Levels of Review
Before submitting a protocol for review, the PI should determine whether the proposed protocol meets the definition of human subjects’ research as defined by the Federal regulations key definitions:
- Research: a systemic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (CFR 46.102.d)
- Human Subject(s): Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (CFR 46.102.F)
There are three levels of review:
The PI must decide and checkmark the review level on the IRB Application Form that best pertains to the intended research.
Case Studies are comprised of one or more cases collected and presented to highlight an interesting condition, treatment, presentation or outcome. What type of review does this require by the IRB?
If the “study” includes a hypothesis, methods/procedures, analysis and/or an outcome, it’s probably research. In this case, IRB approval should be obtained prior to the beginning of any human subject participation.
A true case study is something that is only used to present interesting information to an audience. There is no systemic analysis done. If this describes the planned “study,” the IRB should provide a simplified, “exempt” review focused on the protection of the identity of the person on whom the study is presented. The Principal Investigator of the case study is required to submit a Case Study Form, consent documents (if applicable) and CITI training certificates for all investigators to the IRB.