UNIVERSITY OF ST. THOMAS Institutional Review Board (IRB)

CHECKLIST FOR INVESTIGATORS (Application Will Be Returned If Not Complete)

Print this document for your own reference.

You must make a preliminary judgment about the level of review required for your application. The chair will then determine the level of review after submission and contact you if additional copies are required.

1. The application includes a  brief lay abstract (no more than 2 pages) stating the purpose 
         of the study.
   
   
2. The abstract includes a description of tasks the subjects will be asked to complete.
   
   
3. The application and consent forms includes a full description of anticipated risks and 
        benefits of study participation.
   
   
4. Provisions have been made to minimize risks and those procedures are outlined on the 
        application and consent forms.
   
   
5. Provisions have been made and documented to care for subjects in case of accident or 
        injury.
   
   
6. Procedures to maintain confidentiality have been fully described.
   
   
7. Provisions have been made to obtain informed consent from all individuals related to the 
        study. (e.g., parents, subjects, cooperating institutions, etc.)
   
   
8. All questions on the application form has been completed.
   
   
9. All supporting documents have been attached. Supporting documents must be in final form as you intend to distribute them. Your application will be returned if these documents are not included
   Application                                 Advertisements
   Survey instruments                    Consent form
   Recruitment letters    
   
   
10. If this study requires approval of another committee or cooperating agency, please attach 
         letters of approval.
    
    
11. Appropriate departmental signatures and signature of research advisor for student research
         have been obtained.
    
    
12. A copy each form has been made for the investigator's records.
    
    
13. Attach 11 copies for full review applications, and have submitted the copies to the IRB at 
        least 14 days before the next scheduled meeting; 4 copies for expedited applications or 
        2 copies for exempt applications, including any attached instruments and materials.