Clayton State University IRB

Question 3: Does your proposed research meet the definition of clinical research?

The NIH defines Clinical Research as:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
2. Epidemiologic and behavioral studies.
3. Outcomes research and health services research.

Clinical research that does not meet the criteria for a clinical trial or an NIH-defined Phase III clinical trial must follow the instructions in Scenario D.

Research projects that meet the criteria for Exemption 4 are not considered "clinical research." Investigators who propose research that meets the criteria for Exemption 4 must follow the instructions provided in Scenario B.

Guidance and Additional Instructions

If you answered "Yes" to Question 3, then proceed to Question 4 and Question 5 to determine whether your research meets the criteria for a clinical trial or an NIH-defined Phase III clinical trial.

If you answered "No," then you need to consider an alternative Scenario. Return to the PHS 398 Instructions Decision Table for Section E.