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Modifications

A modification is any proposed change to an IRB-approved protocol, regardless of the level of initial review. When a study is approved by the IRB, it must be carried out as approved.  Any changes must be prospectively approved by the IRB, unless the change is necessary to eliminate an apparent immediate hazard to the research participants (See Policy 18 for reporting requirements for this exception). Minor changes, such as correction of typographical errors, may be reviewed by the IRB Chair or Vice-Chair. Changes that are non-minor, for example, changes that increase the risk of the study, require review by the convened IRB. 

How to submit a modification in IRBManager

PI Responsibilities
  • To conduct the study in accordance with the relevant, current protocol
  • To not make any changes to the research without written IRB approval, except where necessary to eliminate apparent immediate hazard to the research participants (see Policy 18 for reporting requirements)
  • To submit a complete description of the modification
  • To include applicable sponsor correspondence if the modification is requested by the sponsor
  • To follow the IRB's determination with regard to the necessity of re-consenting currently enrolled participant or notifying participants who have completed the research interventions 
 

  

 
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