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Institutional Review Board

East Tennessee State University

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 stated in the approved documents.  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). Administrative changes, such as the correction of typographical errors or adding study staff, may be reviewed by the IRB Staff. Minor changes, such as increasing sample size or adding a new survey, may be reviewed by the IRB Chair or Vice-Chair. Changes that are non-minor, for example, increasing the risk of the study, may 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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