Progress Reports Reapproval and Closure Requests

There is no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. A letter reminding the investigator that a progress report is due is sent via iRIS approximately six weeks prior to the expiration date.  

The following information must be included for a reapproval request: 

  1. Request for Reapproval/Closure Form  
  2. Abstract of the original protocol (from the original application) 
  3. A Protocol Progress Report Abstract/Summary Form with indication that a recent literature search was performed within 30 days of submitting the Progress Report 
  4. Copy of the most recent consent (if applicable) 
  5. Other documents and materials besides the current consent form that were previously approved and will continue to be used in the next year of study such as advertisements, questionnaires, or information sheet 
  6. Updated Research Financial Disclosure form if applicable disclosure status has changed in the past year 
  7.  One copy of the literature search and supporting articles.  

If the Investigator fails to provide a progress reports to the IRB, this will result in expiration of the protocol. Investigators will be notified by the IRB in writing that all research activities must stop, including (but not limited to) new enrollment, screening, study visits, medical record review, data analysis, presentations and publications unless the IRB finds that it is in the best interest of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval. The letter sent will also indicate that the Investigators have 30 days to submit the material or the study will be closed. In order to continue the research after the closure, Investigators will have to submit an initial application and go through the review process. 

The following information must be included for a closure request: 

  1. Request for Reapproval/Closure Form 
  2. A Protocol Progress Report Abstract/Summary Form