Revision Date: 2023.12.15
Table of Contents
| Table of Contents | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
...
Determine if the project meets the definition of Research as defined by the U.S. Department of Health and Human Services regulation.
IRB review and approval is required for projects that:
...
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(l))
A Systematic Investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:
...
Are Human Subjects Involved? (45 CFR 46.102(e))
A Human Subject is a living individual about whom an investigator conducting research obtains:
...
If yes, the last step is to determine whether full board review is required or if the project may be eligible for an exemption determination.
Reference the following decision charts to determine whether the protocol may be considered exempt. All project activities must fit within one or more of the exemption categories defined at 45 CFR 45.104. If the research does not fit strictly within these categories, the project is not eligible for exemption.
...