Which Attribute to Check in the E-IRB Application?
Checking boxes on your IRB application may not seem important, but they are key to identifying applicable regulatory requirements, branching logic in the application, and accurate reporting for the institution. Knowing whether an attribute applies to your research can be tricky, so check for tool tips and ask UK ORI for clarification when unsure. Also, the right hand column on the Research Attributes page provides links to guidance for the investigator.
One such nuanced selection is the broad category of Clinical Research and the sub-category of Clinical Trial. See the ORI FAQ for detailed definitions. The category of Clinical Research refers to a broad range of studies conducted in collaboration with human beings, undertaken to improve human health, e.g.,
- Translational research (in which laboratory and clinical activities are closely aligned)
- Clinical trials of diagnostic, preventive and therapeutic strategies
- Epidemiology
- Behavioral research
- Health services and outcomes research
In general, Clinical Trials typically involve a research intervention. To determine if your research is a Clinical Trial, we recommend the NIH Interactive tool below:
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