#  How Do I Submit A Modification? 

 



###   **How to submit a modification because of the COVID-19 impact.**

####  **For studies that were reviewed by the Convened IRB or received an Expedited review and wish to move to no face-to-face interactions with participants:**

 Submit a modification to the IRB. Instructions on how to submit a modification may be found here - [ESTR Support - Submit a Modification](https://estrsupport.fss.harvard.edu/files/estr/files/irb_study_submission_guide.pdf#page=50)

 Send a comment with the text “COVID-19 modification" to the IRB Administrator that will be assigned to your submission. Instructions on how to leave a comment may be found here - [ESTR Support - Communicating With Staff](https://estrsupport.fss.harvard.edu/files/estr/files/irb_study_submission_guide.pdf#page=41) Be sure to select “IRB Coordinator” before you send!

####  **Studies which offer direct therapeutic benefit to participants or those studies where stopping procedures would cause harm to the study subject:**

 For health and safety, these changes can be instituted immediately; please submit a Report of New Information (RNI) to the IRB to report the temporary modifications within five business days.

####  **For studies that received a not human subjects or exempt determination:**

 These studies may implement changes to prevent face-to-face contact immediately and do not need to submit a modification to the IRB if the change would not change the not human subjects or exempt determination. For example, if you change your study from face-to-face to phone or electronic data collection, a modification is not required. However, if you are changing your study population from adults to children, this would require a modification to the IRB.

 If you must submit a modification, also send a comment with the text “COVID-19 modification" to the IRB Administrator that will be assigned to your submission. Instructions on how to leave a comment may be found here - [ESTR Support - Communicating with Staff](https://estrsupport.fss.harvard.edu/files/estr/files/irb_study_submission_guide.pdf#page=41) Be sure to select “IRB Coordinator” before you send!

 See [6 Tips for Speeding Up the Review of Your Application](/6-tips-speeding-review-your-application)