Is my case study considered human subjects research?
The information below will help determine if your project is considered human subjects research or not research. The requirements differ for the two types of case review projects.
Retrospective Case Study Review/Report
- Generally completed by a retrospective review of medical records that highlights a unique treatment, case, or outcome
- Often clinical in nature
- A report about five or fewer clinical experiences or observations identified during clinical care
- Does not involve biospecimens or FDA-regulated products (e.g., drugs, devices, biologics) that have not been approved for use in humans
- Does not include articles requiring exemption from FDA oversight
- Does not include articles under an IND/IDE
This type of project is considered Not Research at WVU.
Prospective Single Subject Case Study Review/Report
- Often social/behavioral in nature
- In-depth prospective analysis and report involving unique or exceptional observations or experiences about one, or a few, individual human subjects
- Is intended to contribute to generalizable knowledge