Initiating the Clinical Trial Application  |   Application Form and Guidelines  |   Conflict of Interest & Financial Disclosure  |   IRB Oral Presentation Guidelines  |   Application FAQs

Listed below is the information that you will need to present your protocol to the Institutional Review Board. Remember, your presentation is a summary. You will want to keep the information short and the whole presentation around 10 minutes. You will need to present:

1. Objective of the Study
   
2. Rationale for the study: Why is it being done?
3. Research subjects:
   
   • Disease condition, inclusion & exclusion criteria
     
   • Number to be enrolled at this site
     
   • Total number to be enrolled in the study
     
   • Are the subjects considered vulnerable?
     
4. Any unusual aspects about the process of informed consent (i.e. subjects will be decisionally impaired; request waiver of requirement for assent for minor subjects, etc.)
   
5. Study sponsor
   
6. Potential benefits to subjects
   
7. Potential risks to subjects, with estimated probabilities (i.e. very unlikely, likely, highly likely)
   
8. Investigator’s assessment of the risk-benefit ratio
   
9. Anything else the IRB should know