then contact the HSRO for a determination on whether or not their activity is research.*
*Note: many journals require a formal IRB determination before they accept research for publication.
These decision tools are provided to help understand the HSRO determination: