During the course of your ancillary review*, if you would like to request changes to the study or to provide additional information, you can do so via the Add Comment activity.

1. Log in to irb.harvard.edu

2. Navigate to the submission (see Accessing a Submission for more instructions).

3. From the submission, click Add Comment.

4. Use the comment box space to request changes to the study or ask the PI to provide additional information.

5. (Optional) Upload any documentation to support your request (e.g. a tracked changes version of study documents to convey the changes you are requesting).

6. Select the appropriate comment recipients so that the PI/Study Team/IRB Coordinator will know that you’ve requested clarifications. It is recommended that all three are selected.

• All individuals with access to the submission can view the comment, even if they are not marked as recipients of the comment notice.
• If no recipients are selected for the comment notice, the comment will only appear on the History tab of the submission workspace.

7. When you are done, click OK.